US20020076256A1 | 2002-06-20 | |||
US20200268681A1 | 2020-08-27 | |||
US20210369153A1 | 2021-12-02 | |||
US20060189968A1 | 2006-08-24 |
Attorney Docket No.732/2 PCT CLAIMS What is claimed is: 1. Topical product Hands free Applicator Drug delivery System (THADSTM) for individual or for multimodal method of drug treatment, includes an airless metered pump product container or a suitable container with a modified nozzle to hold the applicator wand/tube that is intended for unit dose or multiple dose application, holds pharmaceutical product preferable topical product in “ ready to act state” in which product outlet can connect and disconnect the one end (end #1) of wand of the applicator, the wand is straight or flexible/bendable, is 0.01 inch to 30 inch in length that directs drug product to another end (end #2) which is connected to a applicator sponge tip, the sponge tip can be connected or disconnected, the applicator sponge tip includes soft sponge which holds the drug product, the wand can be disconnected from end #1 after pumping the drug product, and drug is applied to the skin in the area of treatment, with little pressure or rubbing , the drug will be released from the sponge tip or being applied to the skin as “Hand free approach”. When the soft sponge tip of the applicator end #2 can be disconnected and the wand tube can be inserted into the opening of an adhesive application pod (AppodTM) which is adhered to the any part of the skin at the area of treatment, the drug product(s) can be pumped one dose or multiple doses required for one day or more can be pumped into the AppodTM. The Appod system can spread and deliver the drug and biological molecules continuously for one application or drug intended for one day or more and make it more efficacious and consumer compliant topical drug treatment. THADSTM treatment can be used for human and animals. THADSTM system will be used on drugs to treat acute and chronic disorder for systemic and topical, drugs that are toxic, potent and require containment manufacturing that does require special handling instructions such drugs included are hormonal, cytotoxic, immunosuppressant, antibiotic, biological preparation, steroids, sensitizing drug substance, excipients, beta lactam antibiotics, drugs that goes through hepatic first pass metabolism and treatment situation in which can’t be administered by mouth like nausea and vomiting. 2. The topical product of claim 1, wherein the composition is in “Ready to Act State” a liquid, preferably, the drug is completely dissolved state and “ready to act form” and provide consistent effect as a solution or nanosized or micronized suspension, gel or an emulsion with a viscosity of 5000 cP or less more preferable viscosity below 3000 cP, drug releases above 15% in 15 minutes using a Franz diffusion cell Attorney Docket No.732/2 PCT using a 3.0 micron Nylon filter at 800 rpm stirring rate and a volumes of 10 ml dissolution medium (dissolution medium Water: Ethanol 70:30). The formulation does not freeze or change its mobility or rheological properties when it is stored at a refrigerated condition for 2 hours between 35° F and 38° F. The refrigerated for 2 hours products show the load below 200 grams when tested using Brookfield Ametek CT3 Texture analyzer, using probe TA-11 at the following settings, Test Type: Compression, Test Target: Distance with Target value of 15mm and target load of 10 grams with test speed of 1.0mm/second. 3. The pharmaceutical composition of claim 1 comprising anti-itch to prevent the skin irritation. The solution also contains 5 to 90% water and a skin permeation enhancer. The topical product may be mixed with polymers to provide a sustainable action for longer period. This pharmaceutical composition can be applied using an applicator or an Adhesive bandage pod (AppodTM) for skin, mucus, vagina, urethral and rectal applications. 4. An adhesive bandage pod called as Application pod (AppodTM), is similar to an adhesive bandage that will be applied or adhered into the area of treatment of the skin , when claim #2 product composition solution added, the solution will spread and the AppodTM will hold the drug (solution, suspension, gel, lotion, emulsion, cream and ointment) in place for delivery of drug through the skin with adhesive covered in the bottom part of appodTM that adheres to the skin .The drug can be pumped or added from a syringes or from a single unit dose or from a multi dose container in claim 1 or similar ones, after removing the applicator tip sponge from the airless bottle applicator, the AppodTM will stick or adhere to the topical treatment area in the skin, like back, shoulder, knee, wrist etc.. from which the drug will be held in the affected area for treatment for local and systemic action. AppodTM can be used to treat for 1 minute or an hour for 3 hours or of for one day or for multiple day treatment for months. This AppodTM can be a non-irritating and waterproof one. 5. The pod of claim 4, wherein two or more topical products can be administered as multi-modal treatment without any drug-drug incompatibility at the same time to enhance the synergy in topical treatment as combination product using an AppodTM. The active drug in the composition can be nano-sized, micro- sized, lipid encapsulated and dispersed evenly for topical application. The solution will penetrate passively after applying to the skin, it does not require rubbing on to the skin like an ointment or creams Attorney Docket No.732/2 PCT for drug penetration. AppodTM can have multiple compartments to administer more than one drug simultaneously in respective compartment for improved efficacy of the treatment. Two different drugs with different dose regimen can be administered in one AppodTM with multiple compartments for the drugs synergistic effect. The AppodTM can be sterile or non-sterile. Unit dose ready to act product can be added through a syringe or a unit dose container or other mechanism directly into AppodTM. 6. A multimodal method for the treatment of topical disease condition by not touching the drug product by hand and just pumping the drug solution to the AppodTM for systemic and local use for three time a day or once a day application, for 2-day application, for 3-day application, for 4-day application, for 5-day application, for 6-day application, for weekly application and up to one month application .AppodTM can have integrated solution reservoir that can deliver the drug passively or through a battery operated miniature pump that can delivery 1 microliter/min to 1000 microliter /min through a programable logic system for drug treatment for 1 hour or for 4 hours or for 8 hours or for 12 hours or for day or for 2 days, or for 3 days or for 4 days or for 5 days or for 6 days or for 7 days of for months.to treat various disease conditions using local action and for systemic action. 7. The product of claim 1 used for treatment for systemic disease condition with high drug concentration using AppodTM in one place or more than one place of the body like in both arms or both thighs or both arms and both thighs or a larger size. AppodTM can be adhered into stomach or back, thigh, arm areas for treatment of high dose drugs for systemic use that has issue in which the oral administration of the drug causes liver diseases or liver toxicity or goes through first pass metabolism or has severe adverse effects by administering the drug by oral, injection or nasal route of drug administration to treat chronic and acute disease conditions for rapid onset of action and blood levels. 8. The product of claim 1, wherein the wand is flexible and can bend to any direction or may not be flexible or may not bend, so that it is very convenient to apply the drug to skin or tissue in any part of the body. The wand can be connected into the product container as snap on or other suitable mechanism so that the end #1 can be closed with the product container and seamless transfer of the drug product to the end #2 of the wand or drug solution can be poured/pumped through a syringe or other means into a not connected or open end #1 of the wand to the product container , so that drug product can be poured or pumped on to the end #1, so that the product solution can travel to end #2 to the applicator. The wand Attorney Docket No.732/2 PCT can also have a flow control mechanism of the drug product after the end #1 of the wand, so that after pumping the wand can be disconnected and taken to the application area of the skin and the drug product flow control mechanism can be opened, so that drug can travel to end #2 for application. The wand end may have a sponge applicator or a leveling mechanism or an opening to take the drug product solution to the AppodTM. 9. The product of claim 2, wherein the products texture testing show the load below 190grams, preferably load below 80 grams when tested using Brookfield Ametek CT3 Texture analyzer , using probe TA-11 at the following settings, Test Type : Compression, Test Target: Distance with Target value of 15mm and target load of 10grams with test speed of 1.0mm/second. 10. The product of claim 1, wherein the container of the dispensing pump spring tension testing shows the load above 1.0kg and optimally above 5.0kg when tested using Brookfield Ametek CT3 Texture analyzer, using probe TA-11 at the following settings, Test Type: Compression, Test Target: Distance with Target value of 10mm and target load of 250grams with test speed of 1.0mm/second. This tension of the pump dispenser will prevent the back flow of the pumped solution from the applicator wand even in the upright position. 11. The product of claim 3, wherein the AppodTM can have more than one compartment to hold multiple drugs separately, or it can hold one compartment where multiple drugs can be added to it. The adhesive pod can have a chamber that can have uncontrolled delivery of the drug or also control drug delivery over 6 hours period or 12 Hours of period, or 24 hours or 72 Hours of controlled delivery for a week. 12. The product of claim 3, wherein the AppodTM loaded drug will release 40 to 90% of drug in 5 minutes by testing dissolution using USP Apparatus 5 (paddle over disk method), the medium volume per vessel was 200 mL. The temperature should be maintained at 32 ± 0.5 °C. a distance of 25 ± 2 mm between the paddle blade and the surface of the disk assembly. The rotation speed was set at 50 rpm. 13. The method of claim 6 using THADSTM, for multimodal topical drug delivery system, that has penetration enhancers along with skin anti-irritants are added to one compartment of the appod and the drugs like small molecules, peptides and biological drugs intended for the treatment will be held in another Attorney Docket No.732/2 PCT compartment of the appod. The penetration enhances will be pumped continuously on to the treatment are for fixed number of hours follows by pumping the desired dose of the drug like small molecules, peptides and Biologicals from another compartment pod, this method enhances the drug penetration, this method can be used as a standalone dosage form or multimodal drugs treatment as a kit to treat various skin disease conditions requires multiple drug combinations for treatment of Atopic dermatitis, Shingles, Psoriasis, eczema, nausea vomiting, cancer central nervous system treatment, pain disorder, Gastrointestinal disorder, acute disease conditions, etc. where all the drug are administered using THADSTM make more effective, high patient compliance using with or without Appod. The drug combination can be all drug in one formulation or two drug in one formulation or three drug in one formulation or individual drug can be administered using Appod. 14. The product of claim 1, ready to act drug solution that added into the appodTM may contain anti- itching drug like antihistamine or steroids, antimicrobial drug along with the drug product intended for treatment to prevent the itching or irritation or infection that can cause by AppodTM, the PVA ring or non-woven or woven fabric in the AppodTM can be coated with anti-itching and antimicrobial drugs to prevent skin itch and infection that comes from immediate contact of the AppodTM to the skin. 15. The product of claim 3 of the rate controlling layer is made up of a non-woven fabric or woven fabric that may be coated with Diphenhydramine HCl or Hydrocortisone to prevent irritation with 0.1 g/cms2 to 3.0g/ cms2 that will control the flow or retain the ready to act solution intended for local action or systemic action and also may have a pod or a liquid or suspension holding pod or bag that will hold 0.1ml to 50ml and deliver the 0.25 to 25 ml/day intended for local and systemic administration. The AppodTM of claim 3 may have a skin barrier seal ring that will contain the drug product solution of the liquid, or suspension, emulsion, ointment cream within the ring, the ring may be soft, flexible and have adhesive to it, the outer layer of the skin may have an absorbent to any residual solution or drug product seeping or leaking out of the ring, the Claim 3 will have a bag or pod that will contain the drug product in liquid or semi-liquid state that will control the delivery into the AppodTM to deliver the drug for treatment for 0.1 hours to 3 months, this bag can be connected with a micro-motor to pump a predetermined amount of solution from the bag or pod to the treatment area, the motor that is connected to a smart watch or a device that can control the flow rate of the drug product. The inside of the ring may have a non -woven fabric or may not Attorney Docket No.732/2 PCT have then non-woven fabric. The ring may be coated with antibacterial, antiviral or anti itching and anti- irritating drug. |
Attorney Docket No.732/2 PCT Table 1: Classification of topial formulation Attorney Docket No.732/2 PCT Illustration of the topical product (i.e. Ointment , gel, creams and some patch) intended to be treatment for local action for the skin is shown in Fig.1a. Illustration of the topical products (8) i.e., transdermal patches intended for systemic circulation application are illustrated in Fig.1b. Efficacy of topical products using THADS TM : Pharmacokinetics of currently marketed topical products (ointment, creams, and transdermal patches): The drug absorbed into the skin follows a three- step process from ointment creams and TDDS. Step #1: Drug concentration gradient is developed with in the formulation and the drug starts to move down the gradient. The ointment or cream of topical product needs to absorb water from the skin and dissolve the drug in the formulation and form a concentration gradient within the formulation. Step #2: A second drug reservoir is established in the stratum corneum. As the drug moves further into the skin, Step #3: The drug is absorbed into the local capillary vasculature and is then transported into the systemic circulation. Pharmacokinetics of topical products using THADS TM : The drug absorbed into the skin follows a two-step process. Step #1 A reservoir is established at the stratum corneum directly, as the ready to act drug is held closer to the skin by Appod TM . As the drug moves further into the skin. Step #2 The drug is absorbed into the local capillary vasculature and is then transported into the systemic circulation. THADS TM eliminates the one-time consuming step (step #1) of the pharmacokinetics of the topical products like ointment, creams and transdermal patches and put the step #2 directly and enhance the efficacy of the drug with the hands-free application, fast acting and with Appod TM it enhances the patient compliance. Efficacy of the topical products List of currently marketed topical products and how the product is applied on the skin Here are the FDA approved products and its way of application into the skin source (9): Table 2: List of FDA approved topical products and its dose administration Attorney Docket No.732/2 PCT Attorney Docket No.732/2 PCT Attorney Docket No.732/2 PCT Attorney Docket No.732/2 PCT Attorney Docket No.732/2 PCT Attorney Docket No.732/2 PCT Most of the FDA approved topical products are packed in a tube, and it is impossible to take the exact dose each time for use and here is the instruction provided for the application of topical drug from its tube. Figs.2a-2d illustrate the method by which current topical products are applied on to the skin. In Fig.2a, the tube in opened. In Fig.2b, squeeze the gel or an ointment or a cream from the tube onto a fingertip. In Fig.2c, Spread the gel or an ointment or a cream evenly over only the skin area to be treated. Attorney Docket No.732/2 PCT In Fig.2d, wash your hands right away after applying. With all the above FDA approved topical products except transdermal patches, (1) there is no possible way to take the exact dose needed for the topical treatment from the product container; (2) There is no possible way to transfer or apply all the topical product from your hand to skin, there is always inconsistent amount of drug will be sticking to you hand and it will be washed away; (3) When you put on clothes, it gets solid and it takes away part of the topical product. All the above factors create the underdose or overdose with current marketed topical products. The topical solutions, which has the drug in dissolved state can act rapidly and can penetrate the skin faster, but it can’t be hold on to the skin to the treatment, so most of the currently existing topical formulations in the market (ointment, cream, gel, etc. are made up by adding ingredients to make it viscous and thick in consistency and ability to stick to the skin surface, so that the products need to be rubbed on to the skin, whereby the ingredients will melt and by its viscous nature it will hold the drug on to the skin till it penetrates the skin for treatment. Hence longer onset for its activity. The current topical products when applied to the skin and there is no mechanism to hold on the skin for longer period, so it is applied 3 to 4 times a day for local treatment, hence there are not many topical products (ointments, creams and gels) that can be applied on the skin to treat the drug for systemic circulation for which the drug will release into the Epidermis and needs to go to the blood vessel for systemic circulation. Transdermal patches can be applied for both local and for systemic circulation that will be held on the skin for longer periods like EXELON PATCH (rivastigmine transdermal system) Apply patch on intact skin for a 24-hour period; replace with a new patch every 24 hours. Surprisingly, we have found a novel way to provide a topical product that incorporates both hands free approach for the application and much more efficacy with rapid onset of action at ready to act format for local and systemic treatment. Fast acting: The invention uses readily dissolved version of the drug in solution with penetration enhancers, that can act rapidly for the treatment and provides faster onset of action. Exact dose: with the airless container metered dose, exact dose can be applied each time through a metered dose system. During application, when it is pumped the exact dose required for treatment. Hands Free application: When the airless container is pumped, the drug solution is delivered into the applicator, and the drug product can be applied from the applicator to the treatment area without using the hand and will not leave any residue or greasiness Attorney Docket No.732/2 PCT d) Patient compliance: With appod TM all the three doses required for treatment per day can be added all at once in the appod TM , it spreads and continuously delivers for one day treatment without administering 3 times and cloths can we worn Appod TM protect the treatment area and cloths/beds will not get soiled. It is an object to provide a handheld THADS TM system that includes a topical applicator for dispensing a precise amount of liquid or exact dose and can be applied hands free application on a particular surface such as a skin of a human or animal. It is an object to provide a THADS TM system that can provide a ready to act product that may act fast compared to conventional ointment, creams and transdermal patches for a single vertical press of the airless container. It is an object to provide a THADS TM system that can provide a fast acting and administer a topical does once a day application compared to conventional ointment, creams for a single vertical press of airless container and the products pumps into the appod TM . It is an object to provide a topical applicator with a housing and grip that is ergonomic and help hands free application of a topical product. It is an object to provide a topical applicator with a liquid delivery system that releases a sufficient amount of liquid upon application onto a surface without producing any blotches or mess. It is an object to provide a THADS TM system that can provide a, efficacious, multimodal topical method of treatment and prevent soiling of cloths and bed and provide effective dose for treatment effectively. The following marketed topical products, Aspercreme no mess liquid, Icy Hot no mess applicator, Voltaren Emulgel with no mess applicator and Aleve X roller ball applicator are the topical applicators, these commercial ones are integrated with the container and are pull/push or roll-on mechanism. Roll-on applicators are in common use today. They comprise a container for the liquid and a nozzle having a ball seat and a ball rotatably supported on said seat. To apply the liquid to a selected surface, all that need be done is to invert the container so that its nozzle faces downwardly and said container is then moved across said surface with its ball in rolling contact therewith. The ball becomes coated with the liquid contents of the container and it in turn then coats the selected surface. the container is specially made to receive the nozzle and in some cases the container and nozzle are integral with each other and all these technology does not provide the exact dose or metered dose of drug and the applicator is not flexible to apply difficult to reach parts of the body. In specific embodiments, the airless container body 1 from Fig.3, is manufactured using an oil resistant plastic, plastic, metal, or other suitable material such as chemically resistant polypropylene, high Attorney Docket No.732/2 PCT density polyethylene, other homopolymers, silicone etc. and hold the drug product in the volume ranges from 0.25 ml to 500 ml as a single dose container or as a multidose container. The airless bottle is a metered dose system to deliver 0.1 ml to 5 ml per pump of the drug solution without back flow from the wand 5, the pumping of drug solution is ergonomically designed, just to press from the top of the cap 2 by palm, especially this process is friendly to arthritis/elderly patient population to deliver pain relief drugs through this airless container system. The airless container cap 2 from Fig.3 holds the airless pumping mechanism, that can pump a metered dose of 0.1mL to 5 mL per pump, child resistant container mechanism and modified nozzle for an adapter that will hold the wand 5 and the applicator sponge tip 6. The specific embodiment the drug product volume in a form fill seal single unit dose of 0.25ml to 50ml and an airless container for a multidose drug product from 2ml to 500ml volume, most preferred volume is in between 10ml to 300ml for a multidose volume. In specific embodiment, the cap 2 can directly attached to the applicator sponge 6 without the wand. In specific embodiment, the cap 2 has a turn in mechanism to operate for a child resistant container. In specific embodiment, the wand or tube 5 as illustrated in Figs.4a and 4b is made up of flexible soft plastic, soft Aluminum, medical grade non-toxic Polyvinyl chloride, Polyethylene, polypropylene. The wand 5 is made it flexible so one can bend the desired shape to apply any curved shape of the body required for treatment. Wand 5 may compose of a metal wire with a thickness of 0.5-1.5 mm, is embedded tube/wand. This metal wire has the specific purpose of allowing the tube to be bent into any shape or U-shape and remain on the shape for application of the drug solution using the sponge tip, then the wand/tube can be straightened out. Fig.5 indicates the graph of the pump core, when tested using the CT3 Ametek Texture analyzer, when the bottle with cap is subjected to a compression mode test the pump core exerts a pressure when a load of pressure is constantly applied, the 10 indicates the normal container has the load around 2000 grams, and 11 indicated an improved version of the bottle with a maximum load of around 12000 grams, when normal container of 200 grams load was used it showed the back flow of the drug solution from the wand 5 to the airless bottle, 10 with improved core pump form the graph showed maximum pressure load of 12000 grams, when the drug solution is pumped using 12000 grams load container, there is no back flow from the wand 5 of the drug solution. In specific embodiments, the texture analyzer data on the pump core 12 is minimum of 2500 Attorney Docket No.732/2 PCT grams and maximum of 20,000 grams to prevent the back flow of the liquid product that will be pumped through the wand 5. In specific embodiments, the cap 2 which include the pump core 12 as shown in Fig.6 has a minimum tension of 7500 grams when tested the cap tension with the bottle using a CT3 Ametek texture analyzer. This pump core of 7500 grams load prevents the back flow of the drug solution after it gets pumped from the wand back to the airless bottle. In specific embodiments, the applicator adaptor 4, is made up of medical or food grade Poly vinyl chloride, Polyethylene, Silicone, poly propylene, plastic materials, it is a handle to hold the applicator wand and sponge, 4 can have a soft sponge embedded on top of it to provide a soft cushion for hands while connecting and disconnecting it.13 is a wider hole than that of 14 for the insert of the wand, the fitting on 13 has a notch that locks the wand/applicator sponge into the nozzle of the airless container for an easy application for multiuse applications. The 13 has a snap lock-in mechanism to hold the applicator wand assembly tightly when the solution is pumped. After pumping the solution 13 can pulled to disconnect the wand to apply the drug solution on the skin. The connection can be made using quick connection fittings. The 14 is comparatively smaller opening than 13 is place, this setup prevents the pressure build up while pumping the drug solution from the airless bottle to the applicator wand. The thickness of 4 adaptor is critical to hold it for application, the thickness is critical for arthritis patients, its thickness in this specific embodiment is 10 mm to 30 mm and length of 30 mm to 80mm. In specific embodiments, the applicator adaptor 4, is having a luer lock or snap on or push in or twist lock mechanism to lock the applicator with a syringe In specific embodiments, the applicator adaptor 4, the sponge tip 6 can be directly connected without the wand. In specific embodiments, the applicator adaptor 4, is soft to hold and it lock in and locks out by screw type mechanism or as a snap on mechanism. In specific embodiment. The airless bottle system may not have the applicator adaptor 4, but the wand 5 will have the built-in adaptor that can attached to the airless bottle or the airless bottle cap 2 will have a built-in adaptor to insert the wand 5, as shown in Fig.7. In specific embodiment, the wand or tube 5 having a first end 7 connectable to an applicator adaptor and second free end 8 connected to the applicator end to which applicator sponge adaptor for topical dosage, nasal applicator as shown in Fig.8 for nasal drug delivery and rectal applicator/vaginal applicator for rectal/vaginal administration can be attached for its respective application. In specific embodiment, the wand or tube 5, the end 8 of the wand can be inserted with 6 Attorney Docket No.732/2 PCT applicator sponge adaptors for topical application or with 9 for anal application or 10 with for a nasal application and it can be removed and can be administered drugs for oral application, there can be sleeve, which can be a disposable one for oral administration that can be inserted in 8. In specific embodiment, the applicator sponge adaptor 6 contains a hole through with product can be delivered after pumping the cap 2 of the airless bottle, this allows to pump the drug product directly into the treatment area with or without applicator sponge 16. In specific embodiment. The applicator sponge adaptor 6 can be directly inserted into the nozzle 3 of the airless bottle and the needed solution can be pumped and applied into the treatment area. In specific embodiment, the applicator sponge adaptor 6 contains a hole and also 3 to 4 small wheels for a provision for a massage and through which the product can be delivered after pumping the cap 2 of the airless bottle, this allows to pump the drug product directly into the treatment area with or without applicator sponge 16. In specific embodiment, the applicator sponge 16 is made up of hypoallergenic sponge or foam materials, preferably polyurethane foam, or sponge, it holds the drug product without dripping till applied on to the skin with little pressure. The applicator sponge 16 can be a disposable one and van be shrouded to the applicator sponge adaptor 6 as shown in Figs.9a-9c. In specific embodiment, the applicator sponge 16, when pumped 0.1 mL or 0.1 grams using the metered dose of 0.1mL, the applicator sponge holds 0.1mL without dripping and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment, the applicator sponge 16, when pumped 0.2 mL or 0.2 grams using the metered dose of 0.2 mL, the applicator sponge hold 0.1mL without dripping and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment, the applicator sponge 16, when pumped 0.25 mL or 0.25 grams using the metered dose of 0.25 mL, the applicator sponge hold 0.25 mL without dripping and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment, the applicator sponge 16, when pumped 0.3 mL or 0.3 grams using the metered dose of 0.3 mL, the applicator sponge hold 0.3mLl without dripping and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment, the applicator sponge 16, when pumped 0.35 mL or 0.35 grams using the metered dose of 0.35 mL, the Applicator sponge hold 0.35mL without dripping and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment, the applicator sponge 16, when pumped 0.4mL or 0.4 grams using the Attorney Docket No.732/2 PCT metered dose of 0.4 mL, the Applicator sponge hold 0.4mL without dripping and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment, the applicator sponge 16, when pumped 0.45 mL or 0.45 grams using the metered dose of 0.45 mL, the Applicator sponge hold 0.45mL without dripping and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment, the applicator sponge 16, when pumped 0.5 mL or 0.5 grams using the metered dose of 0.5 mL, the Applicator sponge hold 0.5mL without dripping and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment, the applicator sponge 16, when pumped 0.55 mL or 0.55 grams using the metered dose of 0.55 mL, the Applicator sponge hold 0.55mL without dripping and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment, the applicator sponge 16, when pumped 0.6 mL or 0.6 grams using the metered dose of 0.6 mL, the Applicator sponge hold 0.6mL without dripping and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment, the applicator sponge 16, when pumped 0.65 mL or 0.65 grams using the metered dose of 0.65 mL, the Applicator sponge hold 0.65mL without dripping and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment, the applicator sponge 16, when pumped 0.7 mL or 0.7 grams using the metered dose of 0.7 mL, the Applicator sponge hold 0.7mL without dripping and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment, the applicator sponge 16, when pumped 0.75 mL or 0.75 grams using the metered dose of 0.75 mL, the Applicator sponge hold 0.75mL without dripping and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment, the applicator sponge 16, when pumped 0.8mL or 0.8 grams using the metered dose of 0.80 mL, the Applicator sponge hold 0.8mL without dripping and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment, the applicator sponge 16, when pumped 0.85 mL or 0.85 grams using the metered dose of 0.85 mL, the Applicator sponge hold 0.85 mL or 0.85 grams without dripping, and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment, the applicator sponge 16, when pumped 0.9 mL or 0.9 grams using the metered dose of 0.9 mL, the Applicator sponge hold 0.9 mL or 0.9 grams without dripping, and it will release the drug product when the sponge is applied to the skin with little force. Attorney Docket No.732/2 PCT In specific embodiment, the applicator sponge 16, when pumped 0.95 mL or 0.95 grams using the metered dose of 0.95 mL, the Applicator sponge hold 0.95 mL or 0.95 grams without dripping, and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment, the applicator sponge 16, when pumped 1.0 mL or 1.0 grams using the metered dose of 0.1mL, the Applicator sponge hold 1.0 mL or 1.0 grams without dripping, and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment, the applicator sponge 16, when pumped 1.1 mL or 1.1 grams using the metered dose of 0.1mL, the Applicator sponge hold 1.1 mL or 1.1 grams without dripping, and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment, the metered dose pump can pump 0.1mL to 5 mL per pump, so that it can be utilized for topical application, vaginal application, rectal application, nasal application, and oral administration of drugs. In specific embodiment, the applicator sponge 16, when pumped 1.25 mL or 1.25 grams using the metered dose of 0.1mL, the Applicator sponge hold 1.25 mL or 1.25 grams without dripping, and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment, the applicator sponge 16, when pumped 1.5 mL or 1.5 grams using the metered dose of 0.1mL, the Applicator sponge hold 1.5 mL or 1.5 grams without dripping, and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment, the applicator sponge 16, when pumped between 0.1 mL or 0.1 grams to 2 mL or 2 grams using the metered dose of between 0.1 mL or 0.1 grams to 2 mL or 2 grams, the Applicator sponge hold 0.1m l without dripping and it will release the drug product when the sponge is applied to the skin with little force. In specific embodiment the 6 is wrapped with a sponge 16 and it can be disposable, or it can have a sponge sticking 17 to the 6 as shown in Figs.9a-9c. The graphs from Figs.10a and 10b illustrate the topical products texture testing shows the load of 450 grams to 600 grams from the Fig.10a for the conventional ointment, which needs hands to spread it, with this high load of above 400 grams can’t be used in the Appod TM . The load of around 40 grams from the Fig.10b for THADS product of Diclofenac and Lidocaine solution when tested using Brookfield Ametek CT3 Texture analyzer, using probe TA-11 at the following settings, Test type: Compression, Test Target: Distance with Target value of 15 mm and target load of 10grams with test speed of 1.0mm/second. The lower the load of less than 100 grams will enable the THADS TM product to spread itself through the inner non-woven fabric of the Appod TM for an efficient and hands-free topical treatment. Attorney Docket No.732/2 PCT In specific embodiments texture testing load on the THADS TM drug product less than 100 grams tested using Brookfield Ametek CT3 Texture analyzer , using probe TA-11 at the following settings, Test Type : Compression, Test Target: Distance with Target value of 15mm and target load of 10grams with test speed of 1.0mm/second is preferable to use in Appod TM . In specific embodiments texture testing load on the THADS TM drug product less than 90 grams to 100 grams tested using Brookfield Ametek CT3 Texture analyzer , using probe TA-11 at the following settings, Test Type : Compression, Test Target: Distance with Target value of 15mm and target load of 10grams with test speed of 1.0mm/second is preferable to use in Appod TM . In specific embodiments texture testing load on the THADS TM drug product less than 80 grams to 90 grams tested using Brookfield Ametek CT3 Texture analyzer , using probe TA-11 at the following settings, Test Type : Compression, Test Target: Distance with Target value of 15mm and target load of 10grams with test speed of 1.0mm/second is preferable to use in Appod TM . In specific embodiments texture testing load on the THADS TM drug product less than 70 grams to 80 grams tested using Brookfield Ametek CT3 Texture analyzer , using probe TA-11 at the following settings, Test Type : Compression, Test Target: Distance with Target value of 15mm and target load of 10grams with test speed of 1.0mm/second is preferable to use in Appod TM . In specific embodiments texture testing load on the THADS TM drug product less than 60 grams to 70 grams tested using Brookfield Ametek CT3 Texture analyzer , using probe TA-11 at the following settings, Test Type : Compression, Test Target: Distance with Target value of 15mm and target load of 10grams with test speed of 1.0mm/second is preferable to use in Appod TM . In specific embodiments texture testing load on the THADS TM drug product less than 60 grams to 50 grams tested using Brookfield Ametek CT3 Texture analyzer , using probe TA-11 at the following settings, Test Type : Compression, Test Target: Distance with Target value of 15mm and target load of 10grams with test speed of 1.0mm/second is preferable to use in Appod TM . In specific embodiments texture testing load on the THADS TM drug product less than 50 grams to 60 grams tested using Brookfield Ametek CT3 Texture analyzer , using probe TA-11 at the following settings, Test Type : Compression, Test Target: Distance with Target value of 15mm and target load of 10grams with test speed of 1.0mm/second is preferable to use in Appod TM . In specific embodiments texture testing load on the THADS TM drug product less than 50 grams to 60 grams tested using Brookfield Ametek CT3 Texture analyzer , using probe TA-11 at the following settings, Test Type : Compression, Test Target: Distance with Target value of 15mm and target load of 10grams with test speed of 1.0mm/second is preferable to use in Appod TM . Attorney Docket No.732/2 PCT In specific embodiments texture testing load on the THADS TM drug product less than 40 grams to 50 grams tested using Brookfield Ametek CT3 Texture analyzer , using probe TA-11 at the following settings, Test Type : Compression, Test Target: Distance with Target value of 15mm and target load of 10grams with test speed of 1.0mm/second is preferable to use in Appod TM . In specific embodiments texture testing load on the THADS TM drug product less than 30 grams to 40 grams tested using Brookfield Ametek CT3 Texture analyzer , using probe TA-11 at the following settings, Test Type : Compression, Test Target: Distance with Target value of 15mm and target load of 10grams with test speed of 1.0mm/second is preferable to use in Appod TM . Figs.11 and 12 illustrate the applicator sponge adaptor 6, in which the wand end 8 get inserted, when the topical product is pumped using the cap 2, the drug product after pumped from the container, it travels through the wand 5 and through the hole 24 in the applicator sponge adaptor, it is collected the applicator sponge. If the THADS TM solution texture analyzer load is less than 100 grams by testing using Brookfield Ametek CT3 Texture analyzer, using probe TA-11 at the following settings, Test Type : Compression, Test Target: Distance with Target value of 15mm and target load of 10grams with test speed of 1.0mm/second. The THADS solution will soak into the sponge. Fig.13 is the cover 25 that can be inserted to cover up the applicator sponge from dust and any external contamination for multiple use, the 25 has ‘U’ shaped grove, that is inserted into the neck of the applicator sponge adaptor 6 where it is gets locked. The grove on the 25 locks into the neck of the sponge applicator adaptor 6. In a specific embodiment the cover 25 for the sponge tip locks into the sponge applicator adaptor and protects the sponge tip from the dust and other external contaminants. Fig.14 illustrates an application pod which will be called as an appod TM , that will be adhered to the skin or the treatment area for a treatment period of 0.1 hours, to few hours, to multiple days and months, if needed appod TM can be replaced hourly, or every 4 hours or every 12 hours or every 24 hours or every 2 days or every week or every month, Appod TM is a pod or reservoir or a system that will spread and hold the ready to act topical product(s) in which the topical product solution or suspension or emulsion or cream, or gel or an ointment can be added or pumped using a metered dose by airless bottle 1 from Fig.3. The appod TM makes the drug product to spread uniformly and held for the treatment period and can be utilized for immediate application and for extended duration of application. Fig.14 illustrates that the appod has an inlet 18 to add or pump the drug product solution, An outer polymeric fabric 19 is the top layer and provides the various shape/structure and holds all the components of the appod TM , followed by the inner non-woven fabric/pad 20 that spread or hold the added drug product and keeps the drug Attorney Docket No.732/2 PCT product very close contact to the skin, part of the outer polymeric fabric 19 on the outer or periphery or border of it includes adhesive area 21 that adheres to the skin surface and hold the appod TM to the treatment area during its treatment period In some embodiments the appod TM system that shown in Fig.14, the outer polymeric fabric 19 includes 10 to 100 % area of appod TM with hypoallergenic adhesive that adheres to the skin. In some embodiments the appod TM system that shown in Fig.14, the outer polymeric fabric 19 includes less than 80 % area of appod TM with hypoallergenic adhesive that adheres to the skin. In some embodiments the appod TM system that shown in Fig.14, the outer polymeric fabric 19 includes less than 70 % area of appod TM with hypoallergenic adhesive that adheres to the skin. In some embodiments the appod TM system that shown in Fig.14, the outer polymeric fabric 19 includes less than 60 % area of appod TM with hypoallergenic adhesive that adheres to the skin. In some embodiments the appod TM system that shown in Fig.14, the outer polymeric fabric 19 includes less than 50 % area of appod TM with hypoallergenic adhesive that adheres to the skin. In some embodiments the appod TM system that shown in Fig.14, the outer polymeric fabric 19 includes less than 40 % area of appod TM with hypoallergenic adhesive that adheres to the skin. In some embodiments the appod TM system that shown in Fig.14, the outer polymeric fabric 19 includes less than 30 % area of appod TM with hypoallergenic adhesive that adheres to the skin. In some embodiments the appod TM system that shown in Fig.14, the outer polymeric fabric 19 includes less than 20 % area of appod TM with hypoallergenic adhesive that adheres to the skin. In some embodiments the appod TM system that shown in Fig.14, the outer polymeric fabric 19 includes less than 15 % area of appod TM with hypoallergenic adhesive that adheres to the skin. In some embodiments the appod TM system the shown in Fig.14 includes 10 to 90 % area of appod TM with hypoallergenic adhesive that adheres to the skin. In some embodiments the appod TM system the shown in Fig.14 includes 10 to 80 % area of appod TM with hypoallergenic adhesive that adheres to the skin. In some embodiments the appod TM system the shown in Fig.14 includes 10 to 70 % area of appod TM with hypoallergenic adhesive that adheres to the skin. In some embodiments the appod TM system the shown in Fig.14 includes 10 to 60 % area of appod TM with hypoallergenic adhesive that adheres to the skin. In some embodiments the appod TM system the shown in Fig.14 includes 10 to 50 % area of appod TM with hypoallergenic adhesive that adheres to the skin. In some embodiments the appod TM system the shown in Fig.14 includes 10 to 40 % area of Attorney Docket No.732/2 PCT appod TM with hypoallergenic adhesive that adheres to the skin. In some embodiments the appod TM system the shown in Fig.14 includes 10 to 30 % area of appod TM with hypoallergenic adhesive that adheres to the skin. In some embodiments the appod TM system the shown in Fig.14 includes 10 to 20 % area of appod TM with hypoallergenic adhesive that adheres to the skin. In some embodiment, the inlet 18 is between 0.25 mm to 100 mm in diameter to add the ready of act solution, suspension, gel, ointment, foam, cream, emulsion for the treatment. In some embodiment, the inlet 18 is between 2 mm to 50 mm in diameter to add the ready of act solution, suspension, gel, ointment, foam, cream, emulsion for the treatment. In some embodiment, the inlet 18 is between 5 mm to 12 mm in diameter to add the ready of act solution, suspension, gel, ointment, foam, cream, emulsion for the treatment. In some embodiment, the inlet 18 is between 6 mm to 10 mm in diameter to add the ready of act solution, suspension, gel, ointment, foam, cream, emulsion for the treatment. Fig. 15 illustrates an appod TM that has additional protection pad 22, that absorbs the extra solution that might be seeping out of the area of the inner non-woven fabric 20, to prevent the adhesive area to be compromised by the different solvents or solution from the topical product by dissolving the adhesive, which may result in the seeping drug solution out of the appod TM . As shown in Figs.14 and 15, the border 21 contains the adhesive material in the periphery of the appod TM , that will seal of the border areas of the APPOD TM , which will hold the ready to act solution inside the appod TM from leaking. The protective layer 22 includes highly absorbent material to absorb the excess ready to act solution from the non-woven fabric, so that this protective layer will prevent the ready to act solution reaching the adhesive and prevent any compromise of the adhesiveness of the APPOD TM . The Fig.14 and 15 appod TM may be in the form of a generally available rectangular shape, However, other embodiments of the Fig 15 may have different shapes like circular, heart shape, triangle and uncommon shapes represent various configuration of the body and configurations for different placements on the skin, and for use by persons of different sizes. Table 3 % Drug dissolved Attorney Docket No.732/2 PCT TM Fig.16 Illustrates the dissolution testing of the Lidocaine in the appod TM with the marketed Icy Hot patch that contains Lidocaine 4% and Menthol 1% and by testing dissolution using USP Apparatus 5 (paddle over disk method), Purified water as the dissolution medium, 200 mL volume per vessel was used. The temperature was maintained at 32 ± 0.5 °C. a distance of 25 ± 2 mm between the paddle blade and the surface of the disk assembly was maintained. The rotation speed was set at 50 rpm. The dissolution data shows that the THADS TM Lidocaine product releases 85% of drug in 5 minutes of dissolution, whereas the Marketed Icy Hot patches released only 6.3% of the drug. This dissolution indicates THADS TM solution in the Appod TM is in ready to act state, whereas the marketed product is of low dissolution this is due to the drug is mixed with the adhesive. The application of THADS TM product with appod TM will provide “rapid onset” of action compared to the marketed product. THADS TM appod TM the inner non-woven fabric just spreads and holds the drug solution also the dissolution data shows that the non-woven fabric does not hold back the drug. In specific embodiments, the Appod TM loaded drug will release above 30% of drug in 5 minutes by testing dissolution using USP Apparatus 5 (paddle over disk method), with purified water as the medium volume, 200 mL per vessel. The temperature is maintained at 32 ± 0.5 °C a distance of 25 ± 2 mm between the paddle blade and the surface of the disk assembly. The rotation speed was set at 50 rpm. In specific embodiments, the Appod TM loaded drug will release above 40% of drug in 5 minutes by testing dissolution using USP Apparatus 5 (paddle over disk method), with purified water as the medium volume, 200 mL per vessel. The temperature is maintained at 32 ± 0.5 °C. a distance of 25 ± 2 mm between the paddle blade and the surface of the disk assembly. The rotation speed was set at 50 rpm. In specific embodiments, the Appod TM loaded drug will release above 50% of drug in 5 minutes by testing dissolution using USP Apparatus 5 (paddle over disk method), with purified water as the medium volume, 200 mL per vessel. The temperature is maintained at 32 ± 0.5 °C. a distance of 25 ± 2 mm between the paddle blade and the surface of the disk assembly. The rotation speed was set at 50 rpm. In specific embodiments, the Appod TM loaded drug will release above 60% of drug in 5 minutes by testing dissolution using USP Apparatus 5 (paddle over disk method), with purified water as the medium volume, 200 mL per vessel. The temperature is maintained at 32 ± 0.5 °C. a distance of 25 ± Attorney Docket No.732/2 PCT 2 mm between the paddle blade and the surface of the disk assembly. The rotation speed was set at 50 rpm. In specific embodiments, the Appod TM loaded drug will release above 70% of drug in 5 minutes by testing dissolution using USP Apparatus 5 (paddle over disk method), with purified water as the medium volume, 200 mL per vessel. The temperature is maintained at 32 ± 0.5 °C. a distance of 25 ± 2 mm between the paddle blade and the surface of the disk assembly. The rotation speed was set at 50 rpm. In specific embodiments, the Appod TM loaded drug will release above 80% of drug in 5 minutes by testing dissolution using USP Apparatus 5 (paddle over disk method), with purified water as the medium volume, 200 mL per vessel. The temperature is maintained at 32 ± 0.5 °C. a distance of 25 ± 2 mm between the paddle blade and the surface of the disk assembly. The rotation speed was set at 50 rpm. In specific embodiments, the Appod TM loaded drug will release above 90% of drug in 5 minutes by testing dissolution using USP Apparatus 5 (paddle over disk method), with purified water as the medium volume, 200 mL per vessel. The temperature is maintained at 32 ± 0.5 °C. a distance of 25 ± 2 mm between the paddle blade and the surface of the disk assembly. The rotation speed was set at 50 rpm. Fig.17 illustrates an appod TM includes a reservoir pod 23, which allows easy way to add or pump drug solution into the appod TM and also it can hold the drug solution and release over a period of time. When the solution was added inlet of the reservoir pod, the solution gets into the inner non-woven fabric 20 and spread the entire area and keeps the drug constantly to the skin where appod TM is applied for treatment. The reservoir pod allows to keep the appod TM for longer period of time may be for a day or for two days or for a week or for a moth and just keep adding the drug solution though the inlet of the reservoir pod 23. Fig.18 illustrates an appod TM with an isolation ring 26 at the middle made up of polymer, so that the drug solution can be contained within the ring to maintain the specific area of treatment. The inside of the isolation ring can have a non-woven fabric or may openly expose the skin area intended for treatment like surgery and wounds etc. The isolation ring 26 contains the drug solution within the ring area. In some embodiments the appod TM system the isolation ring 26 is non absorbing and it is made up of silicone, Ethyl vinyl acetate and does not sensitize or irrigate the skin. In some embodiments the appod TM system the isolation ring 26 is non absorbing and is 1 cm to Attorney Docket No.732/2 PCT 19 cms in diameter. In some embodiments the appod TM system the isolation ring 26 is non absorbing and is 2 cm to 4 cms in diameter. In some embodiments the appod TM system the isolation ring 26 is non absorbing and is 4 cm 6 cms in diameter. In some embodiments the appod TM system the isolation ring 26 is non absorbing and is 6 cm to 8 cms in diameter. In some embodiments the appod TM system the isolation ring 26 is non absorbing and is 8 cm to 10 cms in diameter. In some embodiments the appod TM system the isolation ring 26 is non absorbing and is 10 cm to 12 cms in diameter. In some embodiments the appod TM system the isolation ring 26 is non absorbing and is 12 cm to 14 cms in diameter. In some embodiments the appod TM system the isolation ring 26 is non absorbing and is 14 cm to 16 cms in diameter. In some embodiments the appod TM system the isolation ring 26 is non absorbing and is 16 cm to 18 cms in diameter. In some embodiments the appod TM system the isolation ring 26 is non absorbing and is 18 cm to 20 cms in diameter. In some embodiments, the appod TM system the isolation ring 26 has spikes so that the THADS drug product solution can be filled in the pouch of Fig.19 and adhered to the top layer of reservoir pod 23 or outer polymeric fabric 19 as a unit dose for once-a-day application or for more than one a day application. After applying the appod TM into the skin of the treatment area, by tapping the top part of the appod TM by hand the pouch of Fig.19 gets ruptured by the spike in the isolation ring and the drug product solution is released for its activity within the appod TM . In some embodiments, the appod TM system the pouch showed in Fig.19 is made up of very soft, flexible materials like silicone, Polyethylene, polypropylene, or polyethylene/polypropylene co-polymers and can be in different shapes and can hold 0.25mL to 10mL per pouch. In some embodiments, the appod TM system the pouch showed in Fig.19 is sterile. In some embodiments, the appod TM system the pouch showed in the Fig.19 is sterile used to treat pain after surgery, infections, wounds, and burns. In some embodiments, the appod TM system the pouch showed in the Fig.19 can hold 0.1 mL to Attorney Docket No.732/2 PCT 12 mL of drug product solution, suspension, or emulsion. In some embodiments, the appod TM system the pouch showed in the Fig.19 can hold 0.5 mL to 2 mL of drug product solution, suspension, or emulsion. In some embodiments, the appod TM system the pouch showed in the Fig.19 can hold 2 mL to 4 mL of drug product solution, suspension, or emulsion. In some embodiments, the appod TM system the pouch showed in the Fig.19 can hold 4 mL to 7 mL of drug product solution, suspension, or emulsion. In some embodiments, the appod TM system the pouch showed in the Fig.19 can hold 7 mL to 10 mL of drug product solution, suspension, or emulsion. Fig.20 illustrates the top view of the reservoir pod 23, which has an inlet 18 for the drug product solution, which can be added from the airless bottle wand 5. The reservoir pod 23 has an elevated dome 27 and a collar 28 extending outwards. The collar 28 was adhered to the outer layer Polyurethane film 19, beneath the reservoir dome 23 will be the inner non-woven fabric 20 or in some case it will be the isolation ring 26. Fig.21 illustrates the bottom or cross section view of the reservoir pod 23, the bottom part includes a duckbill valve 29 to prevent the back flow of the added solution from the reservoir or from the appod TM and 29A, a wall to stop the further advancement of the wand 5 while pumping the drug product. in some instance the dome wall 27 of the will act like a wand stopper like 29A. In some embodiments the appod TM system has a back flow prevention with the reservoir pod 23 like Duckbill vale as shown in Fig.21 or a screw cap on the inlet tube 18 or a snap on lid attached to the inlet tube 18 or a plug that can be used to close the inlet and prevent back flow of the added drug product solution. In specific embodiments the reservoir pod 23, has embossing on top of it as THADS TM or other name on it. In some embodiments the appod TM system the reservoir pod 23 is made up of very flexible and ductile materials preferable silicone, so that it is light weight and modulate the body curvatures as flexible so that it will not feel its presence or pinching effect while sleeping. In some embodiments the appod TM system the reservoir pod 23 is made up of flexible polymer or a non-flexible polymer with a wall thickness of 0.1 mm to 30 mm, preferable 0.2 mm to 10mm. In some embodiments the appod TM system the reservoir pod 23 act as a reservoir or pod and holds 0.1m l to 50 ml of drug solution preferably from 0.25mL to 10mL. In some embodiments the appod TM system the reservoir pod 23 act as a reservoir or pod and Attorney Docket No.732/2 PCT has a capillary delivery at the bottom of the reservoir pod 23 for the drug solution to pass through porous ceramic wick to the skin in a predetermined control flow rate. In some embodiments the appod TM system the reservoir pod 23 ceramic wick is not soluble in water or in ethanol, methanol, propylene glycol, Dimethyl sulfoxide, ethyl acetate, and isopropyl alcohol. In some embodiments the appod TM system the reservoir pod 23 the flow control wick can be made up of fibers like Cotton, jute, paper, or rayon. In some embodiments the appod TM system the reservoir pod 23 act as a reservoir or pod and has a capillary delivery of the drug solution through porous ceramic wick to the skin and flow is controlled to 0.001mL/ hour to 1mL/ hour for extended hours of time. In some embodiments the appod TM system the reservoir pod 23 act as a reservoir or pod and has a passive capillary delivery of the drug solution through porous sintered particles and bonded fabric. In some embodiments the appod TM system the reservoir pod 23 act as a reservoir or pod and the drug solution is actively controlled the flow using by pumping the drug product through a piezoelectric micro pump or peristaltic micro pump. In some embodiments the appod TM system the reservoir pod 23 act as a reservoir or pod and the drug solution is actively controlled by peristaltic micro pump manufactured by Takasago RP-Q1.2N- P20Z. In some embodiments the appod TM system the reservoir pod 23 act as a reservoir or pod and the drug solution is actively controlled by a piezoelectric micro pump manufactured by Bartel mp6. In some embodiments the appod TM system the reservoir pod 23 act as a reservoir or pod and the drug solution is pumped through a piezoelectric micro pump or peristaltic micro pump and flow is controlled to 0.001mL/ hour to 1mL/ hour for extended hours of time or for 3 times a day through an electronic process control mother board that can be easily controlled and locked by care giver, pharmacist, doctor, nurse, or the consumer. In some embodiments the appod TM system the reservoir pod 23 act as a reservoir or pod can deliver 0.01mL to 1.0mL/ hour of the drug solution to the treatment area of the skin through the capillary wick, sintered material or bonded fabric or using a micro pump. In some embodiments the appod TM system the reservoir pod 23 act as a reservoir or pod can deliver 0.01mL to 1.0mL/ hour of the drug solution to the treatment area of the skin through the combination of the passive capillary wick, sintered material or bonded fabric and active flow control by using a micro pump. In specific embodiments the a second flexible reservoir is provided within the appod TM for housing Attorney Docket No.732/2 PCT a volume of same drug or second drug for bolus dose delivery to the user or synergistic treatment or multi-model drug delivery system. The pre-programmed Appod TM pump can be programmed either by the manufacturing facility or a health care provider and preferably requires no additional user programming to deliver the drug in a periodic time for multiple days. In some embodiments, the outer polymer fabric layer 19 is a nonwoven fabric layer. In some embodiments, the polymer fabric layer 19 is a non-woven fabric includes at least one of a polyurethane film, a polyolefins film, a polyesters film, a polyalkylenes film, a polyamides film, a polystyrenes film, a polyarylsulfones film, a polydienes film, a polyethylene film, a polypropylene film or, a PVC film, the 19 can be a nonwoven material, and/or a woven material. In some embodiments, the Outer polymeric fabric layer 19 is highly breathable and/or porous, making the THADS TM appod TM comfortable to wear. In some embodiments, the Outer polymeric fabric layer 19 is colorless and transparent. In some embodiments, the Outer polymeric fabric layer 19 is in skin color shades. In some embodiments, the Outer polymeric fabric layer 19 is in multicolor shades. In some embodiments, the Outer polymeric fabric layer 19 is polyurethane film. In some embodiments, the Outer polymeric fabric layer 19 is polyurethane film and upon another layer of polymer film to have a colorful design on it. In some embodiments of the invention, the Outer polymeric fabric layer 19 may be a polyurethane film having a thickness in the range of 5-450 microns, preferably, 10-150. In some embodiments of the invention, the Outer polymeric fabric layer 19 may be a polyurethane film having a thickness in the range of 5-450 microns, preferably, 10-80 microns. In some embodiments of the invention, the Outer polymeric fabric layer 19 may be a polyurethane film having a thickness in the range of 5-450 microns, preferably, 10-50 microns. In some embodiments of the invention, the Outer polymeric fabric layer 19 may be a polyurethane film having a thickness in the range of 5-450 microns, preferably 20 to 35 microns. In some embodiments, the Outer polymeric fabric layer 19 is highly stretchable and elastic in nature, preferable polyurethane, and combination of Polyurethane and other resins/polymers, so that it can applied to the highly movement required areas like knees and elbows. In some embodiments of the invention, the Outer polymeric fabric layer 19 may be a polyurethane film having a thickness in the range of 5-450 microns, has 100 % adhesive area, so that it can adhere to the skin for a treatment period. In some embodiments of the invention, the Outer polymeric fabric layer 19 may be a polyurethane Attorney Docket No.732/2 PCT film having a thickness in the range of 5-450 microns, has 80 % to 60% adhesive area, so that it can adhere to the skin for a treatment period. In some embodiments of the invention, the Outer polymeric fabric layer 19 may be a polyurethane film having a thickness in the range of 5-450 microns, has 60 % to 40% adhesive area, so that it can adhere to the skin for a treatment period. In some embodiments of the invention, the Outer polymeric fabric layer 19 may be a polyurethane film having a thickness in the range of 5-450 microns, has 40 % to 20% adhesive area, so that it can adhere to the skin for a treatment period. In some embodiments, the Outer polymeric fabric layer 19 is liquid-impervious, moisture-vapor permeable polymeric films include synthetic organic polymers including, but not limited to: polyurethanes, poly-amide block copolymers, poly-ester block copolymers. The polymeric films can be made of one or more types of monomers (e.g., copolymers) or mixtures (e.g., blends) of polymers. In some embodiments, the Outer polymeric fabric layer 19 composed of non-woven fabric, including polyester, polypropylene, viscose, cotton, rayon, and blended nonwoven fabrics. The blended nonwoven fabrics, including: Cotton/Rayon, Fine Denier Polyester/Course Denier Polyester, Polyester/Rayon. The blend ratio an 90/10 to 10/90 of any two fibers or resins that can include Acrylics, Vinyl Acetate (VAC), Vinyl Acrylics, Ethylene Vinyl Acetate (EVA), Styrene Butadiene Rubber (SBR), Starch, Poly Vinyl Chloride (PVC). In some embodiments, the Outer polymeric fabric layer 19 includes adhesive, this adhesive adheres the appod TM to the skin for the treatment area. In specific embodiment inner non-woven fabric/pad 20 material includes adhesive, this adhesive adheres the appod TM to the skin for the treatment area. In specific embodiment inner non-woven fabric/pad 20 material is selected from the group including a polymeric foam, a non-woven material, a fibrous material, a gel forming fiber, a hydrogel, a matrix containing hydrocolloids, a woven fiber, and a knitted fiber. In specific embodiment inner non-woven fabric/pad 20 is perforated and highly porous in nature and can adsorb the liquid. In specific embodiment inner non-woven fabric/pad 20 is perforated and highly porous in nature and may adsorb the liquid. In specific embodiment inner non-woven fabric/pad 20 is perforated and highly porous in nature and may not absorb the liquid. Attorney Docket No.732/2 PCT In specific embodiment inner non-woven fabric/pad 20 is perforated and highly porous, it spreads the added drug product solution within the appod TM . In specific embodiment inner non-woven fabric/pad 20 is perforated and highly porous, it spreads the added drug product solution and holds the drug product for treatment period within the appod TM . In specific embodiment inner non-woven fabric/pad 20 is perforated and highly porous, multiple layers of the non-woven fabric/pad 20 can be added into the appod TM , to control the drug delivery rate and the treatment period. In specific embodiment inner non-woven fabric/pad 20 does not contain adhesive. In specific embodiment inner non-woven fabric/pad 20 may contain adhesive, that helps to adhere to the skin. In specific embodiment inner non-woven fabric/pad 20 thickness is from 30 grams/m 2 to 950 grams/ m 2 and it is non swellable and it can be one or multilayered fabric. In specific embodiment inner non-woven fabric/pad 20 thickness is from 30 grams/m 2 to 600 grams/ m 2 and it is non swellable and it can be one or multilayered fabric. In specific embodiment inner non-woven fabric/pad 20 thickness is from 30 grams/m 2 to 500 grams/ m 2 and it is non swellable and it can be one or multilayered fabric. In specific embodiment inner non-woven fabric/pad 20 thickness is from 30 grams/m 2 to 400 grams/ m 2 and it is non swellable and it can be one or multilayered fabric. In specific embodiment inner non-woven fabric/pad 20 thickness is from 30 grams/m 2 to 300 grams/ m 2 and it is non swellable and it can be one or multilayered fabric. In specific embodiment inner non-woven fabric/pad 20 thickness is from 30 grams/m 2 to 200 grams/ m 2 and it is non swellable and it can be one or multilayered fabric. In specific embodiment inner non-woven fabric/pad 20 thickness is from 30 grams/m 2 to 100 grams/ m 2 and it is non swellable and it can be one or multilayered fabric. In specific embodiment inner non-woven fabric/pad 20 thickness is from 10 grams/m 2 to 80 grams/ m 2 and it is non swellable and it can be one or multilayered fabric. In specific embodiment inner non-woven fabric/pad 20 thickness is from 30 grams/m 2 to 800 grams/ m 2 and it is a swellable and it can be one or multilayered fabric. In specific embodiment, the adhesive area 21 use a pressure sensitive adhesive that are sticky or tacky to the slight touch of the finger, with light touch of the finger on the surface of the polymeric film 19 is sufficient to adhere appod TM to the surface of the skin. Attorney Docket No.732/2 PCT In specific embodiment, the adhesive area 21 use a pressure sensitive adhesive over 100% of the appod TM . In specific embodiment, the adhesive area 21 use a pressure sensitive adhesive from 70 to 100% area of the appod TM . In specific embodiment, the adhesive area 21 use a pressure sensitive adhesive from 50 to 70% area of the appod TM . In specific embodiment, the adhesive area 21 use a pressure sensitive adhesive from 20 to 50% area of the appod TM . In specific embodiment, the pressure sensitive adhesive used in the appod TM is from the polyarylates (arlylates), polyisobutylene (PIB) and polydimethylsiloxane (silicone) family of adhesives. In some embodiments, the appod TM has two release liners one on the top and one on the bottom on the appod TM , the two release liners provides the structural integrity for the appod TM and easy of application to consumers. The skin contact adhesive layer of the appod TM is adhered to the release liner 30A at the bottom prior to use, once the release liner in removed, the appod TM adheres to the skin site of application. After the appod TM is adhered, the top release liner will be removed to have the structural integrity of the thin polymeric layer based on the polyurethane player film, this is illustrated in Fig.22. In some embodiments, the appod TM has two release liners one on the top and one on the bottom on the appod TM will have a design or a product name on it. In some embodiments, the inner inner non-woven fabric 20 can be non-adherent gauze in a gauze-based dressing, made of cellulose acetate and coated with petrolatum, non-adherent sponge gauze impregnated with PHMB (Polyhexamethylene Biguanide), knitted cellulose acetate fabric and impregnated with a specially formulated petrolatum emulsion, Hydrocolloids dressings containing polymers held in suspension plus gel-forming agents (methylcellulose, pectin, gelatin, polyisobutylene), alginate dressings, hydrogel dressing. In some embodiment the, the inner non-woven fabric 20 can have thickness of 30 grams/m 2 to 700 grams/m 2 . In some embodiments, the Outer polymeric fabric layer 19 has a weight of between about 10 g/m 2 to about 400 g/m 2 . In some embodiments, the Outer polymeric fabric layer 19 has a weight of between about 30 g/m 2 to about 280 g/m 2 . In some embodiments, the Outer polymeric fabric layer 19 has a thickness between about 0.001 mm to 25 mm. Attorney Docket No.732/2 PCT In some embodiments the inner non-woven fabric layer 20 is composed of spunlace non-woven made up of viscose, polyester, polypropylene, Tenel, wood pulp, cotton, nylon and microfiber or the combination of these materials. In some embodiments, the Outer polymeric fabric layer 19 has a thickness between about 0.01 mm to 2.0 mm. The outer polymer fabric layer 19 is from the list of synthetic polymers includes elastomers, i.e., polybutadiene, hydrin rubber, polysiloxane, silicone rubber, nitrile polymer, acrylonitrile, butyl rubber, styrene-butadiene rubber, Styrene-isoprene block copolymers, neoprene polymers, etc. Among other synthetic polymers are polyvinyl alcohol (PVA), polyvinyl chloride (PVC), polyurethane, polyethylene, polypropylene, polyacrylate, polyamide, polyurea, polyvinyl pyrrolidone, polymethyl methacrylate (PMMA), epoxy polymers, etc. In some embodiments the adhesive can be any one or the combination pressure sensitive adhesives or non-pressure sensitive adhesive. Examples of suitable pressure sensitive adhesives include a natural rubber-based adhesive, a silicone-based adhesive, a synthetic rubber based adhesive, a styrene block copolymer-based adhesive, a polyvinyl ether-based adhesive, a poly(methyl acrylate)- based adhesive, or a polyolefin-based adhesive. In some embodiments of the present disclosure also include a release liner. In some embodiments, the THADS TM system uses “Hands free” approach by pumping the “ready to act” solution from the Air less container into the applicator and the pumped solution can be applied to the part of the treatment area using the sponge tip, the same ready to act solution can be used by applying the appod TM and the solution can be pumped into the appod TM and can be used to treat extended treatment time. In specific embodiment of the invention an improved container system that is a child resistant, delivers the exact dose of the drug into the applicator and the drug from the applicator can be applied to the treatment area without using the hand. In some embodiments, the drug product used in THADS TM Drug product includes solvent enhancers that increase the penetration by swelling the drug pathways and fluidizing the lipids on the way of permeation through epidermis skin layers. Polar pathways are swelled by water, alcohols (Methanol, Ethanol, Isopropyl alcohol), alkyl methyl sulfoxides (e.g., dimethyl sulfoxide (DMSO)), dimethylacetamide, dimethylformamide, pyrrolidones (2-pyrrolidone, N-methyl, 2-pyrrolidone), laurocapram (azone) and miscellaneous other solvents including propylene glycol, glycerol, silicone fluids and isopropyl palmitate. Attorney Docket No.732/2 PCT In some embodiments, the drug product used in THADS TM drug product includes surfactants Cationic surfactants cetyltrimethylammonium bromide, sodium lauryl sulfate (SLS) and diacetyl sulfosuccinate, and dodecyl methyl sulfoxide, the anionic surfactant, nonionic surfactants, pluronic F127 and pluronic F68 and the amphoteric surfactant, N-dodecyl-N,N-dimethyl betaine. In some embodiments THADS TM drug product consist natural constituents capable of behaving as permeation enhancers like bile acid salts, oleic and lauric acids, propylene glycol-oleic acid and 1,4- butane diol-linoleic acid, urea, 4-decyloxazolidin-2-one, N, N-dimethyl-m-toluamide, calcium thioglycolate, eucalyptol, di-o-methyl-β-cyclodextrin, soybean casein, imidic cyclic urea, cyclopentadecalactone, cyclodextrins, L-menthol, eucalyptus, peppermint and ylang-ylang essential oils, isopropyl myristate, limonene and honey. In some embodiments, the drug product (solution, suspension, emulsion, gel, and creams) used in THADS TM includes nanosized particles that enhance the solubility and skin permeation. In specific embodiments treating various acute localized skin disease conditions like topical pain, surgical pain, infection, Acne, Psoriasis, Shingles, Dermatitis, Skin Cancer, Eczema, Rosacea, and drugs that are highly toxic in nature or highly potent and sensitizing in nature and for administering drug for systemic administration for human and animals. The THADS TM uses the drugs in ready to act condition, and the drug can be taken exact dose with the metered dose in the Airless dispenser container, it can be applied to skin with the applicator sponge very smoothly to the affected area and the Appod TM will keep the drug in one place for longer time, consistent drug permeability and prevents adhering to cloths and improved patient compliance and efficacy of the topical drugs. These findings have led to the completion of the present invention. Nasal applicator: In specific embodiments, the topical analgesic includes at least one of or the combination of drugs in its topical formulation: Diclofenac sodium, Piroxicam, Acetaminophen, Buprenorphine, Fentanyl, Bupivacaine, menthol, trolamine salicylate, camphor, capsaicin, lidocaine HCl, lidocaine, cannabinoids, propofol and methyl salicylate. In specific embodiments method of treating using Appod TM for various acute and chronic systemic disease conditions like Chronic pain, Essential Hypertension, Cancer, ADHD disorder, Dementia, Major depression disorder, Hypogonadism, Bladder muscle dysfunction, Diabetes, osteoporosis, Flu, Arthritis, obesity, and Alzheimer's disease. In specific embodiments the Appod TM materials can be sterilized by various means such as autoclaving or gamma radiation or by Ethylene oxide and used for open wounds and surgeries. Attorney Docket No.732/2 PCT In specific embodiments the THADS TM product solution or suspension can be filled in a unit dose container made of polyethylene, polypropylene, glass using a Form Fill Seal technology and this unit dose container can be sterilized using autoclaving or ethylene oxide to by Gamma radiation, this product can be used along with sterilized appod TM on open wounds or surgeries. In specific embodiments, the topical analgesic includes as stand alone or in combination of: 0.5- 20% menthol, 10- 30 wt. % trolamine salicylate, 1-15 % camphor, 0.01-5 wt. % capsaicin, 4 – 10% lidocaine, 0.5 – 5%, Diclofenac sodium, 0.1 – 10% cannabinoids and 10-30 wt. % methyl salicylate. In specific embodiments, the topical analgesic includes the systemic analgesic: Oxycodone, Morphine, Fentanyl, Hydromorphone, Oxymorphone, tramadol, methadone, Duloxetine, pregabalin, Ziconotide. In specific embodiments, the topical analgesic includes an emulsifier. In specific embodiments, the topical analgesic includes the emulsifier polysorbate 60, laureth-4, potassium cetyl sulfate, cetyl alcohol, cetearyl alcohol, stearyl alcohol, glyceryl stearate, propylene glycol, polyglyceryl-6 laurate, ceteareth-20, PEG-100 stearate, sodium lauroyl lactylate, myristyl myristate, carbomer, polysorbate 80, polawax, sorbitan stearate, gum Arabic, brassica alcohol, cabomer 980 QD, sodium stearate, polyhydroxystearic acid, PEG-150 distearate, glyceryl oleate, emulsifying wax, glyceryl monooleate, phospholipids, polyoxyethylene alkyl ethers, polyoxyethylene, castor oil derivatives, sorbitan fatty acid esters, polyoxyethylene steartes, polyoxylglycerides, polysorbate, sorbitan esters, lecithin, or any combination thereof. In some embodiments the outer polymer fabric layer 19 has several functions. It serves as a barrier between pressure sensitive adhesive 26 and hold or acts as pod for the readily active drug products such as solution, suspension, emulsion foam etc. or a pod like silicone pod that holds the ready to act solution or sustained acting solution or suspension, The outer polymer fabric layer 19 also protects the treatment site from contamination during the treatment period, has high moisture vapor transmission rate to allow the skin to perspire, protects the content from water while taking bath. The outer polymer fabric layer 19 of Appod TM is thin, highly flexible, or deformable, water- impervious, or water pervious or substantially impervious to external fluids, yet breathable. In some embodiments, in some embodiments a second or multiple polymeric fabric layer can be adhered or blended to the outer polymer fabric layer 19 and these layers are water-impervious, or substantially impervious to external fluids. In general, the thickness of outer polymer fabric layer 19 is between about 15 to about 300 microns ("um"), preferably between about 80 to about 200 um and most preferably, about 150 um to achieve the forming and flexing characteristics desired. Attorney Docket No.732/2 PCT In some embodiments, the polymeric materials used in outer polymer fabric layer 19 are conformable to the contours of the body, and flexible so as to permit free movement of the body part wearing an Appod TM outer polymer fabric layer 19 is very lightweight, and may be elastic (elastomeric) in character. It can be a woven or nonwoven fabric, a film, or a foam. Preferred polymeric materials useful in forming the wound cover 20 could include polyolefin (such as polyethylene), polyurethane, and polyvinylchloride. Other examples of backings include, but are not limited to, nonwoven, woven, or knitted fabrics such as cotton, polyester, polyurethane, rayon, and the like. A polyethylene film may be used as outer polymer fabric layer 19. However, particularly effective results can be achieved with stretchable, elastomeric films formed of polyurethane, which has the further advantage of gas (including water vapor) transmissibility. In addition, outer polymer fabric layer 19 may be made from other polyolefins, vinyl polyethylene acetate, textile non-woven fabrics, rubber, tissue paper, plastic netting, adsorbent pads, or other materials known in the adhesive article art. In some embodiments, outer polymer fabric layer 19 is substantially transparent. The Appod TM may be particularly desirable to protect small wounds, such as non-bleeding cuts and the like, without visible bandages. In other embodiments, outer polymer fabric layer 19 is substantially translucent. In still other embodiments, outer polymer fabric layer 19 is substantially opaque. An opaque outer polymer fabric layer 19 can serve to hide the wound from view. In other embodiments, such as for use in children's wound appod TM , the outer polymer fabric layer 19 may be decorated. Decorations include color or colors, decals, printed messages, or cartoons. The decoration serves the dual purpose of hiding the wound site from view, as well as providing entertainment for the wearer of the Appod TM . Again, outer polymer fabric layer 19 has disposed thereon a pressure sensitive adhesive 26 arranged and configured to adhere to mammalian skin during use. Adhesive 26 comprises at least one colloidal absorbent component dispersed therein. The colloidal absorbent component used may be any substance that has a good performance in this utilization. Preferred colloidal absorbent components include hydrocolloids, such as, sodium carboxymethylcellulose, pectin, xanthan gum, polysaccharides, sodium or calcium alginates, chitosan, seaweed extract (carrageenan), polyaspartic acid, polyglutamic acid, hyaluronic acid or salts and derivatives thereof, among others. polyesters, polyethylenes, polypropylenes, polystyrenes, polyvinylchloride, and a polyethylene terephthalate/ethylene vinyl acetate laminate. Hydrocolloids, such as sodium carboxymethylcellulose and pectin, among others, are agents that form gels as soon as they come into contact with the bodily fluids from the wound. When used in adhesive bandages, these hydrocolloids are combined with elastomers and/or adhesives. Preferably, Attorney Docket No.732/2 PCT the wound cover provides a humid environment but without saturation, cicatrisation, which is a situation suitable for acceleration of the healing. In some embodiment the content of the pressure-sensitive adhesive in appod TM is preferably 5 to 30%% by mass, for example, based on the total mass of the adhesive layer, more preferably 10 to 20% by mass, and further preferably 5 to 15% by mass. The adhesive substance used in the flexible substrate of the present invention may, for example, be any suitable adhesive substance. Preferably, the adhesive substance is a medical grade adhesive, such as acrylic based pressure sensitive adhesives (PSAs), rubber based pressure sensitive adhesives, silicone pressure sensitive adhesives, mixtures thereof, or the like. Examples of polymeric rubber bases include one or more of styrene-isoprene-styrene polymers, styrene-olefin-styrene polymers including styrene-ethylene/propylene-styrene polymers, polyisobutylene, styrene-butadiene-styrene polymers, polyisoprene, polybutadiene, natural rubber, silicone rubber, acrylonitrile rubber, nitrile rubber, polyurethane rubber, polyisobutylene rubber, butyl rubber, halobutyl rubber including bromobutyl rubber, butadiene-acrylonitrile rubber, polychloroprene, and styrene-butadiene rubber. Examples of the acrylic pressure-sensitive adhesive base include a polymer of an alkyl (meth)acrylate, and a copolymer of an alkyl (meth)acrylate and a comonomer. In this regard, the alkyl (meth)acrylate means an alkyl acrylate, or an alkyl methacrylate. Examples of the alkyl (meth)acrylate include butyl (meth)acrylate, isobutyl (meth)acrylate, hexyl (meth)acrylate, octyl (meth)acrylate, 2- ethylhexyl (meth)acrylate, and decyl (meth)acrylate. The alkyl (meth)acrylates may be used singly or in combinations of two or more thereof. Adhesive 26 may be any conventional adhesive known for such use, as for example pressure acrylic adhesives, among others. he interfacing adhesive layer is comprised of one or more polymers selected from selected from acrylates, acrylate copolymers, polyisobutylene, silicone, polystyrene butyl rubber, polyethylene vinyl acetate and copolymers thereof, and plasticized polymers Additionally, such an adhesive may contain a resin for increasing adhesion, a cohesion increasing agent, an absorption agent (preferably a polyacrylate superabsorbent, a polyacrylate salt superabsorbent or a mixture thereof), a plasticizer and optionally a pigment. Adhesive 26 may further be configured in discontinuous patterns, arranged in lines, screen, spray or any other which a person skilled in the art understands as discontinuous, composed by an elastomeric base. The therapeutic or active agent may be selected from any of the various classes of such agents including, but not limited to, analgesic agents , anesthetic agents, anti-anginal agents, antiarthritic agents, anti-arrhythmic agents, antiasthmatic agents, antibacterial agents, anti-BPH agents, anticancer agents, Attorney Docket No.732/2 PCT anticholinergic agents, anticoagulants, anticonvulsants, antidepressants, antidiabetic agents, antidiarrheals, anti-epileptic agents, antifungal agents, antigout agents, antihelminthic agents, antihistamines, antihypertensive agents, anti-inflammatory agents, antimalarial agents, antimigraine agents, antimuscarinic agents, antinauseants, antineoplastic agents, anti-obesity agents, antiosteoporosis agents, antiparkinsonism agents, antiprotozoal agents, antipruritics, antipsychotic agents, antipyretics, antispasmodics, antithyroid agents, antitubercular agents, antiulcer agents, anti- urinary incontinence agents, antiviral agents, anxiolytics, appetite suppressants, attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD) drugs, calcium channel blockers, cardiac inotropic agents, beta-blockers, central nervous system stimulants, cognition enhancers, corticosteroids, COX-2 inhibitors, decongestants, diuretics, gastrointestinal agents, genetic materials, histamine receptor antagonists, hormonolytics, hypnotics, hypoglycemic agents, immunosuppressants, keratolytics, leukotriene inhibitors, lipid-regulating agents, macrolides, mitotic inhibitors, muscle relaxants, narcotic antagonists, neuroleptic agents, nicotine, nutritional oils, parasympatholytic agents, sedatives, sex hormones, sympathomimetic agents, tranquilizers, vasodilators, vitamins, and combinations thereof. Suitable therapeutically active proteins and Biological drugs include fibroblast growth factors, epidermal growth factors, platelet-derived growth factors, macrophage-derived growth factors such as granulocyte macrophage colony stimulating factors, ciliary neurotrophic factors, tissue plasminogen activator, B cell stimulating factors, cartilage induction factor, differentiating factors, growth hormone releasing factors, human growth hormone, hepatocyte growth factors, immunoglobulins, insulin-like growth factors, interleukins, cytokines, interferons, tumor necrosis factors, nerve growth factors, endothelial growth factors, osteogenic factor extract, T cell growth factors, tumor growth inhibitors, enzymes and the like, as well as fragments thereof. The therapeutic or active agent may be selected from any of the various classes of biological drugs for example, an antibody, a cytokine, a vaccine, a fusion protein or a growth factor. In a preferred embodiment, the medication is a TNF alpha. inhibitor, insulin, a TNF fusion protein, or a recombinant TNF binding protein, such as infliximab, anti-TNF dAb, golimumab, adalimumab, etanercept The active agent(s) also can be administered with olaparib, bevacizumab, paclitaxel, altretamine, capecitabine, cyclophosphamide, etoposide, gemcitabine, ifosfamide, irinotecan, doxorubicin, melphalan, pemetrexed, topotecan, or vinorelbine, Cisplatin, mechlorethamine , chlorambucil, cyclophosphamide , ifosfamide, melphalan, streptozocin, carmustine, lomustine , busulfan Triazines: dacarbazine, temozolomide, thiotepa, altretamine fulvestrant , tamoxifen, toremifene , clomifene, raloxifene, mifepristone, ulipristal acetate, aglepristone, lilopristone and onapristone bicalutamide , Attorney Docket No.732/2 PCT flutamide , nilutamide anastrozole , exemestane , letrozole, megestrol acetate Estrogens Gonadotropin- releasing hormone, leuprolide, goserelin Estradiol, Norethindrone, Drospirenone, Ethinyl Estradiol, Conjugated Estrogens and Medroxyprogesterone. Active agent(s) can also be administered with anesthetics including ethanol, bupivacaine, chloroprocaine, levobupivacaine, lidocaine, mepivacaine, procaine, ropivacaine, tetracaine, desflurane, isoflurane, ketamine, propofol, sevoflurane, codeine, fentanyl, hydromorphone, marcaine, meperidine, methadone, morphine, oxycodone, remifentanil, sufentanil, butorphanol, nalbuphine, tramadol, benzocaine, dibucaine, ethyl chloride, xylocaine, and/or phenazopyridine. The present application also includes methods for treating a patient suffering from a condition such as allergy, ADHD, diabetes, epilepsy, pain, inflammation, nausea, convulsions, muscle spasms, depression, and shingles comprising administering THADS TM Appod TM as described below. The specific formulation of the Silicone dome, non-woven fabric and adhesive material may be varied depending upon the condition(s) being treated, as can the location of application of the THADS TM Appod TM . EXAMPLES Example 1 Example 1 illustrates the THADS TM formulation efficacy, ready to act for fast onset of its effect, patients’ compliance and its method for treatment and comparative analytical test data of the marketed products. Lidocaine 4% Topical solution for pain relief. ACTIVE INGREDIENT: THADS TM Lidocaine 4.0%. Table 4 The in vitro dissolution was carried out using jacketed Franz diffusion cell and maintained the temperature at with 32 °C during this study, 3.0-micron nylon membrane was used, 30:70 ratio of the Attorney Docket No.732/2 PCT Ethanol: Purified water was used as dissolution medium, 12mL of the dissolution medium was used, 800rpm of the stirrer RPM was set during the study, the samples solution was replaced at each and every time point. The withdrawn samples were tested using HPLC. Using the above test procedure, the THADS TM Lidocaine and the marketed product was tested, and the result are shown in the table 5 and in graphical format at Fig.23. Table 5 a) Fast onset time: Dissolution data from the Table 5 and Fig.23, indicates the THADS TM lidocaine releases faster around 70% in 15 minutes compared to 7.4%, 2.8%, 10.9% and 3.1% respectively for the currently marketed products. This shows that THADS TM product is faster onset and in “Ready to act” state compared to the marketed products that were tested. Dissolution profile of the THADS TM Lidocaine in Appod TM versus marketed Icy Hot Lidocaine patch. Table 6 % Drug dissolved Data from Table 6 that used the following dissolution method to test the THADS TM Lidocaine in appod TM versus the marketed Icy Hot Patches in 5 minutes by testing dissolution using USP Apparatus Attorney Docket No.732/2 PCT 5 (paddle over disk method), with purified water as the medium volume, 200 mL per vessel. The temperature is maintained at 32 ± 0.5 °C a distance of 25 ± 2 mm between the paddle blade and the surface of the disk assembly. The rotation speed was set at 50 rpm. THADS TM Lidocaine in Appod TM had released 85% of drug in 5 minutes interval than the 6.3% of the marketed Icy Hot Patches, this show the THADS TM appod TM has rapid onset. The lower dissolution rate of the marketed product is due to the drug added with the adhesive in the patches, that hold the drug from releasing faster. All the marketed transdermal products Transdermal Scop TM , Secuado TM , ButransTM,Catapres- TTS TM , Estraderm TM , Climara TM , Vivelle TM , Duragesic TM ,Sancuso TM ,Daytrana TM , Nitrodur TM , Minitran TM , Oxytrol TM ,Excelon TM ,Neupro TM , Emsam TM , Androderm TM Nioderm TM , Zecuity TM , Qutenza TM , Flextor TM , Lidoderm TM Salonpas TM , Aspercreme TM , Biofreeze TM , Icy Hot TM patches all has the drug mixed with adhesive and adhesives covers the entire patches size that is adhering to the skin. THADS TM system is very effective for when used stand-alone using the sponge applicator and the Appod TM and it will provide a rapid onset of action. b) High Efficacy of THADS TM system Fig.24 illustrates appod TM administered with THADS TM lidocaine product and shows the initial time, when the 6 mL (240mg of Lidocaine) was administered through the inlet of appod TM , THADS TM lidocaine 4% product spread across the appod TM through the non-woven fabric intended for the treatment area, after 1 hours the Fig.25 shows the Lidocaine spread throughout the appod TM and it is wet across the area of the appod TM . Fig.26 shows the lidocaine spread throughout the appod TM at 6 th hour and it is wet across the area of the appod TM and shows little dry area on the top left corner. Fig.27 shows the lidocaine spread throughout the appod TM at 12 th hour and it is wet across the area of the appod TM and shows little more dry area on the top left corner. Fig.28 shows the lidocaine spread throughout the appod TM at 24 th hour and it is still wet and shows more dry area on the top left corner. This pictures illustrate, by applying 240 mg of Lidocaine into the inlet as 6mL solution, it spread itself to the treatment area without using the hand and also due to the presence of the non-woven fabric and due to the presence of the top layer of the Polyurethane film layer it breaths and protect the non-woven from drying rapidly and due to the THADS TM Lidocaine is aqueous based and the once administrated THADS TM product can duration of action for 24 hours. This demonstrate “Hands free application” of a topical product and also cloths can be worn on the appod TM without getting soiled or interfering with the drug applied on to the skin and enhances the patient compliance. Attorney Docket No.732/2 PCT c) Low dose and high efficacy: The Over-the-counter topical pain marketed product Salonpas a lidocaine 4% patch contains 560 mg of drug/patch (10), directions indicate apply to affected area not more than 3 to 4 times daily (i.e., per day it requires 1680 mg to 2240 mg of lidocaine drug) and Aspercreme another marketed pain reliver path includes lidocaine 4% patch contains 246 mg /patch, Directions indicate apply to affected are not more than 3 to 4 times daily. i.e. per day it requires 738 mg to 984 mg of lidocaine, compared to 240 mg of lidocaine using THADS TM solution and THADS TM appod TM , it shows the improved and enhanced efficacy of the THADS TM system. d) Patient compliance: Adhesion issues with the marketed Transdermal Patches A commonly reported issue with topical patch products including the 5% lidocaine hydrogel patch is adhesion. FDA Adverse Events Reporting System found that for the lidocaine patch (Lidoderm), about 70% of concerns reported regarded poor product adhesion. FDA adverse events reporting system 9 FAERS public dashboard. Data as of December 31.2018 [cited 2019 Feb 13]. THADS TM appod TM from Figs.24-28 demonstrates its adherence to skin for 24 hours without any leakage or bursting or cold flow or any partial loss of adhesion or lifting at the edges in response to daily activities. This is due to the design of 3 cms of adhesion on the borders and the flexibility of the Polyurethane film. e) Effect of cold conditions on Topical products: The currently marketed topical products (Table 2) like ointment and creams uses a vehicle or base to hold the drug and when rubbed at the skin it will melt and leave the drug for the treatment, but when exposed to cold conditions the vehicle becomes hard and thick in consistency and may not release the drug in cold conditions. This was demonstrated below using the marketed topical temporary pain relief products of various formulation like creams, ointments. When the creams and ointment were at upright position at room temperature in a bottle as shown in Fig.29, after two hours of upright position and when it is inverted after 2 hours, the creams and ointment slowly moved or slide down easily as illustrated in Fig.30. When the marketed products of creams and ointment stored at refrigerated conditions for 2 hours and inverted, there is no movement of the products to its bottom, the creams and ointments became thicker and more viscous during cold conditions, this shows that these products may not work in cold Attorney Docket No.732/2 PCT conditions, during winter states like Minnesota, Michigan, Illinois, New York, and other Northern states gets colder and typical topical product may not work effectively. Whereas the THADS TM Lidocaine PD- lID-23 on the right corner in Fig.31 remained as solution and it will work in old conditions. The invention is very much required to relieve pain in cold regions of Minnesota, New York, New Jersey, and Northeastern States. The THADS TM ready to act will work in the same pattern in hot, warm, and cold conditions with is very unique to the marketed topical products. Example 2 Example 2 illustrates the THADS TM formulation its method for treatment using multi-model treatment and comparative analytical test data of the marketed products. Lidocaine 4% Topical solution for pain relief. ACTIVE INGREDIENT: THADS TM Diclofenac sodium 1.0%. Table 7 The in vitro dissolution was carried out using jacketed Franz diffusion cell and maintained the temperature at with 32 °C during this study, 3.0-micron nylon membrane was used, 30:70 ratio of the Ethanol: Purified water was used as dissolution medium, 12mL of the dissolution medium was used, 800rpm of the stirrer RPM was set during the study, the samples solution was replaced at each and every time point. The withdrawn samples were tested using HPLC. 0.5 grams of the marketed Volaren gel was added first followed by 0.5 g of Aspereme cream was added and the dissolution was performed in Franz diffusion cell and the results are shown in Table 7. Table 7 Dissolution profile of marketed combination Diclofenac sodium and Lidocaine topical products Attorney Docket No.732/2 PCT 0.5 mL of Lidocaine 4% solution from example 1 was used first followed by 0.5mL of the Diclofeanc 1% solution form example 2 was added and the dissolution was performed in Franz diffusion cell and the results are shown in Table 8. Table 8 Dissolution profile of THADS TM combination Diclofenac sodium and Lidocaine topical products Dissolution profile on Table 7, the combination of the marketed product does not show much release and the among the two drugs added, the Aspercreme cream did not show any release at all. This multimodal treatment is not feasible with the marketed product using the conventional ointment and creams. Dissolution profile on Table 8, the combination of the THADS TM product shows both the drug was released considerably at 20 minutes, the release of both the drug is not interfered and with the release of 74.2% THADS TM Diclofenac and 73.5% of THADS TM lidocaine it shows, THADS TM product can be administered for a rapid onset of action and also a successful method of multi-modal treatment in topical treatment and this system will deliver multiple drug at the same time in “ready to act state”. Example 3 The application of transdermal patches is not free from disadvantages. In fact, irritant contact dermatitis (ICD) provoked by the adhesive, the active principle or the excipients may often appear, and Attorney Docket No.732/2 PCT also allergic contact dermatitis (ACD), consequent to sensitization to the administered active principles (7). The side effects of the application of the transdermal system are primarily dues to 1) API irritation, some of the drug included in the transdermal system can cause irritation. 2) Transdermal system composed of occlusive backing polymer, which will not allow the system to breathe and also the formulation does not water in it, so it causes the dryness of the skin and causes the skin irritation 3) the adhesive in the transdermal system, most transdermal patches the adhesives are mixed with the drug in a form of matrix, the adhesive from the patches causes the irritation. The primary component that causes the skin irritation is from the adhesives. Figs.32 and 33 illustrate the blisters that form a Polyurethane film from Nexcare Tegaderm of size 4 in X 4 ¾ in sterile dressing after 24 hours of applying to the skin. Fig.32 shows a blister and rash on the skin with marketed Polyurethane dressing on the hand. Fig.33 shows a blister formed on the skin after applying marketed Polyurethane dressing for 24 hours. Lidocaine 4% Topical solution for pain relief. ACTIVE INGREDIENT: THADS TM Hydrocortisone 1.0%. Table 9 Fig.22 illustrates the THADS TM Appod TM , which has a silicone dome to pump in the THADS TM product for treatment, the pumped solution spread throughout the non-woven fabric and the Polyurethane fabric hold the appod TM in the treatment area for the desired period. THADS TM system has the Polyurethane film, which is highly breathable also the silicone dome in the appod has an inlet, which allows the skin to breathe and the THADS TM products is not mixed with Attorney Docket No.732/2 PCT adhesive and the Topical drug products that contains high amount of water in the formulation compared to marketed transdermal patches ( which has high drug load and negligible amount of water) and also THADS appod contains adhesive in the periphery of the appod, which is very less of adhesive area compared to the marketed transdermal patches keeps the skin under the appod moist and breathable and prevents the skin irritation. In some cases, the 0,5mL of the hydrocortisone 1% solution in example 3 can be added into the appod TM along with the drug product intended for treatment can be added, which prevent and eliminated the skin irritant contact dermatitis (ICD), this is a unique method of treatment of topical drug delivery system that prevents or eliminate irritant contact dermatitis (ICD). Example 4 Example 4 illustrates the THADS TM formulation efficacy, and its method for treatment. Lidocaine 4% Topical solution with inorganic salts to recover of the muscle cramps after workout. ACTIVE INGREDIENT: THADS TM Lidocaine 4.0 %. Table 10 THADS TM Lidocaine topical products with inorganic salts includes Sodium chloride, Magnesium Sulphate and Strontium Nitrate is dissolved in 40% of water and these dissolved salts helps recovery during cramps and muscle fatigue after the workout. Appod TM of Fig.22 is used, the non-woven fabric if of 12 cms diameter and it is applied after or during workout and added 6 ml of solution this helps to Attorney Docket No.732/2 PCT recover from muscle fatigue. Example 5 Shingles usually appears on the side of the chest and back, but it can also occur on the face. On the face. The rash is usually painful, itchy, or tingly. These symptoms may precede rash onset by several days, The rash develops into clusters of vesicles. New vesicles continue to form over three to five days and progressively dry and crust over. They usually heal in two to four weeks. Fig.34 is a picture of a shingles rash, and it very painful and itchy, and it is impossible to wear cloths when the rash is on the chest and back due to the itchiness and pain and the blisters. The current treatment involves oral antiviral medication followed by Lidocaine ointment or cream or transdermal patches. The pain may be a constant, dull, or burning sensation and its intensity can vary from mild to severe. One may experience sharp stabbing pains from time to time, and the affected area of skin will usually be tender. Current Treatment: FDA approved drug for the treatment of Shingles. Table 11 Attorney Docket No.732/2 PCT Sources: Mayo Clinic Current treatment of shingles requires minimum of three drugs i.e., Antiviral, Analgesic & Anti- inflammatory and continuous local anesthetic administered simultaneously to treat shingles. Shingles is impossible to treat shingles as a topical treatment with current FDA approved drugs products: Option #1: If Acyclovir is applied as topical ointment or cream, it is impossible to apply diclofenac gel or the lidocaine topical cream on top of the acyclovir ointment, so this option is not possible, if acyclovir ointment is applied as topical product, diclofenac can be taken orally, but lidocaine can’t be taken topically to relieve from itchiness. Option #2: If Diclofenac topical solution is applied then it is impossible apply Acyclovir ointment and Lidocaine cream or ointment on top of the Diclofenac topical product. Option #3: If Lidocaine topical cream or the transdermal patches can be applied and the Ayclovir and diclofenac can be taken a soral tablets. It is impossible to treat shingles with topical treatment that contains antiviral, analgesic and local anesthetic. Example 6 -THADS TM Shingles treatment Example 6 illustrates the THADS TM formulation efficacy, and its method for treatment. ACTIVE INGREDIENT: THADS TM Acyclovir 5.0 % Table 12 Attorney Docket No.732/2 PCT ACTIVE INGREDIENT: THADS TM Diclofenac sodium 2.0 % Table 13 Method of treatment: Appod TM : Apply Appod TM as shown in Fig.22 to the rashes and blister or to the area of treatment, circular with inner non-woven fabric is 12 cms diameter with 40 gsm/m 2 with no adhesive and with outer polymeric layer with 16 cms diameter and has adhesive at boundary of 4 cms and a silicone dome inlet, this appod can hold 12mL of solution. After applying the appod add on pump from the THADS TM airless container following drug products: Example 5: THADS TM acyclovir: 3mL + THADS TM Diclofenac Sodium 3 ml and THADS TM Lidocaine from example #1 of 6mL (from Figs.24-28 indicates 6mL of Lidocaine can treat for 24 Hours) This total 12 mL is administered once, if needed additional 1 or 2mL of THADS Lidocaine can be applied if needed into the appod. Table 14 Attorney Docket No.732/2 PCT The THADS TM system makes the Singles treatment very effectively compared to the conventional treatment in which, the drug is taken orally, the drugs get absorbed systemically and high doses are required along with its side effects, compared to the doses of the drugs used in THADS TM system is very low. With the THADS system it is very convenient to treat the shingles at the local/topical site and with THADS appod dose adjusted is flexible and it can be once a day. THADS TM system is an example of method of treatment that acts locally to cure the shingles rather than conventional uses of systemic drugs, low dose of drugs will be used as it uses local topical approach and due to rapid onset of action, this system is very conveniently used for multimodal drug approach and with use of Appod the cloths and bed will not get soiled and this provides high patient compliance. According to the present invention, a pharmaceutical product and the treatment of topical disease Attorney Docket No.732/2 PCT for local treatment or for systemic treatment. More specifically, a pharmaceutical solution, appod a THADS TM system for the prevention and/or treatment of various topical disease and drug intended for systemic administration can administered hand free, fast onset of action, provide exact dose, highly efficacious and high patient compliance. The efficiency of transdermal drug delivery systems using patches depends often on the rate of absorption of water from the skin and dissolve the active drug from the transdermal matrix and diffusion rate of the active substance through the skin, which on one hand depends on the active substance and its solubility and the water from the skin and dissolving the drug on the other hand the amount of water from the skin entering into the matrix and dissolve the drug varies from human being to human being, and also from the body area the patch is applied to. The constructions of the patches known from prior art usually try to control these dependencies, but the efficiency is not achieved. It is an object of the present invention to provide a topical delivery system for an which avoids the draw backs known from the prior art. It is a further object of the present invention to provide a THADS technology which is able to administrate the topical drug delivery hands free and delivery drugs, very efficaciously with high patient compliance to a subject over a period of time in a consistent and controllable way. While the present disclosure has been shown and described herein, it will be obvious to those skilled in the art that such aspects are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the disclosure. It should be understood that various alternatives to the aspects of the disclosure described herein may be employed in practicing the disclosure. It is intended that the following claims define the scope of the disclosure and that methods and structures within the scope of these claims and their equivalents be covered thereby. Any discussion of references cited in this description of the Previous Art merely summarizes the disclosures of the cited references and Applicant makes no admission that any cited reference or portion thereof is relevant prior art. Applicant reserves the right to challenge the accuracy, relevancy and veracity of the cited references. REFERENCES Attorney Docket No.732/2 PCT 1. T RANSDERMAL DRUG DELIVERY : PRINCIPLES AND OPIOID THERAPY L YN M ARGETTS , FRCA, R ICHARD SAWYER, FRCA FIPP CONTINUING EDUCATION IN ANAESTHESIA CRITICAL CARE & PAIN, VOLUME 7, ISSUE 5, OCTOBER 2007, PAGES 171–176. 2. FELDMAN SR, CAMACHO FT, KREJCI-MANWARING J, CARROLL CL, BALKRISHNAN R. ADHERENCE TO TOPICAL THERAPY INCREASES AROUND THE TIME OF OFFICE VISITS. J AM ACAD DERMATOL.2007;57:81–83. DOI: 10.1016/J.JAAD.2007.04.005. [PUBMED] 3. O LIVEIRA C., G AIO A.R., L OBO J.M.S., D E A LMEIDA I.F.M., T EIXEIRA A. D EVELOPMENT AND V ALIDATION OF A NOVEL QUESTIONNAIRE FOR ADHERENCE WITH TOPICAL TREATMENTS IN PSORIASIS (QATOP) AM. J. CLIN. DERMATOL.2017;18:571–581. [PUBMED] [GOOGLE SCHOLAR] 4. K REJCI -M ANWARING J., M CCARTY M.A., C AMACHO F., C ARROLL C.L., J OHNSON K., M ANUEL J., BALKRISHNAN R., HARTLE J., FLEISCHER A., FELDMAN S.R. ADHERENCE WITH TOPICAL TREATMENT IS POOR COMPARED WITH ADHERENCE WITH ORAL AGENTS: IMPLICATIONS FOR EFFECTIVE CLINICAL USE OF T OPICAL AGENTS . J. A M . A CAD . D ERMATOL .2006;54:S235–S236. DOI: 10.1016/J.JAAD.2005.10.060. [PUBMED] [CROSSREF] 5. KREJCI-MANWARING J, TUSA MG, CARROLL C, CAMACHO F, KAUR M, CARR D, FLEISCHER AB, JR, B ALKRISHNAN R, F ELDMAN SR. S TEALTH MONITORING OF ADHERENCE TO TOPICAL MEDICATION : ADHERENCE IS VERY POOR IN CHILDREN WITH ATOPIC DERMATITIS. J AM ACAD DERMATOL.2007;56:211–216. 6. M EDICATION THERAPY MANAGEMENT IN DERMATOLOGY : A CALL TO ACTION , A RTICLE , A PR 2021,J DERMATOL TREAT. AMARIS N GEISLER, CAITLIN G. PURVIS, DIEM-PHUONG D DAO 7. CONTACT DERMATITIS DUE TO TRANSDERMAL THERAPEUTIC SYSTEMS: A CLINICAL UPDATE ROMITA P AOLO , 1 F OTI C ATERINA , 1 C ALOGIURI G IANFRANCO , 2 C ANTORE S TEFANIA , 3,4,5 B ALLINI ANDREA, 3,4 DIPALMA GIANNA, 3,4,5 AND INCHINGOLO FRANCESCO 3, 8. HTTPS://WWW.NCBI.NLM.NIH.GOV/PMC/ARTICLES/PMC6017304/ 9. HTTPS :// DAILYMED . NLM . NIH . GOV / DAILYMED / 10. HTTPS://DAILYMED.NLM.NIH.GOV/DAILYMED/DRUGINFO.CFM?SETID=4F3 A438C-F378-4D2A-A95C- 58E56CF1E797
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