TECHNICAL FIELD:

The present invention relates to a novel topical drug delivery system useful in treatment of infections and inflammations on body surfaces of humans and animals.

BACKGROUND OF THE INVENTION:

Infections and inflammations are very common in humans and animals. Infection is an invasion of viruses, bacteria, parasites and fungi in the body; whereas inflammation is the first response of body's immune system to infection, irritation or injury caused to the body surface. Infections and inflammations can occur on any part of the body surfaces such as skin, eyes, ears, nose and mouth.

Skin forms a major part of the body surface which is exposed, and hence is most likely to get infected. Skin infections are often the result of breaks in the integrity of the skin, which enables pathogens such as virus, bacteria, fungi and yeast to inoculate into the dermis to cause infection. Skin infections can also result from a cut, scrape, insect bite, burn or any other skin wound. Skin infections caused by bacteria include acne/pimples, erythrasma, impetigo, ecthyma, folliculitis, erysipelas and cellulites. Skin infection can result in skin inflammation, which is known as infective dermatitis. Moreover infections to ears, nose and mouth that can lead to inflammation are also a growing cause of concern for humans and animals.

Topical treatment of such infections and inflammations generally involve mild cleansing of the infected site, and gentle application of required medication over the infected skin site. However, during such topical treatments, there is a possibility of contamination through hands used for applying the medication to infected site, while the hands barely reaching the site of application in certain cases, due to which hygienic and uniform application of medications to the treatment areas on body surfaces, is not achieved, and the period of treatment is further delayed. Therefore, treatments of infections and inflammations are required to achieve uniform application of medication over the treatment area, while maintaining proper hygiene of hands which is usually obtained using disposable hand gloves.

Many of the viruses, bacteria, parasites and fungi, which invade the human body and cause infections, are also capable of attacking the surface or interior of the eye, leading to eye infections and inflammations.

Eyelid is an important part of the eye, and eyelid inflammations have become a cause of major concern for most of the people suffering from eye diseases. Blepharitis, meibomitis, blepharoconjunctivitis, ocular rosacea, styes and chalazion are some of the eye diseases causing eyelid inflammation, which results into eye irritation, eye itching, eye discharge, excessive tear production and eye discomfort.

Blepharitis is an inflammation of the eyelids, particularly at the margins of the eyelids, caused due to collection of oil, dandruff, mucin, bacteria, pollutants or eye makeup on and around the eyelids and eyelashes. In blepharitis, dandruff-like scales and particles are formed along the eyelid margins and base of eyelashes. Blepharitis is mainly classified into i) anterior blepharitis that affects the outer margin of the eyelids where the eyelashes are located; and ii) posterior blepharitis that affects the inner rim of eyelids where the meibomian glands are situated. Blepharitis can occur as staphylococcal blepharitis, seborrhoeic blepharitis, allergic blepharitis, ulcerative blepharitis and/or blepharitis caused due to skin cancers or systemic medical conditions. Severe blepharitis can be associated with conjunctivitis, known as blepharoconjunctivitis.

Meibomitis is an inflammation of the meibomian glands located in the eyelids, and is very closely related to blepharitis. Meibomitis is also known as meibomian gland dysfunction (MGD), wherein the meibomian gland openings on the eyelid margins become blocked with inspicated meibomian secretions, and the oil secreted by the meibomian glands is thicker and has a milky appearance, rather than a clear oil that prevents tear evaporation, thus leading to eye irritation. Blepharitis usually exists as a chronic condition, and chronic blepharitis can cause chronic meibomian gland dysfunction.

Ocular rosacea is as an inflammatory eye condition which causes persistent burning and a feeling of grittiness in the eyes, or inflamed/swollen eyelids with small-inflamed lesions. In ocular rosacea, the eyes become red or bloodshot, and sometimes eye lashes fall out. The ocular symptoms of rosacea are exceedingly variable and include blepharitis.

Eyelid inflammations such as blepharitis, meibomitis, blepharoconjunctivitis, causes flaking of the skin on eyelids, crusting at eyelid margins, crusting of eyelashes, flaking of eye lashes, eye itching, eye irritation, burning of the eyes, redness of eyes/eyelids, swollen eyelids, gritty sensation in eye, eye discomfort, excessive tearing, gluing of the eyelashes, sticking of eyelids, infectious yellowish/greenish discharge from eyelids, and blurred vision. Blepharitis may localize in the skin of the eyelids, causing a stye or a chalazion. It may even lead to trichiasis, eyelash loss, ectropion and entropion. Some people may develop allergy to the scales or surrounding bacteria near the eyelid margins and eyelashes, leading to more serious complication with inflammation of other eye tissues such as the cornea, and may even lead to loss of vision.

Eye inflammations as well as eye infections, need to be controlled with good eye hygiene. Long-term eye care helps to ease the symptoms of eye infections and inflammations, and prevent it from recurring.

Topical treatments are often used as first-line treatments for eye infections and inflammations. Eye infections and inflammations can be treated within days to weeks depending on its severity. Eye infections are treated utilizing medications, while eyelid inflammations are treated utilizing a combination of eyelid scrubs and medications.

In topical treatment of eyelid inflammations such as blepharitis, meibomitis and blepharoconjunctivitis, medications are applied to the eyelid margins and eyelashes by use of cotton swabs/buds which are soaked or moistened in the solution of medication to rub along the eyelid margins, for at least three to four times a day. The cotton swabs/buds are used for removing the scaling and flaking around eye lashes, excess sebum production, oily scaly eye discharge, and crust and debris accumulated on and around the eyelashes and eyelid margins.

However, the use of cotton swabs/buds, for cleansing eyelid margins and eyelashes during treatment of eyelid inflammations seems to be improper due to the following reasons: i) The large and bulky tip of the cotton swab/bud is not suitable for applying the medication particularly and precisely over the eyelid margins and between the eye lashes, due to which thorough cleansing of eyelid margins and eyelashes is not achieved. ii) Excessive amount of medication gets soaked into the large and bulky tip of the new cotton swab/bud, each time before application of the medication to the eyelid, which leads to wastage of medication during cleansing of eyelids and eyelashes. Due to application of medication through such cotton swabs/buds soaked with excessive medication, some amount of medication is bound to enter into the patient's eye during cleansing of eyelids and eyelashes, leading to eye irritation & discomfort, which makes the cotton swab/bud unsafe for eye use. iii) Fluctuating amounts of medication gets soaked into each new cotton swab/bud used for application of medication to the eyelid, which seems to be an improper way for cleansing of eyelids and eyelashes. iv) The cotton swab/bud does not provide a firm gripping with controlled movement of the bud over the eyelid margins and eyelashes for application of the medication, resulting in damaging of the surrounding eye tissues, and further failing to provide thorough cleansing of eyelids and eyelashes, which makes the cotton swab/bud unsafe for eye use. v) The handling, usage and disposal of several cotton swabs/buds, each time during the cleansing of eyelid margins and eyelashes, is quite tedious, inconvenient and unhygienic. vi) Patient comfort is not achieved, as the patient has to dip a new cotton swab/bud into the medication each time, before application of medication to the eyelid for cleansing. Also, the patient hesitates to apply the medication to the eyelids and eyelashes, in front of others. Moreover, containers/bottles of medications need to be purchased and carried by the patients in their bags or purses, while prone to spillage, during traveling to work places and outdoor places, which is quite inconvenient for the patients.

Thus,from the aforementioned problems observed during treatment of eyelid inflammations, it is clear that there is a need for applicator for treatment of eyelid inflammations that provide thorough cleansing of eyelids and eyelashes, along with the application of medications in a safe and controlled manner.

Also, there exist a need for an applicator which provides hygienic and uniform application of medications to the affected areas of body surfaces in treatment of infections and inflammations, as treatment of infections and inflammations need to be controlled with good hygiene to provide effective and fast results of topical treatments.

There exists several applicators in prior art for individual treatments of body surfaces such as skin, eyes, ears, nose and mouth. However, the present inventors have designed a topical drug delivery system useful in treatment of infections and inflammations on body surfaces of humans and animals, which can apply medications on diverse application areas of body surface including surfaces of eyes, eyelids, eyelid margins, skin surface, external ear surface, nostrils and oral mucous membranes, in a safe, controlled and hygienic manner.

SUMMARY OF THE INVENTION:

The present invention discloses a topical drug delivery system useful in treatment of infections and inflammations on body surfaces including surfaces of eyes, eyelids, eyelid margins, skin surface, external ear surface, nostrils and oral mucous membranes of humans and animals. The topical drug delivery system (1) of present invention, comprises

- a hollow casing (2) having an application end (7) and a non-application end(6) ;

- a medical core member (8) extending in an axial direction within thecasing (2) ;

- a liquid medication contained within the medical core member, and comprising at least one pharmaceutically active substance to be applied over an area of body surface to be treated;

- an applicator tip (3) protruding through the application end (7) of the casing;

- a removable end cap (4) to be fitted over the applicator tip (3) for protecting the tip; • and

- a top cap (5) tightly fitted over the non-application end (6) of the casing, to safely contain the medical core member within the casing.

In the present invention, the medical core member containing the liquid medication, is held safely within the casing, in close contact with the applicator tip. The medical core member stores, retains and transports the liquid medication within the casing to the applicator tip. When the applicator is in use, the applicator tip can be precisely dabbed over or rubbed across the body surface area to be treated, so as to apply the medication over the treatment area, without contamination through hands.

The topical drug delivery system of the present invention, provides a finer, safer, hygienic and more convenient way of applying medications to body surface areas, which leads to effective and quick treatment of inflammations and infections.

BRIEF DESCRIPTION OF THE DRAWINGS:

In the accompanying drawings:

Fig. 1 is a perspective view of a topical drug delivery system of the present invention. Fig.2 is a cross-sectional view of a topical drug delivery system of the present invention. Fig. 3 illustrates the technique of application of a liquid medication to a lower eyelid margin of a blepharitis-infected eye, through use of the topical drug delivery system of the present invention.

Fig. 4 illustrates the technique of application of a liquid medication to an infected body surface area, through use of the topical drug delivery system of the present invention.

Fig. 5 depicts a microscopic sketch of a healthy skin-hair/eyelash having circular cutical layers into which the medication gets delivered using the topical drug delivery system of the present invention.

Fig. 6 shows a microscopic sketch of an inflamed skin-hair/eyelash having ruffled cuticle layers with longitudinal grooves, and into which the medication gets delivered using the topical drug delivery system of the present invention.

DETAILED DESCRIPTION:

The present invention will now be described with reference to the accompanying drawings.

Figure 1 refers to a perspective view of the topical drug delivery system (1) of present invention, which serves as an applicator for treatment of infections and inflammations on the body surfaces. The topical drug delivery system comprises a hollow casing (2) having an application end (7) and a non-application end (6); a medical core member extending in an axial direction within the casing (2); and an applicator tip (3) protruding through the application end (7) of the casing. The casing (2) is sealed at the non-application end (6) with a top cap (5) to safely contain the medical core member within the casing (2). The medical core member contains a liquid medication comprising at least one pharmaceutically active substance to be applied over an infected/inflamed body surface area to be treated. A removable end cap (4) is mounted over the application end (7) of the casing, in order to protect the applicator tip (3). The casing (2) has a flange (2a) near its application end (7), and the removable end cap (4) correspondingly has an internal recessed portion (4a) to fit over the flange (2a) for secured mounting of the cap over the application end (7) of the casing. However, different conventional mechanisms can be utilized for secured mounting of the top and end caps over the casing. The removable end cap can be of any shape that securely fits over the application end of the casing. Moreover, the removable end cap may be provided with a clip, so as to hook the applicator to the user's pocket or belonging.

Fig. 2 is a cross-sectional view of the topical drug delivery system (I) of present invention, which shows the medical core member (8) impregnated with the liquid medication (9),extending axially within the hollow casing (2). The medical core member (8) stores, retains as well as transports the liquid medication (9) within the casing. (2) to the applicator tip (3) that protrudes through the casing. The medical core member (8) is in close contact with the applicator tip (3), and is safely held within the hollow casing (2) with the help of a screwed cap (5) fitted over the casing. Although not shown in the figure, a spring member, a valve assembly and/or a dispensing mechanism, may be fitted within the casing, to regulate the flow of liquid medication through the applicator tip.

The liquid medication used in present invention, comprises at least one pharmaceutically active substance selected from but not limited to the group consisting of anti-infective and antiseptic agents. The concentration of liquid medication ranges from 0.001% to 10%.

Antiseptic agents are used for destroying fungi, bacteria, virus and other biological pathogens on the body surfaces. The antiseptic agents used in the present invention include but are not limited to alcohols such as ethanol, propanol, isopropanol or mixtures thereof, chlorbutanol, benzalkonium chloride, chlorhexidine and derivative thereof, povidohe-iodine alone or in combination with methylated spirits or detergents, tincture iodine, cetrimide, benzethonium chloride, boric acid, hydrogen peroxide, sodium chloride, sodium hypochlorite, calcium hypochlorite, sodium bicarbonate, thymol, thiomerosal, thiomersalate, hexachlorophene, triclosan, sodium 3,5-dibromo-4- hydroxybenzenesulfonate, polyhexanide and mixtures thereof . Anti-infective agents are used for removing the organisms causing infection from the body surfaces. The anti-infective agents used in the present invention comprises antibacterials, antifungals and antiparasitics, which include but are not limited to penicillin, streptomycin, tetracyclines and derivative thereof, fluoroqinolones such as ciprofloxacin, ampicillin, amoxicillin, gentamicin, vancomycin, clindamycin, erythromycin, azithromycin, polymyxin, bacitracin, neomycin, polysporin, chloramphenicol , sulfaacetamide and its salts/derivatives, sulfur and mixtures thereof.

In one aspect of invention, the medical core member is an absorbent material impregnated with the liquid medication, wherein the absorbent material is selected from but not limited to natural or synthetic absorbent fibers, such as cotton, sponge or foam. Moreover, the medical core is encased within a thin impervious material, while being exposed at both the axial ends, to prevent the oozing of the liquid medication from the delivery system.

In another aspect of invention, the medical core member is a container containing the liquid medication, and the container is provided with a valve assembly and/or a dispensing mechanism, to control the dispensing of liquid medication from the container.

The applicator tip of the drug delivery system of the present invention, is soft enough to be dabbed, moved or rubbed across the area of body surface to be treated, without causing pain, discomfort or damage to the patient. The applicator tip is designed to have varied shape and width, and made of varied materials of construction, depending on the area of body surface to be treated for infection or inflammation, so as to conveniently deliver the medicated drug at the treatment area of the patient, without causing pain or damage. The shape of the applicator tip can be circular, triangular, cylindrical or rectangular in nature. The width of the applicator tip is in the range of 20 microns to 5000 microns.

The applicator tip of the drug delivery system of present invention, is made of a material selected from a group consisting of natural fibers such as cotton fibers, synthetic fibers such as nylon fibers and polyester fibers, felt, porous sponge, synthetic foam such as polyurethane foam, polymers such as polyethylene, polypropylene and polytetrafluoroethylene, and other conventional materials used for making applicator tips. The. hollow casing, medical container and the caps of the drug delivery system of the present invention, are made from impervious material selected from but not limited to polymeric materials such as plastic, polyester, polyethylene and polypropylene, metal, glass and wood. Moreover, the height and width of the casing of applicator will differ depending on the location of body surface to be treated for infection or inflammation, and corresponding changes will be acquired for the width and heights of the container encased within the casing, as well as the caps of the applicator.

Fig. 3 illustrates the technique of application of a liquid medication to a lower eyelid margin (10) of a blepharitis-infected eye, through use of the applicator of the present invention. Accordingly, as the fine tip (3) is brought in contact and rubbed across the lower eyelid margin (10) and eyelashes (12), the liquid medication flows out from the fine tip (3) to be applied across them for cleansing of eyelids and eyelashes. In a similar manner, the liquid medication can be applied to the upper eyelid margin ( 1 1) and eyelashes (12) for cleansing of eyelids and eyelashes.

Most of the anti-infective medications show poor permeability into skin, and hence bacteria residing deeper in the skin or beneath the skin surface and in the hair follicles, often remain unaffected by the conventional methods, further worsening the skin condition.

Figure 4 illustrates the technique of application of a liquid medication to an infected area (13) of a body surface (14) using the topical drug delivery system (1) of the present invention, which has an applicator tip (3) specifically designed for application of medication over the desired body surface (14) to be treated. The application of anti- infective medication using the topical drug delivery system of present invention, enables the anti-infective medication to reach deeper within the skin, beneath the skin surfaces and also in the hair follicles, thus killing the bacteria residing therein and providing an effective skin treatment.

FIG. 5 shows a microscopic sketch of a healthy skin-hair/eyelash having circular cutical layers (15) which serve as natural reservoirs for the liquid medication (16) applied using the topical drug delivery system of the present invention, thus offering a long lasting effect of the applied medication to provide an effective treatment.

During infections and inflammations of skin and eyes, skin hair and eyelashes exhibit ruffled cuticle layers with longitudinal grooves, within which pathogenic fungi, yeast and bacteria reside that further worsen the skin/eye condition. FIG. 6 shows a microscopic sketch of an inflamed skin-hair/eyelash having ruffled cuticle layers with longitudinal grooves (17), and into which the liquid medication (16) gets delivered using the topical drug delivery system of the present invention. When the drug delivery system of present invention is applied across the infected skin site or eyelid margins and eye lashes, the applicator tip enables the liquid medication (16) to be deposited into the ruffled cuticles and longitudinal grooves (17) of the skin-hair or eyelash, thus offering a long lasting effect of the applied medication, killing off the pathogenic fungi, yeast and bacteria, and providing an effective and facile treatment for the infections and inflammations on the body surfaces of humans and animals.

The topical drug delivery system of present invention is useful in treatment of infections and inflammations on body surfaces of humans and animals, and can uniformly apply medications on diverse application areas of body surface including surfaces of eyes, eyelids, eyelid margins, skin surface, external ear surface, nostrils and oral mucous membranes, in a safe, controlled and hygienic manner.

The topical drug delivery system of present invention is designed & dimensioned to be held conveniently in the hand with a firm grip, for application of the medication precisely over the treatment area, and without contamination through hands. The drug delivery system of present invention safely contains the desired medication, and applies the medication to the treatment area without any spillage. As a result, the drug delivery system provides easy, hygienic and safe application of the medication to the body surfaces to be treated, in a convenient manner. The novel topical drug delivery system of present invention is portable and can be easily carried in pockets and purses, without causing any inconvenience during travel. The topical drug delivery system is cost effective, and is easily affordable by common people.

As a result, the topical drug delivery system of present invention provides a hygienic, safer, finer and convenient way for application of medication to the body surface areas for treatment of inflammations and infections on body surfaces of humans and animals, while preventing contamination through hands, and leading to facile and effective treatment.

The topical drug delivery system of present invention serves as an applicator in treatment of skin infections e.g. acne, eye infections, external ear infection, nostril infection, oral mucous membranes infections, and inflammations thereof which may be allergic, immunological or traumatic in nature.

The use of topical drug delivery system is particularly advantageous in treatment of eyelid inflammations such as blepharitis, meibomitis and blepharoconjunctivitis, as the applicator tip can precisely apply as well as rub the medication to the eyelid margins and eyelashes, providing a thorough cleansing of the eyelids and eyelashes, while reducing the risk of entering of the medication into the patient's eye, and thus avoiding eye irritation and discomfort'. Thus, the applicator of present invention provides a finer, safer and convenient way for application of medication to the eyelids and eyelashes in effective dose concentrations for eye cleansing during treatment of eye inflammations, leading to effective and quick treatment of eye inflammations.

The advantages of using the topical drug delivery system of present invention in treatment of inflammations and infections related to eyes and eyelids such as blepharitis, meibomitis and blepharoconjunctivitis, are stated as follows: i) The applicator offers a pen-like comfort with a firm grip and a fine tip for applying medication over the eyelids and eyelashes with better control and precision, and prevents the applied medication from entering into the patient's eye during the application, thus avoiding eye irritation & discomfort which makes the applicator safe for eye use. ii) The applicator provides thorough cleansing of eyelid margins and base of eyelashes due to its fine applicator tip which effectively reaches between the eyelashes; and applies the medication easily and uniformly over the eyelid margins and in between the eyelashes, while preventing the medication from entering into the eye. iii) The applicator contains measured quantities of medication already within it, to be dispensed for each application to the eyelids, thus making the applicator easy to be

- used by the patient during cleansing of eyelids and eyelashes. iv) The applicator applies the medication with greater ease and greater efficiency, while minimizing the risk of eye injury. ^" v) The applicator provides improved patient comfort due to its ease of handling and use, and ease of disposal with hygiene and safety. The applicator eliminates the use of gloves and there is no possibility of contamination of the hands, during application of medication by the applicator. Also, the applicator is superior in terms of portability and storage. vi) The applicator facilitates the treatment for inflammation and infection related to eyes and eyelids. For example: When a liquid medication of 5% povidone iodine solution which is known to have a pH of 5.4, is brushed across the eyelashes of the infected eye, using the topical drug delivery system of the present invention, said solution rightly reaches at the root of the eyelashes or in the meibomian gland posterior to the eyelashes, which are considered to be the main sites of infection. And, since the pH of a cyst or an abscess or a septic focus at the root of the eyelashes or in the meibomian gland posterior to the eyelashes, is known to be alkaline i.e around 8, the said solution pH being acidic, rightly neutralizes the pH at said sites of infection, and thus makes the environment hostile for the infection-causing germs that grow in such alkaline pH at these sites, consequently enabling the patient to get rid of the inflammation and infection related to eyes and eyelids, in a facile manner.

Thus, the use of topical drug delivery system of present invention is advantageous over the prior art cotton swabs useful in treatment of inflammations and infections related to eyes and eyelids, such as blepharitis, blepharoconjunctivitis, meibomitis and ocular rosacea, while preventing styes, chalazion, trichiasis, eyelash loss, ectropion and entropion.

The topical drug delivery system of present invention, serves as an applicator in treatment of infections and inflammations related to eyes, eyelids, skin, external ear, nose and mouth. The topical drug delivery system thoroughly cleanses as well as uniformly applies the liquid medications on diverse body surface areas of humans and animals, including surfaces of eyes, eyelids, eyelid margins, skin surface, external ear surface, nostrils and oral mucous membranes, in a safe, controlled and hygienic manner, leading to facile and effective treatment. The topical drug delivery system of present invention, can be used for applying liquid medication to cuts and wounds or to desired body surface areas prior to surgery, and can be used in dental surgery.