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Title:
SORE RELIEF FORMULATION
Document Type and Number:
WIPO Patent Application WO/2011/045803
Kind Code:
A1
Abstract:
The present invention relates to sore relief formulations containing calamine, zinc oxide and boric acid as well as a method for preparing the same.

Inventors:
LUTHRIA AKSHAY (IN)
VIJAY LUTHRIA VANDANA (IN)
Application Number:
PCT/IN2009/000574
Publication Date:
April 21, 2011
Filing Date:
October 13, 2009
Export Citation:
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Assignee:
LUTHRIA AKSHAY (IN)
VIJAY LUTHRIA VANDANA (IN)
International Classes:
A61K9/14; A61K33/30; A61P17/02
Foreign References:
US20040022863A12004-02-05
US20030158165A12003-08-21
AU2003218281A12003-11-03
Attorney, Agent or Firm:
VAIDYANATHAN, Anuradha et al. (2nd Cross3rd Block,3rd Stage,Basaveshwaranagar,Bangalore 9, Karnataka, IN)
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Claims:
CLAIMS:

1. The Sore relief formulation for Bedsore can be prepared easily at normal laboratory conditions, which comprises of Calamine, Zinc Oxide and Boric acid and it gives relief to the patients suffering from bedsores.

2. The Sore relief formulation for Bedsore as claimed in claim 1, wherein Calamine is contained in the range of 400 to 3000gms.

3. The Sore relief formulation for Bedsore as claimed in claim 1, wherein Zinc Oxide is contained in the range of 200 to 800gms.

4. The Sore relief formulation for Bedsore as claimed in claim 1, wherein Boric acid is contained in the range of 200 to 1 OOOgms.

-.5. A method of preparing Sore relief formulation for Bedsore comprising the step of mixing calamine and zinc oxide to obtain a finely powdered baby pink powder, adding boric acid to the resultant mixer at a temperature ranging from 16 to 20° C, followed by filtering the mixture in a filtration machine to obtain a fine, smooth powder.

Description:
SORE RELIEF FORMULATION

BACKGROUND

FIELD OF INVENTION

The present invention relates to a sore relief formulation for bedsores, which is a concoction of medicinal powders. The application eases the pain and provides relief to the sores caused to bed ridden patients. Its application is external.

DISCUSSION OF PRIOR ART

Bed sores are ulcers that occur on areas of the skin that are under pressure from lying in bed, sitting in a wheelchair, and/or wearing a cast for a prolonged period of time. Bed sores can occur when a person is bedridden, unconscious, unable to sense pain, or immobile. Patients, who were bedridden and not properly repositioned, would often develop ulcerations or sores on their skin, typically over bony prominences such as sacrum, elbows, knees and ankles etc. These bed sores, which result from prolonged pressure, are also called "decubitus ulcers" (consequence of lying in one position too long), "pressure sores," and "pressure ulcers." Bed sores result when prolonged pressure prevents sufficient blood flow to supply the tissues with nutrients. The resulting bed sore represents the death of the involved soft tissues, then bedsore stats as a red, painful, which finally turns purple. If the bedsore left untreated, the skin can break open and become infected. A bed sore can become deep, extending into the muscle. Once a bed sore develops, it is often very slow to heal.

People who are bedridden or cannot move to change their position in bed are at a high risk of developing bed sores. Once sores develop, they progress quickly and it is difficult to heal them. There are four stages of bed-sore development, and, if left untreated, complications can occur. When a sore begins to develop in first stage, the infected area initially becomes red. In this emerging stage, the sore may cause itchiness and intense pain when pressure is applied to the area. The affected area may be warm when touched, or feel spongy in texture and painful to the patient. If the affected area is properly cared for, and prevented from progressing further, a sore at this stage can heal.

Stage II affects the outermost layer of the skin (the epidermis) and the skin's deeper layer (the dermis). At this stage the wound will begin to open into a sore that is similar in appearance to a blister or abrasion.

Stage III is a crucial stage in the development of a bed sore and it will extended through all the skin layers down to the muscle, damaging or destroying the affected tissue and creating a deep, crater-like wound.

By stage IV, the advancement of sore development is serious. In this stage the necrosis or tissue death of the skin will occur and it affects muscle, bone, and the tendons.

If bed sores are left untreated, serious complications can result, including cellulitis, an infection of the skin that can cause swelling and severe pain. Cellulitis can lead to sepsis or to meningitis, an infection of the brain and spinal cord.

Pressure sores are more likely to develop in people subject to one or more risk factors. While risk factors may vary depending upon the particular circumstances, the following represents a list of the most common: 1. Sensory perception- An individual with decreased mental awareness may not have the level of sensory perception or ability to act to prevent the development of pressure- induced injury. The lack of mental awareness may arise from medications.

2. Moisture - Sources of moisture on the skin from urine, stool, or perspiration can irritate the skin. 3. Activity and mobility- Persons confined to beds, chairs, or wheelchairs who are unable to move themselves, can develop pressure-induced injuries in as little as 1-2 hours if the pressure is not relieved;

4. Nutrition - Bed sores are more likely to form when the skin is not properly nourished. 5. Friction and shear - slightest rubbing between a hard surface and skin stretched over bones, can cause minor pressure ulcers.

The damage first appears on the skin surface as a red or dark patch. As the sore progresses, the skin will break down to form blisters, dead skin, and ultimately infect underlying tissues, bones and joints. Skin damage can also be exacerbated by friction and moisture. The area is painful, firm, mushy, boggy, warmer and cooler as compared to adjacent tissues. In the early stages, pressure sores can be treated at home by relieving the pressure, cleaning the sores and applying the appropriate dressing. In the later stages of severity, professional medical treatment, possibly, surgery will be necessary. The Common treatments of. bed sores include removing pressure on the affected area, protecting the wound with medicated care, keeping the wound clean, use of antibiotics, pain relievers, ointments and surgical removal of dead tissue etc.

Treating bed sores can be difficult. The open wounds of bed sores are slow to heal, and often the skin and other tissues have already been damaged or destroyed. Infected sores heal slowly and the infection can spread to other parts of the body. The best cure for bed sores is prevention.

The dead or necrotic tissue can be removed by autolytic debridement, biological debridement, chemical debridement, mechanical debridement, sharp debridement, surgical debridement and ultrasound -assisted wound therapy. In bed sores the skin turns black or becomes inflamed, tender, swollen, or warm to the touch, the patient develops a fever, pain, erythema, oedema and a bedsore contains pus or has a foul-smelling discharge. This infection can be controlled by treating the bed sores with antiseptics and antimicrobials. The patients suffering form bedsores must be properly nourished because a malnourished person does not have the ability to synthesize enough protein to repair tissue. The patients should take dietary supplements and nutrients like arginine, glutamine, vitamin A, vitamin B complex, Vitamin E, vitamin C, magnesium, manganese, selenium and zinc etc with proper consultation with dietitian.

The pressure should be removed immediately by lifting the patient from the area and the patient being turned at least every two hours. The pressure can be relieved by using standing frames, dry sheets, impermeable dressing, cushion featuring pressure relief components, pressure- distributive mattress etc. Education should be given to the patient family and caregivers on measures to be taken to avoid pressure sores, proper way to turn the patient, how to properly dress the wound, how to properly nourish the patient, and how to deal with crisis, among other things.

Ί The patients suffering form Stage I or II bed sores, .the care giver should use the ·;. guidelines established by the American Medical Directors Association (AMD A) for the treatment of these low-grade sores.

The treatment of Stage III or IV ulcers includes surgery such as a tissue flap, skin graft or other closure methods. The widely used method is Negative Pressure Wound Therapy, wherein the topical negative pressure is applied to the wound. A vacuum is used to reduce pressure around the wound, drawing out excess fluids and cellular wastes. In this therapy, the foam is placed into the wound cavity, which is then covered in a film which creates an airtight seal. This vacuum seal helps the technician to remove exudates and other infectious materials.

Bed sores several complications include autonomic dysreflexia, bladder distension, osteomyelitis, pyarthroses, sepsis, amyloidosis, anemia, urethral fistula, gangrene and very rarely malignant transformation. Sores often recur because patients do not follow recommended treatment or develop seromas, hematomas, infections, or dehiscence paralytic patients are the most likely people to have pressure sores recur. In some cases, complications from pressure sores can be life threatening. The most common causes of fatality stem from renal failure and amyloidosis.

Indian Patent application no. 769/BOM/1999 discloses Faster and qualitatively better healing of surface wounds of various burns that provides application of Lysine/Lysine - HCI Lysine HBr in L, D and DL forms in combination with suitable base, additives and preservatives for healing of superficial and deep wounds.

Indian Patent application no. 293/KOLNP/2008 discloses Biomaterials based on carboxymethylcellulose salified with Zinc associated with hyaluronic acid derivatives wherein the biomaterials are used in from of non-woven felts at various percentages for use in treatment of pressure sores, burns, wounds and protective action with antibacterial and antifungal action. US Patent no. 6911196 (A 1) discloses an Topical medicament for treating nappy rash wherein the invention relates to the method containing a combination of Salicylic acid, Boric acid, tannic acid, Zinc Oxide, calamine and lanolin and oils like Olive Oil, Cod Liver Oil and white petroleum jelly is used for treating nappy rash. The fact that makes it most effective against nappy rash and other similar dermatological disorders is its anti- septic nature combined with its sealing ability, the introduction of both Tannic and Salicylic Acids into the formula makes it a one of a kind formula since it is the first formula to use these acids in the treatment of nappy rash.

China Patent no. 1100954 (A) discloses Pearl powder for curing bedsore that includes pearl, fresh rhubarb, coptis root, Scutellaria root and talcum powder that provides characteristics of promoting blood circulation, clearing and activating the channels and collaterals, clearing away heat and detoxicating, antibiosis and regeneration of tissue.

CN 101185696 (A) discloses Cream shape medicine for treating II or III degree bedsore wherein raw materials of ephedra, cortex phellodendri, cinnabar, ligusticum chuangiong hort, indigo naturalis and clalamine are used to prepare an egg white colored cream for treating II or III degree bedsore.

CN 1190008 (A) discloses Tissue regeneration promoting ointment for curing bedsore that includes medicinal materials like tortoise plastron, Renhmannai glutinosa, Chineseangelica are filtered after they are decocted in hot sesame oil for 30- 40 min to remove the residue and then decocted with calamine powder and gypsum powder for 30 - 50 min, beeswax is used as vaseline and vehicle for the extract and the extract is cooled at 30-40°C and mixed with rubber powder, crinis carbnisatus powder and Resina Draconis powder to obtain a Ointment.

US Application no. 20060035957 discloses Preventive or remedy for bedsore wherein the N-acetylated derivative of hydroxyproline is used treating the bedsore.

SUMMARY OF THE INVENTION

.

This invention provides a unique sore relief formulation, the topical application of which provides great relief from bed sores. The major components of this wonder drug are Calamine, Zinc Oxide and Boric Acid. Patients suffering for a long time from various ailments who are bed ridden develop bedsores. From the description hereinbefore, it can be understood that bedsores are cause for concern and the same needs to be addressed in an effective manner.

With the advent of the formulation of the present invention, the patients will be able to apply this powder externally on to the severely effected areas and observe the results in as less than a couple of days. The powder has no side effects and can be easily applied to any part of the body. The powder is not restricted for anyone on the basis of age or gender. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The powders of Calamine (range- 400 to 3000gms), Zinc Oxide (range - 200 to 800gms), Boric acid (range - 200 to lOOOgms) are all mixed together finely to obtain a baby pink colored powder.

Firstly, using gloves Calamine packets are carefully opened and mixed with Zinc Oxide in the machine that carefully blends them together without any human intervention. To this mixture boric acid is later added and allowed to blend further.

This arrangement is to be carried out in & under, clan & germ free condition in a lab/room, which is cooled by an air conditioner (temperature ranging from 16- 20 degrees centigrade). The blended mixture now needs to undergo the filtration process. The coarse mixture of Calamine, Zinc Oxide and Boric acid needs to be passed through a filtration machine, which filters the powder 3 times'which results in achieving the desired level. This desired level is a fine, smooth powder, which is soft and soothing to the skin. Quality check is carried out to ensure the powder has reached its fine and smooth texture. The finely prepared, bay pink powered will be carried out to packaging area, where they will be stored in airtight containers/ sachets, ranging from lOOgms, 200gms, 500gms and lOOOgms. These containers/sachets are then to be stored in a cool and dry place. To obtain full effectiveness of the powder, it needs to be used/applied during its productive life of 2 years from the day of manufacturing. For best results the powder can be applied liberally twice a day over the affected areas.

The wonder drug here in particular contributes heavily in the following ailments and diseases. 1. Baby Diaper rash

2. Bedsores 3. Pimples, Acne, Boils & various skin allergies

4. Rashes on thighs during the heat of the summer

5. Helps in enhancing the face complexion (Dark circles)

6. Cellulitis (in diabetic patients).

Examples

EXAMPLE 1 : 400gms of Calamine powder is mixed with 200gms of zinc oxide in a blender for a period of half an hour to one hour. 200gms of boric acid is added to the resultant mixer and the same is again blended.

The mixture is removed from the blender and dissolved in lOlitres of water or (is there any other liquid one could use as a solvent) and filtered in a filtration machine. The said machine filters the ingredients three times to obtain a fine, smooth powder.

The fine powder is then packed in airtight containers/sachets, which are stored in a cool and dry place.

EXAMPLE 2: 800gms of Calamine powder is mixed with 200gms of zinc oxide in a blender for a period of half an hour to one hour. 200gms of boric acid is added to the resultant mixer and the same is again blended.

The mixture is removed from the blender and dissolved in lOlitres of water or (is there any other liquid one could use as a solvent) and filtered in a filtration machine. The said machine filters the ingredients three times to obtain a fine, smooth powder.

The fine powder is then packed in airtight containers/sachets, which are stored in a cool and dry place.