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Claims for Patent: 5,914,322

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Claims for Patent: 5,914,322

Title: Treatment of disease and conditions
Abstract:A topically applied transdermally penetrating systemic independent acting pharmaceutical combination and formulation for the treatment of a disease or condition of the skin and exposed tissue for example, basal cell carcinoma, the precancerous, often recurrent, actinic keratoses lesions, fungal lesions, "liver" spots and like lesions (found for the most part in the epidermis), squamous cell tumours, metastatic cancer of the breast to the skin, primary and metastatic melanoma in the skin, genital warts (condyloma acuminata) cervical cancer, and HPV (Human Papilloma Virus) including HPV of the cervix, psoriasis (both plaque-type psoriasis and nail bed psoriasis), corns on the feet and hair loss on the head of pregnant women, comprising, together with pharmaceutical excipients suitable for topical application, a therapeutically effective non-toxic amount of a drug which inhibits prostaglandin synthesis administered with, or carried in, an amount of hyaluronic acid and/or salts thereof and/or homologues, analogues, derivatives, complexes, esters, fragments, and/or sub-units of hyaluronic acid (preferably hyaluronic acid and salts thereof) sufficient to facilitate the drug's penetration through the skin and tissue (including any scar tissue) at the site requiring treatment, to block prostaglandin synthesis.
Inventor(s): Falk; Rudolf Edgar (Toronto, CA), Asculai; Samuel Simon (Toronto, CA)
Assignee: Hyal Pharmaceutical Corporation (Mississauga, CA)
Application Number:08/466,774
Patent Claims: 1. A topically applied transdermally penetrating systemic independent acting pharmaceutical formulation for the treatment of a disease or condition of the skin and exposed tissue said disease or condition being selected from the group consisting of basal cell carcinoma, the precancerous, often recurrent, actinic keratoses lesions, fungal lesions, "liver" spots, lesions (found for the most part in the epidermis), squamous cell tumours, metastatic cancer of the breast to the skin, primary and metastatic melanoma in the skin, genital warts, cervical cancer, and HPV (Human Papilloma Virus), psoriasis (both plaque-type psoriasis and nail bed psoriasis), corns on the feet and hair loss on the head of pregnant women, said formulation comprising, together with pharmaceutical excipients suitable for topical application, a therapeutically effective non-toxic amount of a drug which inhibits prostaglandin synthesis administered with, or carried in, an amount of a form of hyaluronic acid selected from the group consisting of hyaluronic acid and its non-toxic salts and combinations thereof sufficient to facilitate the drug's penetration through the skin and tissue at a site requiring treatment, to block prostaglandin synthesis, wherein the molecular weight of the form of hyaluronic acid is less than 750,000 daltons and greater than 150,000 daltons and wherein the form of hyaluronic acid is present in an amount between about 1% and about 3% by weight, and wherein the drug is present in an amount between about 1% and about 5% by weight of the formulation.

2. The formulation of claim 1 wherein the drug is a non-steroidal anti-inflammatory drug (NSAID).

3. The formulation of claim 2 wherein the form of hyaluronic acid is sodium hyaluronate.

4. The formulation of claim 3 wherein the NSAID is selected from the group consisting of diclofenac, indomethacin, naproxen, and (.+-.) tromethamine salt of ketorolac.

5. The formulation of claim 3 wherein the NSAID is selected from the group consisting of ibuprofen, piroxicam, Propionic Acid derivatives, acetylsalicylic acid and Flunixin.
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