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Details for Patent: 6,103,704

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Details for Patent: 6,103,704

Title: Therapeutic methods using hyaluronic acid
Abstract:A method of accumulating a drug and a form of hyaluronic acid in the skin and/or exposed tissue of a human includes topically administering a therapeutically effective dosage amount of a formulation which comprises at least 5 mg/cm.sup.2 of the form of hyaluronic acid and a therapeutically effective amount of the drug.
Inventor(s): Falk; Rudolf Edgar (Toronto, CA), Asculai; Samuel Simon (Toronto, CA), Klein; Ehud Shmuel (Givat Savyon, IL), Harper; David William (Oakville, CA), Hochman; David (Thornhill, CA), Purschke; Don (Toronto, CA)
Assignee: Hyal Pharmaceutical Corporation (Mississauga, CA)
Filing Date:Feb 17, 1993
Application Number:08/018,754
Claims:1. A method of accumulating a drug and a form of hyaluronic acid in the skin or exposed tissue of a human, for treatment of a disease or condition of the skin or exposed tissue selected from the group consisting of basal cell carcinoma, actinic keratosis lesions, fungal lesions, "liver" spots, squamous cell tumors, metastatic cancer of the breast to the skin, primary and metastatic melanoma in the skin, malignancies and tumors in the skin, genital warts, cervical cancer, HPV (Human Papilloma Virus) infection, psoriasis, corns on the feet, and hair loss on the head of pregnant women, comprising topically administering a composition comprising (a) between about 52.2% and about 95.5% by weight of water; (b) an effective non-toxic dosage amount between about 1% and about 5% by weight of a drug selected from the group consisting of a non-steroidal anti-inflammatory drug and an anti-cancer drug; and (c) between about 1% and about 3% by weight, and at least 5 mg per square centimeter of skin or exposed tissue, of a form of hyaluronic acid selected from the group consisting of hyaluronic acid and pharmaceutically acceptable salts thereof, wherein the form of hyaluronic acid has a molecular weight between 150,000 and 750,000 daltons, and wherein the form of hyaluronic acid is effective to transport the drug through the skin or exposed tissue where the drug and the form of hyaluronic acid accumulate and remain until discharged through the lymphatic system.

2. The method of claim 1 wherein the accumulation takes place in the epidermis.

3. The method of claim 1 wherein the composition comprises more than 10 mg per square centimeter of skin or exposed tissue of the form of hyaluronic acid.

4. The method of claim 1 wherein the disease or condition is selected from the group consisting of basal cell carcinoma, actinic keratosis lesions, fungal lesions, "liver" spots, squamous cell tumors, metastatic cancer of the breast to the skin, primary and metastatic melanoma in the skin, malignancies and tumors in the skin, genital warts, cervical cancer, HPV (Human Papilloma Virus) infection, psoriasis, corns on the feet, and hair loss on the head of pregnant women, wherein the administration is repeated until the disease or condition is ameliorated.

5. The method of claim 1, 2, 3, or 4 wherein the composition comprises about 2.5% of the form of hyaluronic acid.

6. A method of transporting a drug into the epidermis or exposed tissue of a human suffering from a disease or condition selected from the group consisting of basal cell carcinoma, actinic keratosis lesions, fungal lesions, "liver" spots, squamous cell tumors, metastatic cancer of the breast to the skin, primary and metastatic melanoma in the skin, malignancies and tumors in the skin, genital warts, cervical cancer, HPV (Human Papilloma Virus) infection, psoriasis, corns on the feet, and hair loss on the head of pregnant women, and accumulating and maintaining the drug therein until discharged via the lymphatic system, comprising topically administering a composition comprising (a) an effective non-toxic dosage amount between about 1% and about 5% by weight of a drug selected from the group consisting of a non-steroidal anti-inflammatory drug and an anti-cancer drug; and (b) between about 1% and about 3% by weight, and at least 5 mg per square centimeter of skin or exposed tissue, of a form of hyaluronic acid selected from the group consisting of hyaluronic acid and pharmaceutically acceptable salts thereof, wherein the form of hyaluronic acid has a molecular weight between 150,000 and 750,000 daltons, and wherein the form of hyaluronic acid is effective to transport the drug through the skin or exposed tissue.

7. The method of claim 6 wherein the composition comprises more than 10 mg per square centimeter of skin or exposed tissue of the form of hyaluronic acid.

8. The method of claim 6 wherein the drug is an anti-cancer drug and is selected from the group consisting of novantrone and 5-fluorouracil.

9. The method of claim 6 wherein the drug is a non-steroidal anti-inflammatory drug and is selected from the group consisting of diclofenac, indomethacin, naproxen, (+/-) tromethamine salt of ketorolac, ibuprofen, piroxicam, acetylsalicylic acid, propionic acid derivatives, and flunixin.

10. The method of claim 6, 7, 8, or 9 wherein the composition comprises about 3% of the drug and about 2.5% of the form of hyaluronic acid.

11. A method for accumulating a drug in the epidermis of a human suffering from a trauma or pathology of the skin, comprising topically administering a composition comprising (a) an effective non-toxic dosage amount between about 1% and about 5% by weight of a non-steroidal anti-inflammatory drug; and (b) between about 1% and about 3% by weight, and at least 5 mg per square centimeter of skin, of a form of hyaluronic acid selected from the group consisting of hyaluronic acid and pharmaceutically acceptable salts thereof, wherein the form of hyaluronic acid has a molecular weight between 150,000 and 750,000 daltons, and wherein the form of hyaluronic acid is effective to transport the drug to the epidermis where both the drug and the form of hyaluronic acid accumulate.

12. The method of claim 11 wherein the form of hyaluronic acid is sodium hyaluronate.

13. The method of claim 11 wherein the composition comprises more than 10 mg per square centimeter of skin or exposed tissue of the form of hyaluronic acid.

14. The method of claim 11 wherein the composition comprises about 3% of the drug and about 2.5% of the form of hyaluronic acid.

15. The method of claims 11, 12, 13, or 14 wherein the drug is a drug which inhibits prostaglandin synthesis.

16. The method of claim 12, 13, or 14 wherein the drug is a non-steroidal anti-inflammatory drug and is selected from the group consisting of diclofenac, indomethacin, naproxen, (+/-) tromethamine salt of ketorolac, ibuprofen, piroxicam, acetylsalicylic acid, propionic acid derivatives, and flunixin.
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