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Details for Patent: 6,136,793

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Details for Patent: 6,136,793

Title: Formulations containing hyaluronic acid
Abstract:A method of treating a disease or condition comprising administering topically to the skin or exposed tissue of a human, a dosage amount of a pharmaceutical composition, said dosage comprising a therapeutically effective amount of a drug to treat said disease or condition and a form of hyaluronic acid characterized in that the composition is immediately available to transport the drug percutaneously into the epidermis of the skin or exposed tissue to the site of trauma or pathology of the disease or condition to be treated.
Inventor(s): Falk; Rudolf Edger (Toronto, CA), Asculai; Samuel Simon (Toronto, CA), Hochman; David (Thornhill, CA), Purschke; Don (Toronto, CA), Klein; Ehud Shmuel (Givat Savyon, IL), Harper; David William (Oakville, CA)
Assignee: Hyal Pharmaceutical Corporation (Mississauga, CA)
Filing Date:Jun 06, 1995
Application Number:08/466,715
Claims:1. A method of treating a disease or condition in humans, said disease or condition selected from the group consisting of i) involving underperfused or pathological tissue; and ii) of the skin or exposed tissue, the method comprising topically administering a pharmaceutical composition from which effective non-toxic dosage amounts may be taken and applied to skin or exposed tissue of a human, each effective dosage amount comprising pharmaceutical excipients suitable for topical application, an effective non-toxic dosage amount of a drug to treat the disease or condition of a human and an effective non-toxic dosage amount of a form of hyaluronic acid selected from the group consisting of hyaluronic acid and its non-toxic salts and combination thereof sufficient to transport the drug, to a site in the skin, epidermis or exposed tissue of the disease or condition for percutaneous transport into the skin or exposed tissue to accumulate and remain there for a prolonged period of time and which is systemic independent acting and wherein the concentration of the drug is 3% by weight and the concentration of the form of hyaluronic acid is 2.5% by weight having a molecular weight less than 750,000 daltons and greater than 150,000 daltons and wherein the dosage amount of the form of hyaluronic acid exceeds 5 mg/cm.sup.2 of the skin or exposed tissue to which the dosage amount is to be applied.

2. A method of treating a disease or condition selected from the group consisting of basal cell carcinoma, actinic keratoses, liver spots, squamous cell tumours, metastatic cancer of the breast to the skin, primary and metastatic melanoma of the skin, malignancies or tumour of the skin, genital warts, cervical cancer, Human Papilloma Virus, Psoriasis, corns on the feet, and hair loss on the head of pregnant women, said method comprising administering topically to the skin or exposed tissue of a human, a dosage amount of a pharmaceutical composition, said dosage amount comprising:

(1) an agent effective to treat the disease or condition, said agent being in a therapeutically effective amount to treat the disease or condition of the skin or exposed tissue and;

(2) a form of hyaluronic acid selected from the group consisting of hyaluronic acid and its non-toxic salts and combination thereof,

characterized in that said dosage amount of said composition is in a dosage form suitable for topical application to the skin or exposed tissue and in a dosage amount in which component (2) exceeds 5 mg/cm.sup.2 of the skin or exposed tissue to which the dosage amount is to be applied, and is in such form that component (2) is immediately available to transport component (1) percutaneously into the epidermis of the skin or exposed tissue to the site of trauma or pathology of the disease or condition to be treated in the skin or exposed tissue, where the dosage amount of the composition accumulates in the epidermis for a prolonged period before passage therefrom, wherein the concentration of component (1) is between 1% and 5% by weight of the composition and the concentration of component (2) is between 1% and 3% having a molecular weight less than 750,000 daltons and greater than 150,000 daltons.

3. The method of claim 1 or 2 wherein the form of hyaluronic acid is sodium hyaluronate.

4. The method of claim 1 or 11 wherein the drug is a non-steroidal anti-inflammatory drug (NSAID) selected from the group consisting of diclofenac, indomethacin, naproxen, and (+/-) tromethamine salt of ketorolac, Ibuprofen, piroxicam, propionic acid derivatives, acetylsalicylic acid and flunixin.

5. The method of claim 2 wherein component (2) is sodium hyaluronate and is in the concentration of 21/2% by weight of the dosage amount, component (1) is diclofenac sodium and is in the concentration of 3% by weight of the dosage amount, and said dosage amount further comprises a solubilizer for solubulizing the diclofenac, and a preservative.

6. The method of claim 3 wherein the disease or condition is basal cell carcinoma.

7. The method of claim 3 wherein the disease or condition is actinic keratosis lesions.

8. The method of claim 3 wherein the disease or condition is liver spots.

9. The method of claim 3 wherein the disease or condition is squamous cells tumours.

10. The method of claim 3 wherein the disease or condition is metastatic cancer of the breast to the skin.

11. The method of claim 3 wherein the disease or condition is metastatic melanoma in the skin.

12. The method of claim 3 wherein the disease or condition is malignancies and/or tumours of the skin.

13. The method of claim 3 wherein the disease or condition is genital warts.

14. The method of claim 3 wherein the disease or condition is cervical cancer.

15. The method of claim 3 wherein the disease or condition is HPV (Human Papilloma Virus).

16. The method of claim 3 wherein the disease or condition is psoriasis.

17. The method of claim 3 wherein the disease or condition is corns on the feet.

18. The method of claim 3 wherein the disease or condition is hair loss on the head of pregnant women.

19. The method of claim 16 wherein psoriasis is plaque type psoriasis or nail bed psoriasis.
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