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Details for Patent: 5,910,489

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Details for Patent: 5,910,489

Title: Topical composition containing hyaluronic acid and NSAIDS
Abstract:A pharmaceutical composition comprising a plurality of effective non-toxic dosage amounts of a composition for topical administration to the site of pathology and/or trauma of skin and/or exposed tissue of a human patient in need of treatment suffering from a disease or condition, each such dosage amount comprising a therapeautically effective non-toxic (to the patient) dosage amount of a drug for the treatment of the disease and/or condition of the skin and/or exposed tissue at the site of the pathology and/or trauma and an effective non-toxic dosage amount of hyaluronic acid and/or salts thereof and/or homologues, analogues, derivatives, complexes, esters, fragments, and/or sub-units of hyaluronic acid to transport (to facilitate or cause the transport of) the drug to the site of the pathology and/or trauma of the disease or condition.
Inventor(s): Falk; Rudolf Edgar (Toronto, CA), Asculai; Samuel Simon (Toronto, CA)
Assignee: Hyal Pharmaceutical Corporation (Mississauga, CA)
Filing Date:Aug 19, 1994
Application Number:08/290,848
Claims:1. A method of treating a disease or condition selected from the group consisting of liver spots, malignancies of the skin, genital warts (condyloma acuminata), cervical cancer, 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 consisting essentially of:

(1) an agent selected from a medicinal and therapeutic agent 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 hyaluronic acid and salts 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 and wherein the form of hyaluronic acid has a molecular weight less than 750,000 daltons and greater than 150,000 daltons, said administrations continuing until such time as no longer required and wherein component (2) is between about 1% and about 3% by weight of the composition and wherein component (1) is between 1% and about 5% by weight of the composition.

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

3. The method of claim 1 or 2 wherein component (2) is sodium hyaluronate whose molecular weight is between 150,000 daltons and 225,000 daltons.

4. The method of claim 1 or 2 wherein component (2) exceeds 10 mg/cm.sup.2.

5. The method of claim 1 or 2 wherein component (1) is a non-steroidal anti-inflammatory drug selected from the group consisting of indomethacin, naproxen, (+/-) tromethamine, salt of ketorolac, ibuprofen, piroxicam, acetylsalicylic acid and flunixin.

6. The method of claim 1 or 2 wherein component (1) is a non-steroidal anti-inflammatory drug selected from the group consisting of diclofenac and diclofenac sodium and wherein the form of hyaluronic acid is 21/2% by weight of the composition and the form of NSAID is 3% by weight of the composition.

7. The method of claim 1 or 2 wherein the malignancies of the skin is squamous cell tumors.

8. A multiple gram pharmaceutical composition from which an effective non-toxic dosage amount of the compositlon may be taken for topical administration to a site of pathology or trauma of skin or exposed tissue of a human patient in need of treatment suffering from a disease or condition involving pathological tissue, each such dosage amount consisting essentially of a therapeaticaly effective non-toxic dosage amount of a drug which inhibits prostaglandin synthesis for the treatment of the disease or condition of the skin or exposed tissue at the site of the pathology or trauma and an effective non-toxic dosage amount of at least about 5 mg./cm.sup.2 of a form of hyaluronic acid selected from the group consisting of hyaluronic acid and salts thereof to transport the drug to the site of the pathology or trauma of the disease or condition wherein the form of hyaluronic acid is between about 1% and about 3% by weight of the composition having a molecular weight less than 750,000 daltons and greater than 250,000 daltons and wherein the drug is between about 1% and about 5% by weight of the composition.

9. The pharmaceutical composition of claim 8 wherein the drug is a non-steroidal anti-inflammatory drug (NSAID) and the form of hyaluronic acid is sodium hyaluronate.

10. The pharmaceutical composition of claim 8 wherein the disease or condition is pain and the amount of the form of hyaluronic acid is at least 10 mg/cm.sup.2.

11. The pharmaceutical composition of claim 10 wherein the drug which inhibits prostaglandin synthesis is a non-steroidal anti-inflammatory drug (NSAID).

12. The pharmaceutical composition of claim 9 wherein the NSAID is selected from the group consisting of diclofenac and diclofenac sodium and wherein the form of hyaluronic acid is 21/2% by weight of the composition and the form of NSAID is 3% by weight of the composition.
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