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Details for Patent: 6,087,344

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Details for Patent: 6,087,344

Title: Formulations containing hyaluronic acid
Abstract:Pharmaceutical compositions from which effective non-toxic (to the patient) dosage amounts may be taken and applied to the skin and/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 and to assist to resolve a disease and/or condition of the skin and/or exposed tissue of a human 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 sufficient to transport (to facilitate or cause the transport of) the drug, to a site in the skin including epidermis or exposed tissue of a disease or condition for percutaneous transport into the skin and/or exposed tissue to accumulate and remain there for a prolonged period of time and which is systemic independent acting.
Inventor(s): Falk; Rudolf E (Glencairn, CA), Asculai; Samuel S (Toronto, CA), Klein; Ehud S (Givat Savyon, IL), Harper; David W (Toronto, CA), Hochman; David (Thornhill, CA), Purschke; Don (Toronto, CA)
Assignee: Hyal Pharmaceutical Corporation (Mississauga, CA)
Filing Date:Jun 07, 1995
Application Number:08/474,732
Claims:1. A pharmaceutical composition from which effective non-toxic dosage amounts may be taken and applied to the 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 non-steroidal anti-inflammatory drug to treat a disease or condition of the skin or exposed tissue of a human involving a pathology 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 percutaneously into the skin or exposed tissue to accumulate and remain in the epidermis for a prolonged period of time and which is systemic independent acting and wherein said pharmaceutical composition comprises 3% by weight of the drug and 2.5% by weight of the form of hyaluronic acid having a molecular weight less than 750,000 daltons and greater than 150,000 daltons.

2. A dosage amount of a pharmaceutical composition comprising:

(1) a medicinal or therapeutic agent in a therapeutically effective amount to treat a disease or condition of the skin or exposed tissue involving a pathology; and

(2) a form of hyaluronic acid selected from the group consisting of hyaluronic acid and pharmaceutically acceptable salts thereof and combination thereof having a molecular weight less than 750,000 daltons and greater than 150,000 daltons,

characterized in that the 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 in a form immediately available to transport component (1) percutaneously into the epidermis of skin or exposed tissue to the site of trauma or pathology of the disease in the skin or exposed tissue to be treated on application to the skin or exposed tissue for accumulation in the epidermis before passage therefrom and wherein the concentration by weight of component (1) and the concentration by weight of component (2) are selected from one of the group consisting of:

(i) the concentration of component (2) equals 2.5% by weight of the dosage amount and component (1) is a non-steroidal anti-inflammatory drug (NSAID);

(ii) component (2) equals or is less than 3% by weight of the dosage amount but equals or exceeds 1% by weight and component (1) equals or exceeds 1% by weight of the dosage amount but is less than 5% by weight.

3. The dosage amount of claim 1 wherein the form of hyaluronic acid is sodium hyaluronate and the molecular weight is in the order of 665,000 daltons.

4. The dosage amount of claim 1 wherein the form of hyaluronic acid is sodium hyaluronate and the molecular weight is in the order of 207,000 daltons.

5. The dosage amount of claim 1 wherein the form of hyaluronic acid is sodium hyaluronate and the molecular weight is between 150,000 daltons and 225,000 daltons.

6. The dosage amount of claim 1 wherein the non-steroidal anti-inflammatory drug (NSAID) is selected from the group consisting of diclofenac, diclofenac sodium, ibuprofen, piroxicam, flunixin and flunixin meglumine.

7. The dosage amount of claim 1 wherein the pharmaceutical excipients comprises a solubilizer.

8. The dosage amount of claim 7 wherein the solubilizer is methoxypolyethylene glycol 350.

9. The dosage amount of claim 1 wherein the form of hyaluronic acid is in an amount of at least 10 mg/cm.sup.2 of skin or exposed tissue to which it is to be applied.

10. The dosage amount of claim 1 wherein the form of hyaluronic acid is in an amount of at least 20 mg/cm.sup.2 of skin or exposed tissue to which it is to be applied.

11. The dosage amount of claim 2 wherein component (2) is sodium hyaluronate and is in the concentration of 2.5% by weight of the dosage amount and component (1) is diclofenac sodium and is in the concentration of 3% by weight of the dosage amount.

12. The dosage amount of claim 11 wherein component (2) is sodium hyaluronate and the molecular weight is in the order of 665,000 daltons.

13. The dosage amount of claim 11 wherein component (2) is sodium hyaluronate and the molecular weight is in the order of 207,000 daltons.

14. The dosage amount of claim 11 wherein component (2) is sodium hyaluronate and the molecular weight is between 150,000 daltons and 225,000 daltons.

15. The dosage amount of claim 2 or 11 wherein component (1) is a non-steroidal anti-inflammatory drug (NSAID).

16. The dosage amount of claim 15 wherein the NSAID is selected from diclofenac, diclofenac sodium, ibuprofen, piroxicam, flunixin and flunixin meglumine.

17. The dosage amount of claim 2 wherein component (1) is an anti-cancer agent.

18. The dosage amount of claim 11 further comprising suitable topical excipients.

19. The dosage amount of claim 18 wherein the topical excipients comprises a solubilizer.

20. The dosage amount of claim 19 wherein the solubilizer is methoxypolyethylene glycol 350.

21. The dosage amount of claim 11 or 18 wherein component (2) is in an amount of at least 10 mg/cm.sup.2 of skin or exposed tissue to which it is to be applied.

22. The dosage amount of claim 11 or 18 wherein component (2) is in an amount of at least 20 mg/cm.sup.2 of skin or exposed tissue to which it is to be applied.

23. An effective non-toxic dosage amount suitable for topical application to the skin or exposed tissue of a human, each effective dosage amount consisting essentially of one or more pharmaceutical excipients suitable for topical application, an effective non-toxic dosage amount of a drug for the topical treatment of a disease or condition of the skin and exposed tissue 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 non-toxic salts thereof sufficient to transport the drug percutaneously into the epidermis of the skin or exposed tissue to accumulate and remain in the epidermis for a period of time sufficient to treat said disease or condition before passage therefrom and which is systemic independent acting, wherein the drug is present in an amount between about 1% and about 5% by weight of the dosage amount and the form of hyaluronic acid is present between about 1% and about 3% by weight of the dosage amount and wherein the molecular weight of the form of hyaluronic acid is in the range of 150,000 to 750,000 daltons.
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