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Details for Patent: 6,147,059

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Details for Patent: 6,147,059

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 or 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 or 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 or 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 06, 1995
Application Number:08/468,330
Claims:1. A multigram pharmaceutical composition from which effective non-toxic dosage amounts of the composition may be taken and applied to the skin or exposed tissue of a human, each effective dosage amount consisting essentially of pharmaceutical excipients for topical application, an effective non-toxic dosage amount of a nonsteroidal anti-inflammatory drug (NSAID) having a percentage of 1-5% by weight of the composition to treat a disease or condition of the skin or 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, pharmaceutically acceptable salts thereof and combination thereof sufficient to transport the drug percutaneously into the epidermis of the skin or exposed tissue to accumulate and remain in the epidermis of the skin or exposed tissue for a prolonged period of time before passage therefrom and which is systemic independent acting, and wherein the form of hyaluronic acid, is in a dosage amount of at least 5 mg/cm.sup.2 of the skin or exposed tissue, has a molecular weight of less than 750,000 daltons and greater than 150,000 daltons, and has a concentration of 1-3% by weight.

2. A method of accumulating a drug and a form of hyaluronic acid in the skin of a human comprising topically administering a therapeutically effective non-toxic dosage amount of a composition comprising pharmaceutical excipients suitable for topical applications, an effective non-toxic dosage amount of a drug which inhibits prostaglandin synthesis to treat a disease or condition of the skin involving pathological tissue or underperfused tissue and an effective non-toxic dosage amount of a form of hyaluronic acid selected from the group consisting of hyaluronic acid, pharmaceutically acceptable salts thereof and combinations thereof effective to transport the drug percutaneously to the site in the epidermis of the skin of the disease or condition to accumulate and remain at the site in the skin or exposed tissue for a prolonged period of time before passage therefrom, wherein the amount of the form of hyaluronic acid administered is at least 5 mg/cm.sup.2 of skin having a molecular weight of less than 750,000 daltons and greater than 150,000 daltons wherein the form of hyaluronic acid is 1-3% by weight of the composition and the percent of the drug in the composition is 1-5% by weight.

3. The method of claim 2 where the accumulation takes place into the epidermis of the skin.

4. The method of claim 2 wherein the form of hyaluronic acid is sodium hyaluronate.

5. A method of accumulating a medicine or therapeutic agent which inhibits prostaglandin synthesis (component (1)) and a form of hyaluronic acid selected from the group consisting of hyaluronic acid, salts thereof and, combination thereof, having a molecular weight of less than 750,000 daltons and greater than 150,000 daltons (component (2)) in the epidermis of the skin of a human comprising, topically administering a therapeutically effective non-toxic dosage amount of a pharmaceutical composition comprising components (1) and (2) characterized in that said dosage amount of said composition is in a dosage form suitable for topical application to the skin and in a dosage amount in which component (2) exceeds 5 mg/cm.sup.2 of the skin 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 to the site of trauma or pathology of the disease or condition to be treated in the skin, where the dosage amount of the composition accumulates in the epidermis for a prolonged period before passage therefrom, wherein the form of hyaluronic acid is 1-3% by weight of the composition and the percent of the drug in the composition is 1-5% by weight and wherein the pharmaceutical composition further comprises pharmaceutical excipients suitable for topical application.

6. The method of claim 5 wherein the form of hyaluronic acid is sodium hyaluronate.

7. A method of accumulating a drug in the skin or exposed tissue of a human suffering from trauma or a pathology comprising topically administering to the skin or exposed tissue a composition comprising the drug which inhibits prostaglandin synthesis and an effective non-toxic amount of a form of hyaluronic acid selected from the group consisting of hyaluronic acid, salts thereof and combination thereof, having a molecular weight of less than 750,000 daltons and greater than 150,000 daltons to transport the drug into the skin wherein the amount of the form of hyaluronic acid exceeds at least about 10 mg/cm.sup.2 of the surface area of the skin to which the composition is applied and wherein the form of hyaluronic acid is 1-3% by weight of the composition and the percent of the drug in the composition is 1-5% by weight.

8. The method of claim 7 wherein the form of hyaluronic acid is sodium hyaluronate.

9. The method of claim 8 wherein the molecular weight of the form of hyaluronic acid is less than about 750,000 daltons and greater than 225,000 daltons and the drug is a non-steroidal anti-inflammatory drug (NSAID).

10. The method of claim 5 wherein the drug is a drug which inhibits prostaglandin synthesis.

11. The composition of claim 1 where in the disease or condition involves underperfused or pathological tissue.
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