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Details for Patent: 5,977,088

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Details for Patent: 5,977,088

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): Harper; David William (Oakville, CA), Klein; Ehud Shmuel (Givat Savyon, IL), Falk; Rudolf Edger (Toronto, CA), Asculai; Samuel Simon (Toronto, CA), Hochman; David (Thornhill, CA), Purschke; Don (Toronto, CA)
Assignee: Hyal Pharmaceutical Corporation (Mississauga, CA)
Filing Date:Jun 06, 1995
Application Number:08/467,995
Claims:1. A dosage amount of a pharmaceutical composition suitable for application to the skin or exposed tissue of a human, the dosage amount comprising pharmaceutical excipients suitable for topical application, an effective non-toxic amount of a non-steroidal anti-inflammatory drug (NSAID) to treat pain of the skin and exposed tissue of a human and an effective non-toxic amount of a form of hyaluronic acid selected from the group consisting of hyaluronic acid and salts thereof and combinations thereof sufficient to transport and facilitate the drug percutaneously into the epidermis of the skin or exposed tissue of the pain to be treated wherein the dosage amount of the composition accumulates and remains in the epidermis for a prolonged period of time and which is systemic independent acting and wherein the effective amount of the form of hyaluronic acid exceeds 10 mg/cm.sup.2 of the skin or exposed tissue and the molecular weight of the form of hyaluronic acid is greater than 150,000 daltons and less than 750,000 daltons and wherein the NSAID is present in an amount between about 1% to 5% by weight of the dosage amount and the form of the hyaluronic acid is present in an amount between about 1% to 3% by weight of the dosage amount.

2. A method of treating pain topically, said method comprising administering topically to the skin or exposed tissue of a human, a dosage amount a pharmaceutical composition, said dosage amount comprising:

(1) a non-steroidal anti-inflammatory drug (NSAID) in a therapeutically effective amount to treat pain of the skin or exposed tissue and;

(2) a form of hyaluronic acid selected from the group consisting of hyaluronic acid, salts thereof 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 10 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 pain 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 and wherein the molecular weight of component (2) is less than 750,000 daltons and greater than 150,000 daltons and wherein the NSAID is present in an amount between about 1% to 5% by weight of the dosage amount and the form of the hyaluronic acid is present in an amount between about 1% to 3% by weight of the dosage amount.

3. The method of claim 2 wherein component (2) is sodium hyaluronate having a molecular weight less than 750,000 daltons.

4. The method of claim 3 wherein component (1) is diclofenac.

5. The method of claim 4 wherein the NSAID is diclofenac sodium.

6. A dosage amount of a pharmaceutical composition comprising:

(1) a therapeutically effective amount of a drug to treat a disease or condition of the skin or exposed tissue and;

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

characterized in that said dosage amount of said composition is in a dosage form suitable for topical application to the skin or exposed tissue in which component (2) exceeds 10 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, and wherein the concentrations by weight of components (1) and (2) in the dosage amount are selected from the group consisting of:

(xii) component (2) equals 2.5% by weight of the dosage amount and component (1) equals 3% by weight of the dosage amount; and

(xiii) component (2) equals or is less than 3% by weight of the dosage amount but equal to or greater than 1% by weight of the dosage amount and component (1) equals or is less than 5% by weight of the dosage amount but equal to or greater than 1% by weight of the dosage amount.

7. The dosage amount of claim 1 or 6 wherein the form of hyaluronic acid is sodium hyaluronate and wherein the drug is diclofenac or salts thereof.
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