Claims for Patent: 5,457,093

Summary for Patent: 5,457,093

Title:	Gel formulations containing growth factors
Abstract:	Gel formulations containing polypeptide growth factors having human mitogenic or angiogenic activity are provided. The gel formulations are useful for topical or incisional wound healing for cutaneous wounds, in the anterior chamber of the eye and other ophthalmic wound healing. The gel formulations also comprise a water soluble, pharmaceutically or ophthalmically compatible polymeric material for providing viscosity within various ranges determined by the application of the gel. The gel formulations provide controlled release and increased contact time of the growth factor to the wound site.
Inventor(s):	Cini; John K. (Bethlehem, PA), Finkenaur; Amy L. (Neshanic Station, NJ)
Assignee:	Ethicon, Inc. (Somerville, NJ)
Application Number:	08/135,230
Patent Claims:	1. A pharmaceutical composition, comprising: a) an effective wound healing amount of platelet derived growth factor (PDGF); b) a pharmaceutically acceptable cellulose polymer; and c) a pharmaceutically acceptable positively charged chemical species selected from the group consisting of lysine, arginine, histidine, protamine, aminoguanidine, zinc and magnesium, wherein the composition is an aqueous gel having a viscosity in the range of about 50,000 to about 150,000 cps at room temperature. 2. The composition of claim 1, wherein the PDGF is the PDGF B-B homodimer. 3. The composition of claim 1, wherein the cellulose polymer is selected from the group consisting of carboxymethylcellulose, hydroxypropylmethyl cellulose and methyl cellulose. 4. The composition of claim 1, wherein the PDGF concentration is within the range of about 1.0 ug/gram to about 1,000 ug/gram. 5. The composition of claim 1, wherein the cellulose polymer concentration is about 1.5% (w/w) to about 3.0% (w/w) and the polymer has a molecular weight of about 500,000 to about 800,000. 6. The composition of claim 1, wherein the concentration of the charged species is within the range of about 0.1% (w/w) to about 3.0% (w/w). 7. A method for healing a wound in a patient, comprising contacting the wound with a composition of claim 1. 8. A pharmaceutical composition, comprising: a) an effective wound healing amount of human PDGF B-B homodimer; b) carboxymethylcellulose (CMC); and c) lysine, wherein the composition is an aqueous gel having a viscosity in the range of about 50,000 to about 150,000 cps at room temperature. 9. The composition of claim 8, wherein the cellulose polymer concentration is about 1.5% (w/w) to about 3.0% (w/w) and the polymer has a molecular weight of about 500,000 to about 800,000. 10. The composition of claim 8, wherein the lysine concentration is within the range of about 0.1% (w/w) to about 3.0% (w/w). 11. A pharmaceutical composition, comprising: a) an effective wound healing amount of platelet derived growth factor (PDGF); b) a pharmaceutically acceptable cellulose polymer at a concentration in the range of about 1.5% (w/w) to about 3.0% (w/w) and having a molecular weight in the range of about 500,000 to about 800,000; and c) a pharmaceutically acceptable positively charged chemical species selected from the group consisting of positively charged amino acids, positively charged polyamino acids and positively charged metal ions at a concentration in the range of about 0.1% (w/w) to about 3.0% (w/w), wherein the composition is an aqueous gel having a viscosity in the range of about 50,000 to about 150,000 cps at room temperature. 12. The formulation of claim 11, wherein the chemical species is selected from the group consisting of lysine, arginine, histidine, protamine, aminoguanidine, zinc and magnesium.

Details for Patent 5,457,093

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	REGRANEX	becaplermin	Gel	103691	December 16, 1997	5,457,093	2012-10-10

International Patent Family for US Patent 5,457,093

Country	Patent Number	Estimated Expiration
South Africa	968398
South Africa	886947
World Intellectual Property Organization (WIPO)	9712601