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Details for Patent: 5,545,409

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Details for Patent: 5,545,409

Title: Delivery system for controlled release of bioactive factors
Abstract:A composition and method for controlled release of water-soluble proteins comprising a surface-eroding polymer matrix and water-soluble bioactive factors is described. The composition bioerodes in the biological environment of the subject at a controlled rate, thereby releasing the water soluble proteins at a rate which allows them to interact with local cell populations.
Inventor(s): Laurencin; Cato T. (Somerville, MA), Lucas; Paul A. (Macon, GA), Syftestad; Glenn T. (Sacramento, CA), Domb; Abraham (Baltimore, MD), Glowacki; Julianne (Jamaica Plan, MA), Langer; Robert S. (Newton, MA)
Assignee: Massachusetts Institute of Technology (Cambridge, MA)
Filing Date:Apr 05, 1994
Application Number:08/222,880
Claims:1. A composition for the controlled release of a bioactive substance for inducing formation of cartilage or bone in an animal or wound healing comprising:

a. a shaped matrix sized and adapted for administration of the bioactive substance to an animal and formed of a polymer selected from the group consisting of polyanhydride and polyorthoester; and

b. a therapeutically effective amount of a bioactive substance selected from the group consisting of water soluble chondrogenic or osteogenic proteins derived from demineralized bone matrix, TGF-beta, EGF, FGF and PDGF, wherein the bioactive substance is present in an amount of between about 10 and 90 percent by weight of matrix;

wherein the composition erodes at a controlled rate over a period of time, thereby administering the bioactive substance to the animal in an amount effective to induce formation of cartilage and bone or wound healing.

2. The composition of claim 1 wherein the polyanhydride is selected from the group consisting of:

poly[bis(p-carboxyphenoxy)propane anhydride], poly[bis(p-carboxy)methane anhydride] and poly[bis)p-carboxyphenoxy)propane anhydride]--sebacid acid copolymer.

3. The composition of claim 1 wherein the water soluble chondrogenic or osteogenic proteins derived from demineralized bone matrix is a mixture of cold water-soluble proteins.

4. The composition of claim 3 wherein the cold water-soluble proteins are proteins derived from demineralized bone matrix.

5. The composition of claim 1 wherein the chondrogenic or osteogenic proteins is derived from demineralized bovine femur bone matrix.

6. The composition of claim 1 where in the bioactive substance is selected from the group consisting of TGF-beta, EGF, FGF and PDGF.

7. The composition of claim 1 wherein the composition comprises a continuous matrix having a bioactive substance interspersed therethrough.

8. The composition of claim 1 wherein the matrix is sized, shaped and adapted for use as an implant.

9. The composition of claim 1 which is adapted for releasing bioactive substance intramuscularly.

10. The composition of claim 1

wherein the shaped matrix sized and adapted for administration of the cartilage and bone inducing substance is formed from a polyanhydride polymer selected from the group consisting of poly(bis(p-carboxyphenoxy)propane anhydride), poly(bis(p-carboxyphenoxy)methane anhydride) and

poly(bis(p-carboxyphenoxy)propane anhydride-sebacic acid); and

the cartilage and bone inducing amount of a protein preparation derived from demineralized bone matrix consists of a mixture of cold water-soluble proteins capable of inducing chondrogenesis and osteogenesis having a range of molecular weight of from about 10 to about 100 Kd.
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