Claims for Patent: 8,920,827

Summary for Patent: 8,920,827

Title:	Keratin bioceramic compositions
Abstract:	A malleable bone graft composition is described. The composition comprises: (a) keratose; (b) particulate filler; (c) antibiotic; and (f) water. The invention may be provided in sterile form in an container, and optionally lyophilized. Methods of treating a fracture with such compositions are also described.
Inventor(s):	Van Dyke; Mark E. (Winston Salem, NC)
Assignee:	Wake Forest University Health Sciences (Winston-Salem, NC)
Application Number:	11/549,748
Patent Claims:	1. A sterile malleable bone graft composition, comprising: (a) from 1 to 90 percent by weight keratose; (b) from 1 to 90 percent by weight osteoconductive particulate filler; (c) from 0.001 to 5 percent by weight antibiotic; and (d) water to attain 100 percent by weight; wherein said keratose is glutamine-lysine crosslinked keratose comprising a mixture of alpha keratose and gamma keratose, and wherein said composition has a viscosity of at least 3 centipoise at a temperature of 37.degree. C. 2. The composition of claim 1, wherein said keratose comprises from 10 to 90 percent by weight alpha keratose and from 90 to 10 percent by weight gamma keratose. 3. The composition of claim 1, further comprising from 0.001 to 5 percent by weight bone morphogenic protein. 4. The composition of claim 1, wherein said particulate filler is selected from the group consisting of tetracalcium phosphate, tricalcium phosphate, calcium alkali phosphate ceramic, bioglass, calcium carbonate, calcium hydroxide, calcium oxide, calcium fluoride, calcium sulfate, magnesium hydroxide, hydroxyapatite, calcium phosphorus apatite, magnesium oxide, magnesium carbonate, magnesium fluoride, collagen, and mixtures thereof. 5. The composition of claim 1, wherein said particulate-filler comprises hydroxyapatite, tricalcium phosphate, or a mixture thereof. 6. The composition of claim 1, wherein said antibiotic is selected from the group consisting of cefazolin, vancomycin, gentamycin, erythromycin, bacitracin, neomycin, penicillin, polymycin B, tetracycline, biomycin, chloromycetin, streptomycin, ampicillin, azactam, tobramycin, clindamycin, gentamicin and combinations thereof. 7. The composition of claim 1, packaged in a sterile container. 8. A lyophilized or freeze-dried composition which upon reconstitution with a sterile water or saline solution produces a sterile malleable bone graft composition comprising: (a) from 1 to 90 percent by weight keratose; (b) from 1 to 90 percent by weight osteoconductive particulate filler; (c) from 0.001 to 5 percent by weight antibiotic; and (d) water to attain 100 percent by weight; wherein said keratose is glutamine-lysine crosslinked keratose comprising a mixture of alpha keratose and gamma keratose. 9. A method of treating a fracture in a subject in need thereof, comprising contacting a composition of claim 1 to said fracture in a treatment-effective amount. 10. The composition of claim 1, wherein said composition has a viscosity such that said composition is able to hold a form or shape without a supporting structure. 11. A sterile malleable bone graft composition consisting essentially of: (a) from 1 to 90 percent by weight keratose; (b) from 1 to 90 percent by weight particulate filler; (c) from 0.001 to 5 percent by weight osteoconductive antibiotic; and (d) water to attain 100 percent by weight; wherein said keratose is a mixture of alpha keratose and gamma keratose, wherein said keratose is glutamine-lysine crosslinked keratose, and wherein said composition has a viscosity of at least 3 centipoise at a temperature of 37.degree. C. 12. A sterile malleable bone graft composition comprising: (a) from 1 to 90 percent by weight keratose; (b) from 1 to 90 percent by weight osteoconductive particulate filler; (c) from 0.001 to 5 percent by weight antibiotic; and (d) water to attain 100 percent by weight, wherein said keratose is glutamine-lysine crosslinked keratose comprising a mixture of alpha keratose and gamma keratose. 13. The composition of claim 12, wherein said particulate filler is selected from the group consisting of tetracalcium phosphate, tricalcium phosphate, calcium alkali phosphate ceramic, bioglass, calcium carbonate, calcium hydroxide, calcium oxide, calcium fluoride, calcium sulfate, magnesium hydroxide, hydroxyapatite, calcium phosphorus apatite, magnesium oxide, magnesium carbonate, magnesium fluoride, collagen, and mixtures thereof. 14. The composition of claim 12, wherein said particulate filler comprises hydroxyapatite, tricalcium phosphate, or a mixture thereof. 15. The composition of claim 12, wherein said antibiotic is selected from the group consisting of cefazolin, vancomycin, gentamycin, erythromycin, bacitracin, neomycin, penicillin, polymycin B, tetracycline, biomycin, chloromycetin, streptomycin, ampicillin, azactam, tobramycin, clindamycin, gentamicin and combinations thereof. 16. The composition of claim 1, wherein said composition comprises from 20 to 90 percent by weight keratose. 17. The composition of claim 1, wherein said composition comprises from 20 to 50 percent by weight keratose. 18. The composition of claim 1, wherein said composition comprises from 5 to 20 percent by weight keratose. 19. The composition of claim 1, wherein said composition comprises from 7 to 20 percent by weight keratose. 20. The composition of claim 1, wherein said composition comprises from 5 to 10 percent by weight keratose. 21. The composition of claim 1, wherein said composition comprises from 7 to 10 percent by weight keratose. 22. The composition of claim 11, wherein said composition is 20 to 90 percent by weight keratose. 23. The composition of claim 11, wherein said composition is 20 to 50 percent by weight keratose. 24. The composition of claim 11, wherein said composition is 5 to 20 percent by weight keratose. 25. The composition of claim 11, wherein said composition is 7 to 20 percent by weight keratose. 26. The composition of claim 11, wherein said composition is 5 to 10 percent by weight keratose. 27. The composition of claim 11, wherein said composition is 7 to 10 percent by weight keratose. 28. The composition of claim 12, wherein said composition comprises from 20 to 90 percent by weight keratose. 29. The composition of claim 12, wherein said composition comprises from 20 to 50 percent by weight keratose. 30. The composition of claim 12, wherein said composition comprises from 5 to 20 percent by weight keratose. 31. The composition of claim 12, wherein said composition comprises from 7 to 20 percent by weight keratose. 32. The composition of claim 12, wherein said composition comprises from 5 to 10 percent by weight keratose. 33. The composition of claim 12, wherein said composition comprises from 7 to 10 percent by weight keratose.

Details for Patent 8,920,827

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2025-10-21