Implantable putty material

Abstract

The present invention provides compositions for an implantable putty material for delivery of active compounds to a patient. More specifically, the present invention provides a material having a pH of between about 3 and 6 and possessing putty-like physical properties, wherein the composition of the material includes collagen and water. The present invention also provides a method for using the implantable putty material.

What is claimed is:  
     
         1 . A putty material comprising collagen and water, wherein the putty material has a pH of between about 3.0 to about 6.0.  
     
     
         2 . The putty material of  claim 1 , wherein said collagen is selected from the group consisting of fibrillar collagen, atelopeptide collagen, telopeptide collagen and tropocollagen.  
     
     
         3 . The putty material of  claim 1 , wherein said collagen is bovine tendon Type I collagen.  
     
     
         4 . The putty material of  claim 1 , wherein the material is prepared by a process comprising addition of an acid to said collagen.  
     
     
         5 . The putty material of  claim 4 , wherein said acid is selected from the group consisting of ascorbic acid, acetic acid, acetyl salicylic acid, benzoic acid, citric acid, glutamic acid, glycolic acid, lactic acid, malic acid, salicylic acid, and hydrochloric acid.  
     
     
         6 . The putty material of  claim 4 , wherein said acid is ascorbic acid.  
     
     
         7 . The putty material of  claim 1 , wherein said putty material further comprises an active ingredient.  
     
     
         8 . The putty material of  claim 7 , wherein said active ingredient is selected from the group consisting of osteoinductive materials, growth factors, cartilage inducing factors, angiogenic factors, hormones, antibiotics, and antiviral compounds.  
     
     
         9 . The putty material of  claim 8 , wherein said active ingredient is an osteoinductive material.  
     
     
         10 . The putty material of  claim 9 , wherein the osteoinductive material comprises an osteoinductive protein or protein mixture selected from the group consisting of BGP, BMP 1, BMP 2, BMP 3, BMP 4, BMP 5, BMP 6, BMP 7, BMP 8, BMP 9, BMP 10, BMP 11, BMP 12, BMP 13, and OP1.  
     
     
         11 . The putty material of  claim 10 , wherein said osteoinductive factor is BGP.  
     
     
         12 . The putty material of  claim 1 , further comprising a demineralized bone material.  
     
     
         13 . A method for preparing a putty material comprising the step of admixing collagen, an acid, an active ingredient and water to form a gel.  
     
     
         14 . The method of  claim 13 , further comprising the step of sterilizing said gel.  
     
     
         15 . The method of  claim 14 , wherein said step of sterilizing comprises exposing said gel to g-radiation.  
     
     
         16 . The method of  claim 13 , further comprising the step of lyophilizing said gel.  
     
     
         17 . The method of  claim 13 , further comprising the step of adding a demineralized bone material to the gel to produce an osteogenic putty, wherein said osteogenic putty has a pH of between about 3.0 to about 6.0.  
     
     
         18 . The method of  claim 17 , further comprising sterilizing said lyophilized gel by contacting it with ethylene oxide.  
     
     
         19 . The method of  claim 13 , wherein said collagen is selected from the group consisting of fibrillar collagen, atelopeptide collagen, telopeptide collagen and tropocollagen.  
     
     
         20 . The method of  claim 19 , wherein said collagen is bovine tendon Type I collagen.  
     
     
         21 . The method of  claim 13 , wherein said acid is selected from the group consisting of ascorbic acid, acetic acid, acetyl salicylic acid, benzoic acid, citric acid, glutamic acid, glycolic acid, lactic acid, malic acid, salicylic acid, and hydrochloric acid.  
     
     
         22 . The method of  claim 13 , wherein said acid is ascorbic acid.  
     
     
         23 . The method of  claim 13 , wherein said step of admixing further comprises admixing an osteoinductive material.  
     
     
         24 . The method of  claim 23 , wherein said osteoinductive material comprises an osteoinductive protein or protein mixture selected from the group consisting of BGP, BMP 1, BMP 2, BMP 3, BMP 4, BMP 5, BMP 6, BMP 7, BMP 8, BMP 9, BMP 10, BMP 11, BMP 12, BMP 13, and OP1.  
     
     
         25 . The method of  claim 24 , wherein said osteoinductive material is BGP.  
     
     
         26 . The method of  claim 13 , wherein the active ingredient comprises a protein or protein mixture selected from the group consisting of BGP, BMP 1, BMP 2, BMP 3, BMP 4, BMP 5, BMP 6, BMP 7, BMP 8, BMP 9, BMP 10, BMP 1, BMP 12, BMP 13, OP1, bFGF, and TGF-beta.  
     
     
         27 . A process for making a dry osteoinductive composition comprising the steps of: 
 admixing collagen, an acid, an osteoinductive material and water to form a gel; and    lyophilizing said gel.    
     
     
         28 . The process of  claim 27 , wherein said acid comprises from about 0.05 mmol of said acid per 100 mg of said collagen to about 2.3 mmol of said acid per 100 mg of said collagen.  
     
     
         29 . The process of  claim 27 , wherein said acid is selected from the group consisting of ascorbic acid, acetic acid, acetyl salicylic acid, benzoic acid, citric acid, glutamic acid, glycolic acid, lactic acid, malic acid, salicylic acid, and hydrochloric acid.  
     
     
         30 . The process of  claim 27 , wherein said acid is ascorbic acid.  
     
     
         31 . The process of  claim 27 , wherein said collagen comprises from about 1.0% by weight to about 10.0% by weight of said dry osteoinductive composition.  
     
     
         32 . The process of  claim 27 , wherein said collagen is selected from the group consisting of fibrillar collagen, atelopeptide collagen, telopeptide collagen and tropocollagen.  
     
     
         33 . The process of  claim 27 , wherein said collagen is bovine tendon Type I collagen.  
     
     
         34 . The process of  claim 27 , wherein said osteoinductive material comprises from about 0.1% by weight to about 10.0% by weight of said dry osteoinductive composition.  
     
     
         35 . The process of  claim 27 , wherein said osteoinductive material comprises an osteoinductive protein or protein mixture selected from the group consisting of BGP, BMP 1, BMP 2, BMP 3, BMP 4, BMP 5, BMP 6, BMP 7, BMP 8, BMP 9, BMP 10, BMP 11, BMP 12, BMP 13, and OP1.  
     
     
         36 . The process of  claim 27 , wherein said osteoinductive material is BGP.  
     
     
         37 . A method for administering an active compound to a patient comprising the steps of: 
 preparing a delivery vehicle by admixing collagen and an acid to form a composition having a pH of between about 3.0 and about 6.0;    incorporating an active compound into said delivery vehicle; and    implanting said delivery vehicle in a desired portion of the patient's body.    
     
     
         38 . The method of  claim 37 , wherein said step of implantation comprise a surgery.  
     
     
         39 . The method of  claim 37 , wherein said step of implantation comprises an injection.