Lyophilized moldable implants containing an oxysterol

Abstract

Provided is a lyophilized implant configured to fit at or near a bone defect to promote bone growth, the lyophilized implant containing a biodegradable polymer in an amount of about 0.1 wt. % to about 20 wt. % of the implant, mineral particles in an amount from about 0.1 wt. % to about 75 wt. % of the implant, and an oxysterol in an amount of about 5 wt. % to about 90 wt. % of the implant. Methods of making and using the implant are further provided.

1 - 18 . (canceled) 
     
     
         19 . A method of treating a bone defect in a patient in need thereof, the method comprising implanting at or near the bone defect a lyophilized implant hydrated with a fluid, the lyophilized implant comprising a biodegradable polymer in an amount of about 0.1 wt. % to about 20 wt. % of the implant, mineral particles in an amount from about 0.1 wt. % to about 75 wt. % of the implant, and an oxysterol in an amount of about 0.01 wt. % to about 90 wt. % of the implant, wherein the oxysterol is in dihydrate form. 
     
     
         20 . A method of treating a bone defect of  claim 19 , wherein the lyophilized implant further comprises an expandable phase material in an amount from about 2 wt. % to about 4 wt. %. 
     
     
         21 . A method of treating a bone defect of  claim 19 , wherein the fluid is water, sodium chloride, dextrose, Lactated Ringer's solution, PBS, blood, bone marrow aspirate, bone marrow fractions or a combination thereof in an amount from about 0.25 mL to about 50 mL. 
     
     
         22 . A method for making a lyophilized implant of  claim 20 , wherein the expandable phase material is carboxymethylcellulose, pectin or chitosan. 
     
     
         23 . A method of treating a bone defect of  claim 19 , wherein the volume of the lyophilized implant comprises from about ¾ mL to about 10 mL. 
     
     
         24 . A method of treating a bone defect in a patient in need thereof, the method comprising implanting at or near the bone defect a lyophilized implant hydrated with a fluid, the lyophilized implant comprising a biodegradable polymer in an amount of about 0.1 wt. % to about 20 wt. % of the implant, mineral particles in an amount from about 0.1 wt. % to about 75 wt. % of the implant, and an oxysterol in an amount of about 5 wt. % to about 90 wt. % of the implant wherein the oxysterol has a particle size range of about 5 microns to about 100 microns and the oxysterol is in dihydrate form.