Composition for an injectable bone mineral substitute material

Abstract

The invention refers to an injectable composition for a bone mineral substitute material, which comprises a dry powder mixed with an aqueous liquid. The powder comprises a first reaction component comprising a calcium sulphate hemihydrate with the capability of being hardened to calcium sulphate dihydrate when reacting with said aqueous liquid; a second reaction component, which comprises a calcium phosphate with the capability of being hardened to a calcium phosphate cement when reacting with said aqueous liquid; and at least one accelerator for the reaction of said first and/or second reaction component with said aqueous liquid. A method of producing an injectable bone mineral substitute material is also provided, wherein the composition is mixed in a closed mixing and delivery system for delivery.

1 - 33 . (canceled) 
     
     
         34 . A composition for a bone mineral substitute material comprising a first setting reaction component, which is a calcium sulphate hemihydrate;
 a second setting reaction component, which is a calcium phosphate; and   at least one particulate accelerator for the setting reaction of the second setting reaction component, wherein the at least one accelerator for the reaction of the second setting reaction component is disodium hydrogen phosphate.   
     
     
         35 . The composition of  claim 34 , wherein the calcium sulphate hemihydrate is an α-calcium sulphate hemihydrate. 
     
     
         36 . The composition of  claim 34 , wherein the calcium phosphate is a tricalcium phosphate. 
     
     
         37 . The composition of  claim 34 , wherein at least one of the calcium sulfate hemihydrate or the calcium phosphate reaction component is in particulate form with a particle size of 1 μm to 100 μm. 
     
     
         38 . The composition of  claim 37 , wherein the particle size is 1 μm to 10 μm. 
     
     
         39 . The composition of  claim 36 , wherein the tricalcium phosphate is α-tricalcium phosphate. 
     
     
         40 . The composition of  claim 34 , wherein the composition further comprises an aqueous liquid. 
     
     
         41 . The composition of  claim 40 , wherein the aqueous liquid comprises between 0.1 ml and 2 ml per gram of the composition. 
     
     
         42 . The composition of  claim 41 , wherein the aqueous liquid comprises between 0.5 ml and 1 ml per gram of the composition. 
     
     
         43 . The composition of  claim 40 , wherein the aqueous liquid comprises distilled water or a balanced salt solution. 
     
     
         44 . The composition of  claim 40 , wherein the composition is contacted with the aqueous liquid and is capable of being hardened in a body fluid in vivo to a bi-phasic cement implant that with time obtains a porous structure for bone ingrowth. 
     
     
         45 . The composition of  claim 40 , wherein the disodium hydrogen phosphate is dissolved in the aqueous liquid. 
     
     
         46 . The composition of  claim 34 , wherein the disodium hydrogen phosphate comprises 0.1 wt % to 10 wt % of the second reaction component. 
     
     
         47 . The composition of  claim 46 , wherein the disodium hydrogen phosphate comprises 1 wt % to 5 wt % of the second reaction component. 
     
     
         48 . The composition of  claim 34 , wherein the calcium sulfate hemihydrate comprises 2 wt % to 80 wt % of the composition. 
     
     
         49 . The composition of  claim 48 , wherein the calcium sulfate hemihydrate comprises 10 wt % to 30 wt % of the composition. 
     
     
         50 . The composition of  claim 34 , wherein the calcium phosphate reaction component comprises 10 wt % to 98 wt % of the composition. 
     
     
         51 . The composition of  claim 50 , wherein the calcium phosphate reaction component comprises 70 wt % to 90 wt % of the composition. 
     
     
         52 . The composition of  claim 34 , further comprising a biologically active substance. 
     
     
         53 . The composition of  claim 52 , wherein the biologically active substance comprises a growth factor, an anti-cancer substance, an antibiotic, an antioxidant, and mixtures thereof. 
     
     
         54 . The composition of  claim 52 , wherein the biologically active substance comprises 0.1 wt % to 5 wt % of the composition. 
     
     
         55 . The composition of  claim 54 , wherein the biologically active substance comprises 0.5 wt % to 2 wt % of the composition. 
     
     
         56 . The composition of  claim 34 , further comprising a pH reducing component. 
     
     
         57 . The composition of  claim 56 , wherein the pH reducing component is ascorbic acid or citric acid. 
     
     
         58 . The composition of  claim 56 , wherein the pH reducing component comprises 0.1 wt % to 5 wt % of the composition. 
     
     
         59 . The composition of  claim 57 , wherein the pH reducing component comprises 0.5 wt % to 2 wt % of the composition. 
     
     
         60 . A kit for use in preparing a composition for a bone mineral substitute material, said kit comprising:
 (1) the composition according to  claim 34 ; and   (2) optionally an aqueous liquid.