Injectable calcium phosphate solid rods and pastes for delivery of osteogenic proteins
AssigneesEtex Corporation, Wyeth
InventorsRebecca Li, Howard Seeherman, Hyun Kim
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Abstract
Osteogenic proteins are delivered via an injectable solid rod or hardenable paste. The formulation comprises a calcium phosphate material, an osteogenic protein, and optional additives and active ingredients such as a bone resorption inhibitor. Methods of making injectable pharmaceutical compositions and methods of using the osteogenic compositions to treat bone defects are also disclosed.
Claims37
A composition for injectable delivery of osteogenic proteins, comprising:
- at least one osteogenic protein in an amount ranging from 0.01% to 2% by weight of the composition, and
- at least one calcium phosphate material chosen from amorphous apatitic calcium phosphate and poorly crystalline apatitic calcium phosphate,
- wherein said composition is in the form of a hardenable paste that hardens into a solid form at 37° C.
A method for preparing a composition for injectable delivery of osteogenic proteins comprising mixing a dry form of at least one calcium phosphate material chosen from amorphous apatitic calcium phosphate and poorly crystalline apatitic calcium phosphate with an aqueous buffer containing at least one osteogenic protein to form a paste, wherein said paste hardens into a solid form at 37° C. and wherein the at least one osteogenic protein is present in the paste in an amount ranging from 0.01% to 2% by weight of the paste.
Dependencies are inferred from the claim text.