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US 8,895,506 B2Granted
Protein stabilization formulations
AssigneeDePuy Synthes Products, Inc.
InventorsVenkata R. Garigapati, Dongling Su, Rehan Khanzada, Steven J. Sawamura
Life of this patent
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Abstract
The present invention is directed to stabilizing Bone Morphogenetic Protein in various lyophilized formulations and compositions. The present invention comprises formulations primarily including trehalose as an excipient for lyophilized compositions and their subsequent storage and reconstitution, and can also optionally include other excipients, including buffers and surfactants.
Claims1
A method of stabilizing a BMP comprising the steps of:
- a.) providing a composition containing at least one BMP, wherein the at least one BMP is rhGDF-5, and an amount of trehalose sufficient to stabilize said BMP, and
- b.) adding at least one excipient selected from the group consisting of glycine, polysorbate 80, polysorbate 20, and mixtures thereof, wherein said excipient has a pH of about 2.5 to about 3.5, and
- c.) lyophilizing the composition.
Dependencies are inferred from the claim text.