Lyophilized somatotropin formulations

Details Lyophilized somatotropin formulations Lyophilized somatotropin formulations

A - Human Necessities

61

K

A61K 38/27 (2006.01) A61K 9/08 (2006.01) A61K 9/14 (2006.01) A61K 9/19 (2006.01) A61K 47/18 (2006.01) A61K 47/26 (2006.01) A61K 47/10 (2006.01)

Patent

CA 2133737

2133737 9319773 PCTABS00027 Somatotropin solutions which remain clear for extended periods and which remain clear when subjected to mechanical agitation are prepared by mixing a lyophilized somatotropin composition containing about 1 part somatotropin per 2 to 8 parts arginine HC1 on a weight basis, wherein the pH of the composition prior to lyophilization was about 7.2 to about 8.5, and a biocompatible diluent which comprises EDTA and a nonionic surfactant. If the pH of the somatotropin composition prior to lyophilization was between 7.2 and 7.8, the diluent further comprises a buffer; otherwise the diluent optionally further can comprise a buffer or nonbuffering agent.

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