LYOPHILIZED SOMATOTROPIN FORMULATIONS

摘要

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.