| 摘要 |
A stabilized pharmaceutical composition in the form of a lyophilized product to be later reconstituted to generate an aqueous drug product is described herein. The therapeutically active ingredient in the form of a peptide of sequence TDLQERGDNDISPFSGDGQPFKD is stabilized with a buffer, carbohydrate stabilizer, a nonionic bulking agent and a surfactant to facilitate reconstitution. The preferred preparation contains a peptide of the sequence TDLQERGDNDISPFSGDGQPFKD, histidine buffer, mannitol or glycine, sucrose and/or Polysorbate 20. This combination of excipients has demonstrated exceptional stability as a lyophilized product when stored at the elevated temperature of 40° C. for at least 6 months and for at least 3 Months at 50° C. The lyophilized mixture thus formed is reconstituted to a high peptide concentration without apparent loss of stability of the peptide. Also, this combination of excipients has also enabled the ability to terminally sterilize the lyophilized product using gamma irradiation without affecting the stability of the active ingredient of the formulation.
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