HIGH TEMPERATURE STABLE PEPTIDE FORMULATION

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 and has also enabled the ability to terminally sterilize the lyophilized product using gamma irradiation without affecting stability.