(265) How to make robust a commercial peptide-based lyophilized formulation .

Introduction: Formulation development is an essential part of the process of developing an effective drug product (DP) in a specific dosage form while ensuring its stability,usability, and patient safety. Scope of this work was optimizing a peptide-based therapeutic lyophilized formulation and enhance the likelihood of its commercial success. During stability studies of the DP it was observed that a degradation peak grew over time. It was hypothesized that the degradation is caused by lyophilization or by the reactions between the peptide and mannitol (the bulking agent) in solid state after lyophilization.