注射用冻干制剂新药申报中的药学常见问题和基本考虑

Common pharmaceutical problems and basic considerations in new drugapplication for lyophilized preparations for injection

注射用冻干制剂作为注射剂中的常用剂型之一,在药品注册申报中占较高比例。基于剂型特点、风险防范,梳理总结了注射用冻干制剂新药申报中常见的药学问题,包括未进行合理的灭菌或无菌工艺筛选与研究,未结合品种特点开展处方工艺开发,有关物质分析方法的检出能力研究不充分,配伍稳定性、输液管路相容性研究不全面等。结合相关行业指南及指导原则,从处方工艺开发、质量研究、稳定性研究等方面,阐述了注射用冻干制剂药学审评的基本考虑,以期为该类制剂的研发申报和技术评价提供参考。

As one of the commonly used dosage forms in injection,lyophilized preparations for injection account for a high proportion in drug registration applications.Based on the characteristics of dosage forms and based on risks,this paper summarizes the common pharmaceutical problems of lyophilized preparations for injection in the new drug application.For example,the rationality of sterilization or aseptic process screening and research is insufficient,pharmaceutical development without considering the characteristics of the drug products,insufficient research on the detection ability of related substances analysis methods,incomplete research on compatibility stability and infusion pipeline compatibility,etc.Combining relevant industry guidelines and guidances,the basic considerations for pharmaceutical evaluation of freeze-dried formulations for injection were elaborated from the aspects of pharmaceutical development,quality studies,stability studies,etc,in order to provide reference for the research and development of such preparations.