新赋形剂的表征要求
Novel excipients can play a major role in innovation processes, but physicochemical properties, performance and safety must be adequately demonstrated. Characterization requirements for novel excipients are discussed and illustrated with two examples, polyethyleneglycol-polyvinyl caprolactam polyvinyl acetate grafted copolymer (Soluplus®）和甲醛甲酯和二乙基氨基乙基甲基丙烯酸酯共聚物分散剂（Kollicoat®Smartseal30 d）。
介绍：
随着药品技术的最新进展，药物制剂已从传统药品发展为药物输送系统。通过在制药行业中使用新技术以及引入新的或新颖的赋形剂，这一进步是通过新技术提出的。
ICH Guideline M4Q defines an excipient to be novel if it is used for the first time in a drug product of if it is used a new route of administration. Regulatory filings should include full details of manufacture, characterization and controls, with cross references to supporting safety data (nonclinical and/or clinical) according to the drug substance format. But excipients as such are not approved or rejected by health authorities. They are reviewed only in the context of a drug product application. This puts a significant regulatory burden on the excipient user, particularly in Europe, due to the lack of an excipient master file system.
新颖的赋形剂需要彻底表征，重点是三个方面：
- 功能：药物的性能，例如药物输送特性。
- 生理化学：化学评估，包括理化特性，杂质和稳定性。
- 安全：毒理学评估与新的活性成分非常相似。
新颖的赋形剂的发展需要制造商的坚定承诺。
请参阅此处的海报（单击以放大）：