Talaczynska Alicja, Dzitko Jakub, Cielecka-Piontek Judyta
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Poznan University of Medical Sciences, Grunwaldzka 6, 60-780 Poznań, Poland.
Curr Pharm Des. 2016;22(32):4975-4980. doi: 10.2174/1381612822666160804100036.
Active pharmaceutical ingredients (APIs) can exist in different polymorphic forms as well as in amorphous state. Polymorphic and amorphous forms of APIs can differ in physicochemical properties which in turn can significantly influence their therapeutic safety and effectiveness of the treatment. This review focuses on benefits and limitations of polymorphic and amorphous forms of APIs used in preformulation and formulation studies. Authors present their work on safety precautions for the use of polymorphic and amorphous forms of APIs, analytical techniques used for their identification as well as methods of their preparation especially in regard to limitations of labile APIs.
活性药物成分（APIs）可以以不同的多晶型形式以及非晶态存在。活性药物成分的多晶型和非晶态形式在物理化学性质上可能不同，这反过来又会显著影响其治疗安全性和治疗效果。本综述重点关注用于制剂前研究和制剂研究的活性药物成分的多晶型和非晶态形式的优点和局限性。作者介绍了他们在使用活性药物成分的多晶型和非晶态形式时的安全注意事项、用于鉴定它们的分析技术以及它们的制备方法，特别是关于不稳定活性药物成分的局限性。
