Shen Jie, Burgess Diane J
Department of Pharmaceutical Sciences, University of Connecticut, 69 North Eagleville Road U 3092, Storrs, CT 06269, USA.
Drug Deliv Transl Res. 2013 Oct 1;3(5):409-415. doi: 10.1007/s13346-013-0129-z.
Nanoparticulate systems have emerged as prevalent drug delivery systems over the past few decades. These delivery systems (such as liposomes, emulsions, nanocrystals, and polymeric nanocarriers) have been extensively used to improve bioavailability, prolong pharmacological effects, achieve targeted drug delivery, as well as reduce side effects. Considering that any unanticipated change in product performance of such systems may result in toxicity and/or change efficacy, it is essential to develop suitable dissolution/release testing methods to ensure product quality and performance, and to assist in product development. The present review provides an overview of the current dissolution/release testing methods such as dialysis, sample and separate, as well as continuous flow methods. Challenges and future directions in the development of standardized and biorelevant dissolution/release testing methods for novel nanoparticulate systems are discussed.
在过去几十年中，纳米颗粒系统已成为普遍的药物递送系统。这些递送系统（如脂质体、乳剂、纳米晶体和聚合物纳米载体）已被广泛用于提高生物利用度、延长药理作用、实现靶向给药以及减少副作用。鉴于此类系统产品性能的任何意外变化都可能导致毒性和/或疗效改变，开发合适的溶出/释放测试方法以确保产品质量和性能，并协助产品开发至关重要。本综述概述了当前的溶出/释放测试方法，如透析法、取样分离法以及连续流动法。还讨论了新型纳米颗粒系统标准化和生物相关性溶出/释放测试方法开发中的挑战和未来方向。
