State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macau, China.
Zhitong Laboratories Co., Ltd, Shanghai, China.
J Control Release. 2017 Sep 28;262:222-231. doi: 10.1016/j.jconrel.2017.07.043. Epub 2017 Jul 31.
The tablet of multi-unit pellet system (TMUPS), using coated pellets, for controlled release of drugs is an effective therapeutic alternative to conventional immediate-release dosage forms. The main advantages of TMUPS include a) ease of swallowing and b) divisible without compromising the drug release characteristics of the individual units. TMUPS can be prepared more economically than pellet-filled capsules because of the much higher production rate of tableting process. In spite of the superiorities of TMUPS, its adoption has been challenged by manufacturing problems, such as compromised integrity of coated pellets and poor content uniformity. Herein, we provide an updated review on research, from both scientific literatures and patents, related to the compaction of TMUPS. Factors important for the successful production of TMUPS are summarized, including model drug property, potential cushioning agents, and novel techniques to protect pellets from damage. This review is intended to facilitate the future development of manufacturable TMUPS with drug release behavior similar to that of the original coated pellets.
多单位微丸系统片(TMUPS)是一种使用包衣微丸的药物控释制剂,它是传统速释剂型的有效治疗替代方法。TMUPS 的主要优点包括:a)易于吞咽和 b)可分割而不会影响单个单位的药物释放特性。由于片剂生产过程的生产率更高,TMUPS 的制备成本比填充微丸的胶囊更低。尽管 TMUPS 具有优势,但由于制造问题(如包衣微丸的完整性受损和含量均匀性差),其应用受到了挑战。本文提供了对 TMUPS 压缩相关研究的最新综述,包括科学文献和专利。总结了成功生产 TMUPS 的重要因素,包括模型药物性质、潜在的缓冲剂和保护微丸免受损坏的新技术。本综述旨在促进具有与原始包衣微丸相似的药物释放行为的可制造 TMUPS 的未来发展。