School of Pharmacy, Shanghai University of Traditional Chinese Medicine, No.1200, Cai-lun Road, Pudong District, Shanghai 201203, PR China.
Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine of Ministry of Education, Shanghai University of Traditional Chinese Medicine, No.1200, Cai-lun Road, Pudong District, Shanghai 201203, PR China.
Carbohydr Polym. 2022 Feb 15;278:118968. doi: 10.1016/j.carbpol.2021.118968. Epub 2021 Dec 2.
Microcrystalline cellulose (MCC) is one of the most popular cellulose derivatives in the pharmaceutical industry. Thanks to its outstanding tabletability, MCC is generally included in direct compression (DC) tablet formulations containing poor-tabletability active pharmaceutical ingredients. Nowadays, numerous grades of MCC from various brands are accessible for pharmaceutical manufacturers, leading to variability in MCC properties. Hence, it seems to be worthy and urgent to evaluate the influences of MCC variability on tablet quality and to identify critical material attributes (CMAs) based on the idea of Quality by Control. Besides, MCC-based co-processed excipients can effectively combine the functions of the filler, binder, disintegrant, lubricant, glidant, or flavor, and thus have drawn extensive interest. In this review, we focused specifically on the recent advances and development of MCC on DC tableting, including the functions in tablet formulations, potential CMAs, and MCC-based co-possessed excipients, therefore providing a reference for further studies.
微晶纤维素（MCC）是制药工业中最受欢迎的纤维素衍生物之一。由于其出色的可压性，MCC 通常包含在含有较差可压性的活性药物成分的直接压片（DC）片剂配方中。如今，各种品牌的 MCC 有许多不同的等级可供制药制造商使用，导致 MCC 性能的可变性。因此，基于质量源于控制的理念，评估 MCC 变异性对片剂质量的影响并确定关键物料属性（CMA）似乎是值得和紧迫的。此外，基于 MCC 的共处理赋形剂可以有效地将填充剂、粘合剂、崩解剂、润滑剂、助流剂或调味剂的功能结合在一起，因此引起了广泛的关注。在这篇综述中，我们特别关注了 MCC 在 DC 压片中的最新进展和发展，包括在片剂配方中的功能、潜在的 CMA 和基于 MCC 的共赋形剂，为进一步的研究提供了参考。
