Paul Shubhajit, Sun Changquan Calvin
Pharmaceutical Materials Science and Engineering Laboratory, Department of Pharmaceutics, College of Pharmacy, University of Minnesota, 9-127 B Weaver-Densford Hall, 308 Harvard Street S.E., Minneapolis, MN 55455, United States.
Pharmaceutical Materials Science and Engineering Laboratory, Department of Pharmaceutics, College of Pharmacy, University of Minnesota, 9-127 B Weaver-Densford Hall, 308 Harvard Street S.E., Minneapolis, MN 55455, United States.
Int J Pharm. 2017 May 30;524(1-2):111-120. doi: 10.1016/j.ijpharm.2017.03.073. Epub 2017 Mar 28.
Capping or lamination is an unsolved common problem in tablet manufacturing. Knowledge gaps remain despite an enormous amount of effort made in the past to better understand the tablet capping/lamination phenomenon. Using acetaminophen - containing formulations, we examined the potential use of a compaction simulator as a material-sparing tool to predict capping occurrence under commercial tableting conditions. Systematical analyses of the in-die compaction data led to insight on the potential mechanism of tablet capping/lamination. In general, capping strongly correlates with high in-die elastic recovery, high Poisson's ratio, low tensile strength, and radial die-wall pressure. Such insight can be used to guide the formulation design of high quality tablet products that are free from capping problems for challenging active pharmaceutical ingredients.
裂片或分层是片剂生产中一个尚未解决的常见问题。尽管过去付出了巨大努力以更好地理解片剂裂片/分层现象，但仍存在知识空白。我们使用含对乙酰氨基酚的制剂，研究了压实模拟器作为一种节省材料的工具在商业压片条件下预测裂片发生的潜在用途。对模内压实数据的系统分析使我们深入了解了片剂裂片/分层的潜在机制。一般来说，裂片与模内高弹性回复、高泊松比、低拉伸强度和径向模壁压力密切相关。这些见解可用于指导高质量片剂产品的配方设计，这些产品对于具有挑战性的活性药物成分不存在裂片问题。
