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多层片剂生产的关键因素——评估材料属性、过程控制、生产工艺和产品性能。

Critical factors in manufacturing multi-layer tablets--assessing material attributes, in-process controls, manufacturing process and product performance.

机构信息

Division of Chemistry III, OGD, Center for Drug Evaluation and Research, United States Food and Drug Administration, Rockville, MD, USA.

出版信息

Int J Pharm. 2010 Oct 15;398(1-2):9-13. doi: 10.1016/j.ijpharm.2010.07.025. Epub 2010 Jul 23.

DOI:10.1016/j.ijpharm.2010.07.025
PMID:20656000
Abstract

Advancement in the fields of material science, analytical methodologies, instrumentation, automation, continuous monitoring, feed forward/feed back control and comprehensive data collection have led to continual improvement of pharmaceutical tablet manufacturing technology, notably the multi-layer tablets. This review highlights the material attributes, formulation design, process parameters that impact the performance, and manufacturability of the multi-layer tablets. It also highlights on critical-to-quality elements that needs to be addressed in the regulatory submission.

摘要

材料科学、分析方法、仪器仪表、自动化、连续监测、前馈/反馈控制和综合数据收集等领域的进步推动了制药片剂制造技术的不断改进，特别是多层片剂。本文重点介绍了影响多层片剂性能和可制造性的材料属性、配方设计和工艺参数，并强调了在法规提交中需要解决的关键质量要素。

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