期刊
JOURNAL OF PHARMACEUTICAL SCIENCES
卷 106, 期 11, 页码 3328-3336出版社
WILEY
DOI: 10.1016/j.xphs.2017.06.020
关键词
hot-melt extrusion; injection molding; immediate release; crystalline solid suspension; continuous manufacturing; griseofulvin; maltodextrin
资金
- Novartis-MIT Center for Continuous Manufacturing
The combination of hot-melt extrusion and injection molding (HME-IM) is a promising process technology for continuous manufacturing of tablets. However, there has been limited research on its application to formulate crystalline drug-containing immediate-release tablets. Furthermore, studies that have applied the HME-IM process to molded tablets have used a noncontinuous 2-step approach. The present study develops maltodextrin (MDX)-based extrusion-molded immediate-release tablets for a crystalline drug (griseofulvin) using an integrated twin-screw HME-IM continuous process. At 10% w/w drug loading, MDX was selected as the tablet matrix former based on a preliminary screen. Furthermore, liquid and solid polyols were evaluated for melt processing of MDX and for impact on tablet performance. Smooth-surfaced tablets, comprising crystalline griseofulvin solid suspension in the amorphous MDX-xylitol matrix, were produced by a continuous process on a twin-screw extruder coupled to a horizontally opening IM machine. Real-time HME process profiles were used to develop automated HME-IM cycles. Formulation adjustments overcame process challenges and improved tablet strength. The developed MDX tablets exhibited adequate strength and a fast-dissolving matrix (85% drug release in 20 min), and maintained performance on accelerated stability conditions. (C) 2017 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.
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