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中试级喷雾干燥器与实验室级喷雾干燥器的比较:结构、粉末性质及直接压片应用。

The Comparison between Pilot-Grade Spray Dryer and Laboratory-Grade Spray Dryer: Structure, Powder Properties and Application for Direct Compaction.

机构信息

Key Laboratory of Modern Preparation of TCM, Ministry of Education, Institute for Advanced Study, Jiangxi University of Chinese Medicine, Nanchang, 330004, People's Republic of China.

Macau Centre for Research and Development in Chinese Medicine, State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, People's Republic of China.

出版信息

AAPS PharmSciTech. 2024 Nov 27;25(8):275. doi: 10.1208/s12249-024-02991-8.

DOI:10.1208/s12249-024-02991-8
PMID:39604593
Abstract

This study investigates the improvements in direct compaction powder properties achieved through particle design using laboratory and pilot-scale spray dryers. Hydroxypropyl methylcellulose and polyvinylpyrrolidone were used as modifying agent, which have low hygroscopicity and surface tension, good flowability, and excellent compactibility. Ammonium bicarbonate and sodium bicarbonate were used as pore-forming agents, and the composite particles were prepared using laboratory and pilot-scale spray dryers. The results showed that the structure of the composite particles and porous particles can effectively improve the flowability, tabletability, and disintegration behaviour; the composite particles prepared by laboratory-scale spray drying have better tabletability; the composite particles prepared by spray drying at pilot-scale had better flowability. In summary, there are significant differences in the properties of products prepared by different scales of spray drying. It will be beneficial to choose the appropriate equipment and the appropriate experimental design. Consequently, this study may contribute to the development of natural plant tablets.

摘要

本研究通过使用实验室和中试规模喷雾干燥器进行颗粒设计,考察了直接压片粉末性能的改善。羟丙基甲基纤维素和聚乙烯吡咯烷酮被用作改性剂,它们具有吸湿性低、表面张力低、流动性好、可压性好的特点。碳酸氢铵和碳酸氢钠被用作成孔剂,使用实验室和中试规模喷雾干燥器制备复合颗粒。结果表明,复合颗粒和多孔颗粒的结构可以有效改善流动性、可压性和崩解行为;实验室规模喷雾干燥制备的复合颗粒具有更好的可压性;中试规模喷雾干燥制备的复合颗粒具有更好的流动性。综上所述,不同规模喷雾干燥制备的产品性能存在显著差异。选择合适的设备和实验设计将是有益的。因此,本研究可能有助于天然植物片剂的开发。

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本文引用的文献

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Co-amorphous systems of sulfasalazine with matrine-type alkaloids: Enhanced solubility behaviors and synergistic therapeutic potential.柳氮磺胺吡啶与苦参型生物碱共无定形系统:增强的溶解行为和协同治疗潜力。
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Improved direct compression properties of water extract powders fluid bed-mediated surface engineering.
通过流化床介导的表面工程改善水提取物粉末的直接压缩性能。
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Direct Compaction Drug Product Process Modeling.直接压片药物产品工艺建模。
AAPS PharmSciTech. 2022 Jan 31;23(1):67. doi: 10.1208/s12249-021-02206-4.
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Pharmaceutics. 2021 May 30;13(6):814. doi: 10.3390/pharmaceutics13060814.
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