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药物纳米晶体:全面综述及现行法规指南

Drug Nanocrystals: A Comprehensive Review with Current Regulatory Guidelines.

机构信息

B.K. Mody Government Pharmacy College, Rajkot, Gujarat, India.

K. V. Virani Institute of Pharmacy and Research Centre, Badhada, Gujarat, India.

出版信息

Curr Drug Deliv. 2020;17(6):470-482. doi: 10.2174/1567201817666200512104833.

DOI:10.2174/1567201817666200512104833
PMID:32394834
Abstract

Drug nanocrystals offer an attractive approach for improving the solubility and dissolution rate of poorly soluble drugs which accounts for nearly 40 % newly discovered drug molecules. Both methods for manufacturing drug nanocrystals have high industrial acceptability for being simple and easy to scale which is evident from the number of approved products available in the market. Ability to modify multiple aspects of dosage form like bioavailability, release pattern and dosage form requirement along with flexibility in choosing final dosage form starting from the tablet, capsule, suspension to parenteral one, have made nanocrystal technology one of the very promising and adaptable technology for dosage form design.

摘要

药物纳米晶体为提高溶解度和溶解速率提供了一种有吸引力的方法,这些药物的溶解度和溶解速率很差,占近 40%的新发现药物分子。这两种制造药物纳米晶体的方法都具有很高的工业可接受性,因为它们简单易用,易于扩展,这从市场上现有的批准产品数量就可以明显看出。药物纳米晶体技术能够改变剂型的多个方面,如生物利用度、释放模式和剂型要求,并且可以灵活选择最终剂型,从片剂、胶囊、混悬剂到注射剂,这使得该技术成为最有前途和适应性最强的剂型设计技术之一。

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