Suppr超能文献

在早期片剂或胶囊制剂研发中,采用复合方法将粉末流动性量化作为一种筛选方法。

Composite method to quantify powder flow as a screening method in early tablet or capsule formulation development.

作者信息

Taylor M K, Ginsburg J, Hickey A, Gheyas F

机构信息

Drug Delivery and Disposition, School of Pharmacy, University of North Carolina, Chapel Hill, NC 27599, USA.

出版信息

AAPS PharmSciTech. 2000 Jun 24;1(3):E18. doi: 10.1208/pt010318.

Abstract

The flow properties of typical tablet and capsule formulation excipients, active compounds, and representative formulation blends were tested with current and novel flow measurement techniques to identify a reliable bench test to quantify powder flow as a screening method in early tablet and capsule formulation development. Test methods employed were vibrating spatula, critical orifice, angle of repose, compressibility index, and avalanching analysis. Powder flow results from each method were compiled in a database, sorted, and compared. An empirical composite index was established and powder flow was ranked in accordance with formulator experience. Principal components analyses of the angle of repose, percent compressibility, and critical orifice of the powder materials were also performed. The first principal component accounted for 72.8% of data variability; scores associated with this principal component score can serve as an index of flowability. Data generated from vibrating spatula and avalanching methods were not reproducible and were inconsistent with formulator experience and cited vendor references for flow. Improvements of test instruments and further studies are necessary for better assessment of these approaches.

摘要

采用当前和新型的流动测量技术,对典型片剂和胶囊制剂辅料、活性化合物以及代表性制剂混合物的流动特性进行了测试,以确定一种可靠的实验室测试方法,用于在片剂和胶囊制剂早期研发阶段将粉末流动性量化作为一种筛选方法。所采用的测试方法包括振动刮刀法、临界孔径法、休止角法、压缩性指数法和崩塌分析法。每种方法的粉末流动结果都被汇编到一个数据库中,进行分类和比较。建立了一个经验综合指数,并根据配方设计师的经验对粉末流动性进行排名。还对粉末材料的休止角、压缩百分比和临界孔径进行了主成分分析。第一主成分占数据变异性的72.8%;与该主成分得分相关的分数可作为流动性的指标。振动刮刀法和崩塌法产生的数据不可重复,与配方设计师的经验以及引用的供应商流动参考不一致。为了更好地评估这些方法,需要改进测试仪器并进行进一步研究。

相似文献

2
Development of a dual approach to assess powder flow from avalanching behavior.
AAPS PharmSciTech. 2000 Jul 21;1(3):E21. doi: 10.1208/pt010321.
4
Improved blend and tablet properties of fine pharmaceutical powders via dry particle coating.
Int J Pharm. 2015 Jan 30;478(2):447-55. doi: 10.1016/j.ijpharm.2014.11.068. Epub 2014 Dec 2.
5
Comprehensive powder flow characterization with reduced testing.
Int J Pharm. 2023 Jul 25;642:123107. doi: 10.1016/j.ijpharm.2023.123107. Epub 2023 Jun 4.
6
Effects of powder flow properties on capsule filling weight uniformity.
Drug Dev Ind Pharm. 2013 Sep;39(9):1464-75. doi: 10.3109/03639045.2012.728227.
7
Flowability characterisation of drug-excipient blends using a novel powder avalanching method.
Eur J Pharm Biopharm. 2010 Feb;74(2):388-96. doi: 10.1016/j.ejpb.2009.09.010. Epub 2009 Sep 29.
9
Rapid formulation screening with a Multipart Microscale Fluid bed Powder processor.
Pharm Dev Technol. 2011 Aug;16(4):358-66. doi: 10.3109/10837451003739271. Epub 2010 Apr 13.
10
Understanding the Factors That Control the Quality of Mini-Tablet Compression: Flow, Particle Size, and Tooling Dimension.
J Pharm Sci. 2018 Apr;107(4):1204-1208. doi: 10.1016/j.xphs.2017.12.002. Epub 2017 Dec 9.

引用本文的文献

本文引用的文献

2
Effect of glidants in tableting.
J Pharm Sci. 1966 Apr;55(4):418-23. doi: 10.1002/jps.2600550414.

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验