Taylor M K, Ginsburg J, Hickey A, Gheyas F
Drug Delivery and Disposition, School of Pharmacy, University of North Carolina, Chapel Hill, NC 27599, USA.
AAPS PharmSciTech. 2000 Jun 24;1(3):E18. doi: 10.1208/pt010318.
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.
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。
