不同甘露醇和乳糖级别的流动和压实性能的比较分析。
Comparative analyses of flow and compaction properties of diverse mannitol and lactose grades.
机构信息
Pharmaceutical Materials Science and Engineering Laboratory, Department of Pharmaceutics, College of Pharmacy, University of Minnesota, 9-127B Weaver-Densford Hall, 308 Harvard Street S.E., Minneapolis, MN 55455, USA.
AstraZeneca, Gothenburg, Sweden.
出版信息
Int J Pharm. 2018 Jul 30;546(1-2):39-49. doi: 10.1016/j.ijpharm.2018.04.058. Epub 2018 Apr 26.
Appropriate selection of excipient grade during tablet formulation development depends on thorough knowledge in their compaction and flow properties. Each chemically unique pharmaceutical excipient is usually available in several commercial grades that are widely different in powder properties, which influence their performance for a specific formulation application. In this work, 11 grades of mannitol were systematically characterized, in terms of their particulate, flow and tableting properties, and compared against 5 grades of lactose. Principal component analysis (PCA) identified significant correlations among selected variables, such as particle size, surface area, flowability, wall friction, plasticity parameter, tensile strength, and tablet brittleness. PCA also revealed similar grades of the two excipients, which may be used to select replacement grade, if needed, based on similarity in their overall properties.
在片剂配方开发过程中，适当选择赋形剂等级取决于对其压缩和流动性能的深入了解。每种化学独特的药物赋形剂通常有几种商业等级，其粉末性质差异很大，这会影响它们在特定配方应用中的性能。在这项工作中，对 11 种甘露醇等级进行了系统的颗粒特性、流动特性和压片特性的表征，并与 5 种乳糖等级进行了比较。主成分分析（PCA）确定了所选变量之间的显著相关性，如粒径、比表面积、流动性、壁摩擦、塑性参数、拉伸强度和片剂脆性。PCA 还揭示了两种赋形剂相似的等级，如果需要，可根据其整体性质的相似性选择替代等级。
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