首页> 外文期刊>Journal of Pharmaceutical and Biomedical Analysis: An International Journal on All Drug-Related Topics in Pharmaceutical, Biomedical and Clinical Analysis >Analytical method development for powder characterization: Visualization of the critical drug loading affecting the processability of a formulation for direct compression
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Analytical method development for powder characterization: Visualization of the critical drug loading affecting the processability of a formulation for direct compression

机译:粉末表征的分析方法开发:影响药物直接压制的可加工性的关键药物负载量的可视化

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摘要

Characterization of particulate systems (powders) is one of the remaining scientific challenges. Evaluation of powder behaviour is often empirical and the decision-making processes are experience-based. There is a need for development of analytical instrumentation enabling more fundamental understanding of powder behaviour. Flowability and tabletability, two key factors in commercial scale manufacturing of tablets with direct compression (DC) approach, were analysed for formulations containing increasing amounts of several model active pharmaceutical ingredients (APIs). Flowability was investigated using a ring shear tester and tablets were prepared at four different compression pressures using a single punch tablet press. Thereby, a material sparing screening approach was developed to estimate the influence of APIs on behaviour of a given DC formulation. Additionally, this approach is useful for estimating the low threshold amount of API (wt%), at which the properties of an API start affecting the powder behaviour of a given formulation (API-excipient mixture). This threshold will be referred to as critical drug loading. The flowability of microcrystalline cellulose (reference grade pH 102) was used as a threshold for adequate flowability of model formulations. The threshold for tablet tensile strength was set to 2 MPa.
机译:颗粒系统(粉末)的表征是剩余的科学挑战之一。粉末行为的评估通常是经验性的,决策过程是基于经验的。需要开发能够对粉末行为有更基本了解的分析仪器。分析了流动性和可压片性,这是采用直接压片(DC)方法以商业规模生产片剂的两个关键因素,分析了包含越来越多的几种模型活性药物成分(API)的制剂。使用环形剪切测试仪研究流动性,并使用单冲片压片机在四种不同的压缩压力下制备片剂。因此,开发了一种节省材料的筛选方法来估计API对给定DC配方行为的影响。此外,此方法可用于估计API的低阈值量(wt%),在该阈值下API的属性开始影响给定制剂(API赋形剂混合物)的粉末行为。该阈值将被称为关键药物负荷。微晶纤维素(参考级pH 102)的流动性用作模型制剂适当流动性的阈值。片剂抗张强度的阈值设定为2MPa。

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