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Application of multivariate techniques in the evaluation of melt granulation products

机译:多元技术在熔体造粒产品评价中的应用

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In this work, principal component analysis and cluster analysis were applied as helping tools to extract useful information in the development of formulations and manufacturing processes of melt granulates. Two melt granulation processes that differ in the shear stress applied to the solid bed during melting step were designed. These processes employ equipment frequently used in the local pharmaceutical industry. The selected binders include both hydrophilic and hydrophobic excipients, which were used alone or in binary mixtures. Granulates were characterized regarding their physicomechanical properties, including their compaction behavior. The resulting tablets were also evaluated. The selected multivariate statistical methods proved to be useful in facilitating the interpretation of the collected data and the study of the properties of granulates and tablets, as well as the selection of more efficient production processes.
机译:在这项工作中,主成分分析和聚类分析被用作帮助工具,以在熔融颗粒的配方开发和制造过程中提取有用的信息。设计了两种熔融制粒工艺,它们在熔融步骤中施加于固体床的剪切应力不同。这些过程采用了当地制药业常用的设备。选择的粘合剂包括亲水性和疏水性赋形剂,它们可以单独使用或以二元混合物形式使用。对颗粒的物理力学性能(包括压实行为)进行了表征。还评估了所得片剂。事实证明,所选的多元统计方法可用于帮助解释所收集的数据以及研究颗粒和片剂的特性,以及选择更有效的生产工艺。

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