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Influence of process parameters on content uniformity of a low dose active pharmaceutical ingredient in a tablet formulation according to GMP

机译:工艺参数对根据GMP的片剂配方中低剂量活性药物成分含量均匀度的影响

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摘要

The article describes the development and production of tablets using direct compression of powder mixtures. The aim was to describe the impact of filler particle size and the time of lubricant addition during mixing on content uniformity according to the Good Manufacturing Practice (GMP) process validation requirements. Processes are regulated by complex directives, forcing the producers to validate, using sophisticated methods, the content uniformity of intermediates as well as final products. Cutting down of production time and material, shortening of analyses, and fast and reliable statistic evaluation of results can reduce the final price without affecting product quality. The manufacturing process of directly compressed tablets containing the low dose active pharmaceutical ingredient (API) warfarin, with content uniformity passing validation criteria, is used as a model example. Statistic methods have proved that the manufacturing process is reproducible. Methods suitable for elucidation of various properties of the final blend, e.g., measurement of electrostatic charge by Faraday pail and evaluation of mutual influences of researched variables by partial least square (PLS) regression, were used. Using these methods, it was proved that the filler with higher particle size increased the content uniformity of both blends and the ensuing tablets. Addition of the lubricant, magnesium stearate, during the blending process improved the content uniformity of blends containing the filler with larger particles. This seems to be caused by reduced sampling error due to the suppression of electrostatic charge.
机译:该文章介绍了直接压制粉末混合物来开发和生产片剂的方法。目的是根据《良好生产规范》(GMP)工艺验证要求,描述填料粒径和混合期间添加润滑剂的时间对含量均匀性的影响。流程受复杂指令的约束,迫使生产者使用复杂的方法验证中间体和最终产品的含量均匀性。减少生产时间和材料,缩短分析时间以及对结果进行快速可靠的统计评估可以降低最终价格,而不会影响产品质量。包含低剂量活性药物成分(API)华法林的直接压制片剂的制造过程,其含量均一性通过验证标准,被用作模型示例。统计方法证明制造过程是可重复的。使用了适用于阐明最终混合物各种特性的方法,例如通过法拉第桶测量静电荷以及通过偏最小二乘(PLS)回归评估研究变量的相互影响。使用这些方法,已证明具有较高粒度的填料提高了共混物和随后的片剂的含量均匀性。在共混过程中添加润滑剂硬脂酸镁改善了含有较大颗粒填料的共混物的含量均匀性。这似乎是由于抑制静电荷而降低了采样误差引起的。

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