Soft Gelatine Capsules- Critical Quality Attributes of Chosen Excipients and Capsules Parameters Following the Quality by Design Concept

Barbara Owczarek, E. Łukowska-Chojnacka
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Abstract

Soft gel capsules are a common form of medicine and food supplements. Quality, productivity and manufacturing time is crucial for producers during their development and industrial operations. To ensure the best quality of the product, it is necessary to know all critical process steps and parameters. The use of QbD elements is to ensure the quality of the drug product throughout its "life cycle". Quality by design (QbD) and its elements are described by the International Council of Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and in their guideline - chapter ICH Q8 (Pharmaceutical Development). One of the first steps in pharmaceutical product development is to prepare Quality Target Product Profile (QTPP) and analyse Critical Material Attributes (CMAs) and Critical Quality Attributes (CQAs) of excipients, active pharmaceutical ingredient (API) and final product. During this research, we investigated the CQAs of the excipients used in vitamin D3 soft gelatin capsules containing high doses of cholecalciferol, from 10 000 to 200 000 IU per capsule. We considered the viscosity of the gelatin mass, the effect of the addition of dye on the viscosity, and the impact of the colour of the gelatin mass on the active substance content in the final capsules. It was also investigated oily carriers (medium chain triglycerides and safflower oil) and antioxidants (alpha-tocopherol acetate vs butylhydroxytoluene), and their effect on API concentration in the capsule.
明胶软胶囊--按照设计质量理念选择辅料和胶囊参数的关键质量属性
软胶囊是一种常见的药品和食品补充剂。质量、生产率和生产时间对生产商的研发和工业运营至关重要。为了确保产品的最佳质量,有必要了解所有关键的工艺步骤和参数。使用 QbD 要素是为了确保药品在整个 "生命周期 "内的质量。国际人用药品技术要求协调理事会(ICH)在其指南 ICH Q8 章(药品开发)中对设计质量(QbD)及其要素进行了描述。医药产品开发的第一步是编制质量目标产品简介 (QTPP),分析辅料、活性药物成分 (API) 和最终产品的关键材料属性 (CMA) 和关键质量属性 (CQA)。在这项研究中,我们调查了维生素 D3 软胶囊所用辅料的 CQA,该胶囊含有高剂量的胆钙化醇(每粒 10 000 至 200 000 IU)。我们考虑了明胶块的粘度、添加染料对粘度的影响以及明胶块的颜色对最终胶囊中活性物质含量的影响。我们还研究了油性载体(中链甘油三酯和红花油)和抗氧化剂(α-生育酚醋酸酯和丁基羟基甲苯),以及它们对胶囊中原料药浓度的影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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