Department of Pharmaceutics, Sanjivani College of Pharmaceutical Education and Research, At Sahajanandnagar, Post-Shinganapur, Tal-Kopargaon, Dist-Ahmednagar, Maharashtra 423603, India; Department of Pharmaceutics, MET's Institute of Pharmacy, Affiliated to Savitribai Phule Pune University, Bhujbal Knowledge City, Adgaon, Nashik 422003, India.
Department of Pharmaceutics, Sanjivani College of Pharmaceutical Education and Research, At Sahajanandnagar, Post-Shinganapur, Tal-Kopargaon, Dist-Ahmednagar, Maharashtra 423603, India.
Int J Pharm. 2023 Mar 25;635:122699. doi: 10.1016/j.ijpharm.2023.122699. Epub 2023 Feb 8.
The Sediment Delivery Model explains experimental analysis and quantitative assessment of the powdered substance characterizing parameters, which offer pertinent data about the material's appropriateness for direct compression (DC) of tablet, which involves mathematical modeling and Semisolid Control Diagram using software like iTCM. The SeDeM diagram expert system (DES) determines the suitability of excipients and active ingredients for DC and the ratio of API to excipient is calculated. The DC is most suitable as it saves time and makes process easy, but these technique excipients compensate for their poor flow. Thus, a new system was required to help reduce number of experiments and time for making an optimized direct compression tablet. The SeDeM DES is based on quality by design (QbD) (ICH Q8) as it evaluates critical quality attributes that affect finished product's quality. This review mainly focuses on various dosage forms like Solid, Semisolid, Liquisolid, and Solidified liquid dosage forms. These techniques mainly characterize all substances using 12 parameters, resulting 12-sided regular polygon. However, parameters may increase or decrease according to the requirement of a particular dosage form like an Orodispersible tablet 15 and a Semisolid dosage form applying 5 parameters. The rationales behind limits for indexes are justified accordingly.
泥沙输送模型解释了粉末物质特征参数的实验分析和定量评估，这些参数提供了有关该物质是否适合直接压缩（DC）片剂的相关数据，这涉及使用 iTCM 等软件进行数学建模和半固态控制图。SeDeM 图专家系统（DES）确定赋形剂和活性成分是否适合 DC，并计算 API 与赋形剂的比例。由于 DC 节省时间且易于操作，因此是最适合的方法，但这些技术赋形剂补偿了它们较差的流动性。因此，需要一个新系统来帮助减少实验次数并缩短优化直接压缩片剂的时间。SeDeM DES 基于质量源于设计（QbD）（ICH Q8），因为它评估了影响成品质量的关键质量属性。本文主要关注各种剂型，如固体制剂、半固体制剂、液体制剂和固液体制剂。这些技术主要使用 12 个参数来描述所有物质，形成 12 边正多边形。然而，根据特定剂型的要求，参数可能会增加或减少，例如口腔分散片需要 15 个参数，半固体制剂需要应用 5 个参数。相应地，对索引限值的合理性进行了说明。
