Elamrawy Fatema, Helal Nada A, Abou-Taleb Basant A, Elagouri Ghada, Vattelana Olivia, Nounou Mohamed I
Med Princ Pract. 2024 Mar 20;33(4):372-84. doi: 10.1159/000538417.
Background & Purpose A new discriminatory system for evaluating the quality of pharmaceuticals is described in this paper as the Pharmaceutical Polygon Fingerprint Matrix system (PharmP-FM). To assess the quality of various pharmaceutical formulations and dosage forms, PharmP-FM uses both qualitative and quantitative fingerprinting techniques. The system expands on the SeDeM expert system, which was initially created to evaluate the suitability of powder for direct compression. PharmP-FM creates a graphical representation of the product's pharmaceutical quality using a set of input parameters. The Performance Index (PI), Normalized Parameter Index (NPI), and Formulation Index (FI) are among the system's output parameters. Methods To evaluate PharmP-FM's performance, the paper examines its application in assessing batch-to-batch variability of weight loss supplement capsules and the quality of multisource brand products of levothyroxine tablets. The findings demonstrate PharmP-FM's capability to identify variations in pharmaceutical quality across these products. Results & Conclusion This paper concludes that PharmP-FM exhibits potential promise as a pharmaceutical quality assessment tool. Its user-friendly nature and adaptability to different formulations and dosage forms make it a versatile discriminatory system. Additionally, PharmP-FM is an open-ended and scalable system that can incorporate additional parameters and accommodate products of varying complexities. The study's results strongly suggest its potential as a potential tool for pharmaceutical quality assessment.
背景与目的 本文介绍了一种用于评估药品质量的新型鉴别系统,即药品多边形指纹图谱矩阵系统(PharmP-FM)。为评估各种药物制剂和剂型的质量,PharmP-FM采用了定性和定量指纹图谱技术。该系统是在最初创建用于评估直接压片用粉末适用性的SeDeM专家系统的基础上扩展而来的。PharmP-FM利用一组输入参数创建产品药品质量的图形表示。性能指数(PI)、归一化参数指数(NPI)和制剂指数(FI)是该系统的输出参数。方法 为评估PharmP-FM的性能,本文考察了其在评估减肥补充剂胶囊的批次间差异以及左甲状腺素片多源品牌产品质量方面的应用。研究结果证明了PharmP-FM识别这些产品药品质量差异的能力。结果与结论 本文得出结论,PharmP-FM作为一种药品质量评估工具具有潜在的前景。其用户友好的特性以及对不同制剂和剂型的适应性使其成为一个多功能的鉴别系统。此外,PharmP-FM是一个开放式且可扩展的系统,能够纳入额外参数并适应不同复杂程度的产品。该研究结果有力地表明了其作为药品质量评估潜在工具的潜力。