Research and Laboratories Sector, National Drug and Cosmetic Control Laboratories (NDCCL), Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Sci Rep. 2024 Feb 1;14(1):2636. doi: 10.1038/s41598-024-52674-4.
Market drugs including brand or generic with poor quality, don't meet the acceptable standard guidelines. Vildagliptin is an important antidiabetic drugs used in monotherapy or in combinations protocols for treatment of diabetes mellites. The main goal of the current study is to assess the pharmaceutical equivalence of two marketed generics of vildagliptin 50 mg tablets compared to the branded product (Galvus 50 mg). The in vitro dissolution test was used as a quality control tool to obtain the dissolution profile of vildagliptin compared to the reference drug. The results revealed that all tested samples showed dissolution behavior like standard drug. Whole samples dissolution reached after 15 min in accordance with the standard. According to the similarity factors records, tested vildagliptin samples showed a comparable dissolution to the reference drug. The current work presents an in vitro protocol for quality evaluation of recently released generic drugs.
市场上的药品包括质量差、不符合可接受标准指南的品牌或仿制药。维格列汀是一种重要的抗糖尿病药物，用于单药治疗或联合治疗糖尿病。本研究的主要目的是评估两种已上市的维格列汀 50mg 片剂仿制药与品牌药物（Galvus 50mg）的药学等效性。体外溶出度试验被用作质量控制工具，以获得与参比药物相比的维格列汀溶出度曲线。结果表明，所有测试样品的溶出行为均与标准药物相似。所有样品在 15 分钟后完全溶解，符合标准。根据相似因子记录，测试的维格列汀样品与参比药物具有相当的溶出度。本工作提出了一种用于评价最近上市的仿制药质量的体外方案。
