ABSTRACT

The present research was aimed to develop Metoprolol succinate sustained-release tablet by wet granulation using novel polymersEulophia herbacae and Remusatia vivipara tuber mucilage as release retardants. The formulations were prepared using a 3² full factorial design. In the current research, two factors were tested each at three levels. The concentration of Eulophia herbacea mucilage (X1) and Remusatia vivipara mucilage (X2) were selected as independent variables, and swelling index, t₇₅ of % cumulative drug release, and drug content were selected as dependent variables. The prepared tablets were evaluated by weight variation test, hardness, friability, swelling index, drug release, and drug content. The optimized tablet was compared with reference formulation PROLOMET XL 100. The drug release kinetics study was performed by various models. It reveals that formulation follows anomalous diffusion (non-fickian) pattern and follows both diffusion-controlled and swelling controlled mechanisms of drug release.

摘要

本研究旨在通过湿法制粒制备琥珀酸美托洛尔缓释片剂，采用新型聚合物芡实 和 蜉蝣 粘液作为缓释剂。使用 3 ² 全因子设计制备制剂。在目前的研究中，两个因素分别在三个水平上进行了测试。选择Eulophia herbacea  mucilage (X1) 和 Remusatia vivipara mucilage (X2)的浓度  作为自变量，肿胀指数 t ₇₅ % 累积药物释放和药物含量被选为因变量。通过重量变化试验、硬度、脆碎度、溶胀指数、药物释放和药物含量对制备的片剂进行评价。将优化后的片剂与参考配方 PROLOMET XL 100 进行了比较。药物释放动力学研究通过各种模型进行。它揭示了制剂遵循异常扩散（非菲克式）模式，并遵循药物释放的扩散控制和溶胀控制机制。