Shah Aamna, Khan Gul M, Ullah Hanif, Khan Kamran Ahmad, Ullah Kaleem, Khan Shujaat A
Acta Pol Pharm. 2016 Jul;73(4):1037-1043.
The present study aimed at developing the sustained release matrix tablets of enalapril maleate and evaluating the effect of polymer concentration and viscosity grade on drug release. The sustained release enalapril maleate tablets were successfully formulated by direct compression method using nonionic cellulose ethers HPMC K15, HPMC K100 and HPC polymers either alone or in combination. In-vitio drug release study was carried out in phosphate buffer (pH 6.8) for a period of 24 h following USP dissolution apparatus II i.e., paddle apparatus. Model dependent approaches like zero-order, first order, Higuchi's model and Korsmeyer-Peppas model were used to assess drug release from various formulations. All the three polymers alone or in combination sustained the drug release. The drug release characteristics from HPMC and HPC polymer followed zero order release kinetics except for 45% concentration of all polymers alone or in combination where by the drug release followed Higuchi's model. In all cases, the drug release mechanism was both diffusion as well as erosion.
本研究旨在研制马来酸依那普利缓释骨架片，并评估聚合物浓度和粘度等级对药物释放的影响。采用非离子型纤维素醚HPMC K15、HPMC K100和HPC聚合物单独或组合使用，通过直接压片法成功制备了马来酸依那普利缓释片。按照美国药典溶出度装置II（即桨法装置），在磷酸盐缓冲液（pH 6.8）中进行了24小时的体外药物释放研究。使用零级、一级、Higuchi模型和Korsmeyer-Peppas模型等模型依赖方法来评估各种制剂的药物释放情况。所有三种聚合物单独或组合使用均能维持药物释放。HPMC和HPC聚合物的药物释放特性遵循零级释放动力学，但所有聚合物单独或组合使用时45%浓度的情况除外，此时药物释放遵循Higuchi模型。在所有情况下，药物释放机制均为扩散和溶蚀。
