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首页> 美国卫生研究院文献>ISRN Pharmaceutics >Statistical Optimization and In Vitro Evaluation of Metformin Hydrochloride Asymmetric Membrane Capsules Prepared by a Novel Semiautomatic Manufacturing Approach
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Statistical Optimization and In Vitro Evaluation of Metformin Hydrochloride Asymmetric Membrane Capsules Prepared by a Novel Semiautomatic Manufacturing Approach

机译：一种新型半自动制备方法制备的盐酸二甲双胍不对称膜胶囊的统计优化及体外评价

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摘要

Asymmetric membrane capsules (AMCs) are one of the novel osmotic delivery devices which deliver a wide range of drugs in controlled manner. In the present work, we developed and validated a semiautomatic process by fabricating a hydraulic assisted bench top model for manufacturing AMCs. The capsule walls of AMCs were prepared by dip coating phase inversion process using cellulose acetate butyrate (CAB) as coating polymer and propylene glycol (PG) as plasticizer and pore former. The comparative examination of physical parameters confirmed the consistency, efficiency, and reproducibility of the semiautomatic process over the manual procedure. The SEM studies revealed a thin dense region supported on a thicker porous membrane of the capsule shells. Formulations of AMCs were prepared based on a 23 full factorial design using metformin hydrochloride as the model drug. The effect of formulation variables such as concentration of PG and levels of fructose and potassium chloride were studied on the in vitro drug release using Design-Expert 8.0.2 (USA) software. From the in vitro release studies, it was observed that the concentration of pore former and level of osmogents had a direct effect on the drug release. From the validation studies of the optimized formulation (OPT) with the predicted response, it was observed that the drug release was independent of pH and agitation intensity but dependent on osmotic pressure of the dissolution medium. The OPT followed controlled zero-order release kinetics over a period of 13 h.
机译：不对称膜胶囊（AMC）是新型的渗透传递装置之一，它以可控方式传递多种药物。在当前的工作中，我们通过制造用于制造AMC的液压辅助台式模型开发并验证了半自动过程。 AMCs的胶囊壁是通过浸涂相转化法制备的，其中乙酸丁酸纤维素（CAB）作为涂层聚合物，丙二醇（PG）作为增塑剂和成孔剂。物理参数的比较检查确认了半自动过程相对于手动过程的一致性，效率和可重复性。 SEM研究表明，在胶囊壳的较厚多孔膜上支撑着一个薄而密集的区域。基于2 3 全因子设计，以盐酸二甲双胍为模型药物，制备AMC制剂。使用Design-Expert 8.0.2（USA）软件在体外药物释放中研究了配方变量（例如PG的浓度以及果糖和氯化钾的水平）的影响。从体外释放研究中，可以观察到成孔剂的浓度和渗透剂的含量对药物释放有直接影响。从对具有预期响应的优化配方（OPT）的验证研究中，可以观察到药物释放与pH和搅拌强度无关，但与溶出介质的渗透压有关。 OPT在13h内遵循受控的零级释放动力学。

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