Formulation and Evaluation of Extended Release Oral Suspension of Metformin Hydrochloride

Dipali Patil, Shashikant Barhate, Manoj Bari, Shaikh Samir
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Abstract

The research scheme of formulation and evaluation of extended-release oral suspension of metformin hydrochloride with the objective to develop a stable, redispersible oral liquid suspension based on extended-release pellets to facilitate swallowing in patients with diabetes. Pellets were prepared by using Bed Coating During Sliding method with the Metformin hydrochloride used as antidiabetic drug and various polymers. Extended release was affected by the ethylcellulose coating of drug formulation used as coating agent, MCC, Lactose, PVP K-30 Prepared metformin hydrochloride pellets putted in to prepared sugar free syrup vehicle using polymers like Xanthan Gum as a suspending agent for uniform drug distribution, Sorbitol solution, Aspartame are artificial sweeteners, Sodium Citrate, Potassium sorbate, Methyl paraben. The formulation was optimized based on Design expert software and Central Composite Design was used for study. Drug and polymers were studied for compatibility and interaction study, carried out by FTIR and DSC and found to be compatible to each other. The Redispersibility, Sedimentation volume, Sedimentation rate, Rheological Study, Viscosity, Specific gravity, Particle Size, dissolution study and %Drug content of formulated batches was evaluated. All the results were within the acceptable pharmacopeial limits and were evaluated statistically by using one way ANOVA test for quadratic model. From the result, MET6 batch was observed optimized formulation because up to 8 hrs 85.25% drug was released. kinetic studies of the drug release for optimized formulation follows zero order kinetics.
盐酸二甲双胍缓释口服混悬液的配制与评估
本研究制定了盐酸二甲双胍缓释口服混悬液的配方和评估方案,目的是在缓释颗粒的基础上开发一种稳定、可再分散的口服液混悬液,以方便糖尿病患者吞咽。研究人员采用滑动床包衣法,将盐酸二甲双胍作为抗糖尿病药物与各种聚合物一起制备颗粒。将制备好的盐酸二甲双胍颗粒放入制备好的无糖糖浆载体中,使用黄原胶等聚合物作为药物均匀分布的悬浮剂、山梨糖醇溶液、人工甜味剂阿斯巴甜、柠檬酸钠、山梨酸钾、对羟基苯甲酸甲酯。配方的优化基于 Design expert 软件,并采用中央复合设计进行研究。通过傅立叶变换红外光谱和 DSC 对药物和聚合物的相容性和相互作用进行了研究,发现它们之间是相容的。对配制批次的再分散性、沉降体积、沉降速率、流变学研究、粘度、比重、粒度、溶出研究和药物含量进行了评估。所有结果均在药典规定的可接受范围内,并采用单向方差分析对二次方模型进行了统计评估。从结果来看,MET6 批次被认为是最佳配方,因为在 8 小时内,85.25% 的药物被释放出来。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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