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首页> 外文期刊>Pharmacology & Pharmacy >Development and Optimization of Venlafaxine Hydrochloride Sustained Release Triple Layer Tablets Adopting Quality by Design Approach
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Development and Optimization of Venlafaxine Hydrochloride Sustained Release Triple Layer Tablets Adopting Quality by Design Approach

机译：盐酸文拉法辛缓释片的设计开发与优化

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Purpose:Venlafaxine hydrochloride sustained release formulation increases patient compliance by reducing frequency of administration and it also reduces side effects like nausea and vomiting. Hence the objective of present investigation was to develop triple layer sustained release tablets of venlafaxine HCl using xanthan gum or polyethylene oxide. Methods:The venlafaxine HCl 150 mg sustained release tablets were prepared by wet granulation technique where drug was incorporated in middle layer with part of polymer. The barrier layers were composed of remaining polymer and other excipients. The granules and tablets were characterised. Optimized batches were also tested for drug release at different pH and in presence of ethanol, for kinetics of drug release and for water uptake/swelling. Results: Preliminary trials of monolayer tablet showed burst release due to high dose and solubility of venlafaxine HCl and hence triple layer tablets were developed. Granules of middle layer exhibited good flow properties. The comparative drug release to Effexor? XR capsule 150 mg could be achieved by modulating the concentration of polymer and diluents in middle layer as well as in barrier layers. Higher amount of polyethylene oxide was required as compared to xanthan gum which may be due to high water uptake and poor gel strength of polyethylene oxide. The optimized formulations showed pH independent drug release as well as ethanol had no effect on drug release. Effexor? XR capsule and optimized batches followed Weibull kinetics for drug release. The radar diagrams showed the comparable drug release to innovator in both the optimized formulations but point to point correlation was observed in batch with xanthan gum. Conclusion: The layered matrix tablets formulated successfully using hydrophilic polymers, xanthan gum or polyethylene oxide, to sustain the release of highly soluble drug like venlafaxine HCl.
机译：目的：盐酸文拉法辛缓释制剂可通过减少给药频率来提高患者依从性，还可以减少恶心和呕吐等副作用。因此，本研究的目的是使用黄原胶或聚环氧乙烷开发盐酸文拉法辛的三层缓释片剂。方法：采用湿法制粒技术制备盐酸文拉法辛150 mg缓释片，将药物与部分聚合物掺入中间层。阻挡层由剩余的聚合物和其他赋形剂组成。表征颗粒和片剂。还测试了优化的批次在不同pH值和乙醇存在下的药物释放，药物释放动力学和吸水率/溶胀率。结果：单层片剂的初步试验显示由于盐酸文拉法辛的高剂量和高溶解度而导致的突发释放，因此开发了三层片剂。中间层颗粒表现出良好的流动性。比较药物释放到Effexor？通过调节中间层以及阻隔层中聚合物和稀释剂的浓度，可以获得150 mg的XR胶囊。与黄原胶相比，需要更高量的聚环氧乙烷，这可能是由于聚环氧乙烷的高吸水率和较差的凝胶强度。优化的配方显示pH依赖性药物释放以及乙醇对药物释放没有影响。 Effexor？ XR胶囊和优化批次遵循Weibull动力学进行药物释放。雷达图显示，两种优化配方的药物释放量均与创新者相当，但与黄原胶分批观察到点对点相关性。结论：使用亲水性聚合物，黄原胶或聚环氧乙烷成功配制了层状基质片剂，以维持盐酸文拉法辛等高可溶性药物的释放。

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