DESIGN AND DEVELOPMENT OF ANTI-INFLAMMATORY DRUG NAPROXEN SOLID DISPERSIONS AND FORMULATIONS BY FACTORIAL DESIGN APPROACH

Abstract

Naproxen is a non-steroidal anti-inflammatory (NSAID) drug that can be used as an analgesic, anti-inflammatory, and antipyretic. Objectives: The study’s major goal was to improve the drug’s solubility and dissolution rate, as well as its oral bioavailability. Methods: Physical mixture, kneading process, and solvent evaporation method were used to make Naproxen solid dispersions (SDs). Using a two-level factorial design and three independent components, X1 β-Cyclodextrin, X2: Kolliphor p-188, and X3: PVPK-30 and designed by a Design expert (DOE). The formulation was studied by flow parameters, physical characteristics, Fourier-transform infrared spectroscopy, and comparative investigations with commercially available Naprosyn and F2. Major Results: In vitro performance of solid dispersions SD’s was favorable (100% drug release 20 minutes), compared to a pure drug, where 100 percent drug release takes 80 minutes. The FTIR spectra of pure drug and combinations with excipients were having no chemical interaction. The F44

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用因子设计法设计和开发消炎药萘普生的固体分散体和制剂

萘普生是一种非甾体抗炎药（NSAID），可用作镇痛、消炎和解热剂。研究目的研究的主要目标是提高药物的溶解度和溶解速率，以及口服生物利用度。研究方法采用物理混合法、捏合法和溶剂蒸发法制备萘普生固体分散体（SDs）。采用两级因子设计和三个独立组分，即 X1 β-环糊精、X2：Kolliphor p-188 和 X3：PVPK-30，并由设计专家（DOE）进行设计。通过流动参数、物理特性、傅立叶变换红外光谱以及与市售 Naprosyn 和 F2 的对比研究，对配方进行了研究。主要结果：与纯药物相比，固体分散体 SD 的体外性能良好（20 分钟内 100%释放药物），而纯药物需要 80 分钟才能 100%释放药物。纯药物和辅料组合的傅立叶变换红外光谱没有化学作用。F44

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