Formulation and Evaluation of Ketoprofen Emulgels by Model Independent Approach

Gnana Prakash
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Abstract

In the current study, ketoprofen emulgels were prepared using Sodium CMC, Sodium alginate and Hibiscus as gelling agents in order to overcome gastric side effects and to achieve pharmacological response. Pre formulation parameters were performed to know the compatibility of pure drug ketoprofen with polymers CMC, Na alginate, hibiscus prior to the preparation of Emulgel. It indicates that no change was observed in the peak values of the drug in the physical mixture thus providing that both the drug and polymer were said to be compatible with each other. Emulgel of ketoprofen 2.5% w/w was prepared in 3 steps i.e., Preparation of gel, emulsion phases separately and incorporate both phases in homogenizer for a period of 45 min and stabilized it for 2 hrs. The prepared emulgels were evaluated for physical characteristics, drug content, pH, spreadability and in-vitro  permeation studies. The physical appearance of all the formulations was creamy white, consistent, homogenous and stable. The pH of the prepared emulgels was found well within the range of 6-7. Release rate kinetics of the drug was studied with in vitro  drug permeation data for all the formulations F1 to F9 and results were stated the best fit model for selected formulation F6 were found to be Zero order model with non-fickian diffusion. The formulations were compared with the reference product. The in-vitro dissolution of F6 was nearest to the reference product F10 (f2 = 85.17).
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模型独立法制备酮洛芬凝胶及评价
本研究以CMC钠、海藻酸钠和芙蓉为胶凝剂制备酮洛芬凝胶,以克服其对胃的副作用,达到药理作用。在制备凝胶之前,通过预处方参数考察了纯酮洛芬与聚合物CMC、海藻酸钠、木槿的相容性。它表明在物理混合物中没有观察到药物的峰值变化,从而提供药物和聚合物都被认为是相互兼容的。制备酮洛芬2.5% w/w的乳状液,分凝胶、乳状液两相制备,两相均入均质机45 min,稳定2 h。对制备的凝胶进行了物理特性、药物含量、pH值、涂抹性和体外渗透研究。所有配方的物理外观为乳白色,一致,均匀和稳定。制备的乳液的pH值在6-7范围内。利用体外药物渗透数据研究了F1 ~ F9制剂的药物释放动力学,结果表明,F6制剂的最佳拟合模型为零级非黏性扩散模型。并与对照品进行了比较。F6的体外溶出度与对照品F10最接近(f2 = 85.17)。
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