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首页> 外文期刊>Journal of Young Pharmacists >Application of Response Surface Optimization Methodology in Designing Ordispersible Tablets of Antdiabetic Drug
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Application of Response Surface Optimization Methodology in Designing Ordispersible Tablets of Antdiabetic Drug

机译：响应面优化方法在设计抗糖尿病药物设计中的应用

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Objectives: The aim of the present investigation is to study the application of Response Surface Methodology (RSM), a mathematical model and graphical representation to formulate and Optimize Orodispersible Tablets (ODTs) of sitagliptin phosphate, a class III BCS drug. Methods: ODTs were prepared by direct compression method using dibasic calcium phosphate (DCP), as diluent and croscarmellose sodium sodium (CCS) as super disintegrant. Formulation was designed using design expert software 9.0 version. RSM based 2sup2/sup full factorial design, considering DCP and CCS as variables and dissolution time at 5, 15 and 30 min was taken as response. Mathematical models in the form of regression equations and graphs were developed. Results: The adequacy of the developed mathematical models was statistically checked through the analysis of variance (ANOVA) . The responses were analyzed using ANOVA and polynomial equation was generated for each response using RSM. Responses were mostly affected by the specific combinations of independent variable. Rsup2/sup predicted and Rsup2/sup adjusted values for the constructed models, which revealed the competence for the proposed mathematical model. Based on the results obtained DF1 formulation was optimized. The developed mathematical models can be successfully used for their prediction of measured responses. Conclusion: DoE Concept in formulation could pave way for adaptation of Quality Based Design (QbD) in pharmaceutical industry RSM was successfully applied to optimize diluents and disintegrate concentration of ODTs. The variables employed in the study had a great effect on the quality of formulation. Modeling of experimental data allowed the generation of useful equations for prediction of responses.
机译：目的：本研究的目的是研究响应面方法（RSM），数学模型和图形表示的应用，以配制和优化SITAGLIPTIN磷酸盐，III级BCS药物的酸性蛋白酶（ODTS）。方法：通过使用二元磷酸钙（DCP）的直接压缩方法制备ODTS，作为稀释剂和Croscarmellose钠（CCS）作为超级崩解剂。配方使用设计专家软件9.0版本设计。基于RSM的2 2 完整因子设计，将DCP和CCS视为5,15和30分钟的变量和溶解时间作为响应。开发了回归方程和图形形式的数学模型。结果：通过对方差分析（ANOVA）进行统计检查发达的数学模型的充分性。使用ACOVA分析响应，并使用RSM为每个响应产生多项式方程。响应主要受到独立变量的特定组合的影响。 R 2 预测和R 2 的构建模型的调整值，这揭示了所提出的数学模型的能力。基于该结果，优化了DF1配方。开发的数学模型可以成功地用于它们预测测量的响应。结论：配方中的DOE概念可以为制药工业的质量设计（QBD）进行铺平方式，RSM已成功应用于优化稀释剂和崩解浓度的ODTS。研究中使用的变量对配方质量产生了很大的影响。实验数据的建模允许生成有用方程以预测响应。

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