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Statistical Design of Experiments Using R Program for the Optimization of an Extended-Release Neem Oil Matrix Tablet
Journal of Pharmaceutical Innovation ( IF 2.6 ) Pub Date : 2022-03-29 , DOI: 10.1007/s12247-022-09640-2
Swathy K K , Sarath Chandran C , Sourav K , Jafna M C , Alan Raj , Shijina Kappally

Purpose

The objective of the investigation was to assess the adaptability and application of the R program tool for the optimization of an extended-release neem oil matrix tablet by 32 face-centered central composite design.

Methods

The mathematical model for each response variable was generated by using multiple linear regression analysis approaches. The effect of two independent variables, hydroxypropyl methylcellulose K100M and ethyl cellulose on responses, i.e., cumulative % azadirachtin release on the 14th day, cumulative % azadirachtin release on the 28th day, and time for 50% of azadirachtin release, was demonstrated on the 2D contour plots and 3D response surface plots. A simultaneous optimization technique with a desirability function was used for optimizing the three response variables.

Results

The results of the mathematical models and the response surface plots developed by the software denoted the significant influence of both independent variables on the release of azadirachtin. The neem oil extended-release matrix tablet with a combination of 65%w/w of HPMC K100M and 80%w/w of ethylcellulose had a desirability value of 1, and was predicted as the optimized formulation by R-studio software version 1.4. The optimized tablet shows 39.1% of azadirachtin release on the 14th day, 91.7% of azadirachtin release on the 28th day, and 50% of azadirachtin release on the 21st day.

Conclusion

The R-studio tool was successfully applied in the optimization of the neem oil extended-release matrix tablet and recommended for the optimization of pharmaceutical products instead of existing tools.



中文翻译:

使用 R 程序优化缓释印楝油基质片剂的实验统计设计

目的

调查的目的是评估 R 程序工具通过 3 2面心中心复合设计优化缓释印楝油骨架片剂的适应性和应用。

方法

每个响应变量的数学模型是通过使用多元线性回归分析方法生成的。两个自变量,羟丙基甲基纤维素 K100M 和乙基纤维素对反应的影响,即第 14 天的累积印楝素释放百分比、第 28 天的累积印楝素释放百分比和 50% 印楝素释放的时间,在 2D 上得到证明等高线图和 3D 响应曲面图。具有意愿函数的同时优化技术用于优化三个响应变量。

结果

软件开发的数学模型和响应曲面图的结果表明两个自变量对印苦楝子素释放的显着影响。印楝油缓释骨架片由 65%w/w 的 HPMC K100M 和 80%w/w 的乙基纤维素组合而成,其合意性值为 1,并通过 R-studio 软件 1.4 版预测为优化配方。优化后的片剂在第 14 天显示 39.1% 的印楝素释放,在第 28 天释放 91.7% 的印楝素,在第 21 天释放 50% 的印楝素。

结论

R-studio 工具成功应用于印楝油缓释骨架片剂的优化,并推荐用于医药产品的优化,而不是现有工具。

更新日期:2022-03-29
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