Statistical Design of Experiments Using R Program for the Optimization of an Extended-Release Neem Oil Matrix Tablet.

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. [ABSTRACT FROM AUTHOR]