Statistical Optimization and Fabrication of a Press Coated Pulsatile Dosage Form to Treat Nocturnal Acid Breakthrough

Vaibhav      Agarwal; Mayank      Bansal

Abstract

Objective: Present work focuses on the use of mimosa seed gum to develop a drug delivery system making combined use of floating and pulsatile principles, for the chrono-prevention of nocturnal acid breakthrough. Methodology: The desired aim was achieved by fabricating a floating delivery system bearing time – lagged coating of Mimosa pudica seed polymer for the programmed release of Famotidine. Response Surface Methodology was the statistical tool that was employed for experiment designing, mathematical model generation and optimization study. A 3² full factorial design was used in designing the experiment.% weight ratio of mimosa gum to hydroxy propyl methyl cellulose in the coating combination and the coating weight were the independent variables, whereas the lag time and the cumulative % drug release in 360 minutes were the observed responses. Key findings: Results revealed that both the coating composition and the coating weight significantly affected the release of drug from the dosage form. Conclusion: The optimized formulation prepared according to the computer generated software, Design-Expert^® deciphered response which were in close proximity with the experimental responses, thus confirming the robustness as well as accuracy of the predicted model for the utilization of natural polymer like mimosa seed gum for the chronotherapeutic treatment of nocturnal acid breakthrough.

Keywords: Chrono-prevention, Nocturnal acid breakthrough, Response Surface Methodology, Full factorial design.

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