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Risk based approach for design and optimization of site specific delivery of isoniazid
Chintan Vora,Riddhish Patadia,Karan Mittal,Rajashree Mashru 한국약제학회 2015 Journal of Pharmaceutical Investigation Vol.45 No.2
The research envisaged focuses on risk managementapproach for development and optimization ofenteric coated tablet of isoniazid giving extended release inpH 6.8 phosphate buffer. Risk assessment using failure modeand effects analysis was done to depict the effects ofunambiguous failure modes related to particular formulation/process variable. A 2³ full factorial design wasemployed for optimization of core tablet to investigate effectof amount of Polyox WSR303 (A), hardness (B) and amountof ethyl cellulose (C) on percent drug release in pH 6.8phosphate buffer. Main effects and interaction plots weregenerated to study effects of variables. The selection ofoptimized formulation was done on overlay contour plotsand desirability function. The optimized formulationexhibited percent drug release at first hour of 26.97 %, secondhour of 44.20 %, fourth hour of 66.15 %and eighth hourof 97.9 % in phosphate buffer pH 6.8. Akaike informationcriteria and Model selection criteria revealed that the modelwas best described by Korsmeyer–Peppas power law. TheKopcha and Peppas–Sahlin model revealed diffusion aspredominant mechanism of release which may be due to highsolubility of drug and drug loading. Enteric coating optimizationrevealed weight gain of 10 %w/w as optimum; givingnil release of isoniazid in 0.1 N hydrochloric acid. Thecomposite desirability for optimized formulation computedusing equations and software were 0.91 and 0.90 respectively. Capability analysis on reproducibility batchesrevealed all indices above 1.33 signifying process was withincontrol of producing batches as per desired specifications.