Formulation Development and Optimization of Bilayer Sustained Release Matrix Tablets of Valsartan Using 32 Factorial Design
Year: 2025
Type: article
Abstract: ABSTRACTThe development of bilayered sustained release tablets of Valsartan acetate aimed to provide acontrolled drug release profile with a fast-releasing loading dose and a sustained-maintenancedose. The tablets were formulated using wet granulation, incorporating Eudragit RSPO andEudragit RLPO as polymers, and sodium starch glycolate as a super disintegrant. Drug-polymerinteractions were studied using FTIR providing critical insights for formulation optimization.The granules and tablets underwent extensive evaluation for pre- and post-compressionparameters, including angle of repose, compressibility index, Hausner’s ratio, tablet hardness,friability, weight variation, drug content, and in vitro dissolution, with satisfactory results. A 32full factorial design was employed to optimize the drug release, with Eudragit RSPO (X1) andEudragit RLPO (X2) as independent variables and the time to achieve 90% drug dissolution(t90%) as the dependent variable. Multiple regression analysis identified the optimal levels of thepolymers for achieving the desired release profile. A checkpoint batch, formulated to validate themathematical model, showed a high degree of accuracy (p = 0.0079). Formulation F6, whichexhibited the highest f2 value (86.33) and a t90% closest to the checkpoint batch, was selected asthe optimized formulation. Kinetic analysis of in vitro release data revealed that the optimizedbatch followed zero-order, non-Fickian diffusion. These findings suggest that the bilayeredValsartan tablets offer an effective strategy for sustained drug delivery with predictablepharmacokinetic behavior.
Author: Dr.S.Bhama, Ms.J.Vannila, Dr.P.Perumal, Dr.S.Selvaraj
Language: English
Subfield: Pharmaceutical Science
Domain: Life Sciences
Open Access status: green
OpenAlex ID: W6930823165
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