Formulation, development and evaluation of extended release tablets of Valsartan potassium and Enalapril maleate
Keywords:
Extended release, Valsartan potassium, Enalapril maleate, Matrix tablets, HPMC, Ethyl celluloseAbstract
The present study aimed to formulate, develop, and evaluate extended-release (ER) tablets of Valsartan potassium and Enalapril maleate for once-daily management of hypertension. ER matrix tablets were prepared using a combination of hydrophilic and hydrophobic polymers to achieve controlled drug release over 24 hours. Preformulation studies, including solubility analysis, FTIR, DSC, and XRD, confirmed drug–excipient compatibility and stability. Twelve formulations (F1–F12) were developed and evaluated for micromeritic properties, post-compression parameters, and in-vitro dissolution behavior. Dissolution data were subjected to kinetic modeling to elucidate the release mechanism. Among all formulations, F4 exhibited optimal physicochemical properties and a near zero-order release profile, achieving approximately 95% cumulative drug release at 24 hours. Kinetic analysis indicated diffusion-controlled non-Fickian transport. Comparative assessment showed performance comparable to marketed extended-release antihypertensive products. The study concludes that a hydrophilic–hydrophobic polymer matrix system is effective for developing stable, predictable, and patient-friendly extended-release combination tablets of Valsartan potassium and Enalapril maleate.
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