Abstract

FORMULATION DEVELOPMENT, OPTIMIZATION AND EVALUATION OF VALSARTAN PRESS COATED TABLETS FOR CHRONOTHERAPY

*Dr.A.Sambasivarao M.S,Ph.D, Mathe Ark, E.Venkata Sai, V.Bhumika

ABSTRACT

In order to improve treatment efficacy in treating hypertension through controlled and time-dependent medication release, the current study sought to develop a chronotherapeutic drug delivery system for valsartan employing the press coating approach. Solid dispersion techniques were used to increase the solubility of valsartan; formulation F6 (solvent evaporation method) demonstrated the highest saturation solubility (0.55 mg/mL). The direct compression approach was used to create fast-dissolving core tablets using sodium starch glycolate and croscarmellose sodium as coprocessed superdisintegrants. Using different concentrations of the superdisintegrants (5%, 10%, and 15% w/w), six formulations (F1–F6) were created. The quickest medication release was shown by F3 which included 15% croscarmellose sodium. The optimized fast-dissolving core (F3) was then used to formulate press-coated tablets with HPMC K-100 and ethyl cellulose (EC) in different ratios. The coating was designed to achieve a specific lag time before drug release, ideal for chronotherapeutic applications. The mechanism involves erosion or dissolution of the coating layer, enabling delayed release from the core. Dissolution studies were carried out in 0.1 N HCl for 2 hours, followed by phosphate buffer (pH 6.8) for 12 hours. The press-coated formulation containing 350 mg EC and 50 mg HPMC K-100 exhibited the desired drug release profile, with a lag time of 3–3.5 hours and sustained release thereafter. The developed system has potential to reduce dosing frequency and enhance therapeutic outcomes in hypertension management.

Keywords: Valsartan, Chronotherapeutic, Press coating, Lag time and Hypertension.