Pulsatile Release Tablets of Valsartan: Development, Statistical Optimization, and In Vitro Evaluation

Pulsatile release tablet containing Valsartan will be developed with an objective to get desired drug release according to Circardian Rhythm of body and attack episodes of Hypertension where blood pressure is at its lowest during the sleep cycle and rises steeply during the early morning awakening period. Core tablet was prepared by direct compression using super disintegrants like sodium starch glycolate. The core tablet was compression coated with different quantities of coating material containing different polymers. A 32 Full factorial design was used for optimization of barrier layer. Total coat weight (X1) and % KLUCEL EXF (X2) were selected as independent variables. The lag time for Valsartan (Y1), CPR at 1st hr after lag time for Valsartan (Y2), time for 90% drug release for Valsartan (Y3), were selected as dependent variables. Tablets were evaluated for various evaluation parameters. Comparative dissolution profiles of all the batches indicate drug release from tablet was inversely proportional to coat weight. From release profile it also found that delay lag time was observed for the press-coated tablet containing a higher amount of KLUCEL EXF in the outer shell. The press coated tablets coated with KLUCEL EXF: KLUCEL HXF IN 64.39:35.61 ratios with 250 mg coat weight are most likely to provide desired delivery of Valsartan.