Abstract

FORMULATION AND EVALUATION OF FLOATING PULSATILE TABLET IN TABLET DRUG DELIVERY SYSTEM FOR HYPERTENSION

Mansi Shah* and Dipti Patel

Abstract

The objective of this study was to prepare and characterize floating pulsatile tablet of Captopril giving pulsatile release for hypertension. Floating pulsatile drug delivery gives highest concentration at the early morning when it is needed the most. So it increases the patient compliance and decreases the side effects. Floating pulsatile tablets were prepared by direct compression method using HPMC K4M, avicel PH101, sodium starch glycolate and sodium bicarbonate polymers to achieve pulsatile drug release. Effects of all the polymers, with different concentrations, on physical properties of floating pulsatile tablets were investigated. To evaluate the effect of HPMC and sodium bicarbonate concentrations, 32 factorial designs was employed and for avicel PH101 and sodium starch glycolate, 22 factorial designs was employed. The optimization of core tablet was done on the basis of disintegration time. The optimization of floating pulsatile tablet was done based on the floating lag time & release rate. The core tablet formulation C3 and floating pulsatile tablet formulation F1 were selected as optimum production formulation. The Floating lag time, floating time, drug content, disintegration time and in-vitro drug release were found to be 43.4 sec, >8hrs, 99.06%, 45.6 sec, 95.3% respectively. Stability study at 40 ºC±2 ºC / 75 ± 5% RH revealed that there was no significant change in disintegration time, drug content and % CDR after 45 days. So, prepared formulation was stable during stability study. The developed floating pulsatile tablet can be effectively used for oral administration in case of hypertension as it releases the drug in a pulsatile manner up to 7 hours thus improving patient compliance.

Keywords: Floating pulsatile tablet, Captopril, Chronotherapy, Hypertension.