European Journal of Biomedical and Pharmaceutical Sciences

FORMULATION DEVELOPMENT AND EVALUATION OF FLOATING OSMATIC DRUG DELIVERY SYSTEM FOR MODEL DRUG

R. Sunitha*, S. Madhavilatha and J. Vasavi

ABSTRACT

This study was conducted to develop floating osmotic tablets of Manitol, a H2 receptor antagonist, to release the drug as two distinct pulses separated by a lag time that achieve plasma concentration profiles varying in a circadian rhythm fashion, for the chronotherapy of ulcer. Floating osmotic tablets were developed using effervescence method consisted of three different steps viz, preparation of floating sustained release drug containing tablets followed by time-lagged (4 hrs) coating with hydrophobic rupturable polymer, ethyl cellulose (EC), and finally compression coating with immediate release dose of Mannitol and supporting buoyant layer. Three ratios of Ethyl cellulose to HPMC E15 (32.5:67.5, 50:50, and 67.5:32.5) at three coating levels (5%, 10%, 15%) were used to optimize the lag time (4 hrs). Carbopol 934P, cross povidone and sodium bicarbonate were used in buoyant layer. The developed floating osmotic tablets by effervescence method were evaluated for pre-formulation parameters, weight variation, thickness, hardness, friability, drug content, content uniformity, In-vitro floating properties, and In-vitro drug release. The optimized formulation provided expected two-phase release pattern of Mannitol with initial immediate dose release in 30 min and then lag time 4 hrs of no drug release followed by sustained release for 8hrs in stomach during floating.

Keywords: Pulsatile drug delivery systems; Gastric retention; Chronopharmacokinetics; Mannitol.