DEVELOPMENT AND EVALUATION OF BOSENTAN PULSINCAP FORMULATION FOR CONTROLLED RELEASE

A controlled release Pulsincap dosage form of Bosentan was developed for the treatment of pulmonary arterial hypertension (PAH), which lead to serious cardiovascular complications. Empty hard gelatin capsules were used to develop the Pulsincap formulations. Bodies of hard gelatin capsules were treated with formaldehyde for insolubility, and the caps of the gelatin capsules were used as such. The developed system contained hydrogel plug prepared with swellable polymer such as hydroxypropyl methyl cellulose (HPMC 10K), Guar Gum, Xanthan gum, and Sodium alginate together with pellets coated with drug and polymers separately at concentrations of 20, 30 and 40mg. Drug coating of Bosentan pellets was done by Fluid Bed Process Technology. All the formulations were assayed to determine drug content and the ability of the Pulsincap formulation to provide controlled release was assessed by in vitro drug release studies in buffer pH 1.2 for 2 hours, simulated intestinal fluid pH 7.4 for 3 hours and simulated colonic fluid pH 6.8 for 7 hours. The results indicated that significant drug release was obtained after 5 h from the start of experiment. Thus, Bosentan could be successfully delivered using developed Pulsincap formulation thereby reducing the systemic side effects.