Development and evaluation of or dispersible tablet of Propranolol Hydrochloride by sublimation technique

Abstract

Propranolol Hydrochloride (PHCl) is a synthetic beta adrenergic receptor blocking agent used widely in the treatment of angina pectoris, cardiac arrhythmias and hypertension. The purpose of this study was to develop PHCl orodispersible tablet of fast disintegration in mouth with high mechanical strength to withstand handling during manufacturing and patient use. Sublimation technique was used to prepare the orodispersible tablets of PHCl using four subliming agents; camphor, thymol, ammonium bicarbonate and menthol by direct compression method in presence of 2.5%w/w crospovidone as superdisintegrant. The product is of high porosity after sublimation of agent from the tablets. To mask the bitter taste of the drug, increase sweetness and to provide acceptable feeling in mouth, aspartame, saccharin sodium, and citric acid were added. Mannitol was used as sugar based multifunctional diluents. The formulas powder blend was evaluated before compression for angle of repose and compressibility index while the post-compression parameters were evaluated for weight variation, content uniformity, hardness, friability, disintegration time, and drug in vitro release of the formulated tablets. The weight and drug content of tablets of all batches were within the acceptable limits. The in vitro disintegration time was less than 62.8 seconds for all batches except that containing 2.5% w/w menthol shows disintegration in 202.73 sec. Menthol 15% w/w shows the shortest disintegration time among subliming agents with acceptable friability and hardness, thus selected as the best formula (F9). The optimized formulation showed faster release profile in comparison to the conventional tablets.