FORMULATION OF PROPRANOLOL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS BY DIRECT COMPRESSION USING SIMPLEX LATTICE DESIGN

Abstract

Simple lattice experimental design was used to study the effects of three superdisintegrants; sodium starch glycolate (SG), crospovidone (Polyplasdone® XL, CP) and croscarmellose sodium (Ac-Di-Sol®, CS), on disintegration times of propranolol hydrochloride tablets intended to be prepared as orally disintegrating tablets. The contents of SG, CP and CS were varied according to the simplex lattice design resulting in seven tablet formulations. The PH tablets were prepared by direct compression using microcrystalline (Avicel® PH 102) and spray-dried lactose as diluents. Aspartame, magnesium stearate and talcum were used as sweetening agent, lubricant and glidant, respectively. The prepared tablets were tested for uniformity of weight, hardness, friability, disintegration time and dissolution. The equation representing the tablet disintegration time as function of SG, CP and CS ratios utilized in the tablet formulations was computed. A triangular contour plot of the predicted equation was also drawn. From the predicted equation and the contour plot, an optimum propranolol hydrochloride orally disintegrating tablet formulation yielding the predicted disintegration time of 2.98 seconds was selected. The propranolol hydrochloride orally disintegrating tablet, prepared according to the chosen formulation, provided the observed disintegration time of 3.08 seconds and met the USP drug dissolution requirement.