FORMULATION AND OPTIMIZATION OF VARDENAFIL HYDROCHLORIDE ORAL DISINTEGRATING TABLETS: EFFECT OF SUPERDISINTEGRANTS

Abstract

One of the fruitful results of oral technological advancement in dosage forms is the orally disintegrating tablets (ODTs) as they disintegrate rapidly in the mouth and do not require water for administration. This work employed mixture design approach for developing and optimizing oral disintegrating tablets of a slightly water soluble drug, vardenafil hydrochloride. Three component mixture design was used to optimize the type and concentration of superdisntegrants, crosscarmellose sodium (X 1), crosspovidone (X 2) and sodium starch glycolate (X 3) using water soluble dextrates (Emdex ®) as a filler. Disintegration time, wetting time and t 90 values for all formulations ranged from 33.69 to 208.68 s, 40.42 to 209.83 s and 80.04 to 484.63 s, respectively. According to the results, the selected variables have a strong influence on disintegration time, wetting time and t 90 of the ODTs. The lowest disintegration time, wetting time and t 90 were showed by ODTs formula composed of 1.72 % of crosscarmellose in combination with 4.28 % of crosspovidone. So, this formula was chosen as the optimized formula. Stability studies also showed that the optimized formula was stable under accelerated conditions. And, by comparing the selected formula with Prosolv ® ODT G2 as a ready ODT system, it showed faster disintegration time and higher dissolution rate. Hence, the best superdisintegrants to be used with the water soluble dextrates are crosspovidone in combination with crosscarmellose sodium.