Original Articles
Upendra C Galgatte, Pooja P Pa
Abstract
The aim of the present research work was to develop, optimize and evaluate fast dissolving sublingual wafer of Tamsulosin hydrochloride using film former by solvent casting technique to treat benign prostatic hyperplasia. The xanthan gum, a natural polymer along with cross carmellose sodium as a super disintegrant and polyethylene glycol 400 as a plasticizer were used for forming sublingual wafer. The prepared film was evaluated for mechanical properties like percent elongation and tensile strength, weight variation, thickness, disintegration time, drug content, pH, folding endurance and in vitro drug release. Formulations were optimized by 32 factorial design. Drug loaded sublingual wafers of size 2 cm 1.5 cm exhibited folding endurance of 210 ± 0.547, disintegration time 20 ± 0.577 seconds, tensile strength 27.33 ± 0.325 dyne/cm2and drug release of 101.88% at the end of 20 seconds. The optimized formulation of film was characterized by DSC and PXRD. Multicrystalline nature of drug was observed in pure drug sample whereas crystalline nature was observed in optimized formulation. Drug release was observed to follow Korsmeyer peppas model of kinetics with R2 value 0.996 and fickian diffusion. Surface and contour plots were also studied for dependent variables. In the accelerated stability study of one month no significant difference in disintegration time, tensile strength and drug release was found.