DEVELOPMENT AND CHARACTERIZATION OF TASTE MASKED MOUTH DISSOLVING TABLETS OF ZOLPIDEM TARTRATE

Abstract

The present investigation was undertaken to design a simple, rapid, cost effective and highly efficient process to fabricate a tasteless complex of zolpidem tartrate using ion exchange resin (IER), evaluate the molecular properties of the resinate and finally incorporate it into orally disintegrating tablets (ODT). The resinate formation using tulsion-335, was confirmed using the characterization methods: Fourier Transform-Infra Ray (FTIR), X-Ray Diffraction (XRD) and Differential Scanning Calorimetry (DSC). The maximum drug loading efficiency achieved was in 1:3 (drug: resin weight) ratio at pH 6.8 in a period of 4.0 hrs using methanol: water as the complexation medium. The drug release from the complex was about 0.05 mg in 60 sec in 5 ml of pH 6.8 Sorenson’s buffer which has been used to mimic the salivary fluid volume and pH. The complex was compressed into mouth dissolving tablet. Dissolution studies for tablets carried out using 900 ml of Sorenson’s buffer pH 6.8 at 50rpm in USP Apparatus II showed 98% or drug release in 5mins, indicating complete drug release from the complex. Resinate was tasteless and hence the fabricated ODTs would also be pleasantly tasting without any bitterness.