The aim of present study was to prepare and evaluate the enteric coated tablets of Duloxetine Hydrochloride (DLX), a selective serotonin and nor-epinephrine reuptake inhibitor clinically used for treatment of depression disorders. The Solid dispersions (SD) of DLX were prepared using Chitosan (CH) as a biocompatible and mucoadhesive carrier. The SD formulations were prepared by varying ratios of drug to polymer using freeze drying method. The prepared SD formulations were characterized by Differential Scanning Calorimetry (DSC), Fourier Transform Infra Red (FTIR), X-ray diffraction (XRD) and Scanning Electron Microscopy (SEM). The enteric coated tablets of DLX were formulated using solid dispersions along with suitable excipients by direct compression method. The formulated tablets were characterized for the swelling behavior, mucoadhesion time and in vitro drug release. FT-IR showed a good physical compatibility between CH and DLX. From DSC and XRD studies it may be concluded that there is change in crystalline form of drug into amorphous during formation of SD. A slow and prolonged release of the drug was observed from tablets by in vitro studies as compared to marketed formulation. The swelling properties of the polymer seemed to be the main parameter affecting the mucoadhesion time and drug release profile from tablets. From the in vitro swelling studies, mucoadhesion time and in vitro release studies, the 1:3 DLX-CH solid dispersion tablets was optimized. The release pattern of optimized formulation followed the Higuchi Model.
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