DESIGN AND EVALUATION OF CONTROLLED RELEASE TABLETS OF PAROXETINE HYDROCHLORIDE

The present study aimed at Formulation Development and Evaluation of controlled release tablets for the programmed release of Paroxetine hydrochloride for the treatment of Major Depression. The matrix tablets of Paroxetine hydrochloride were prepared using wet granulation. Physical characterization of tablet and powder blends used to form the matrix tablet was under taken using a range of experimental techniques. Instacoat EN II was used as enteric coat polymer for coating the matrix tablet. The ratio of Methocel K100M and Methocel K4M, concentration of Compritol 888 ATO and percentage of coating with Instacoat EN II was optimized using Design of experiment software and effect of factors on in-vitro drug release at Q2 and Q9 Studied. Dissolution studies of paroxetine hydrochloride controlled release tablets in media with different dissolution media 0.1 N HCl, pH (7.5). The study showed that, drug release in 2 h was highly affected by the coating level. Optimization enabled formulation of Paroxetine hydrochloride CR tablets shown that formulation F 12 with Methocel K100M and Methocel K4m (1:2 ratio), Compritol 888 ATO (12 mg) and (10 %) coating of Instacoat EN II met the desired release profile. Formulation F12 was compared with marketed brand in same dissolution medium. Stability study of the optimized formulation indicates no significant difference in release profile after a period of one month