FORMULATION DEVELOPMENT AND INVITRO EVALUATION OF MOUTH DISSOLVING TABLETS OF PAROXETINE HCL BY DIRECT COMPRESSION METHOD

Thota Ravi Kumar, V. Jhansi Priya Marabathuni* and Naidu Narapusetty

ABSTRACT

The present study is formulation and evaluation of immediate release tablets of Paroxetine. HCl with respect to Direct compression method used for formulating tablets was best suitable to achieve 100% results. Preformulation studies involving organo-leptic bulk density, angle of repose, tapped density, compressibility index, hausner ratio, melting point range, pH and solubility were carried out as per USP specifications. Drug excipients compatibilities were carried out physical, which showed no significant change in any way to the mixture. Polymers such as Polyplasdone (Crospovidon-XL), Croscarmellose Sodium (CCS), Sodium Starch Glycolate (SSG) were utilized in the trails. All the physical evaluations carried in Preformulation studies were carried out on all the three different polymers utilized. All the formulations exhibited values within the acceptable range. Tablets were evaluated for weight variations, hardness, friability, thickness and Dissolution studies. Release studies were carried out in 7.4 pH Saline, for 20 minutes. Evaluated samples for all the three polymer systems. Results indicated that formulation F12, gave 98.14% release within 8 minutes which is formulated with Crospovidon-XL alone. Assay was carried out for formulation F12 and was found to be 96.12%. Remaining formulations gave fluctuating release profiles. The formulation F12 was considered to be better among the trails accomplished.

Keywords: Paroxetine, Preformulation, Polymers, Immediate release tablets, Dissolution rate.