Abstract

FORMULATION, DEVELOPMENT AND EVALUATION OF CARBAMAZEPINE EXTENDED RELEASE TABLET: DISSOLUTION APPARATUS USP IV

Roshan Bodhe*, Rameshwar Deshmukh, Ashish Gorale, Rajendra Shinde, Pankaj Bodhe

Abstract

Aim: The aim of the present study was to develop sustained release drug delivery system of neuroleptic drug (Carbamazepine). Oral route is considered as one of the most popular, non-invasive, convenient and safest route of administration. Control drug delivery system generally implemented to overcome drawback associated with conventional drug delivery system. Objective: Objective of present study was to develop Carbamazepine extended release tablet by wet granulation method by using RSPO & RLPO polymer as drug release retardant. Method: Carbamazepine extended release tablet 400 mg prepared by wet granulation method. Different excipients used in the formulation of CBZ extended release tablet are; MCC (Avicel pH101 and 112) used as diluent. Low viscosity ethyl cellulose (Ethocel 7 cps) used as binding agent. Croscarmellose Sodium (Ac-di-sol) used as disintegrant, Colloidal silicon dioxide (Aerosil 200) used as glident, Magnesium Stearate used as lubricant, Purified talc used as Opacifier, Opadry peach is used as coating agent. Result: Resultant Carbamazepine extended release 400 mg tablet were evaluated for physicochemical properties such as; drug content by (RP-HPLC) were 99.20%, Bulk density 0.57 mg/ml, Tapped density were 0.69 mg/ml, Carr’s index were (17.14%), Hauser’s ratio were (1.21%), Angle of repose were 27., dissolution apparatus IV showed a synchronous release of CBZ extended release tablet 15 minute (16.5 %) with sustained release after 70 minute (75 %) and Cumulative drug release of CBZ extended release tablet after 90 minute was found to be (87.5 %). RSPO & RLPO Polymer are responsible for extended release. Conclusion: Evaluation of physicochemical parameters like; Hardness, Thickness, friability, weight variation, Disintegration and dissolution indicated that the tablets were mechanically stable and complied with applicable pharmacopoeia specifications for dissolution test. Hence we consider above mention project for extend drug release by using RSPO and RLPO Polymer there for it reduces the dosing frequency and increases patient compliance.

Keywords: Carbamazepine, Neuroleptic, RSPO/RLPO, USP IV apparatus (Flow through cell), RP-HPLC.