Abstract

COMPARATIVE STUDY OF FORMULATIONS OF FAST DISINTEGRATING TABLET OF AMLODIPINE BESYLATE BY DIRECT COMPRESSION AND SUBLIMATION METHODS

Nawa Raj Khadka*, Junu Khatri Silwal, Anil Prasad Shah, Rajendra Ayer, Emi Maharjan and Srijan Maharjan

Abstract

The aim of present study was to formulate and evaluate fast disintegrating tablets of Amlodipine Besylate for faster action. The comparative study was carried out for selecting best super disintegrant and methods used for preparing fast disintegrating tablets. The superdisintegrants used in this study were Croscarmellose Sodium (CCS), Sodium Starch Glycolate (SSG) and Crospovidone (CP) in varying concentrations (4%, 6% and 8%). The methods used were direct compression method and sublimation method. Menthol was used as sublimating agents. The pre-compression parameters such as bulk density, tapped density, angle of repose, carr’s index and hausner’s ratio were evaluated. The post compression parameters such as weight variation, thickness, hardness, friability and assay were also evaluated. The major parameters considered for optimization of the formulation were wetting time, disintegration time and in –vitro drug release. The pre-compression and post compression parameters were found within limit range as specified. Among various formulations containing different superdisintegrants prepared by direct compression method and sublimation method, the formulation SBC3 prepared using 8% Croscarmellose Sodium by sublimation method showed least wetting time of 9 seconds, disintegration time of 10 seconds and faster dissolution rate of about 95% in 4 minutes and 99.2% in 10 minutes. Formulation SBC3 has been chosen as optimized formulation for preparation of fast disintegrating tablet of Amlodipine Besylate. Thus, Fast disintegrating tablet of Amlodipine Besylate can be best prepared using Croscarmellose sodium as super disintegrant by sublimation method for faster action of drug.

Keywords: Fast disintegrating tablets, Amlodipine Besylate, Superdisintegrants, direct compression, sublimation method.