Formulation and Evaluation of Chlorpheniramine Maleate Troches

Abstract

The present study was sought to prepare Chlorphenamine (also called chlorpheniramine) maleate troches. Chlorpheni-ramine maleate (CPM) is a first-generation alkyl amine anti histamine used in the prevention of the symptoms of allergic conditions such as rhinitis and urticarial having oral bio availability about 25-50%, it undergoes first pass metabolism. Troches containing CPM was prepared by non-aqueous granulation technology using Xanthum gum, Gum acacia, HPMC K4M and tragacanth and guar gum as the polymers. The effect of varying the concentration of polymer on release of Chlorpheniramine maleate (CPM) from troches was investigated. Differential scanning calorimetry and X-ray powder diffraction spectroscopy were used for physicochemical characterization. Tablets prepared were evaluated for different parameters such as average weight, hardness, Carr’s index, tapped density, friability, disintegration, content uniformity test. All the parameters were found within the specifications. The drug content was estimated by UV spectrophotometer at 261 nm. In vitro drug release studies of troches formulations were performed in artificial saliva pH 6.8 at 37±1oC. Among the all polymers used the highest drug release is shown with xanthum gum due to its less binding capacity. The in vitro release data was subjected to zero order, first order, Higuchi, Korsemeyer-Peppas, Hixon crowell and erosion model in order to establish the drug release mechanism and kinetics of drug release from the lozenge tablets.