FORMULATION AND EVALUATION OF CHLORPHENOXAMINE HYDROCHLORIDE RAPIDLY DISINTEGRATING TABLETS

Abstract

The aim of the present study was to develop rapid disintegrating tablets of Chlorophenoxamine hydrochloride which acts as antihistaminic, anticholinergic, antipruritic and antiparkinsonian agent. Chlorphenoxamine Hydrochloride is present in the market as conventional tablets with very low bioavailability due to first pass effect. To increase its bioavailability; rapidly disintegrating tablets of chlorophenoxamine hydrochloride to be dissolved and disintegrate quickly in the mouth cavity and reach to the systemic circulation more quickly than conventional tablets. Rapid disintegrating tablets of Chlorophenoxamine hydrochloride were prepared by using different superdisintegrants such as Aci-Di-Sol, crosspovidone and sodium starch glycolate with two different concentrations 2.5 mg and 5 mg. The blend was examined for angle of repose, bulk density, tapped density, compressibility index and Hausner’s ratio. The compressed tablets were evaluated for drug content, friability, disintegration time in-vitro, wetting time and dissolution rate. The flowability tests and the quality control tests for tablets were done and good results were obtained for all formulae. In vitro dissolution studies showed the release in the following descending order of superdisintegrants: Crospovidone > Croscarmellose sodium > Sodium Starch Glycolate. Selection of the best formula was done and it was found that F6 the formula which contains Crosspovidone 5 mg showed the fastest disintegration time in 16 seconds and drug release about 100 % in 8 minutes. The accelerated stability study was done for formula F6. It was concluded that Crosspovidone at a concentration of 5 mg is suitable for preparing rapid disintegrating tablets of Chlorophenoxamine hydrochloride.