FORMULATION DEVELOPMENT AND EVALUATION OF AMBROXOL HCL SUSTIANED RELEASE CAPSULES

Ambroxol Hydrochloride is an active N-desmethyl metabolite of the mucolytic bromhexine and it is referred as “Surface activator” as it stimulates the synthesis and secretion of pulmonary tract surfactant. It acts as mucolytic agent by increasing the quantity and decreasing the viscosity of tracheobronchial secretions. It may also acts as an expectorant, increasing mucociliary transport by stimulation of ciliary motility. The present research was focused mainly to formulate sustain release pellet formulations of Ambroxol Hydrochloride using ethyl cellulose 7 cps , 15cps and 50 cps followed by evaluated for content uniformity weight variation, in-vitro disintegration time, assay, in-vitro drug release study. All the formulation exhibited assay, content uniformity within the range in E.P. Dissolution studies revealed that formulations containing coating agent.PVPK-90, Ethyl Cellulose showed 100% of drug release at the 24th hour. The concentration of coating agents Ethyl Cellulose, had an effect on in-vitro drug release had the same release profile when compare with US dissolution parameters. Angle of repose, tapped density, bulk density, values for the formulations were within the range which indicates that pellets prepared by Wurster process were satisfactory for further studies. The percentage drug content of Ambroxol was determined by extraction with methanol and analyzed by using UV-Visible spectrophotometer at 245nm.