Design of Dual Release Drug Delivery System of Roxythromycin and Ambroxol Hydrochloride

Abstract

Upper respiratory tract infections (URTIs) are illnesses caused by an acute infection which involves the upper respiratory tract: nose, sinuses, pharynx or larynx. Roxithromycin (macrolide antibiotic) and ambroxol HCl (mucolytic) are used for this treatment. The dual release system of roxythromycin and ambroxol HCl was successfully prepared by bi-layer tablet approach for management of URTI. Quick release of roxithromycin was achieved by using disintegrants and slow release of ambroxol HCl was achieved by using matrix formulation of drug with HPMC K4M and ethyl cellulose. The 32 full factorial design was adopted for optimization of polymer concentration to achieve identical drug release with theoretical dissolution profile. The amount of HPMC K4M and ethyl cellulose were selected as independent variable and the similarity factor with theoretical dissolution profile and percentage drug release at 10th hr was selected as dependent variables. The prepared dual release tablets were evaluated for physical parameters, drug content, in vitro drug release study, etc. All the parameters were found to be acceptable in range. As the concentration of HPMC K4M is increased, the drug release decreases and the effect of ethyl cellulose was found to be less compared to HPMC K4M.