Formulation and Evaluation of Solid Self-emulsifying Drug Delivery System of Bambuterol Hydrochloride

The solid self-emulsifying drug delivery system of bambuterol hydrochloride was designed, prepared and evaluated to overcome poor bioavailability. The designing process included selection of oil phase, surfactant and co-solvent/co-surfactant based on saturated solubility studies. Psuedoternary phase diagram was constructed using dilution method to identify the self-emulsifying region. Liquid self-emulsifying drug delivery formulations were prepared from components obtained from these studies and were converted to solid self-emulsifying drug delivery systems by adsorption technique using microcrystalline cellulose:aerosil mixture as the adsorbent. The prepared solid self-emulsifying drug delivery system-based formulations were evaluated for drug content, morphology, globule size, micromeritic properties, ex vivo permeability and stability. Formulation F1 containing 10 mg bambuterol hydrochloride, triacetin (12.50 % w/w), Tween 80 (43.75 % w/w) and ethanol (43.75 % w/w) was concluded to be optimal. These results suggested that bambuterol hydrochloride can be formulated as a solid self-emulsifying drug delivery system, which could be used to improve oral bioavailability of bambuterol hydrochloride.