Study on novel galantamine hydrobromide sustained-release capsules and its in vitro releasing property

Abstract

In present study, we prepared a novel galantamine hydro bromide sustained-release capsules with the new manufacturing technology, extrusion-spheronization method, and the optimized preparative formulation. A simple, rapid and accurate high performance liquid chromatography method (HPLC) was developed and validated for the quantification and release evaluation of galantamine hydro bromide. Experimental results showed that the method was specific, sensitive and reliable, could be effectively applied to the in vitro release study of galantamine hydro bromide sustained-release capsules. Our resulting samples had superior properties, worked better as sustained-release carriers and lasted longer hours to release drugs compared with the marketed control, Razadyne ER. The in vitro releasing characteristics of different batches of preparations are quite similar with each other, the total release proportions of galantamine hydro bromide from sustained-release capsules reached higher than 90 % within 12 h. The testing sustainedrelease preparation may be a promising new product for curing the related diseases.