Study on dissolution behavior in vitro of an osteoporosis treatment drug: eldecalcitol soft capsule

Abstract

Objective：To establish a method for the dissolutions profile determination of Eldecalcitol softgels, evaluate the in vitro dissolutions behavior between domestic Eldecalcitol soft capsules and the original preparation。Methods：The effects of different stirring apparatus, different dissolutions medium, different agitation speeds on the dissolutions behavior of Eldecalcitol soft capsules were investigated, cumulative dissolutions were calculated by measuring the dissolutions samples with HPLC-MS/MS method. Results：The dissolutions test of Eldecalcitol soft capsules was carried out by rotating basket method, agitation speed of 75 rpm, temperature of 37℃ in four mediums。Conclusion：This dissolutions method can be effectively applied to the dissolutions test of soft Eldecalcitol capsules. and the selected generics have good dissolution consistency with the original drugs. Keywords：Eldecalcitol soft capsules；dissolutions method；dissolutions behavior；consistency evaluation