다파글리플로진 함유 구강 붕해 정제의 개발

Abstract

The purpose of this study is to develop a novel dapagliflozin orally disintegrating tablet (DF-ODT) to improvemedication compliance when administered orally for diabetics caused by chronic type 2. HPLC analytical method wasestablished for quantification of dapagliflozin L-proline, selected as a stable dapagliflozin cyrstalline salt form, then thephysicochemical properties and solubility were investigated. Various ODT formulations were prepared by using simplemixing and compression process. The effect of various excipients on tablet properties and impact of hardness on wettingand disintegrating time were investigated. Among the formulations tested, the formulation composed of dapagliflozin Lproline,Ludiflash®, crospovidone, mint flavor powder, aspartame and Pruv® at the weight ratio of 7.8/168.2/9/4/4/2 showedthe fastest wetting and disintegrating time with optimal hardness and friability. In addition, finally selected DF-ODTformulation showed the equivalence in the comparative dissolution test with Forxiga® (dapagliflozin commercial product). Therefore, this DF-ODT could be a potential alternative to the dapagliflozin commercial product with increasedconvenience in treating type 2 diabetes.