Research On Ondansetron Orally Disintegrating Tablet

[Objective]To make research on preparation of ondansetron orally disintegrating tablets,aiming at providing a new kind of formulations with more convenience, larger limit of safety and more effectiveness for the clinic use.[Method]On the basis of preliminary experiment,in vitro disintegrating as its investigation index,the formulation was optimized by central composite design and response surface methodology.The angle of repose of compressibility was used to investigate the flowability of powder,ondasetron ODTs were prepared by pressing the powder directly.In vivo and in vitro disintegrating time,hardness and content evenness of ondansetron ODT were examined,the dissolution rate of ondansetron ODT being compared with that of conventional ones.The in vivo behavior of tablets was evaluated in Rhesus after administration of orally disintegrating tablets and marketed ordinary tablets.Pharmacokinetic parameters of two formulations were compared,and the relative bioavailability was calculated.[Results]Content of three effervescent determined by the method of response surface was respectively 9%of MCC,6.5%of PVPP and 17.5%of effervescent. After prescription being optimized,powder's angle of repose was 38.99℃and compressibility being 31.82%.Both in vivo and in vitro disintegrating time was within 1min.Hardness and content evenness of ondansetron ODT were consistent with requirement of Chinese Pharmacopoeia 2005 with better dissolution rate than ordinary tablets.The C_maxof ODTs and common tablets of ondansetron was 174.20±57.26 and 94.39±53.84 ng·mL^-1h respectively;the AUC_0-24was 438.97±142.43 and 383.29±114.08 ng·mL^-1h respectively.The relative bioavailability of ondansetron ODT was114.53±64.02%.The C_maxand AUC_0-24between ODTs and ordinary tablets had significant difference(P<0.05),which showed that absorption ability of ondansetron ODTs was better than ordinary tablets.The T_maxwas1.42±0.38 and 3.83±2.11h respectively,showing significant difference(P<0.05).[Conclusion]The orally disintegrating tablets of ondansetron which are prepared in this dissertation have these advantages:pleasant taste,rapid disintegration and remarkable dissolution speed.Compared with the common tablets,the orally disintegrating tablets showed quicker dissolution in vitro.