Purpose: Aprepitant, an antiemetic drug that blocks the neurokinin 1 receptor, is classified as a BCS Class II drug (poor solubility, high permeability). SYO-1020, a spray dried solid dispersion formulation of aprepitant, is developed by Samyang biopharmaceutical Co. to improve its solubility and oral absorption by enhancing its dissolution rate.
Methods: The present study was conducted to assess relative bioavailability of SYO-1020 and to establish pharmacokinetic bioequivalence of SYO-1020 versus Emend® in rat and beagle dogs.
Results: Following administration of SYO-1020 and Emend® to rats (5 mg/kg) and beagle dogs (125 mg/head), the AUC0-24h for SYO-1020 and Emend® were showing no significant difference. Also, no significant difference were found in Cmax between the two formulations. The relative magnitude of AUC0-24hr and Cmax of test drug (SYO-1020) to those of reference drug (Emend®) were within ±20% (80% to 120%) regarded as being bioequivalent
Conclusion: In conclusion, with demonstration of bioequivalence, they may be prescribed interchangeably.
Minhyuk Yun
– Principal researcher, Samyang Biopharmaceuticals Corporation, Seongnam-si, Gyeonggi-doSangwoo Cho
– Researcher, Samyang Biopharmaceuticals CorporationJi Yeong Kim
– Senior researcher, Samyang Biopharmaceuticals Corporation, Seongnam-siSangyeop Park
– Senior researcher, Samyang Biopharmaceuticals CorporationHyejung Lim
– Senior researcher, Samyang Biopharmaceuticals Corporation, Seongnam-siJaeyoung Lee
– Researcher, Samyang Biopharmaceuticals CorporationSawon Lee
– Team manager, Samyang Biopharmaceuticals CorporationSeungwei Jung
– Team manager, Samyang Biopharmaceuticals CorporationMinhyo Seo
– Vice President, Samyang Biopharmaceuticals CorporationMinhyuk Yun
– Principal researcher, Samyang Biopharmaceuticals Corporation, Seongnam-si, Gyeonggi-do296 Views