WHITE, Jay, A.,MELNICK, Joel, Z.,AGUDOAWU, Sammy, A.,TABASH, Samir, P.
申请号:
DK14717038
公开号:
DK2968172T3
申请日:
2014.03.14
申请国别(地区):
DK
年份:
2020
代理人:
摘要:
A stabilized formulation for controlled release of a vitamin D compound is disclosed. The formulation comprises one or both of 25-hydroxyvitamin D 2 and 25-hydroxyvitamin D 3 . The formulation further comprises an effective amount of a stabilizing agent, and a secondary additive comprising one or more compounds from the group consisting of: calcium salts, bisphosphonates, calcimimetics, nicotinic acid, iron, phosphate binders, cholecalciferol, ergocalciferol, active Vitamin D sterols, glycemic control agents, hypertension control agents, antineoplastic agents, and inhibitors of CYP24, inhibitors of cytochrome P450 enzymes that can degrade vitamin D agents. The stabilized formulations exhibit a stable dissolution profile following exposure to storage conditions and demonstrate improved pharmacokinetic parameters compared to unstabilized formulations.