EP3650016A1 — Stabilized modified release vitamin d formulation and method of administering same

USPTO Abstract

A stabilized formulation for controlled release of a vitamin D compound is disclosed. The formulation comprises one or both of 25-hydroxyvitamin D<sub>2</sub>and 25-hydroxyvitamin D<sub>3</sub>. 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.