AU2019200268B2 — 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 D2 and 25-hydroxyvitamin D3 and a cellulosic compound. The stabilized formulations exhibit a stable dissolution profile following exposure to storage conditions and demonstrate improved pharmacokinetic parameters compared to unstabilized formulations. See Fig. 1A. WO 2014/143941 PCT/US2014/028132 1/10 Figure 1A 30 pg - 25°C/60%RH 150 • Initial 1• 1 month (fl 1001 3mnh •• 3 months ••• 6 months ••$*• 9 months -G• 12 months 2 50 -&- 18 months Q 24 months 0 5 10 15 Time (hour) Figure 1B 60 pg- 250C/60% RH 150 • Initial ••1 month •• 3 months 0 0 100 6 months ••• 9 months ••I•• 12 months C -E• 18 months 50, +A 24 month 0+ 0 5 10 15 Time (hour)