abstract |
A stabilized formulation for controlled release of a vitamin D compound is disclosed. The nformulation comprises one or both of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 and na cellulosic compound. The stabilized formulations exhibit a stable dissolution profile nfollowing exposure to storage conditions and demonstrate improved pharmacokinetic nparameters compared to unstabilized formulations. See Fig. 1A.nWO 2014/143941 PCT/US2014/028132 n1/10 nFigure 1A n30 pg - 25°C/60%RH n150 n• Initial n1• 1 month (fl 1001 3mnh n•• 3 months n••• 6 months n••$*• 9 months n-G• 12 months n2 50 -&- 18 months nQ 24 months n0 5 10 15 nTime (hour) nFigure 1B n60 pg- 250C/60% RH n150 n• Initial n••1 month n•• 3 months 0 n0 100 6 months n••• 9 months n••I•• 12 months nC -E• 18 months n50, +A 24 month n0+n0 5 10 15 nTime (hour) |