Stabilized modified release vitamin D formulation and method of administering same
AssigneeEirgen Pharma Ltd.
InventorsJay A. White, Samir P. Tabash, Sammy A. Agudoawu, Joel Z. Melnick
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Abstract
A stabilized formulation for controlled release of a vitamin D compound is disclosed. The formulation can comprise one or both of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 and a stabilizing compound. The stabilized formulations exhibit a stable dissolution profile following exposure to storage conditions and demonstrate improved pharmacokinetic parameters compared to unstabilized formulations.
Claims21
A pharmaceutical composition comprising a storage-stabilized formulation for sustained release of a vitamin D compound, wherein the storage-stabilized formulation comprises a mixture of:
- a vitamin D compound;
- and a stabilizing agent selected from one or more of a povidone polymer and a fumed silica, in an amount of about 5 wt % to about 30 wt % of the storage-stabilized formulation, wherein the stabilizing agent maintains a difference of less than 30% between the amount of vitamin D compound released at any given time point after four hours during in vitro dissolution after two months exposure to storage conditions of 25° C. and 60% relative humidity and the amount released at the same dissolution time point during in vitro dissolution conducted prior to exposing the formulation to the storage conditions,
- wherein the storage-stabilized formulation comprises a lipophilic matrix comprising the vitamin D compound.
A pharmaceutical composition comprising a storage-stabilized formulation for sustained release of a vitamin D compound, wherein the storage-stabilized formulation comprises a mixture of:
- a vitamin D compound;
- and a stabilizing agent selected from one or more of a povidone polymer and a fumed silica, in an amount of about 5 wt % to about 30 wt % of the storage-stabilized formulation, wherein the stabilizing agent maintains a difference of less than 30% between the amount of vitamin D compound released at any given time point after four hours during in vitro dissolution after two months exposure to storage conditions of 25° C. and 60% relative humidity and the amount released at the same dissolution time point during in vitro dissolution conducted prior to exposing the formulation to the storage conditions,
- wherein the storage-stabilized formulation comprises an oily vehicle and a lipophilic matrix comprising the vitamin D compound.
Dependencies are inferred from the claim text.