Claims for Patent: 11,253,528

Summary for Patent: 11,253,528

Title:	Stabilized modified release Vitamin D formulation and method of administering same
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.
Inventor(s):	Jay A. White, Samir P. Tabash, Sammy A. Agudoawu, Joel Z. Melnick
Assignee:	Eirgen Pharma Ltd
Application Number:	US16/448,838
Patent Claims:	1. 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 comprising a cellulose ether 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. 2. The pharmaceutical composition of claim 1, wherein the lipophilic matrix comprises a wax. 3. The pharmaceutical composition of claim 1, wherein the storage-stabilized formulation is an oral formulation for sustained release of the vitamin D compound in the gastrointestinal tract of a subject which ingests the formulation. 4. The pharmaceutical composition of claim 1, wherein the storage-stabilized formulation comprises a matrix that releasably binds and controllably releases the vitamin D compound. 5. The pharmaceutical composition according to claim 1, wherein the cellulose ether comprises one or more of methylcellulose, hydroxyl propyl methylcellulose, hydroxyl ethyl methylcellulose, hydroxyl ethyl cellulose, and hydroxyl propyl cellulose. 6. The pharmaceutical composition according to claim 4, wherein the cellulose ether comprises hydroxyl propyl methylcellulose. 7. The pharmaceutical composition according to claim 1, wherein the vitamin D compound is one or more of vitamin D3 (cholecalciferol), vitamin D2 (ergocalciferol), 25-hydroxyvitamin D3, 25-hydroxyvitamin D2, 25-hydroxyvitamin D4, 25-hydroxyvitamin D5, 25-hydroxyvitamin D7, 1α,25-dihydroxyvitamin D3, 1α,25-dihydroxyvitamin D2, 1α,25-dihydroxyvitamin D4, 1,25-dihydroxy-19-nor-vitamin D2, and 1α-hydroxyvitamin D3. 8. The pharmaceutical composition according to claim 7, wherein the vitamin D compound comprises one or both of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3. 9. The pharmaceutical composition according to claim 1, wherein the vitamin D compound comprises 25-hydroxyvitamin D3. 10. The pharmaceutical composition of claim 1, wherein the storage-stabilized formulation is in the form of a capsule, tablet, sachet, dragee, or suppository. 11. The pharmaceutical composition of claim 10, wherein the storage-stabilized formulation is in the form of a capsule.