Treating Vitamin D insufficiency and deficiency with 25-hydroxyvitamin D
Methods and compositions for treating 25-hydroxyvitamin D insufficiency and deficiency in a patient are described herein. The method includes orally administering to the patient a delayed, sustained release formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D 2 , 25-hydroxyvitamin D 3 , or a combination of 25-hydroxyvitamin D 2 and 25-hydroxyvitamin D 3 , or it includes gradually administering to the patient a sterile intravenous formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D 2 , 25-hydroxyvitamin D 3 , or a combination of 25-hydroxyvitamin D 2 and 25-hydroxyvitamin D 3 .
1. A soft gelatin capsule dosage form, consisting of:
a) a soft gelatin shell optionally treated with a cross linking agent and which gradually dissolves after oral administration, and
b) a pharmaceutical composition disposed in the soft gelatin shell and consisting essentially of
(1) (a) an active ingredient selected from 25(OH) vitamin D
(b) a matrix material comprising one or more compounds in the group of a glyceride, a fatty acid, a fatty alcohol, and a fatty acid ester; and
(c) ethanol; or
(2) (a) an active ingredient selected from 25(OH) vitamin D;
(b) an insoluble polymer comprising one or more selected from the group of swellable methacrylic acid esters, polyvinyl esters, polyvinyl acetal esters, polyacrylic acid esters and butadiene styrene copolymers; and
(c) ethanol.
2. The dosage form of claim 1 , wherein the pharmaceutical composition disposed in the soft gelatin shell consists essentially of
(1) (a) an active ingredient selected from 25(OH) vitamin D
(b) a matrix material consisting comprising one or more compounds in the group of a glyceride, a fatty acid, a fatty alcohol, and a fatty acid ester; and
(c) ethanol.
3. The dosage form of claim 2 , wherein the matrix material consists essentially of one or more in the group of a glyceride, a fatty acid, a fatty alcohol, and a fatty acid ester.
4. The dosage form of claim 2 , wherein the matrix material comprises a glyceride.
5. The dosage form of claim 2 , wherein the matrix material comprises a fatty acid.
6. The dosage form of claim 2 , wherein the matrix material comprises a fatty alcohol.
7. The dosage form of claim 2 , wherein the matrix material comprises a fatty acid ester.
8. The dosage form of claim 2 , wherein the matrix material comprises fractionated coconut oil.
9. The dosage form of claim 2 , wherein the soft gelatin shell is treated with a cross linking agent.
10. The dosage form of claim 2 , wherein the active ingredient comprises vitamin D 3 .
11. The dosage form of claim 1 , wherein the pharmaceutical composition disposed in the soft gelatin shell consists essentially of
(2) (a) an active ingredient selected from 25(OH) vitamin D;
(b) an insoluble polymer comprising one or more selected from the group of swellable methacrylic acid esters, polyvinyl esters, polyvinyl acetal esters, polyacrylic acid esters and butadiene styrene copolymers; and
(c) ethanol.
12. The dosage form of claim 11 , wherein the insoluble polymer comprises a swellable methacrylic acid ester.
13. The dosage form of claim 11 , wherein the insoluble polymer comprises a polyvinyl ester.
14. The dosage form of claim 11 , wherein the insoluble polymer comprises a polyvinyl acetal ester.
15. The dosage form of claim 11 , wherein the insoluble polymer comprises a polyacrylic acid ester.
16. The dosage form of claim 11 , wherein the insoluble polymer comprises a butadiene styrene copolymer.
17. The dosage form of claim 11 , wherein the soft gelatin shell is treated with a cross linking agent.
18. The dosage form of claim 11 , wherein the active ingredient comprises Vitamin D 3 .
19. A soft gelatin capsule dosage form, consisting of a soft gelatin shell optionally treated with a cross linking agent and which gradually dissolves after oral administration, and a pharmaceutical composition disposed in the soft gelatin shell and consisting essentially of 25(OH) vitamin D 3 , a matrix material consisting of a fatty acid ester, and ethanol.
20. A soft gelatin capsule dosage form, consisting of a soft gelatin shell optionally treated with a cross linking agent and which gradually dissolves after oral administration, and a pharmaceutical composition disposed in the soft gelatin shell and consisting essentially of 25(OH) vitamin D 3 , an insoluble polymer consisting essentially of swellable methacrylic acid esters, and ethanol.