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Claims for Patent: 6,051,567

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Claims for Patent: 6,051,567

Title: Low oxygen content compositions of 1.alpha., 25-dihydroxycholecalciferol
Abstract:The invention relates to stable aqueous formulations comprising 1.alpha., 25-dihydroxycholecalciferol, a unit dose system comprising the same in a sealed vessel, and a process for preparing them.
Inventor(s): Abrahamson; Kent (Libertyville, IL), Anderson; Amy N. (Waukegan, IL), Grady; Haiyan (Mundelein, IL)
Assignee: Abbott Laboratories (Abbott Park, IL)
Application Number:09/365,533
Patent Claims: 1. A stable aqueous solution of 1.alpha., 25-dihydroxycholecalciferol, wherein each milliliter (mL) of the solution consists essentially of:

a. about 1.0 to about 2.0 microgram (mcg) of 1.alpha., 25-dihydroxycholecalciferol;

b. 4.0 mg of polysorbate 20;

c. 2.5 mg of sodium ascorbate;

d. hydrochloric acid quantum sufficiat (q.s.);

e. sodium hydroxide q.s.; and

f. water for injection q.s.,

said solution in a container having no more than about 2.0% of oxygen in the headspace of the container.

2. The stable solution according to claim 1, having 1.0 mcg of 1.alpha., 25-dihydroxycholecalciferol per 1 mL of solution.

3. The stable solution according to claim 1, having 2.0 mcg of 1.alpha., 25-dihydroxycholecalciferol per 1 mL of solution.

4. The stable solution according to claim 2 or 3, wherein the pH of the solution is between about 5.9 and about 8.5.

5. The stable solution according to claim 2 or 3, wherein the pH of the solution is about 7.0.

6. The stable solution according to claim 2 or 3, wherein the solution has less than or equal to about one part per million (1 ppm) of aluminum during the shelf life of the composition.

7. A unit dose system comprising an aqueous solution of 1.alpha., 25-dihydroxycholecalciferol in a sealed vessel, wherein each mL of the aqueous solution consists essentially of:

a. about 1.0 mcg to about 2.0 mcg of 1.alpha., 25-dihydroxycholecalciferol,

b. 4.0 mg of polysorbate 20;

c. 2.5 mg of sodium ascorbate;

d. hydrochloric acid q.s.;

e. sodium hydroxide q.s.; and

f. water for injection q.s.;

said unit dose system having less than or equal to 2.0% of oxygen in the headspace.

8. The stable aqueous solution according to claim 1 or 7, wherein the container is a unit dose vial.

9. The stable aqueous solution according to claim 1, wherein the solution measures a mean color value of less than about 100 APHA units immediately after container sealing.

10. The stable aqueous solution according to claim 1, wherein the composition measures a mean color value of less than about 400 APHA units during the shelf life of the product.
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