Claims for Patent: 6,051,567

Summary 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.