Calcium gluconate formulation without calcium saccharate
Described is an aqueous calcium gluconate solution formulated without calcium saccharate, which can be stored in a flexible plastic bag and can be terminally sterilized.
1. A stable, aqueous calcium gluconate solution comprising:
about 1 to 15 wt. % calcium gluconates,
wherein said calcium gluconate solution is substantially free of calcium saccharate and is packaged in a flexible plastic container with water, the packaged calcium gluconate solution having a shelf-life greater than 12 months.
2. The solution of claim 1 , wherein the calcium gluconate solution is isotonic.
3. The solution of claim 2 , wherein the isotonic calcium gluconate solution comprises about 0.6 to 0.8 wt. % sodium chloride.
4. The solution of claim 1 , wherein the flexible plastic container is a bag and the solution has a pH of from 6.0 to 8.2.
5. The solution of claim 1 , wherein the water is deionized water or water for injection.
6. The solution of claim 1 , wherein the calcium gluconate solution is free of a calcium ion-containing ingredient other than calcium gluconate.
7. The solution of claim 1 , wherein the solution has a pH between about 6 and about 8.2.
8. The solution of claim 7 , without pH-adjustment using an acid or base.
9. The solution of claim 7 , wherein the pH is adjusted using 1N HCl or 1N NaOH.
10. The solution of claim 9 , wherein the flexible plastic container is terminally sterilized by steam sterilization without altering the properties of the flexible plastic container.
11. The solution of claim 10 , wherein the steam sterilization is autoclaving at 110° C.-130° C. for 10 to 30 minutes.
12. The solution of claim 1 , wherein the water is water-for-injection.
13. The solution of claim 1 , wherein the calcium gluconate solution comprises about 1 wt. % calcium gluconate.
14. The solution of claim 1 , wherein the calcium gluconate solution comprises about 2 wt. % calcium gluconate.
15. The solution of claim 1 , said solution having a shelf life between 12 months and 24 months.