IP Library › Granted Patent US 11,672,823
Granted Patent B2
US 11,672,823 · App. 17/871,058 · Granted Jun 13, 2023

Calcium gluconate formulation without calcium saccharate

Inventors: Thirupathi Mangali (Davis, CA); Bala Tripura Sundari Chodavarapu (Davis, CA); Anand Shukla (Davis, CA); Jay Shukla (Davis, CA); Dasaradhi Lakkaraju (Davis, CA)
Assignee: Nivagen Pharmaceuticals, Inc.
A61K33/06A61K9/08A61K41/10A61K47/02
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Quick Facts
Patent No.
US 11,672,823
App. No.
17/871,058
Granted
Jun 13, 2023
Kind
B2
Abstract

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.

Claims (17)

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.

Assignments (3)
CORRECTIVE ASSIGNMENT TO CORRECT THE CORRECT THE PATENT APPLICATION NO. 17/466,063 PREVIOUSLY RECORDED AT REEL: 60657 FRAME: 158. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST. Recorded May 10, 2024
From: NIVAGEN PHARMACEUTICALS, INC.
To: CORBEL CAPITAL PARTNERS SBIC, L.P.
Reel/Frame 067531/0287 →
SECURITY INTEREST Recorded Jul 28, 2022
From: NIVAGEN PHARMACEUTICALS, INC.
To: CORBEL CAPITAL PARTNERS SBIC, L.P.
Reel/Frame 060657/0158 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 22, 2022
From: MANGALI, THIRUPATHI; SUNDARI CHODAVARAPU, BALA TRIPURA; SHUKLA, ANAND; SHUKLA, JAY; LAKKARAJU, DASARADHI
To: NIVAGEN PHARMACEUTICALS, INC.
Reel/Frame 060599/0707 →
Continuity (2)
Provisional Application 63225352 · Jul 23, 2021
Related Publication 20230043597A1 · Feb 9, 2023