Claims for Patent: 12,447,190

Summary for Patent: 12,447,190

Title:	Vasopressin premix systems and uses thereof
Abstract:	Provided is a system comprising a flexible container for intravenous administration which comprises a premix vasopressin pharmaceutical formulation, and uses thereof.
Inventor(s):	II Robert W. Garber, Sydney Cope, Jason Mantei, Mark Doty
Assignee:	Baxter Healthcare SA , Baxter International Inc
Application Number:	US18/907,424
Patent Claims:	1. A sealed container system for stable storage of a pharmaceutical premix vasopressin formulation, the sealed container system comprising: a primary container comprising a premix vasopressin formulation, wherein the premix vasopressin formulation is an aqueous formulation having a pH of about 3.1 to 4.5 and comprising about 0.1 unit/mL to about 1.0 unit/mL vasopressin or about 180 ng/mL to about 910 ng/mL vasopressin, sodium chloride, and a sodium lactate, wherein the primary container is a multi-layer plastic container comprising a layer of polyethylene, wherein the primary container is an intravenous bag having a volume of 50 mL to 500 mL, and wherein the premix vasopressin formulation is stable for at least 5 months of storage at 25 degrees Celsius. 2. The sealed container system according to claim 1, wherein the concentration of sodium chloride is about 8.5 mg/mL to about 9.5 mg/mL. 3. The sealed container system according to claim 2, wherein the concentration of sodium chloride is about 9 mg/mL. 4. The sealed container system according to claim 1, wherein the concentration of vasopressin is about 0.2 unit/mL to about 1 unit/mL vasopressin; about 0.1 unit/mL to about 0.5 unit/mL vasopressin; about 0.2 unit/mL to about 0.4 unit/mL vasopressin; or about 360 ng/mL to about 730 ng/mL vasopressin. 5. The sealed container system according to claim 4, wherein the concentration of vasopressin is about 0.2 unit/mL, about 0.4 unit/mL, about 360 ng/mL, or about 730 ng/mL. 6. The sealed container system according to claim 1, wherein the premix vasopressin formulation further comprises sodium hydroxide and/or hydrochloric acid as pH adjusters. 7. The sealed container system according to claim 1, wherein the premix vasopressin formulation has a pH between about 3.6 and about 4.0. 8. The sealed container system according to claim 1, wherein the concentration of the lactate salt is about 2.5 mM to about 3.5 mM or about 280 μg/mL to about 400 μg/mL. 9. The sealed container system according to claim 1, wherein the concentration of the lactate salt is about 3 mM or about 336 μg/mL. 10. The sealed container system of claim 1, wherein the primary container has a volume of 50 mL to 250 mL. 11. The sealed container system of claim 1, wherein the primary container has a volume of about 100 mL and contains the premix vasopressin formulation of about 100 mL. 12. The sealed container system of claim 1, wherein the sodium lactate is sodium D,L-lactate. 13. The sealed container system of claim 1, wherein the primary container has a single port, the single port comprising an administration port for delivering the premix vasopressin formulation to a subject. 14. A sealed container system for stable storage of a premix vasopressin formulation, the sealed container system comprising a primary container comprising a premix vasopressin formulation comprising about 0.1 unit/mL to about 0.5 unit/mL vasopressin, about 8.5 mg/mL to about 9.5 mg/mL sodium chloride, about 2.5 mM to about 3.5 mM or about 280 μg/mL to about 400 μg/mL sodium lactate, and, optionally, a pH adjustor(s) which is sodium hydroxide and/or hydrochloric acid, wherein the premix vasopressin formulation is an aqueous formulation and has a pH of about 3.1 to about 4.5, wherein the primary container is a multi-layer plastic container comprising a layer of polyethylene, and wherein the primary container is an intravenous bag having a volume of 50 mL to 500 mL, and wherein the premix vasopressin formulation is stable for at least 5 months of storage at 25 degrees Celsius. 15. The sealed container system of claim 14, wherein the premix vasopressin formulation comprises about 0.2 unit/mL to about 0.4 unit/mL vasopressin. 16. The sealed container system of claim 14, wherein the premix vasopressin formulation comprises about 0.2 unit/mL, about 0.4 unit/mL, about 360 ng/mL, or about 730 ng/mL vasopressin. 17. A sealed container system for stable storage of a premix vasopressin formulation, the sealed container system comprising a primary container comprising a premix vasopressin formulation consisting essentially of about 0.1 unit/mL to about 0.5 unit/mL vasopressin; about 9 mg/mL sodium chloride, about 3 mM or about 336 μg/mL sodium lactate, and, optionally, a pH adjustor(s) which is sodium hydroxide and/or hydrochloric acid, wherein the premix vasopressin formulation is an aqueous formulation and has a pH of about 3.5 to about 4.1, wherein the primary container is a multi-layer plastic container comprising a layer of polyethylene, wherein the primary container is an intravenous bag having a volume of 50 mL to 500 mL, and wherein the premix vasopressin formulation is stable for at least 5 months of storage at 25 degrees Celsius. 18. The sealed container system of claim 17, wherein the premix vasopressin formulation comprises about 0.2 unit/mL to about 0.4 unit/mL vasopressin. 19. The sealed container system of claim 17, wherein the premix vasopressin formulation comprises about 0.2 unit/mL, about 0.4 unit/mL, about 360 ng/mL, or about 730 ng/mL vasopressin.