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Last Updated: April 24, 2024

Claims for Patent: 9,289,381

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Summary for Patent: 9,289,381

Title:	Stabilization and storage of biological pharmaceutical compositions
Abstract:	The present invention relates to compositions and methods for the preparation, stabilization, and/or storage of active agents, particularly therapeutic proteins and polypeptides such as Interleukin-2.
Inventor(s):	Elliott; Gloria (Midland, NC), MacFarlane; Douglas (Brighton, AU), Foureau; David M. (Charlotte, NC), McKillop; Iain (Charlotte, NC)
Assignee:	The University of North Carolina at Charlotte (Charlotte, NC) The Charlotte-Mecklenburg Hospital Authority (Charlotte, NC) Monash University (Clayton VIC, AU)
Application Number:	13/392,784
Patent Claims:	1. A parenterally injectable pharmaceutical composition comprising: (a) from 0.01 to 40 weight percent choline dihydrogen phosphate; (b) an added base included in an amount not greater than 40 weight percent, wherein said added base is choline hydroxide; (c) at least 60 weight percent water; and (d) from 0.01 to 10 weight percent active compound selected from the group consisting of Interleukin-2, gelsolin, antibodies, erythropoietin, interferon, human growth hormone, follicle stimulating hormone, and granulocyte colony stimulating factor; said composition having a pH of from 6 up to 8; said composition packaged in a sterile container. 2. The composition of claim 1, wherein said active compound is included in an amount of not more than 5 weight percent. 3. The composition of claim 1, wherein said water is included in an amount up to 99 weight percent. 4. The composition of claim 1, wherein said choline dihydrogen phosphate is included in an amount of not more than 40 weight percent. 5. The composition of claim 1, wherein said base and said choline dihydrogen phosphate are included together in a combined amount not more than 50 weight percent. 6. The composition of claim 1, wherein said composition is a single phase liquid solution. 7. The composition of claim 1, wherein said composition has an osmolality of 100 to 3,000 milliOsmoles per kilogram of water. 8. The composition of claim 1, wherein said active compound is Interleukin-2. 9. The composition of claim 8, wherein said Interleukin-2 is human Interleukin-2. 10. The composition of claim 8, wherein said Interleukin-2 is aldesleukin. 11. The composition of claim 1, wherein said active compound is gelsolin. 12. The composition of claim 11, wherein said gelsolin is human gelsolin. 13. The composition of claim 1, wherein said active compound is recombinant. 14. The composition of claim 1, wherein said active compound is non-glycosylated. 15. The composition of claim 1 having a shelf life of from 2 days to 2 years at 37.degree. C. 16. The composition of claim 1, wherein said active compound is Interleukin-2 and said composition has a shelf life of 2 days to 2 months at 37.degree. C. 17. A method comprising administering a composition of claim 1 to a subject in need thereof. 18. The composition of claim 1, wherein: said active compound is included in an amount of not more than 5 weight percent; said water is included in an amount up to 99 weight percent; said choline dihydrogen phosphate is included in an amount of not more than 40 weight percent; said base and said choline dihydrogen phosphate are included together in a combined amount not more than 50 weight percent; said composition is a single phase liquid solution; said composition has an osmolality of 100 to 3,000 milliOsmoles per kilogram of water; and said active agent is Interleukin-2. 19. The composition of claim 1 having a shelf life of from 2 weeks to 2 years at 37.degree. C. 20. The composition of claim 1 having a shelf life of at least 2 weeks at 37.degree. C. 21. The composition of claim 1 having a shelf life of at least 1 month at 37.degree. C. 22. The composition of claim 1 having a shelf life of at least 1 year at 37.degree. C. 23. The composition of claim 1, further comprising from 0.01 to 50 weight percent of at least one osmolyte.

Details for Patent 9,289,381

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Clinigen, Inc.	PROLEUKIN	aldesleukin	For Injection	103293	05/05/1992	⤷ Try a Trial	2029-12-03
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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