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Last Updated: April 23, 2024

Claims for Patent: 6,250,469

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Summary for Patent: 6,250,469

Title:	Formulations for protection of peg-interferon alpha conjugates
Abstract:	The present invention provides formulations that prevent loss and damage of PEG-interferon alpha conjugates during and following lyophilization. The formulations of the present invention protect PEG-interferon alpha conjugates from loss and degradation during the lyophilization process, as well as degradation during subsequent storage. The formulations of the present invention are suitable for protection of PEG-interferon alpha conjugates from various types of degradation, including, but not limited to loss of biological activity and changes in the degree and/or nature of conjugation. A preferred PEG-interferon alpha conjugate protectable in the formulations of the present invention is an interferon alpha-2b-polyethylene glycol (12,000) conjugate.
Inventor(s):	Kline; Douglas (New York, NY)
Assignee:	Schering Corporation (Kenilworth, NJ)
Application Number:	09/703,581
Patent Claims:	1. An article of manufacture, comprising a container containing a lyophilized powder produced by lyophilizing a solution comprising PEG-interferon alpha conjugates, a buffer, a stabilizer, a cryoprotectant and a solvent, wherein said buffer is sodium phosphate, said stabilizer is a poly(oxy-1,2-ethanediyl), said cryoprotectant is sucrose and said solvent is water. 2. The article of claim 1, wherein said container is a syringe. 3. The article of claim 2, wherein said sodium phosphate comprises sodium phosphate dibasic anhydrous and sodium phosphate monobasic dihydrate. 4. The article of claim 3, wherein the mass of said PEG-interferon alpha conjugates is 0.1 mg of interferon alpha, the mass of said sodium phosphate dibasic anhydrous is 0.75 mg, the mass of said sodium phosphate monobasic dihydrate is 0.75 mg, the mass of said sucrose is 40 mg, the mass of said poly(oxy- 1,2-ethanediyl) is 0.05 mg and the volume of said water is 0.5 ml. 5. The article of claim 2, wherein said PEG-interferon alpha conjugates comprise single PEG molecules conjugated to single interferon alpha molecules. 6. The article of claim 5, wherein said interferon alpha molecules are selected from the group consisting of interferon alpha-2a, interferon alpha-2b, interferon alpha-2c and consensus interferon. 7. The article of claim 6, wherein said polyethylene glycol is PEG.sub.12000. 8. The article of claim 7, wherein said interferon alpha molecules are interferon alpha-2b. 9. The article of claim 8, wherein said interferon alpha-2b molecules are linked to said PEG.sub.12000 molecules with a urethane bond. 10. The article of claim 9, wherein said PEG-interferon alpha conjugates comprise a mixture of positional isomers. 11. The article of claim 10, wherein one of said positional isomers comprises said interferon alpha-2b molecule linked to said PEG.sub.12,000 molecule at a histidine residue on said interferon alpha-2b molecule. 12. The article of claim 2, further comprising a volume of water for reconstitution of said powder. 13. The article of claim 12, wherein said water comprises bacteriostatic water. 14. The article of claim 1, wherein said container is a vial. 15. The article of claim 14, wherein said sodium phosphate comprises sodium phosphate dibasic anhydrous and sodium phosphate monobasic dihydrate. 16. The article of claim 15, wherein the mass of said PEG-interferon alpha conjugates is 0.1 mg of interferon alpha, the mass of said sodium phosphate dibasic anhydrous is 0.75 mg, the mass of said sodium phosphate monobasic dihydrate is 0.75 mg, the mass of said sucrose is 40 mg, the mass of said poly(oxy-1,2-ethanediyl) is 0.05 mg and the volume of said water is 0.5 ml. 17. The article of claim 14, wherein said PEG-interferon alpha conjugates comprise single PEG molecules conjugated to single interferon alpha molecules. 18. The article of claim 17, wherein said interferon alpha molecules are selected from the group consisting of interferon alpha-2a, interferon alpha-2b, interferon alpha-2c and consensus interferon. 19. The article of claim 18, wherein said polyethylene glycol is PEG.sub.12000. 20. The article of claim 19, wherein said interferon alpha molecules are interferon alpha-2b. 21. The article of claim 20, wherein said interferon alpha-2b molecules are linked to said PEG.sub.12000 molecules with a urethane bond. 22. The article of claim 21, wherein said PEG-interferon alpha conjugates comprise a mixture of positional isomers. 23. The article of claim 22, wherein one of said positional isomers comprises said interferon alpha-2b molecule linked to said PEG.sub.12000 molecule at a histidine residue on said interferon alpha-2b molecule. 24. The article of claim 14, further comprising a volume of water for reconstitution of said powder. 25. The article of claim 24, wherein said water comprises bacteriostatic water.

Details for Patent 6,250,469

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	PEGINTRON	peginterferon alfa-2b	Injection	103949	01/19/2001	⤷ Try a Trial	2018-03-26
Merck Sharp & Dohme Corp.	SYLATRON	peginterferon alfa-2b	For Injection	103949	03/29/2011	⤷ Try a Trial	2018-03-26
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

International Patent Family for US Patent 6,250,469

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Country	Patent Number	Estimated Expiration
United States of America	6180096	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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