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Last Updated: April 19, 2024

Claims for Patent: 6,852,314

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Summary for Patent: 6,852,314

Title:	IFN-.beta. liquid formulations
Abstract:	Interferon-.beta. liquid formulations stabilized with a polyol, a non-reducing sugar or an amino acid. In particular, the formulations are stabilized with a polyol, such as mannitol. The formulations, preferably, furthermore comprise a buffer, such as acetate buffer, at a pH comprised between 3.0 and 4.0 and human albumin at a minimum quantity. The interferon-.beta. is preferably recombinant.
Inventor(s):	Samaritani; Fabrizio (Rome, IT), Natale; Patrizia (Rome, IT)
Assignee:	Applied Research Systems ARS Holding N.V. (Curacao, AN)
Application Number:	08/737,633
Patent Claims:	1. A liquid pharmaceutical formulation consisting of from about 0.6 to 24 MIU/ml of interferon-.beta., mannitol, an acetate buffer at a pH between 3.0 and 4.0 and, optionally, albumin. 2. A liquid pharmaceutical formulation according to claim 1, in which interferon-.beta. is recombinant. 3. A liquid pharmaceutical formulation according to claim 1, in which interferon-.beta. is in a quantity between 0.6 and 1 MIU/ml. 4. A liquid pharmaceutical formulation according to claim 3, in which the buffer solution has a concentration of 0.01 M. 5. A liquid pharmaceutical formulation according to claim 1, in which the optional albumin is present and comprises human albumin. 6. A liquid pharmaceutical formulation according to claim 1, comprising 1 MIU/ml of interferon-.beta., 54.6 mg/ml of mannitol, 0.5 mg/ml of albumin in a solution of 0.01 M acetate buffer at pH 3.5. 7. A process for the preparation of a liquid pharmaceutical formulation according to claim 1, comprising combining interferon-.beta. with mannitol, an acetate buffer at a pH between 3.0 and 4.0 and, optionally, albumin. 8. A container hermetically sealed in sterile conditions comprising the liquid pharmaceutical formulation according to claim 1 and appropriate for storage prior to use. 9. A process for the preparation of a liquid pharmaceutical formulation according to claim 7 in which interferon-.beta. is recombinant and is in a quantity between 0.6 and 1 MIU/ml. 10. A process for the preparation of a liquid pharmaceutical formulation according to claim 9 in which conditions comprising interferon-.beta. at 1 MIU/ml, mannitol at 54.6 mg/ml, and 0.5 mg/ml of albumin in a solution of 0.01 M acetate buffer at pH 3.5 are employed. 11. A container hermetically sealed in sterile conditions comprising the liquid pharmaceutical formulation according to claim 6 and appropriate for storage prior to use. 12. A container hermetically sealed in sterile conditions comprising the liquid pharmaceutical formulation according to claim 2 and appropriate for storage prior to use. 13. A liquid pharmaceutical formulation according to claim 6, in which interferon-.beta. is recombinant.

Details for Patent 6,852,314

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10/21/1942	⤷ Try a Trial	2014-05-16
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954	⤷ Try a Trial	2014-05-16
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976	⤷ Try a Trial	2014-05-16
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978	⤷ Try a Trial	2014-05-16
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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