Stabilized liquid protein formulations in pharmaceutical...

Special receptacle or package – For ampule – capsule – pellet – or granule

Reexamination Certificate

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C424S085600, C526S255000

Reexamination Certificate

active

07540382

ABSTRACT:
A container comprising a closure means coated by an inert fluorinated material and containing a liquid pharmaceutical composition. In particular, the container comprises a closure means coated by TEFLON (polytetrafluoruethylene (PTFE)) and contains a HSA-free Interferon-β formulation having the following composition: 30 to 100 μg/ml of interferon-β, an isotonicity agent, 0.1 to 2 mg/ml of Poloxamer 188, at least 0.12 mg/ml of L-Methionine and a buffer solution capable of maintaining the pH of the liquid formulation at a value between 3.0 and 4.0.

REFERENCES:
patent: 5183746 (1993-02-01), Shaked et al.
patent: 5661125 (1997-08-01), Strickland
patent: 6171586 (2001-01-01), Lam et al.
patent: 2004/0043973 (2004-03-01), Ahlem et al.
patent: 0 641 567 (1995-03-01), None
patent: 0 736 303 (1996-10-01), None
patent: 97/17087 (1997-05-01), None
patent: 98/28007 (1998-07-01), None

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