Drug – bio-affecting and body treating compositions – Lymphokine – Interferon
Reexamination Certificate
2005-08-11
2009-12-15
Saoud, Christine J (Department: 1647)
Drug, bio-affecting and body treating compositions
Lymphokine
Interferon
C424S085100, C424S085700, C514S012200, C530S350000, C530S351000
Reexamination Certificate
active
07632491
ABSTRACT:
The present invention relates to lyophilized formulations of pegylated interferon which are prepared using trehalose as a cryoprotectant. The formulations have a low moisture content, which helps stabilize the pegylated interferon during storage of the formulations at room temperature. In addition, methods for preparing these formulations are provided.
REFERENCES:
patent: 4496537 (1985-01-01), Kwan
patent: 5595732 (1997-01-01), Hakini et al.
patent: 5691298 (1997-11-01), Gosselink et al.
patent: 5762923 (1998-06-01), Gross et al.
patent: 5951974 (1999-09-01), Gilbert et al.
patent: 6180096 (2001-01-01), Kline
patent: 0 420 049 (1991-04-01), None
patent: 0 593 868 (1994-04-01), None
patent: 0 736 303 (1996-09-01), None
patent: 0 809 996 (1997-03-01), None
patent: WO 95/13090 (1995-05-01), None
patent: WO 96/11018 (1996-04-01), None
patent: WO 96/24369 (1996-08-01), None
patent: WO 97/18832 (1997-05-01), None
patent: WO 98/48840 (1998-11-01), None
patent: WO 01/12214 (2001-02-01), None
patent: WO 03/049760 (2003-06-01), None
Carpenter, J. F. et al., “Rational Design of Stable Lyophilized Protein Formulations: Some Practical Advice”Pharmaceutical Research,14(8):969-975 (1997).
Carpenter, J. F. et al., “Rational Design of Stable Lyophilized Protein Formulations: Theory and Practice”Rational Design of Stable Protein Formulations,J. F. Carpenter and M. C. Manning Editors, pp. 109-133, Kluwer Academic / Plenum Publishers, New York (2002).
Chang, B. S. et al., “Physical Factors Affecting the Storage Stability of Freeze-Dried Interleukin-1 Receptor Antagonist: Glass Transistion and Protein Conformation”,Archives of Biochemistry and Biophysics,331(2):249-258 (1996).
Fox, Karen Celia, “Putting Proteins Under Glass”,Science,267:1922-1923 (Mar. 31, 1995).
Heller, M. C. et al., “Conformational Stability of Lyophilized PEGylated Proteins in a Phase-Separating System,”Journal of Pharmaceutical Sciences,88(1):58-64 (1999).
The Merck Index, 12th ed. Merck & Co., Inc., Whitehouse Station, N.J., pp. 1517-1518, entry No. 9051, 1996.
PEG-Intron® Product Information, Rev. 2/05.
Tang, X. (C) et al., “Design of Freeze-Drying Process of Pharmaceuticals: Practical Advice”,Pharmaceutical Research,21(2):191-200 (Feb. 2004).
International Search Report for related International Application No. PCT/US2005/028441, mailed Apr. 13, 2006 (5 pages).
Written Opinion of the International Searching Authority for related International Application No. PCT/US2005/028441, mailed Apr. 13, 2006 (7 pages).
Dabbara Anita
Shameem Mohammed
Saoud Christine J
Schering Corporation
Seharaseyon Jegatheesan
LandOfFree
Stable pegylated interferon formulation does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Stable pegylated interferon formulation, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Stable pegylated interferon formulation will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-4145202