Stable insulin formulations

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai

Reexamination Certificate

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Details

C514S004300, C514S012200, C530S303000, C530S304000, C530S305000

Reexamination Certificate

active

06906028

ABSTRACT:
The present invention provides a monomeric insulin analog formulation stabilized against aggregation in which the buffering agent is either TRIS or arginine. The stable formulations of the present invention are useful for treating diabetes, and are particularly advantageous in treatment regimes requiring lengthy chemical and physical stability, such as, in continuous infusion systems.

REFERENCES:
patent: 4472385 (1984-09-01), Brange et al.
patent: 4476118 (1984-10-01), Brange et al.
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patent: 5461031 (1995-10-01), DeFelippis
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patent: WO 87/06137 (1987-10-01), None
patent: WO 99/34821 (1999-07-01), None
J. Brange, et al., “Chemical stability of insulin,”Acta Pharm. Nord.4(3) 149-158 (1992), Swedish Pharmaceutical Press, Stockholm, Sweden.
R. Quinn, et al., “Minimizing the aggregation of neutral insulin solutions”Journal of Pharmaceutical Sciences72(12), Dec. 1983, John Wiley & Sons, Hoboken, New Jersey.
Brems, et al.,Protein Engineering, 6:527-533 (1992), Oxford University Press, New York, New York.
Brange, et al.,Current Opinion in Structural Biology, 1:934-940 (1991), Elsevier Science Inc., New York, New York.
Patent Abstract of Japan, vol. 006, No. 143, C-117, Aug. 3, 1982 and JP 57 067548 A (Shionogi & Co. Ltd.), Apr. 24, 1982, refers to preparation comprising insulin analogues in the presence of glycerine, trishydroxy-methylaminomethane, ZnCl2 and cresol-phenol as an antiseptic.
Markussen Jan, Damgaard U, Jorgensen KH, Sorensen, Thim L, “Human Monocomponent Insulni”,Acta. Med. Scand., Suppl., No. 671, pp. 99-105, 1983, Almquist and Wiksell, Stockholm, Sweden.
Pending claims of Application No. 09/450,794 (3 pages).

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