Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2005-06-14
2005-06-14
Tate, Christopher (Department: 1654)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
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.
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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.
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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).
DeFelippis Michael Rosario
Dobbins Michael Allen
Frank Bruce Hill
Li Shun
Rebhun Dawn Marie
Eli Lilly and Company
Reed Grant E.
Tate Christopher
Teller Roy
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