Stable insulin formulations

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

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530304, A61K 3828

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active

060340541

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.
patent: 4783441 (1988-11-01), Thurow
patent: 4839341 (1989-06-01), Massey et al.
patent: 5461031 (1995-10-01), DeFelippis
patent: 5474978 (1995-12-01), Bakaysa et al.
patent: 5514646 (1996-05-01), Chance et al.
patent: 5547929 (1996-08-01), Anderson et al.
patent: 5650486 (1997-07-01), DeFelippis
patent: 5658878 (1997-08-01), Backstrom et al.
Patent Abstract of Japan, vol. 006, No. 143, C-117, Aug. 3, 1982 & JP 57 067548 A (Shionogi & Co Ltd), Apr. 24, 1982, refers to preparation comprising insulin analogues in the prescence of glycerine, trishydroxy-methylaminomethane, ZnCl2 and cresol-phenol as an antiseptic.
J. Brange, et al., "Chemical stability of insulin", Aeta Pharm. Nord. 4(3) 149-158 (1992).
R. Quinn, et al., "Minimizing the aggregation of neutral insulin solutions", Journal of Pharmaceutical Sciences vol. 72, No. 12, Dec. 1983.
Brems, et al. Protein Engineering, 6:527-533 (1992).
Brange, et al., Current Opinion in Structural Biology, 1:934-940 (1991).

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