Amorphous monospheric forms of insulin derivatives

Details Amorphous monospheric forms of insulin derivatives Amorphous monospheric forms of insulin derivatives

1994-04-25

1995-11-14

Warden, Jill

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Peptide containing doai

530303, A61K 3828, C07K 1462

Patent

active

054666660

ABSTRACT:
A process for the production of an amorphous monospheric form of insulin derivatives is described, wherein the insulin derivative is dissolved in an n-propanol/buffer mixture at a pH of 4.5 to 6.5, an n-propanol content of more than 13% relative to water is established and the resulting solution is subsequently diluted with water.

REFERENCES:
patent: 5015728 (1991-05-01), Obermeier et al.
Ruegg, V. T., Jarvis, D. Rudinger, J. (1979) Biochem. J. 179, 127-134 "2 Sulfobenzyl a new solubilizing and reversible . . . ".
England, S. and Seifter, S. (1990) Method Enzymol. 182, 285-306 "Precipitation Techniques".
Y. Hu et al., "Crystallographic study on highly stable insulins-crystallization and preliminary crystallographic analysis of A21-Ser mutant," Chemical Abstracts, vol. 118, Nos. 11 (Mar. 1993) p. 97.
J. Markussen et al., "Prolonged-acting insulins, stable in acid solution. Crystallizability and biological potency of insulins substituted in positions A21, B27 and B30," chemical abstracts, vol. 114, No. 25 (Jun. 1991) p. 140.
A. Bialobrzeska et al., "Effect of crystallization parameters on the quality of insulin," chemical abstracts, vol. 97, No. 10 (Sep. 1982) pp. 414-415.
David S. Scott, "CCXI. Crystalline Insulin" Biochemical Journal, vol. XXVIII, No. 4, 1592-1603 (Apr. 1934).
Y. Hu et al., "Crystallographic study on highly stable insulins-crystallization and preliminary crystallographic analysis of A21-Ser mutant," Chemical Abstracts, vol. 118, Nos. 11 (Mar. 1993) p. 97.
J. Markussen et al., "Prolonged-acting insulins, stable in acid solution. crystallizability and biological potency of insulins substituted in positions A21, B27 and B30," chemical abstracts, vol. 114, No. 25 (Jun. 1991) p. 140.

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