Method for producing powder formulation comprising an insulin

Details Method for producing powder formulation comprising an insulin Method for producing powder formulation comprising an insulin

1998-03-20

2000-03-28

Weddington, Kevin E.

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Peptide containing doai

514 4, 514866, A61K 3828

Patent

active

060432144

ABSTRACT:
The present invention relates to a process for producing a therapeutic powder formulation, comprising (a) providing an acidic aqueous solution comprising an insulin or analoguc or derivative thereof and an enhancer; (b) adjusting the pH to a pH in the range of 4.5 to 7.4; (c) precipitating a product comprising the insulin or analogue or derivative thereof and the enhancer, wherein the precipitation is performed essentially without evaporation of the solution; and (d) removing the water.

REFERENCES:
patent: 5506203 (1996-04-01), Backstrom et al.
patent: 5747445 (1998-05-01), Backstrom et al.
Danielson et al. (1994) "New Routes and Means of Insulin Delivery", Childhood and Adolescent Diabetes, Chapman & Hall Medical pp. 571-584.
Niven (1995) "Delivery of Biotherapeutics by Inhalation Aerosol" Critical Reviews in Therapeutic Drug Carrier Systems 12(2&3) :151-231.
Sayani et al. (1996) "Systemic Delivery of Peptides and Proteins" Mucosae Critical Reviews in Therapeutic Drug Carrier Systems 13(1&2) : 85-184.

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