Method for producing powder formulation comprising an insulin

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Title: Method for producing powder formulation comprising an insulin
United States Patent: 6,043,214
Inventors: Jensen; Steen (Drag.o slashed.r, DK); Hansen; Philip (Holte, DK).
Assignee: Novo Nordisk A/S (Bagsvaerd, DK).
Appl. No.: 45,397
Filed: Mar. 20, 1998
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.