Patent ID: 6689389
Filing Date: 2004-02-10
Classification: A61K,C08B,Y10T

Abstract:
A process for the production of a starch having a purity of at most 50 ug amino acid nitrogen per gram dry weight of starch and an endotoxin content of less than 25 EU/g and containing fewer than 100 microorganisms per gram, said starch being pharmaceutically acceptable for injection into a human being, which comprisesa) starting from starch in solid form and with an amylopectin content in excess of 85 percent by weight, expressed as dry weight of starch, b) subjecting said solid starch to washing(s) under conditions such that proteins, lipids and endotoxins surface-localized on the starch as well as more sparingly soluble proteins are dissolved while the starch remains undissolved, and separating the starch from the dissolved material, said washings comprising a washing with an aqueous alkaline solution for dissolving said water-soluble proteins, lipids and endotoxins and a washing with an aqueous solvent with the ability to dissolve zein for dissolving said more sparingly soluble proteins; c) causing the washed starch obtained from step b) to dissolve in an aqueous medium, d) subjecting the starch solution to a molecular weight reduction by shearing such that a molecular weight distribution is obtained in which at least 80 percent by weight of the material lies within the range of 10-10000 kDa; and e) removing residual water-soluble proteins from the starch by subjecting the starch solution to ion exchange chromatography, said ion exchange chromatography being performed either before or after the shearing step d) wherein the starch is pharmaceutically acceptable for injection into a human being.