Pharmaceutically acceptable starch
AssigneeJagotec AG
InventorsNils Ove Gustavsson, Monica Jönsson, Per Berdén, Timo Laakso
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Abstract
Production of purified, parenterally administrable starch by washing starch containing more than 85% amylopectin in order to remove surface-localized proteins, lipids and endotoxins, dissolving the starch in aqueous medium, molecular weight reduction by shearing, and optionally removal of residual water-soluble proteins, preferably by anion exchange chromatography. Purified starch and microparticles based on such starch.
Claims33
A pharmaceutically acceptable starch for parenteral administration to a mammal, which
- a) has an amylopectin content in excess of 85 percent by weight, in which the molecular weight of said amylopectin has been reduced by shearing to obtain a molecular weight distribution in which at least 80 percent by weight of the starch lies within the range of 100–4000 kDa;
- b) has a purity of at most 50 μg amino acid nitrogen per gram dry weight of starch;
- and
- c) can be dissolved in a concentration exceeding 25 percent by weight in water.
A pharmaceutically acceptable starch for parenteral administration to a mammal, which
- a) has an amylopectin content in excess of 85 percent by weight, in which the molecular weight of said amylopectin has been reduced by shearing to obtain a molecular weight distribution in which at least 80 percent by weight of the starch lies within the range of 100–4000 kDa;
- b) has a purity of at most 50 μpg amino acid nitrogen per gram dry weight of starch;
- and
- c) lacks hydroxyethylation.
A starch having a purity of at most 50 μg 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 and obtainable by a process starting from starch in solid form with an amylopectin content in excess of 85 percent by weight expressed as dry weight of starch comprising the following steps:
- (a) subjecting said solid starch to one or more washings under conditions such that material comprising 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 one or more washings comprising a washing with an aqueous alkaline solution for dissolving 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;
- (b) causing the washed starched obtained from step (a) to dissolve in an aqueous medium;
- (c) 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 100–4000 kDa;
- and
- (d) 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 (c), wherein the starch is pharmaceutically acceptable for injection into a human being.
Dependencies are inferred from the claim text.