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AssigneeFresenius Kabi Deutschland GmbH
InventorKlaus Henning
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Highly branched, unsubstituted or low-substituted starch products, dialysis solution and plasma expander containing the same, and the use thereof. Known hydroxyethylated and -propylated starch types for use as colloid osmotic agent in peritoneal dialysis or as volume replacement composition (plasma expander) have the disadvantage that complete degradation by amylase is not possible owing to the more or less extensive substitution by hydroxyethyl or hydroxypropyl groups. As a consequence thereof, residual fragments remain in the body and are eliminated only very slowly or are stored in various organs/tissues, especially with relatively high and/or long-term dosage. These disadvantageous properties can be very substantially avoided according to the invention with a highly branched, unsubstituted or low-substituted starch product, i.e. with a starch which has a significantly higher degree of branching than amylopekin, and has the degree of α-1,6 branching of glycogen, or exceeds the latter and—if substituted—has a degree of substitution MS of only up to 0.3.
A modified, unsubstituted or hydroxyethyl- or hydroxypropyl-substituted starch product for clinical use, characterized in that the hydroxyethyl- or hydroxypropyl-substituted starch product has a degree of branching in the range from 8 to 20 mol % and a degree of substitution MS of up to 0.3, and in that the unsubstituted starch product has a degree of branching in the range from 11 to 20 mol %.
A dialysis solution comprising water, a modified, unsubstituted or hydroxyethyl- or hydroxypropyl-substituted starch product which has a degree of branching in the range from 8 to 20 mol % and, in the case of substitution, has a degree of substitution MS of up to 0.3, and conventional additions.
A plasma expander comprising water, a modified, unsubstituted or hydroxyethyl- or hydroxypropyl-substituted starch product which has a degree of branching in the range from 8 to 20 mol % and, in the case of substitution, has a degree of substitution MS of up to 0.3, and conventional additions.
A method of peritoneal dialysis comprising dialyzing with a dialysis solution comprising a modified, unsubstituted or hydroxyethyl- or hydroxypropyl-substituted starch product which has a degree of branching in the range from 8 to 20 mol % and, in the case of substitution, has a degree of substitution MS of up to 0.3, as colloid osmotic agent in dialysis.
A method for volume replacement comprising administering to a patient in need thereof a plasma expander comprising a modified, unsubstituted or hydroxyethyl- or hydroxypropyl-substituted starch product which has a degree of branching in the range from 8 to 20 mol % and, in the case of substitution, has a degree of substitution MS of up to 0.3.
Dependencies are inferred from the claim text.