Glucose polymers for peritoneal dialysis

Patent metadata

Field	Value
Publication number	US-11498939-B2
Application number	US-201716332169-A
Country	US
Kind code	B2
Filing date	Sep 14, 2017
Priority date	Sep 15, 2016
Publication date	Nov 15, 2022
Grant date	Nov 15, 2022

Abstract

The invention relates to a novel glucose polymer which is particularly useful for administration by the parenteral route, and to the method for the production thereof. The invention also relates to compositions comprising such a glucose polymer, and to the methods for the production thereof. The invention further relates to the use thereof as a medicament, for example as an osmotic agent for peritoneal dialysis.

First claim

The invention claimed is:

1. A glucose polymer characterized in that it is obtained by branching and reduction of a starch having an amylose content of at least 10%, and in that said glucose polymer has an α-1,6-bond content of less than 20%, a weight-average molecular weight (Mw) less than 50,000 Da, this Mw being determined by liquid chromatography and detection by differential refractometry, and a polydispersity index (polyD) of less than 3.0 and greater than 0.5; and
wherein reduction results in the conversion of carbonyl groups to hydroxyl groups, and in that it has a reducing sugar content of less than 0.5%, this percentage being expressed by dry weight of reducing sugars relative to the total dry weight of the glucose polymer.

2. The glucose polymer as claimed in claim 1 , characterized in that said glucose polymer has an α-1,6-bond content of greater than 7%.

3. The glucose polymer as claimed in claim 1 , characterized in that said starch has an amylose content of at least 20%.

4. The glucose polymer as claimed in claim 1 , characterized in that it has a weight-average molecular weight (Mw) chosen in the range of from 20,000 to 50,000 daltons (Da); this Mw being determined by liquid chromatography and detection by differential refractometry.

5. The glucose polymer as claimed in claim 1 , characterized in that it has a pH, after sterilization at 121° C. for 45 minutes, in a range of from 6 to 8, when it is formulated as an aqueous 5% solution.

6. The glucose polymer as claimed in claim 1 , characterized in that it has an osmolality of between 200 and 300 mOsm/kg; when it is formulated as a 0.4% solution.

7. The glucose polymer as claimed in claim 1 , characterized in that it has a reducing sugar content of less than 0.1%, this percentage being expressed by dry weight of reducing sugars relative to the total dry weight of the glucose polymer.

8. The glucose polymer as claimed in claim 1 , characterized in that it is soluble to very soluble in water when it is at ambient temperature.

9. The glucose polymer as claimed in claim 1 , characterized in that it is not substituted.

10. A composition, comprising the polymer as defined claim 1 .

11. The composition as claimed in claim 10 , characterized in that it is a solution.

12. The glucose polymer as claimed in claim 1 or the composition as claimed in claim 11 , for use thereof as a medicament.

13. The glucose polymer as claimed in claim 1 or the composition as claimed in claim 11 , for use thereof in peritoneal dialysis, and/or parenteral nutrition, and/or in plasma filling, and/or as an osmotic agent, and/or as a plasma expander, and/or in vaccinology, and/or as an adjuvant, and/or as a protein stabilizer, and/or as a protein carrier.

14. A method for producing a composition as defined in claim 10 , which comprises mixing a polymer as defined in claim 1 with at least one other substance and/or a solvent.

15. A method for producing a glucose polymer as defined in claim 1 , which comprises subjecting a starch having an amylose content of at least 10% to:
(a) a branching step; and
(b) a reduction step.

Assignees

• Roquette Freres

Inventors

• Simon Denis
• Haeusler Olaf
• Bock Solène

Classifications

• A61K31/718

  Starch or degraded starch, e.g. amylose, amylopectin · CPC title

• C08B33/00

  Preparation of derivatives of amylose · CPC title

• A23L29/20

  containing gelling or thickening agents (marmalades, jams, jellies or other similar fruit or vegetable compositions A23L21/10) · CPC title

• A23L33/10

  using additives (addition of substantially indigestible substances A23L33/21) · CPC title

• C07H3/00 Primary

  Compounds containing only hydrogen atoms and saccharide radicals having only carbon, hydrogen, and oxygen atoms (preparation by hydrolysis of di-or polysaccharides C13; separation or purification of sucrose, glucose, fructose, lactose or maltose C13) · CPC title