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Carbohydrate composition for dialysis

A composition and compound technology, applied in the directions of carbohydrate active ingredients, drug combinations, hydroxyl compound active ingredients, etc., can solve the problems of no reports comparing low molecular weight solutions and icodextrin data, etc., and achieve the effect of enhancing ultrafiltration efficiency.

Active Publication Date: 2019-11-29
OPTERION HEALTH AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0023] Despite differences between low and high Mw fractions, no data comparing low molecular weight solutions and icodextrins were reported

Method used

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  • Carbohydrate composition for dialysis
  • Carbohydrate composition for dialysis
  • Carbohydrate composition for dialysis

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0307] Example 1: Industrial carbohydrate polymer preparation:

[0308] Starch milk was prepared from acid fluidized commercial cornstarch. A starch suspension containing 20-50% solids was prepared by stirring until complete dissolution at 90°C. The solution was then cooled to 60°C and adjusted to pH 6-6.5 by citric acid.

[0309] For gelatinization, the starch is treated with 0.1% thermostable alpha-amylase in the reaction medium and the reaction is terminated by heating between 88 and 92 °C for 5 to 10 minutes.

[0310] For dextrinization, the pH was adjusted to 4 to 5, the amylase concentration was increased to 0.3% and the reaction was allowed to proceed for a few more hours. dextrinization may occur

[0311] The final solution is separated in several steps involving 30,000, 10,000, 5,000 Dalton separation devices such as membrane or ceramic filters.

[0312] Table I shows the composition of the physicochemical characteristics of the two target dextran intermediate pre...

example 2

[0315] Example 2: Experimental preparation

[0316] In this example we produced polysaccharide formulations and final osmotically active compositions with Mw between 3.4 and 6.1 kD and Mn between 2 and 3.7 kD.

[0317] In all cases, this polymer fraction contained less than 1.5% by weight of polymers with a molecular weight greater than 18 kD, and even less than 0.6% by weight of polymers with a molecular weight greater than 40 kD.

[0318] The starting material is from commercially available icodextrin. Use 3 to 4 L / m for 80 liter batches as recommended by supplier 2 and inlet pressure below 2.5 bar supply 0.5m 2 pelicon 2 membrane. Sequential steps with membrane cutoffs of 100 kD, 30 kD, 10 kD and 5 kD were tested in different devices. Typically, each filtration step results in about 5-10% retentate, depending on the composition concentration of the filtered solution. Three intermediate carbohydrate polymer formulations, hereinafter referred to as solutions 1, 2 and...

example 3

[0333] Example 3: Example of calculating Mw and Mn of different osmotically active compositions

[0334] Table 6: Calculation of Mw and Mn of solution 3 (taking 5.75% carbohydrate polymer concentration as an example:

[0335]

[0336] For each fraction i, the Mol concentration is taken as the value (ni) of the number of compound molecules of this fraction, and the average molecular weight of this fraction is taken as the molecular weight Mi of all molecules of this fraction. We can then build the sum

[0337] Σ(ni)=27.5, Σ(ni*Mi)=57.5, Σ(ni*Mi 2 )=200.8, and calculate

[0338] Mw=Σ(ni*Mi 2 ) / Σ(ni*Mi)=3.49kD, and

[0339] Mn=Σ(ni*Mi) / Σ(ni)=2.09kD.

[0340] Calculate the Mw and Mn of glycerol (1% solution):

[0341]

[0342] The 1% maltose fraction corresponds to a single fraction with a molecular weight of 0.342kD at a concentration of 29M(ni), giving

[0343] Σ(ni)=ni=29, Σ(ni*Mi)=niMi=10, and Σ(ni*Mi 2 ) = niMi 2 = 3.42.

[0344] Calculate the Mw and Mn of Sol...

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Abstract

A composition, comprising: a) maltose, glycerol, an amino acid, an oligopeptide, or a mixture of one or more thereof, in a content of 5 to 75 wt-% of the total weight of a)-d), b) glucose in a contentof less than 1 / 2 the content of maltose, and in a total content of less than 5 wt-% of the total weight of a)-d), c) glucan molecules of DP 3 and DP 4, taken together, in a content of less than 1 / 2 of the content of maltose, d) glucan molecules of DP>4 in a content to give 100 wt-% together with a), b) and c), wherein glucan molecules of DP>10 are present in an amount of 15-80 wt-% of the total weight of a)-d), glucan molecules of DP>24 are present in an amount of 2-60 wt-% of the total weight of a)-d), glucan molecules of DP>55 are present in an amount of less than 15 wt-% of the total weight of a)-d), a method for producing it and its use as a medicament or for use in therapy, particularly in peritoneal dialysis.

Description

technical field [0001] The present invention relates to osmotically active compositions, aqueous solutions containing the compositions and their use. Background technique [0002] Especially in the field of peritoneal dialysis, much work has been done describing most of the different osmotically active compositions, including carbohydrate polymer formulations, and their dialysis parameters in clinical or animal models, and different measurements have been applied method to establish the parameters of their composition. A very well described medically applied carbohydrate polymer formulation for medical applications is Icodextrin. [0003] Permanent dialysis treatment still causes significant side effects through the interaction between the dialysis material (catheter, dialysis material and solution) and patient tissue. [0004] Hemodialysis (HD) is the most commonly used dialysis treatment. Respective side effects include inflammation and cardiovascular complications, lea...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M1/28A61M1/14A61K9/08A61K47/26A61K31/70
CPCA61M1/287A61K45/06A61K47/26A61K9/08A61K31/716A61P1/10A61P13/12A61P3/02A61P39/02A61P7/08A61K2300/00A61K31/7016A61K31/7004A61K31/047A61K31/195A61K38/03
Inventor G·格兰茨曼H·B·施泰因豪尔
Owner OPTERION HEALTH AG