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Carbohydrate composition for dialysis

A composition and compound technology, applied in the direction of carbohydrate active ingredients, drug combinations, hydroxyl compound active ingredients, etc., can solve the problem of not reporting low molecular weight solutions and icodextrin data and other issues

Active Publication Date: 2022-06-17
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

[0304] Example 1: Industrial carbohydrate polymer preparation:

[0305] Starch milk was prepared from acid-fluidized commercial cornstarch. A starch suspension containing 20-50% solids was prepared by stirring until completely dissolved at 90°C. The solution was then cooled to 60°C and adjusted to pH 6-6.5 with citric acid.

[0306] For gelatinization, starch was treated with 0.1% thermostable alpha-amylase in the reaction medium and the reaction was terminated by heating between 88 and 92°C for 5 to 10 minutes.

[0307] For dextrinization, the pH was adjusted to 4 to 5, the concentration of amylase was increased to 0.3% and the reaction was allowed to proceed for a few more hours.

[0308] The final solution is separated in several steps including 30,000, 10,000, 5,000 Dalton separation devices such as membrane or ceramic filters.

[0309] Table 1 shows the composition of the physicochemical characteristics of two target glucan intermediate preparations or two PDF solution...

example 2

[0312] Example 2: Experimental Preparation

[0313] 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.

[0314] In all cases, this polymer fraction contains less than 1.5 wt% of polymers with molecular weights greater than 18 kD, and even less than 0.6 wt% of polymers with molecular weights greater than 40 kD.

[0315] Starting materials were obtained from commercially available of icodextrin. 80L batches at 3 to 4L / m as recommended by the supplier 2 and supply 0.5m with inlet pressure below 2.5 bar 2 pelicon 2 membrane. Successive steps of membrane cutoff of 100 kD, 30 kD, 10 kD and 5 kD were tested in different devices. Typically, each filtration step results in a retentate of about 5-10%, depending on the compositional concentration of the filtration solution. In this way, three intermediate carbohydrate polymer formulations, hereinafter referred to as soluti...

example 3

[0330] Example 3: Example of calculating Mw and Mn of different osmotically active compositions

[0331] Table 6: Calculated Mw and Mn of solution 3 (taking 5.75% saccharide polymer concentration as an example:

[0332]

[0333] For each fraction i, the MoI concentration is taken as the value (ni) for the number of compound molecules of this fraction, and the average molecular weight of this fraction is considered to be the molecular weight Mi of all molecules of this fraction. Then we can build the sum

[0334] Σ(ni)=27.5, Σ(ni*Mi)=57.5, Σ(ni*Mi) 2 )=200.8, and calculate

[0335] Mw=Σ(ni*Mi 2 ) / Σ(ni*Mi)=3.49kD, and

[0336] Mn=Σ(ni*Mi) / Σ(ni)=2.09kD.

[0337] Calculate Mw and Mn for maltose (1% solution):

[0338]

[0339] A fraction of 1% maltose corresponds to a single fraction with a molecular weight of 0.342 kD at a concentration of 29 M(ni), yielding

[0340] Σ(ni)=ni=29, Σ(ni*Mi)=niMi=10, and Σ(ni*Mi 2 )=niMi 2 = 3.42.

[0341] Calculate Mw and Mn for the...

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PUM

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Abstract

A composition comprising: a) maltose, glycerin, amino acid, oligopeptide or a mixture of one or more thereof, the content of which is 5 to 75 wt% of the total weight of a)-d), b) glucose, the content of which is less than 1 / 2 of the maltose content, and the total content is less than a)-d) 5% by weight of the total weight, c) dextran molecules of DP 3 and DP 4, which together contain less than 1 / 2 of the maltose content, d ) dextran molecules with DP>4 in an amount of 100% by weight together with a), b) and c), wherein dextran molecules with DP>10 are present in an amount of 15-15% of the total weight of a)-d) 80 wt%, dextran molecules with DP>24 are present in an amount of 2-60 wt% of the total weight of a)-d), and dextran molecules with DP>55 are present in an amount of less than 15 wt% of the total weight of a)-d) , a process for its preparation and its use as a medicament or for therapy, especially for peritoneal dialysis.

Description

technical field [0001] The present invention relates to osmotically active compositions, aqueous solutions containing the compositions, and uses thereof. Background technique [0002] In the field of peritoneal dialysis in particular, much work has been done describing most of the different osmotically active compositions (including glycopolymer formulations), and their dialysis parameters in clinical or animal models, and different measurements have been applied methods to establish the parameters of their compositions. A very well described medically used 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 the patient's tissue. [0004] Hemodialysis (HD) is the most commonly used dialysis treatment. The respective side effects include inflammation and cardiovascular complicat...

Claims

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Application Information

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Patent Type & Authority Patents(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