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Application of dissolution tester in evaluation on bioequivalence of sevelamer carbonate tablets

A carbonic acid sevelamer tablet biological, sevelamer technology, applied in the field of pharmaceutical research and development, can solve the problems of different specifications, working modes, poor repeatability and maneuverability, etc., to facilitate the evaluation of bioequivalence , the effect of controllable sample preparation

Inactive Publication Date: 2017-02-15
方达医药技术(苏州)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the specifications and working modes of water bath shakers on the market today are different, and it is difficult to unify them, resulting in poor repeatability and maneuverability
However, there are currently no reports of studies on the application of dissolution apparatus to this project

Method used

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  • Application of dissolution tester in evaluation on bioequivalence of sevelamer carbonate tablets
  • Application of dissolution tester in evaluation on bioequivalence of sevelamer carbonate tablets
  • Application of dissolution tester in evaluation on bioequivalence of sevelamer carbonate tablets

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Experimental program
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Embodiment Construction

[0041] In order to better understand the essence of the present invention, the comparative experiment and the results of the dissolution apparatus and the water-bath shaker will be used below to illustrate its application in the study of the phosphate binding capacity of sevelamer carbonate tablets.

[0042] The application of dissolution apparatus in bioequivalence evaluation of Sevelamer Carbonate Tablets, the bioequivalence evaluation of Sevelamer Carbonate Tablets includes dynamic phosphate binding force research, and phosphate binding force research in equilibrium, etc. The force data is obtained by using the Langmuir equation analysis, and the calculation equation is as follows:

[0043]

[0044] in,

[0045] C eq Indicates the concentration of phosphate in the equilibrium solution (mmol);

[0046] x represents the amount of phosphoric acid bound to Sevelamer at equilibrium (mmol);

[0047] m represents the dosage of Sevelamer (grams);

[0048] x / m represents the ...

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Abstract

The invention discloses application of dissolution tester in the evaluation on bioequivalence of sevelamer carbonate tablets; the evaluation on bioequivalence of sevelamer carbonate tablets includes study on dynamic phosphate binding force, study on balanced phosphate binding force and the like; data of phosphate binding force is acquired by analysis through Langmuir equation; mass experiments prove that it is fully feasible to replace a water bath shaker with a dissolution tester to carry out the study on phosphate binding force of sevelamer carbonate tablets, the defects of the water bath shaker are overcome by the application of the dissolution tester, more convenient and controllable sample experimenting is achieved, and the evaluation on the bioequivalence of sevelamer carbonate tablets is more facilitated accordingly.

Description

technical field [0001] The invention belongs to the technical field of medical research and development, and relates to a new application of a dissolution apparatus, in particular, it is applied to the research on the phosphate binding capacity of sevelamer carbonate tablets. Background technique [0002] Sevelamer Carbonate is a cross-linked polymer that cannot be absorbed by the body and is the active ingredient in Sevelamer Carbonate Tablets. It carries multiple amine groups and is connected to the polymer backbone by a carbon atom. The chemical structure is as follows: [0003] [0004] Wherein, a and b represent the number of primary amine groups, and a+b=9; [0005] c represents the number of crosslinking groups, and c = 1; [0006] m represents the amount of sevelamer carbonate in the extended polymer network. [0007] Sevelamer carbonate is insoluble in water, and its mechanism of action is similar to that of Sevelamer hydrochloride. After oral administration, ...

Claims

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Application Information

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IPC IPC(8): G01N33/15
CPCG01N33/15
Inventor 张家艾唐任能
Owner 方达医药技术(苏州)有限公司
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