Underwater-dispersible tablet of Sevelamer carbonate

A technology of sevelamer carbonate and tablets, which is applied in the direction of pill delivery, organic active ingredients, medical preparations of non-active ingredients, etc., can solve the problems of large dust pollution, high requirements for pulverizers, etc., and achieve good stability, Effect of Stabilizing Disintegration Time

Active Publication Date: 2012-08-22
TIANJIN PACIFIC PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since this product is a polymer with certain plasticity, crushing the raw material to a diameter of less than 45 microns requires high requirements on the pulverizer and will generate relatively large dust pollution.

Method used

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  • Underwater-dispersible tablet of Sevelamer carbonate
  • Underwater-dispersible tablet of Sevelamer carbonate
  • Underwater-dispersible tablet of Sevelamer carbonate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Different particle sizes of sevelamer carbonate can obtain better disintegration stability during storage.

[0045] Table 1: Preparation of 1000 tablets (g) of different particle sizes of sevelamer carbonate

[0046]

[0047]Preparation process: put sevelamer carbonate and polyethylene glycol 6000 in a high-speed mixing granulator, use rapid stirring and rapid shearing, and mix rapidly for 5 minutes, then add microcrystalline fiber PH102, sucralose, and micronized silica gel to mix for 3 Minutes, take the mixture and compress the mixture into tablets using a rotary tablet press. High-density polyethylene bottle with built-in desiccant. Accelerated test was carried out under the condition of 40°C and 75%.

[0048] Disintegration time: according to the inspection method of disintegration time limit of Chinese Pharmacopoeia 2010 edition

[0049] Sedimentation volume ratio: Take one piece and add it to 30ml of water at 25°C, shake gently, it should be completely dispe...

Embodiment 2

[0056]

Embodiment 3

[0058]

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Abstract

The invention relates to an underwater-dispersible tablet of Sevelamer carbonate, which is characterized by containing Sevelamer carbonate salt and a low-melting-point water-soluble adjuvant and is applicable to the field of medical technologies.

Description

technical field [0001] The invention relates to the preparation of a pharmaceutical preparation, in particular to a tablet of sevelamer carbonate which can be swallowed directly or taken after being dispersed in water and a preparation method thereof. Background technique [0002] Sevelamer carbonate, alias 2-propen-1-amine and epichlorohydrin polymer carbonate, English name Sevelamer carbonate, chemical name 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate, structural formula is : [0003] [0004] Sevelamer Carbonate is a non-absorbable polymer with phosphate binding capacity, which is used for the treatment of hyperphosphatemia caused by low renal function such as chronic renal insufficiency. [0005] Sevelamer is the only phosphate binder that contains neither calcium nor metals. It will not be absorbed by the system, so it can provide safe and effective control of serum phosphorus without worrying about calcium and metal accumulation. Sevelamer had the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/785A61K47/38A61P7/00A61P13/12
Inventor 尚丽霞陶秀梅
Owner TIANJIN PACIFIC PHARMA
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