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Underwater-dispersible tablet of Sevelamer carbonate

A carbonic acid sevelamer and dispersing technology, which is applied in the directions of pill delivery, organic active ingredients, medical preparations of non-active ingredients, etc., can solve the problems of high requirements for pulverizers, large dust pollution, etc., and achieve stable disintegration time. , the effect of good stability

Active Publication Date: 2013-11-27
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 sevelamer carbonate with different particle sizes in 1000 tablets (g)

[0046]

[0047] Preparation process: sevelamer carbonate and polyethylene glycol 6000 are placed in a high-speed mixing granulator, fast mixing and fast shearing, fast mixing for 5 minutes, and then adding microcrystalline fiber PH102, sucralose, and micronized silica gel to mix 3 Minutes, take the mixture, use a rotary tablet press to compress the mixture into tablets. Use high-density polyethylene bottle with built-in desiccant. Accelerate the test at 40°C and 75%.

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

[0049] Settlement volume ratio: Take one piece and add it to 30ml of 25℃ water, shake it gently, all should be dispersed, shake and suspend it in a graduated cylinder, stand still for...

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 that can be swallowed directly or taken after being dispersed in water and a preparation method thereof. Background technique [0002] Sevelamer carbonate, alias 2-propene-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 phosphoric acid binding ability, used for the treatment of hyperphosphatemia caused by renal insufficiency such as chronic renal insufficiency. [0005] Sevelamer is the only phosphate binder that contains neither calcium nor metal. It will not be absorbed by the system, so it can provide safe and effective control of the effect of serum phosphorus without worrying about calcium and metal accumulation. Sevelamer has the a...

Claims

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Application Information

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Patent Type & Authority Patents(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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