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Sevelamer carbonate tablet and preparation method thereof

A technology of sevelamer carbonate tablet and sevelamer carbonate, which is applied in the field of pharmaceutical research and development, can solve problems such as long disintegration time, and achieve the effect of stable disintegration time and high effectiveness

Active Publication Date: 2015-07-01
HANGZHOU MINSHENG BINJIANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, in the above-mentioned patent documents, the disintegration time of the sevelamer carbonate tablet is close to 30 minutes at the 10th week, and the disintegration time is relatively long

Method used

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  • Sevelamer carbonate tablet and preparation method thereof
  • Sevelamer carbonate tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Calculated with the prescription amount of sevelamer carbonate as 800mg, mix 16.25% prescription amount of MCC (microcrystalline cellulose), 7% prescription amount of water, and 0.625% prescription amount of sodium carbonate, fully balance for at least 8 hours, and mix with After 800 mg of sevelamer carbonate (about 3% water content) was mixed uniformly, 1% of zinc stearate of the prescription was added and mixed, and then pressed into tablets to obtain sevelamer carbonate tablets.

Embodiment 2

[0022] Calculated with the prescription amount of sevelamer carbonate as 800mg, mix 16.25% prescription amount of MCC (microcrystalline cellulose), 7% prescription amount of water, and 0.3% prescription amount of β-CD (β-cyclodextrin) Uniform, fully balanced for at least 8 hours, mixed with 800 mg of sevelamer carbonate (about 3% water content), and then added with 1% of the prescription amount of zinc stearate, mixed and pressed to obtain sevelamer carbonate tablets .

Embodiment 3

[0024] The difference from Example 1 is that the consumption of sodium carbonate is 0.312% of the sevelamer carbonate recipe quantity, and the remaining steps are the same as in Example 1 to obtain sevelamer carbonate tablets.

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PUM

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Abstract

The invention discloses a sevelamer carbonate tablet including sevelamer carbonate and a stabilizer, wherein the stabilizer is sodium carbonate, and accounts for at least 0.01% of the weight of sevelamer carbonate. The invention also discloses a preparation method of the sevelamer carbonate tablet. The method includes uniformly mixing an excipient, sevelamer carbonate, stabilizer and water, tabletting and coating to obtain the sevelamer carbonate tablet. The sevelamer carbonate tablet provided by the invention employs sodium carbonate or beta-cyclodextrin as a stabilizer, so as to ensure that the prepared sevelamer carbonate tablet has shorter disintegration time, and higher effectiveness of active ingredients to the patients.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical research and development, in particular to a carbonate sevelamer tablet and a preparation method. Background technique [0002] Sevelamer carbonate, alias 2-propen-1-amine and epichlorohydrin polymer carbonate, molecular formula: (C 3 H 7 N) m .(C 3 H 5 ClO)n.(CH 2 O 3 ) x , the structure is as follows: [0003] [0004] Sevelamer, for the treatment of hyperphosphatasia in chronic kidney disease dialysis patients. The original researcher of the drug is Genzyme (now Sanofi), and its hydrochloride capsule was approved by the US FDA in 1998, and its hydrochloride tablet (Renagel 400mg & 800mg) was launched in 2000. In 2007, its second-generation product carbonate tablet (Renvela 800mg) was approved for marketing. [0005] The currently marketed preparations of sevelamer carbonate are tablets with a size of 800 mg. For the control of serum inorganic phosphorus and calcium levels a...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/28A61K31/785A61K47/40A61K47/02A61P13/12A61P3/12A61P5/16
Inventor 严易青高宇航王亦平曹勋学
Owner HANGZHOU MINSHENG BINJIANG PHARMA CO LTD
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