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Febuxostat dispersible tablet drug and preparing method thereof

A technology for febuxostat and dispersible tablets, applied in the field of dispersible tablet medicines and their preparation, can solve the problems of low bioavailability, low solubility of febuxostat, poor dissolution and the like, and achieves improved bioavailability, poor Small response, fast absorption effect

Active Publication Date: 2010-07-21
CHONGQING SHENGHUAXI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the low solubility of febuxostat in water, common oral solid preparations containing this active ingredient have problems such as poor dissolution and low bioavailability, which is an important obstacle affecting its use and curative effect.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Raw materials: 41.2 parts of febuxostat (weight, the same below), 2 parts of povidone K-30, 63 parts of Ludipress LCE, 10.8 parts of sodium carboxymethyl starch, 31 parts of crospovidone, croscarboxymethyl 10.2 parts of sodium cellulose, 15 39.8 parts of polyethylene glycol stearate, 1 part of magnesium stearate, 1 part of micropowder silica gel and appropriate amount of ethanol.

[0028] Preparation: Dissolve povidone K-30 and polyethylene glycol stearate 15 in an appropriate amount of ethanol, add febuxostat, Ludipress LCE, sodium carboxymethyl starch and crospovidone, mix well, pass Sieve, make soft material, dry, granulate, then add croscarmellose sodium, magnesium stearate and micropowder silica gel, mix well, and compress into tablets. Each tablet contains febuxostat 40 mg.

Embodiment 2

[0030]Raw materials: 4 parts of febuxostat, 20 parts of povidone K-30, 117.5 parts of MicroceLac 100, 9.6 parts of sodium starch glycolate, 21 parts of dry starch, 5.9 parts of croscarmellose sodium, polyethylene glycol 15 20 parts of alcohol stearate, 1 part of magnesium stearate, 1 part of micronized silica gel and appropriate amount of ethanol.

[0031] Preparation: Dissolve febuxostat, povidone K-30 and polyethylene glycol stearate 15 in an appropriate amount of ethanol, add MicroceLac 100, sodium carboxymethyl starch and dry starch, mix well, sieve, and prepare Soft material, drying, granulation, then add croscarmellose sodium, magnesium stearate and micropowder silica gel, mix well, and compress into tablets. Each tablet contains febuxostat 10 mg.

Embodiment 3

[0036] Raw materials: 100.5 parts of febuxostat, 0.2 parts of povidone K-30, 13 parts of powdered sugar, 10.8 parts of sodium carboxymethyl starch, 13.2 parts of crospovidone, 15 57.3 parts of polyethylene glycol stearate , 5 parts of magnesium stearate and an appropriate amount of 75% ethanol.

[0037] Preparation: Dissolve povidone K-30 and polyethylene glycol stearate 15 in an appropriate amount of 75% ethanol, add febuxostat, powdered sugar, sodium carboxymethyl starch and crospovidone, and mix well , sieved, made into soft material, dried, granulated, then added with magnesium stearate, mixed evenly, and compressed into tablets. The film-coated tablets are prepared by coating with common film-coating materials based on methyl cellulose. Each tablet contains febuxostat 120 mg.

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PUM

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Abstract

The invention relates to a febuxostat dispersible tablet drug and a preparing method. The drug is prepared from febuxostat as the active drug ingredient, and acceptable auxiliary ingredients in the dispersible tablet preparation. The febuxostat dispersible tablet drug is characterized in that at least one of polyoxyethylene 40 monostearate ingredient, polyethenoxy ether castor oil ingredient and hydrogenated castor oil polyoxyl ingredient in the auxiliary ingredients is used as a solubilizing agent ingredient and has the usage amount of 0.1-5 times the weight of febuxostat. The drug can obviously enhance the dissolution rate of the insoluble effective drug ingredient of febuxostat, and has the advantages of high drug dispersion degree, high dissolution rate, quick absorption and effect taking, high biological utilization degree, and the like.

Description

technical field [0001] The invention relates to a dispersible tablet drug containing insoluble ingredients and a preparation method thereof, in particular to a febuxostat dispersible tablet with improved dissolution rate and a preparation method thereof. Background technique [0002] The occurrence of gout is due to the excessive production of uric acid in the body and the decline in the ability of the kidneys to clear it. The accumulation of uric acid in the body leads to the deposition of urate crystals in the joints and various organs. As the proportion of purine-rich foods in the dietary structure continues to increase, the incidence of gout has increased, especially in middle-aged and elderly people, chronic cardiovascular diseases and people with diabetes. [0003] The current treatment of gout is usually to promote uric acid excretion and inhibit uric acid production, and take appropriate measures to improve related symptoms. The generation of uric acid in the body i...

Claims

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Application Information

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IPC IPC(8): A61K31/426A61K9/20A61K47/34A61K9/24A61K9/36A61P19/06A61K47/10A61K47/14A61K47/26A61K47/44
Inventor 姜维平钟声荣
Owner CHONGQING SHENGHUAXI PHARMA CO LTD
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