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Febuxostat tablet and preparation method thereof

A technology of febuxostat and tablets, which is applied in the field of medicine, can solve the problems of febuxostat that the medicinal effect cannot meet the ideal requirements, high medicinal content of febuxostat, and low bioavailability, and achieve improved Effects of bioavailability, quality control, enhanced solubility and stability

Active Publication Date: 2012-06-13
KANGYA OF NINGXIA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, due to the low solubility of febuxostat itself, the common oral solid preparations containing this active ingredient have problems such as poor dissolution and low bioavailability. In many cases, the medicinal effect of febuxostat does not meet the ideal requirements. , which has caused the problem that the medicinal content of febuxostat is relatively high, but the effect is not ideal

Method used

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  • Febuxostat tablet and preparation method thereof
  • Febuxostat tablet and preparation method thereof
  • Febuxostat tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Tablet prescription:

[0032]

[0033] Adhesive

[0034]

[0035] Coating Solution Prescription

[0036]

[0037] Preparation Process:

[0038] 1. Mix the prescribed amount of febuxostat, lactose and sodium lauryl sulfate evenly, and then pulverize it with an ultrafine pulverizer to control the average particle size below 50 μm;

[0039] 2. Mix the pulverized mixture with the prescribed amount of microcrystalline cellulose and 10 g of carboxymethyl starch sodium evenly, then add 8% of the binder to make soft material from starch slurry, and pass through a 18-mesh sieve to make wet granules;

[0040] 3. Put the wet granules in a drying oven, and dry them with blast at 50-60°C;

[0041] 4. Pass the dry granules through a 18-mesh sieve for granulation, add the prescribed amount of lubricant and the remaining sodium starch glycolate, mix well, and press into tablets to obtain tablet cores;

[0042] 5. Coating with Opadry ethanol solution, the weight gain of the c...

example 2

[0047] Tablet core prescription

[0048]

[0049] Adhesive

[0050]

[0051] Coating Solution Prescription:

[0052]

[0053]

[0054] Preparation Process

[0055] 1. Mix the prescribed amount of febuxostat, pre-crossed starch and Tween evenly, and then pulverize it with an ultrafine pulverizer, and control the average particle size below 30 μm;

[0056] 2. After mixing the pulverized mixture with the prescription amount of microcrystalline cellulose and 10g sodium starch glycolate / , add adhesive 8% starch slurry to make a soft material, and pass through a 18-mesh sieve to make wet granules;

[0057] 3. Put the wet granules in a drying oven, and dry them with blast at 50-60°C;

[0058] 4. Pass the dry granules through a 18-mesh sieve for granulation, add the prescribed amount of lubricant and the remaining sodium starch glycolate, mix well, and press into tablets to obtain tablet cores;

[0059] 5. Coating with Opadry ethanol solution, the weight gain of the co...

example 3

[0064] Tablet prescription:

[0065]

[0066] Adhesive

[0067]

[0068] Coating Solution Prescription

[0069]

[0070] craft

[0071] 1. Mix the prescribed amount of febuxostat, lactose and sodium lauryl sulfate evenly, and then pulverize it with an ultrafine pulverizer, and control the average particle size below 30 μm;

[0072] 2. Mix the pulverized mixture with the prescribed amount of microcrystalline cellulose and 10 g of carboxymethyl starch sodium evenly, then add 8% of the binder to make soft material from starch slurry, and pass through a 18-mesh sieve to make wet granules;

[0073] 3. Put the wet granules in a drying oven, and dry them with blast at 50-60°C;

[0074] 4. Pass the dry granules through a 18-mesh sieve for granulation, add the prescribed amount of lubricant and the remaining sodium starch glycolate, mix well, and press into tablets to obtain tablet cores;

[0075] 5. Coating with Opadry ethanol solution, the weight gain of the coating is a...

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Abstract

The invention discloses a febuxostat tablet and a preparation method thereof. The febuxostat tablet comprises a tablet core and a coating, the tablet core comprises the following compositions: by weight percentage, from 5% to 30% of febuxostat, from 15% to 60% of filler, from 1% to 20% of disintegrating agent, from 0.1% to 5% of surfactant, from 0.1% to 8% of lubricating agent and a defined amount of adhesive. The febuxostat tablet adopts the high-efficient disintegrating agent within a reasonable proportion range, simultaneously, the febuxostat which is difficultly soluble medicine is dissolved by the aid of the surfactant and the high-efficient disintegrating agent, so that solubility of the febuxostat is improved, and bioavailability of the febuxostat is increased. In addition, the preparation method for the febuxostat tablet is simple, and is controllable in quality and fine in stability.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a febuxostat tablet 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. Uric acid has no physiological function in the human body. Under normal circumstances, 2 / 3 of the uric acid produced in the body is excreted by the kidneys, and the remaining 1 / 3 is excreted from the intestines. Uric acid in the body is constantly produced and excreted, so it maintains a certain concentration in the blood. The uric acid contained in each liter of blood of normal people is less than 0.42mmol for men and no more than 0.357mmol for women. In the process of synthesis and decomposition of purine, various enzymes are involved. Due to the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/32A61K9/36A61K31/426A61P19/06
Inventor 杨亚军马攀勤剡郊林
Owner KANGYA OF NINGXIA PHARMA
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