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Febuxostat dispersible tablet and preparation method thereof

A febuxostat and dispersible tablet technology, which is applied in the field of medicine, can solve the problems of incomplete dissolution and low dissolution rate of ordinary tablets, and achieve the effects of stable quality, suitable for long-term storage, and rapid and complete drug dissolution

Inactive Publication Date: 2011-02-09
JIANGSU WANBANG BIOPHARMLS +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0043] Since febuxostat is almost insoluble in water, its ordinary tablets have problems such as low dissolution rate and incomplete dissolution

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0084] 1000 febuxostat dispersible tablets (specification 40mg) contain the following components:

[0085] Febuxostat 40g 17.1%

[0086] Microcrystalline Cellulose 120g 51.2%

[0087] Croscarmellose Sodium 60g 25.6%

[0088] Hypromellose 5g 2.1%

[0089] Silica 3g 1.3%

[0090] Magnesium Stearate 1g 0.4%

[0091] Aspartame 2.8g 1.2%

[0092] Flavor 2.5g 1.1%

[0093] Febuxostat dispersible tablets are prepared through the following steps:

[0094] The first step: pulverize febuxostat with airflow, and control the average particle size below 30 μm;

[0095] Step 2: Weigh the main ingredient febuxostat and auxiliary materials according to the prescription amount, including microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, aspirin Pass through a 100-mesh sieve for Patan and essence, and set aside;

[0096] Step 3: Mix the sieved part of the disintegrant, 57g of croscarmellose sodium (this part of the disintegrant accoun...

Embodiment 2

[0104] 1000 febuxostat dispersible tablets (specification 80mg) contain the following components:

[0105] Febuxostat 80g 18.3%

[0106] Lactose 230g 52.8%

[0107] Cross-linked polyvinylpyrrolidone 100g 23.0%

[0108] Hypromellose 8g 1.8%

[0109] Silica 6.2g 1.3%

[0110] Magnesium Stearate 2.3g 0.4%

[0111] Aspartame 6g 1.2%

[0112] Flavor 5.5g 1.1%

[0113] Febuxostat dispersible tablets are prepared through the following steps:

[0114] The first step: pulverize febuxostat with airflow, and control the average particle size below 30 μm;

[0115] Step 2: Weigh the main ingredient febuxostat and auxiliary materials according to the prescription amount, including lactose, cross-linked polyvinylpyrrolidone, hypromellose, silicon dioxide, magnesium stearate, aspartame and essence, Pass through a 100-mesh sieve and set aside;

[0116] Step 3: Mix the sieved part of the disintegrant, 50 g of cross-linked polyvinylpyrrolidone (this part of the disintegrant accounts for...

Embodiment 3

[0124] 1000 febuxostat dispersible tablets (specification 40mg) contain the following components:

[0125] Febuxostat 40g 21.7%

[0126] Lactose 90g 48.9%

[0127] Cross-linked polyvinylpyrrolidone 22g 12.0%

[0128] Low-substituted hydroxypropyl cellulose 18g 9.8%

[0129] Hypromellose 3.5g 1.9%

[0130] Silica 2.5g 1.4%

[0131] Magnesium Stearate 2g 1.1%

[0132] Aspartame 3.2g 1.7%

[0133] Flavor 2.8g 1.5%

[0134] Febuxostat dispersible tablets are prepared through the following steps:

[0135] The first step: pulverize febuxostat with airflow, and control the average particle size below 30 μm;

[0136] Step 2: Weigh the main ingredient febux and auxiliary materials according to the prescription amount, including microcrystalline cellulose, cross-linked polyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, silicon dioxide, magnesium stearate, asper Tan and essence are passed through a 100-mesh sieve respectively, and set aside;

[0137] The third step:...

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Abstract

The invention relates to a febuxostat dispersible tablet and a preparation method thereof. The febuxostat dispersible tablet comprises febuxostat as a main material and a diluent, a disintegrant, a binder, a flow aid, a lubricant and other assistants as auxiliary materials, wherein the flow aid is silicone dioxide, and the lubricant is magnesium stearate. The febuxostat dispersible tablet is prepared from the following components in percentage by weight: 5-30% of the febuxostat, 20-80% of the diluent, 5-30% of the disintegrant, 0.1-5% of the binder, 1-10% of the silicone dioxide, 0.2-5% of the magnesium stearate and 2-8% of other assistants. The febuxostat dispersible tablet prepared by adding a proper amount of auxiliary materials into crushed febuxostat has the advantages of rapid and complete drug dissolution and stable quality, is suitable for long-term storage and convenient to use, and the bioavailability of human bodies on drugs is increased so as to increase curative effect.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a febuxostat dispersible tablet and a preparation method thereof. Background technique [0002] Hyperuricemia (hyperuricaeia) is a state in which the blood uric acid concentration exceeds the normal range (>0.42mmol / L) due to excessive uric acid production and / or decreased uric acid excretion due to metabolic disorders of purine substances. It is a state that leads to gout ( gout) is the immediate cause. Purine in the human body mainly exists in the form of purine nucleotides, which play a very important role in energy supply, metabolic regulation and composition of coenzymes. Purine undergoes a series of metabolic changes, eventually forming uric acid. 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 ...

Claims

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Application Information

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IPC IPC(8): A61K47/12A61K31/426A61K47/04A61K9/20A61P19/06
Inventor 王克艳乔德水高雪芹
Owner JIANGSU WANBANG BIOPHARMLS
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