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A kind of febuxostat tablet and its preparation process

A febuxostat and tablet technology, applied in the field of febuxostat tablets and their preparation, can solve the problems of unsatisfactory drug hardness and friability, affecting drug taking, drug wear and the like, and improving bioavailability The effect of increasing the disintegration speed and improving the smoothness

Active Publication Date: 2020-12-08
GUANGDONG YILI LUODING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] At present, the existing technology is mainly aimed at the research of tablet stability and dissolution rate, but conventional drug tablets also have requirements for hardness and friability, and the hardness and friability of the drug do not meet the requirements, which will cause the drug to break down during transportation. wear or tear that interferes with the administration of the medicine

Method used

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  • A kind of febuxostat tablet and its preparation process
  • A kind of febuxostat tablet and its preparation process
  • A kind of febuxostat tablet and its preparation process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] A kind of febuxostat tablet of embodiment 1

[0062] Contains the following components:

[0063]

[0064]

[0065] Preparation method: comprising the following steps:

[0066] (1) Preparation of adhesive: dissolve the adhesive of the formula dosage in purified water, stir and dissolve, configure into an aqueous solution, and set aside;

[0067] (2) Preparation of drug mixture: Febuxostat, filler, disintegrating agent and synergist in the formula dosage are added into the high-speed mixing granulator, the stirring speed is 20Hz, the cutting speed is 200Hz, and the mixing time is 7min. Prepare the mixture;

[0068] (3) Preparation of soft materials: Add the adhesive solution obtained in step (1) into the mixture prepared in step (2) and fully stir and mix. The stirring speed is 20Hz, the cutting speed is 20Hz, and the adding time of the adhesive is For 1.5min, the mixing time is 7min to obtain soft material;

[0069] (4) Granulation: granulate the soft material ...

Embodiment 2

[0072] A kind of febuxostat tablet of embodiment 2

[0073] Contains the following components:

[0074]

[0075]

[0076] Preparation method: comprising the following steps:

[0077] (1) Preparation of adhesive: dissolve the adhesive of the formula dosage in purified water, stir and dissolve, configure into an aqueous solution, and set aside;

[0078] (2) Preparation of drug mixture: Febuxostat, filler, disintegrant and synergist in the formula dosage are added into the high-speed mixing granulator with a stirring speed of 40Hz, a cutting speed of 40Hz, and a mixing time of 3min. Prepare the mixture;

[0079] (3) Preparation of soft materials: Add the adhesive solution obtained in step (1) into the mixture prepared in step (2) and fully stir and mix. The stirring speed is 40Hz, the cutting speed is 40Hz, and the adding time of the adhesive is For 2min, the mixing time is 4min to obtain a soft material;

[0080] (4) Granulation: granulate the soft material obtained in...

Embodiment 3

[0083] A kind of febuxostat tablet of embodiment 3

[0084] Contains the following components:

[0085]

[0086] Preparation method: comprising the following steps:

[0087] (1) Preparation of adhesive: dissolve the adhesive of the formula dosage in purified water, stir and dissolve, configure into an aqueous solution, and set aside;

[0088] (2) Preparation of drug mixture: Febuxostat, filler, disintegrant and synergist in the formula dosage were added into the high-speed mixing granulator and the stirring speed was 30Hz, the cutting speed was 30Hz, and the mixing time was 5min. Prepare the mixture;

[0089] (3) Preparation of soft materials: Add the adhesive solution obtained in step (1) into the mixture prepared in step (2) and fully stir and mix. The stirring speed is 30Hz, the cutting speed is 30Hz, and the adding time of the adhesive is Be 1.8min, mixing time is 6min, obtains soft material;

[0090] (4) Granulation: granulate the soft material obtained in step (3)...

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Abstract

The invention provides a febuxostat tablet and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. The tablet comprises 10-25 parts of febuxostat, 20-60 parts of a filler, 5-15 parts of a disintegrant, 5-10 parts of an adhesive, 1-5 parts of a lubricant, 1-3 parts of a glidant and 0.1-1 part of a synergist. In the implementation process, the specific parts of the filler and the adhesive are controlled, and the mass ratio of various components is controlled, so that the dissolution rate of the tablet is obviously improved. In the implementation process of the invention, the invention unexpectedly finds that when the mass ratio of the lubricant to the glidant is controlled to be (0.5-5):1, the smoothness of the tablet can be effectively improved,so that the obtained tablet has higher hardness and brittleness. The synergist is also added into the components disclosed by the invention, so that the stability of the tablet is obviously improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a febuxostat tablet and a preparation method thereof. Background technique [0002] Febuxostat, whose chemical name is 2-[(3-cyano-4-isobutoxy)phenyl]-4-methyl-5-thiazolecarboxylic acid, is a xanthine oxidase (XO) inhibitor , for the long-term treatment of hyperuricemia with gout symptoms. [0003] Its structural formula is as follows: [0004] [0005] Gout is a crystal-associated arthropathy caused by deposition of monosodium urate (MSU), which is directly related to hyperuricemia caused by purine metabolic disorders and / or decreased uric acid excretion, and belongs to the category of metabolic rheumatic diseases. Gout can be complicated by kidney disease. In severe cases, joint damage and renal function damage can occur. It is often accompanied by hyperlipidemia, hypertension, diabetes, arteriosclerosis and coronary heart disease. [0006]...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K31/426A61K47/12A61K47/02A61K47/04A61K47/22A61K47/36A61K47/26A61K47/38A61P19/06
CPCA61K9/2009A61K9/2013A61K9/2018A61K9/205A61K9/2054A61K9/2059A61K9/2866A61K31/426A61P19/06
Inventor 曾胜黄信张坤梁烽焱张永谦程燕梁志军
Owner GUANGDONG YILI LUODING PHARMA
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