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A febuxostat and tablet technology, applied in the field of medicine, can solve the problems of high fluidized bed granulation requirements, complex preparation process, and addition of surfactants, etc., to improve bioavailability, easy to obtain auxiliary materials, and promote full disintegration effect
Active Publication Date: 2013-11-20
SICHUAN EMEISHAN PHARMA
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Problems solved by technology
CN101152142A adopts febuxostat and polyethylene glycol spray drying technology, the whole preparation process requires two granulations, the preparation process is more complicated, and the stability of the preparation is not investigated
In CN101862326A, the surfactant represented by Tween 80 generally has toxic and side effects, and its lipophilic components include unsaturated fatty acids, which are very easy to be oxidized and degraded to produce more toxic components
[0010] The fluidized bed granulation adopted by CN102018705A has relatively high requirements on materials, complex process, and many influencing factors in the preparation process, so it is not the best
Method used
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[0029] For the foregoing embodiments, a method for preparing febuxostat tablets is also provided, including:
[0030] Weigh Febuxostat, fillers, disintegrants, binders, lubricants, and wetting agents;
[0031] Blending the febuxostat, the filler, the disintegrant, and the binder to obtain a first mixture, which is crushed;
[0032] For the first filtration, the fineness of the first filtration is 80-200 mesh;
[0033] Adding a wetting agent to the first mixture after the first filtration;
[0034] Filter and granulate for the second time to obtain wet granules;
[0035] Dry to obtain dry particles;
[0036] Sieve and filter the dry particles;
[0037] Adding a disintegrant and a lubricant to the dry particles obtained after sieving, and blending to obtain a second mixture;
[0038] The second mixture is compressed according to the set tablet weight, and the compressed tablets are coated.
[0039] In the preparation, febuxostat is mixed with fillers, disintegrants, binders, etc. and then co-p...
Example
[0046] Example 2: In parts by weight, 10 parts febuxostat, 40 parts filler, 5 parts disintegrant, 1 part binder, 1 part lubricant, and appropriate amount of wetting agent.
Example
[0047] Example 3: In parts by weight, 20 parts febuxostat, 80 parts filler, 15 parts disintegrant, 10 parts binder, 3 parts lubricant, and appropriate amount of wetting agent.
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Abstract
The invention relates to the field of medicine, and especially relates to a febuxostat tablet and a preparation method thereof. The core tablet of the febuxostat tablet is composed of following raw materials in parts by weight: 5 to 30 parts of febuxostat, 30 to 90 parts of stuffing agent, 2 to 20 parts of disintegrating agent, 0.5 to 15 parts of adhesive, 0.5 to 5 parts of lubricant and a right amount of wetting agent. The preparation method comprises following steps: weighing, mixing the febuxostat, stuffing agent, disintegrating agent and adhesive together, then grinding the mixture, filtering for two times, granulating, drying, filtering the dry particles, then adding the disintegrating agent and lubricant to mix with the dry particles, pressing into tablets, and finally coating. The febuxostat tablet promotes the dissolution of the febuxostat and improves the biological utilization, the components of the formula are few, extra surfactant is not needed to assist the dissolution, the auxiliary materials are available, and the technology is simple and operable.
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] Febuxostat, originally translated as febuxostat, is a new type of non-purine selective xanthine oxidase inhibitor, developed by Japan Teijin Company, registered in the EU for the first time in 2008, with a specification of 80 mg and 120 mg; first launched in the United States in March 2009, with specifications of 40 mg and 80 mg. It is clinically used to treat hyperuricemia. Its structure is as follows: [0003] [0004] Chemical name: 2-(3-cyano-4-isobutoxy)phenyl-4-methyl-5-thiazolecarboxylic acid. [0005] Febuxostat is white to off-white crystal or crystalline powder. This product is easily soluble in dimethylformamide, soluble in dimethyl sulfoxide, slightly soluble in ethanol, methanol and acetonitrile, and insoluble in water. [0006] There are many documents about the preparation technology ...
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