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Orally disintegrating tablet containing topiroxostat and preparation method of orally disintegrating tablet

A technology of oral disintegrating tablet and topirastat, which is applied in the field of pharmaceutical preparations, can solve problems such as adverse reactions, and achieve the effects of enhancing solubility, fast onset of action and improving compliance.

Inactive Publication Date: 2017-06-23
PEKING UNIV FOUNDER GRP CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, in the treatment of allopurinol, repeated high-dose administration is required to maintain a high drug level, which also brings serious or even fatal adverse reactions due to drug accumulation.

Method used

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  • Orally disintegrating tablet containing topiroxostat and preparation method of orally disintegrating tablet
  • Orally disintegrating tablet containing topiroxostat and preparation method of orally disintegrating tablet
  • Orally disintegrating tablet containing topiroxostat and preparation method of orally disintegrating tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026]

[0027]

[0028] Preparation Process:

[0029] (1) co-micronizing the topicastat and mannitol in proportion;

[0030] (2) Topicastat and mannitol, microcrystalline cellulose, sodium carboxymethyl starch are mixed homogeneously in mixer with prescription quantity;

[0031] (3) Add 4% hydroxypropyl cellulose aqueous solution to the above mixture to make wet soft material, and granulate;

[0032] (4) The above-mentioned granules are dried until the water content is less than 3%. After the granules are sized, the dosages of magnesium stearate, peppermint essence and aspartame are converted and mixed evenly with the dried granules;

[0033] (5) Measure the particle content after total blending, convert the tablet weight, and control the hardness to 3-5kgf for tableting. Prepared in 1000 tablets.

Embodiment 2

[0035]

[0036] Preparation Process:

[0037] (1) co-micronizing topinostat and lactose in proportion;

[0038] (2) the topicastat of prescription quantity is mixed with lactose, microcrystalline cellulose, sodium carboxymethyl starch in mixer;

[0039] (3) Add 4% hydroxypropyl cellulose aqueous solution to the above mixture to make wet soft material, and granulate;

[0040] (4) The above-mentioned granules are dried until the water content is less than 3%. After the granules are sized, the dosages of magnesium stearate, peppermint essence and aspartame are converted and mixed evenly with the dried granules;

[0041] (5) Measure the particle content after total blending, convert the tablet weight, and control the hardness to 3-5kgf for tableting. Prepared in 1000 tablets.

Embodiment 3

[0043]

[0044]

[0045] Preparation Process:

[0046] (1) co-micronizing topinostat and lactose in proportion;

[0047] (2) Topicastat and lactose, mannitol, croscarmellose sodium are mixed homogeneously in the blender of prescription quantity;

[0048] (3) adding 3% povidone aqueous solution to the above-mentioned mixture to make wet and soft materials, and granulating;

[0049] (4) The above-mentioned granules are dried until the water content is less than 3%. After the granules are sized, the dosages of magnesium stearate, peppermint essence and aspartame are converted and mixed evenly with the dried granules;

[0050] (5) Measure the particle content after total blending, convert the tablet weight, and control the hardness to 3-5kgf for tableting. Prepared in 1000 tablets.

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PUM

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Abstract

The invention discloses an orally disintegrating tablet containing topiroxostat and a preparation method of the orally disintegrating tablet, belonging to the technical field of medicines. The orally disintegrating tablet contains opiroxostat, a hydrotropic filler, a water-soluble adhesive, a disintegrating agent, a lubricant, a corrigent, and the like, the preparation process is simple, the taking is convenient, the effects are rapid, the time for reaching the peak is short, and the curative effects are obvious.

Description

technical field [0001] The invention relates to a rapidly disintegrating orally disintegrating tablet whose active ingredient is topicastat and a method for producing the dosage form, belonging to the field of pharmaceutical preparations. Background technique [0002] With the development of society and the change of diet structure, the incidence of gout presents an increasing trend. The research on gout in China originated in the 1950s. In 1948, Chen Yueshu reported two cases of gout for the first time. Only 25 cases were reported in the literature before 1958. In 2004, the prevalence rate in Shandong coastal areas was 1.14% (increased by 3 times in the past 10 years). Taiwan Province is a province with a high incidence of gout, and the prevalence rate of gout in indigenous residents over the age of 18 is 11.70%. Gout is also a concern in other developing countries. A survey of rheumatic diseases in Africa shows that the prevalence of gout is increasing across Africa. ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4439A61P19/06
CPCA61K9/0056A61K9/2013A61K31/4439
Inventor 易崇勤王海超冀蕾
Owner PEKING UNIV FOUNDER GRP CO LTD
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