Azilsartan dispersible tablet and preparation process thereof

A technology of dispersible tablets and tablet compression, which is applied to medical preparations containing non-active ingredients, medical preparations containing active ingredients, and organic active ingredients. It can solve the problems of low dissolution and low water solubility, and achieve stable quality. The effect of uniform content and simple process

Inactive Publication Date: 2020-09-04
浙江诺得药业有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0011] Azilsartan is almost insoluble in 0.1mol / L hydrochloric acid and water, for the low water solubility of azilsartan, especially for the low dissolution problem of azilsartan in an acidic environment, the object of the present invention is to provide a Azilsartan dispersible tablet and preparation method thereof, the azilsartan can be dissolved quickly, the process is simple, and the quality is stable

Method used

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  • Azilsartan dispersible tablet and preparation process thereof
  • Azilsartan dispersible tablet and preparation process thereof
  • Azilsartan dispersible tablet and preparation process thereof

Examples

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Embodiment 1

[0037] Embodiment 1, the prescription that comparative example 1-3 adopts is as shown in table 1:

[0038] Table 1

[0039]

[0040] The preparation process of embodiment 1 is as follows:

[0041]Take micronized azilsartan raw material (D90 about 25 μm), dextrose binder, low-substituted hydroxypropyl cellulose, preheat in a fluidized bed to not lower than 30 ° C, and dissolve glycerin in 3% binder Hydroxypropyl cellulose solution, the binder solution is added to the fluidized bed for granulation. During the granulation process, the air inlet temperature is controlled at 50°C, and the material temperature is greater than 27°C. After adding the binder solution, continue to dry until the weight loss on drying is ≤2.0%. Turn on the granulator to sieve with a 0.6mm screen at 500rpm, then add 200g of microcrystalline cellulose and 562.5g of low-substituted hydroxypropyl cellulose and mix for 15 minutes , and then add magnesium stearate and mix for 5 minutes. 7mm round.

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Abstract

The invention provides an azilsartan dispersible tablet and a preparation process thereof. The preparation process comprises the following steps of mixing micronized azilsartan with a glucose bindingagent as a filling agent and partial disintegrating agent, performing wet-method granulation by adopting a stabilizer-added adhesive solution, then adding other fillers, the remaining disintegrating agent and a lubricant, and performing tabletting, wherein micronization of an azilsartan raw material is to more effectively increase the dissolution rate with the glucose binding agent together. For the azilsartan dispersible tablet and the preparation process, by using the glucose binding agent, the hydrophilicity of a drug is improved, so that the azilsartan dispersible tablet still has a relatively high dissolution rate under relatively high hardness, and the bioavailability is improved. Moreover, the process is simple and is suitable for industrial mass production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an azilsartan dispersible tablet and a preparation method thereof. Background technique [0002] Azilsartan (Azilsartan) is an angiotensin II receptor antagonist (ARB) antihypertensive drug developed by Takeda Pharmaceutical Company (Takeda), Japan, for the treatment of hypertension. [0003] Azilsartan chemical name: 2-ethoxy-1-[[2'-(4,5-dihydro-5-oxo-1,2,4-oxadiazol-3-yl)biphenyl- 4-yl]methyl]benzimidazole-7-carboxylic acid. CAS number: 147403-03-0. Its chemical structural formula is as follows: [0004] [0005] CN103933000A discloses an azilsartan tablet and a preparation method thereof, which contains micronized azilsartan, anhydrous lactose 21AN, anhydrous lactose 24AN, a disintegrant, and a lubricant, and is compressed by a direct tableting process . Due to the large difference between the particle size of the raw material and the particle size of lactose, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4245A61K47/26A61P9/12
CPCA61K31/4245A61K9/2018A61K9/2095A61P9/12
Inventor 胡海波殷学治
Owner 浙江诺得药业有限公司
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