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Etoricoxib tablets and preparation method thereof

A technology for etoricoxib and oxic tablets, applied in the field of etoricoxib tablets and their preparation, can solve the problems of reduced particle solubility and/or stability, reduced drug dissolution, and influence on preparation disintegration aging, and achieves avoiding solubility and stability. Reduced drug properties, optimize disintegration and dissolution properties, and avoid the effects of drug dissolution reduction

Active Publication Date: 2020-02-28
HARBIN ZHENBAO PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] During the wet granulation process of etoricoxib tablets, contact with water accelerates the conversion rate of API from anhydrous crystal form to hemihydrate crystal form, which may eventually lead to a decrease in the solubility and / or stability of the granules. In order to solve the above problems, now Some parts are prepared by direct compression method, but the direct compression method can lead to different hardness of the tablet, affect the disintegration time of the preparation, and lead to the problem of reduced drug dissolution

Method used

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  • Etoricoxib tablets and preparation method thereof
  • Etoricoxib tablets and preparation method thereof

Examples

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preparation example Construction

[0025] Specifically, the preparation method includes:

[0026] S1. Mix etoricoxib, microcrystalline cellulose, disintegrant and part of lubricant, and dry granulate to obtain granule product.

[0027] Specifically, step S1 includes:

[0028] S1.1 Prepare the raw materials according to the required ratio.

[0029] Among them, in order to facilitate the subsequent preparation and ensure the uniformity of mixing, optionally, the particle size of etoricoxib does not exceed 30 mesh, the particle size of anhydrous calcium hydrogen phosphate does not exceed 30 mesh, and the particle size of disintegrant does not exceed 30 mesh. mesh, and the particle size of the lubricant does not exceed 120 mesh.

[0030] If the particle size of the raw material does not meet the above requirements, the raw material should be sieved first to obtain the undersize material that meets the target particle size, and the undersize material of each raw material should be prepared according to the require...

Embodiment 1

[0060] An etoricoxib tablet, in terms of mass percentage, comprising: etoricoxib 24.58%, microcrystalline cellulose 35.24%, anhydrous calcium hydrogen phosphate 28.57%, disintegrant 1.9%, lubricant 0.95%, and coating Materials 8.76%.

[0061] Etoricoxib tablets are prepared by the following methods:

[0062] Mix etoricoxib with a particle size of not more than 30 mesh, microcrystalline cellulose with a particle size of not more than 30 mesh, croscarmellose sodium with a particle size of not more than 30 mesh and some magnesium stearate with a particle size of not more than 120 mesh , dry granulation, granulation, to obtain granular products with a particle size of no more than 20 mesh.

[0063] Mix the granular product, the rest of magnesium stearate and anhydrous calcium hydrogen phosphate with a particle size not exceeding 120 meshes, press into tablets, and coat with a coating material to obtain etoricoxib tablets.

[0064] Wherein, the microcrystalline cellulose is micro...

Embodiment 2

[0066] An etoricoxib tablet, in terms of mass percentage, comprising: etoricoxib 36.50%, microcrystalline cellulose 21.35%, anhydrous calcium hydrogen phosphate 28.99%, disintegrant 3%, lubricant 1.14%, and coating Materials 9.02%.

[0067] The preparation method of etoricoxib tablets is the same as in Example 1.

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Abstract

The invention discloses etoricoxib tablets and a preparation method thereof and relates to the field of pharmacy. Raw materials of the etoricoxib tablets include etoricoxib, microcrystalline cellulose, anhydrous calcium hydrogen phosphate, a disintegrant, a lubricant and a coating material. The preparation method includes: mixing etoricoxib, microcrystalline cellulose, disintegrant and part of lubricant, and granulating through a dry process to obtain a granular product; mixing the granular product, the balance of the lubricant and anhydrous calcium hydrogen phosphate, tabletting, and coatingwith a coating material to obtain the etoricoxib tablets. Through the preparation method, disintegration performance and dissolution performance are optimized effectively, and disintegration and dissolution are accelerated; by reasonably optimizing proportion of raw materials, efficacy of the etoricoxib tablets is ensured while the disintegration performance and the dissolution performance are further optimized.

Description

technical field [0001] The application relates to the field of pharmacy, in particular to an etoricoxib tablet and a preparation method thereof. Background technique [0002] During the wet granulation process of etoricoxib tablets, contact with water accelerates the conversion rate of API from anhydrous crystal form to hemihydrate crystal form, which may eventually lead to a decrease in the solubility and / or stability of the granules. In order to solve the above problems, now Some parts are prepared by direct compression method, but the direct compression method can lead to different hardness of the tablet, affect the disintegration time of the preparation, and lead to the problem of reduced drug dissolution. Contents of the invention [0003] The present application provides an etoricoxib tablet and a preparation method thereof to improve the above problems. [0004] The preparation method of etoricoxib tablets according to the embodiment of the first aspect of the pres...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/444A61K47/38A61K47/02
CPCA61K31/444A61K9/2054A61K9/2009A61K9/2866
Inventor 方同华王喜军许国徽朱婷
Owner HARBIN ZHENBAO PHARMA
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