Etoricoxib tablets and optimization method thereof

An optimization method, etoricoxib technology, is applied in the digestive system, pharmaceutical formulations, medical preparations of non-active ingredients, etc., and can solve the problems of large weight differences of etoricoxib tablets, achieving low weight differences and ensuring uniformity sexual effect

Active Publication Date: 2020-07-17
Yung Shin Pharm Ind (Kunshan) Co Ltd
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the production process of etoricoxib tablets, the fluidity of the material before compression is a key indicator that affects the operability of large-scale production and the diffe...

Method used

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  • Etoricoxib tablets and optimization method thereof
  • Etoricoxib tablets and optimization method thereof
  • Etoricoxib tablets and optimization method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Table 1: Formula table of embodiment 1

[0029]

[0030] Preparation method: mix etoricoxib and anhydrous calcium hydrogen phosphate in the prescribed amount, add croscarmellose sodium in the prescribed amount and mix, add microcrystalline cellulose 1 and mix, add magnesium stearate 1 and mix, dry After legal granulation, add microcrystalline cellulose 2 for mixing, add magnesium stearate 2 for mixing; sample for fluidity test;

Embodiment 2

[0032] Table 2: Example 2 formula table

[0033]

[0034] Preparation method: mix etoricoxib and anhydrous calcium hydrogen phosphate in the prescribed amount, add croscarmellose sodium in the prescribed amount and mix, add microcrystalline cellulose 1 and mix, add magnesium stearate 1 and mix, dry After legal granulation, add microcrystalline cellulose 2 and mix, add magnesium stearate 2 and mix, sample for fluidity test; then press tablet to get etoricoxib tablet, etoricoxib tablet is subjected to in vitro dissolution performance test.

Embodiment 3

[0036] Table 3: Example 3 formula table

[0037]

[0038]Preparation method: mix etoricoxib and anhydrous calcium hydrogen phosphate in the prescribed amount, add croscarmellose sodium in the prescribed amount and mix, add microcrystalline cellulose 1 and mix, add magnesium stearate 1 and mix, dry After legal granulation, add microcrystalline cellulose 2 and mix, add magnesium stearate 2 and mix, sample for fluidity test; then press tablet to get etoricoxib tablet, etoricoxib tablet is subjected to in vitro dissolution performance test.

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PUM

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Abstract

The invention relates to an optimization method of etoricoxib tablets. The method comprises the following steps: uniformly mixing etoricoxib, anhydrous calcium hydrophosphate, internally added microcrystalline cellulose, a disintegrating agent and an internally added lubricant, and carrying out dry granulation to obtain a particle product; uniformly mixing the particle product, external microcrystalline cellulose and an external lubricant to obtain a mixture; taking a small amount of the mixture, carrying out fluidity index test, if the test result meets the requirement, entering the next step, otherwise, readjusting the formula until the test result meets the requirement; and tabletting the mixture to obtain tablets, and coating the tablets with a coating material to obtain the etoricoxibtablets, wherein the tablets are subjected to in-vitro dissolution performance test before coating. The optimization method effectively controls the fluidity of the materials before tabletting, so that the weight difference of the tablets is lower.

Description

technical field [0001] The invention relates to a medicine for treating arthritis, in particular to an etoricoxib tablet and an optimization method thereof. Background technique [0002] Etoricoxib (etoricoxib) is a highly selective cyclooxygenase 2 (COX-2) inhibitor, chemical name: 5-chloro-2-(6-methylpyridin-3-yl)–3-(4 -methylsulfonylphenyl)pyridine. It went on the market in Mexico in March 2002, and in the UK in April 2002. The dosage form on the market is a film-coated tablet. It is clinically used for the treatment of osteoarthritis, rheumatoid arthritis, acute gouty arthritis, dental surgery related to acute pain, primary dysmenorrhea and chronic musculoskeletal pain, and chronic low back pain. In the production process of etoricoxib tablets, the fluidity of the material before compression is a key indicator that affects the operability of large-scale production and the difference in tablet weight. All have been investigated, and the fluidity of the material before ...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K9/20A61K47/02A61K47/38A61K31/444A61P29/00A61P19/02A61P19/06A61P1/02A61P15/00A61P21/00
CPCA61K9/2054A61K9/2013A61K9/2095A61K9/2009A61K9/2806A61K31/444A61P29/00A61P19/02A61P19/06A61P1/02A61P15/00A61P21/00
Inventor 萧嘉伟许姣姣王涛吕伟毅刘佳王清平孙雪琴董德勤简忠民吴苗李芳全
Owner Yung Shin Pharm Ind (Kunshan) Co Ltd
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