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Etoricoxib Tablets and Its Optimization Method

An optimization method, the technology of etoricoxib, which is applied to the digestive system, pharmaceutical formulations, inorganic non-active ingredients, etc., can solve the problems of large weight differences of etoricoxib tablets, achieve the effect of low weight difference and ensure uniformity

Active Publication Date: 2022-03-11
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 difference in tablet weight. All have been investigated, and the fluidity of the material before tableting has not been studied, so the tablet weight of etoricoxib tablets obtained varies greatly

Method used

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  • Etoricoxib Tablets and Its Optimization Method
  • Etoricoxib Tablets and Its Optimization Method
  • Etoricoxib Tablets and Its Optimization Method

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 into tablets to obtain etoricoxib tablets, and perform in vitro dissolution performance test for etoricoxib tablets.

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Abstract

The invention relates to an optimization method of etoricoxib tablets, the steps are as follows: after uniformly mixing etoricoxib, calcium hydrogen phosphate anhydrous, internally added microcrystalline cellulose, disintegrant and internally added lubricant, dry granulation, Obtain granule products; mix granule products, external microcrystalline cellulose and external lubricant to obtain a mixture; take a small amount of mixture for fluidity index test, if the test results meet the requirements, go to the next step, otherwise readjust the formula until the test results meet the requirements Requirements: Tablets are obtained by compressing the mixture, and etoricoxib tablets are obtained after coating with coating materials; the in vitro dissolution performance test is performed on the tablets before coating. This optimization method effectively controls the fluidity of the material before tablet compression, so that the tablet weight variance 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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Patent Type & Authority Patents(China)
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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