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Agomelatine-containing dispersible tablet and preparation method thereof

A technology of agomelatine and dispersible tablets, applied in the field of medicine, can solve the problems of poor tolerance, slow onset of action, and high recurrence rate

Inactive Publication Date: 2017-01-18
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Antidepressant drugs have experienced the development and changes of MOAI, TCA, SSRI and SNRI, all of which are based on the monoamine hypothesis and have positive curative effects, but due to the slow onset of effect, low, high relapse rate and poor tolerance and other issues are far from satisfactory

Method used

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  • Agomelatine-containing dispersible tablet and preparation method thereof
  • Agomelatine-containing dispersible tablet and preparation method thereof
  • Agomelatine-containing dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] prescription composition

[0024]

[0025] Dissolution comparison

[0026]

[0027] Mix agomelatine, lactose monohydrate, and cornstarch through a 80-mesh sieve evenly, use the alcoholic water solution of PVP K30 as a binder, make a soft material, pass through a 30-mesh sieve to granulate, and dry in an oven at 50°C to 3.0% moisture , 30-mesh sieve granulation, according to the yield calculation of additional materials, tableting. The determination of dispersion uniformity is qualified. According to the imported quality standard, the dissolution curve of the sample in 0.01M HCL and water medium is measured. Compared with the original preparation, the f2 factor is less than 50, which is unqualified.

Embodiment 2

[0029] prescription composition

[0030] .

[0031] Dissolution comparison

[0032]

[0033] Mix agomelatine, lactose monohydrate, and cornstarch through a 80-mesh sieve evenly, use the alcoholic water solution of PVP K30 as a binder, make a soft material, pass through a 30-mesh sieve to granulate, and dry in an oven at 50°C to 3.0% moisture , 30-mesh sieve granulation, according to the yield calculation of additional materials, tableting. The determination of dispersion uniformity is qualified. According to the imported quality standard, the dissolution curve of the sample in 0.01M HCL and water medium is measured. Compared with the original preparation, the f2 factor is less than 50, which is unqualified.

Embodiment 3

[0035] prescription composition

[0036]

[0037] Dissolution comparison

[0038]

[0039] Mix agomelatine, lactose monohydrate, and cornstarch through a 80-mesh sieve evenly, use the alcoholic water solution of PVP K30 as a binder, make a soft material, pass through a 30-mesh sieve to granulate, and dry in an oven at 50°C to 3.0% moisture , 30-mesh sieve granulation, according to the yield calculation of additional materials, tableting. The determination of dispersion uniformity is qualified. According to the imported quality standard, the dissolution curve of the sample in 0.01M HCL, water, pH4.5 and pH6.8 phosphate buffer medium is measured. Compared with the original preparation, the f2 factor is less than 50, which is unqualified.

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PUM

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Abstract

The invention discloses a preparation method of an agomelatine-containing dispersible tablet. The dispersible tablet contains agomelatine and other pharmaceutically acceptable auxiliary materials, and is prepared by a wet granulation technology; the aim of reducing the dissolving speed to a speed consistent with that of an original triturate is fulfilled by adjusting the use amounts and the adding mode of the functional auxiliary materials, and the probability of bioequivalence is increased.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a agomelatine dispersible tablet and a preparation method thereof. The dissolution curve of the preparation is consistent with that of the original preparation. Background technique [0002] Depression is a common degenerative disease characterized by high incidence, high recurrence and high disability, which imposes a heavy burden on individual patients and society. According to the survey conducted by WHO in 2004, the lifetime prevalence rate of depression in the world reached 14%. By 2020, depression will become the second largest source of disease burden after coronary heart disease. Antidepressant drugs have experienced the development and changes of MOAI, TCA, SSRI and SNRI, all of which are based on the monoamine hypothesis and have positive curative effects, but due to the slow onset of effect, low, high relapse rate and poor tolerance and other issues are ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/36A61K47/32A61K47/26A61K47/12A61K47/04A61K31/165A61P25/24A61P25/22A61P25/20
CPCA61K9/2009A61K9/2013A61K9/2018A61K9/2027A61K9/2059A61K31/165
Inventor 王寅洁马莉
Owner AVENTIS PHARMA HAINAN