Tablets containing Apremilast active ingredients and vitro dissolution determination method thereof

A method of determination, technology of tablets, applied in the field of medicine

Inactive Publication Date: 2015-10-28
NANJING HEALTHNICE MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The patent describes the dissolution behavior of the product in solutions containing Tween or SLS at different concentrations, but the patent focuses on the dissolution method for controlled-release preparations, not for immediate-release samples

Method used

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  • Tablets containing Apremilast active ingredients and vitro dissolution determination method thereof
  • Tablets containing Apremilast active ingredients and vitro dissolution determination method thereof
  • Tablets containing Apremilast active ingredients and vitro dissolution determination method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Tablet prescription (1000 formulation units):

[0048]

[0049]

[0050] Preparation process (dry granulation and tabletting)

[0051] (1) Processing of raw and auxiliary materials: pass Apremilast, lactose, microcrystalline cellulose, and croscarmellose sodium through an 80-mesh sieve, and set aside.

[0052] (2) Mixing: Put Apremilast, lactose, microcrystalline cellulose and croscarmellose sodium in a high-speed mixing granulator, adjust the rotating speed to 150-200rpm, and mix for 15 minutes.

[0053] (3) Dry granulation: Put the mixed powder in a dry granulator, adjust the roller pressure to 2.0-4.0MPa, the roller speed to 10-15rpm, the cutter speed to 10-15rpm, and use a 20-30 mesh sieve for granulation , 20-30 mesh sieve for granulation.

[0054] (4) Total blending: Calculate the yield of granules after dry granulation, and then add converted lubricants and other additional auxiliary materials to the granules and mix evenly.

[0055] (5) Intermediate inspe...

Embodiment 2

[0059] Tablet prescription (1000 formulation units):

[0060]

[0061] Preparation process (dry granulation and tabletting)

[0062] (1) Processing of raw and auxiliary materials: pass Apremilast, lactose, microcrystalline cellulose, and croscarmellose sodium through an 80-mesh sieve, and set aside.

[0063] (2) Mixing: Put Apremilast, lactose, microcrystalline cellulose and croscarmellose sodium in a high-speed mixing granulator, adjust the rotating speed to 150-200rpm, and mix for 15 minutes.

[0064] (3) Dry granulation: Put the mixed powder in a dry granulator, adjust the roller pressure to 2.0-4.0MPa, the roller speed to 10-15rpm, the cutter speed to 10-15rpm, and use a 20-30 mesh sieve for granulation , 20-30 mesh sieve for granulation.

[0065] (4) Total blending: Calculate the yield of granules after dry granulation, and then add the converted lubricant and other external auxiliary materials to the granules and mix evenly.

[0066] (5) Intermediate inspection [co...

Embodiment 3

[0070] Tablet prescription (1000 formulation units):

[0071]

[0072] Preparation process (dry granulation and tabletting)

[0073] (1) Processing of raw and auxiliary materials: pass Apremilast, lactose, microcrystalline cellulose, and croscarmellose sodium through an 80-mesh sieve, and set aside.

[0074] (2) Mixing: Put Apremilast, lactose, microcrystalline cellulose and croscarmellose sodium in a high-speed mixing granulator, adjust the rotating speed to 150-200rpm, and mix for 15 minutes.

[0075] (3) Dry granulation: put the mixed powder in a dry granulator, adjust the roller pressure to 2.0-4.0MPa, the roller speed to 10-15rpm, the cutter speed to 10-15rpm, and use a 30-mesh sieve for granulation. Mesh sieve for whole grains.

[0076] (4) Total blending: Calculate the yield of granules after dry granulation, and then add converted lubricants and other additional auxiliary materials to the granules and mix evenly.

[0077] (5) Intermediate inspection [content, moi...

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Abstract

The invention discloses a dissolution method of tablets containing (+)-1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl) ethylamine N-acetyl-L-leucine salt. According to the technical scheme, a lauryl sodium sulfate aqueous solution with the concentration being 0.1%-1.0% is used as dissolution media, the dissolution temperature is 37 DEG C, a paddle method is used by 50-75 r/min, ultraviolet spectrophotometry is adopted, and the absorption degree is determined at 230 nm. Through the method, the dissolution behavior and the preparation mass of a reaction preparation can be reflected objectively. Meanwhile, the invention discloses a preparation technology of the tablets. The preparation technology includes the steps of sieving, mixing, dry granulating, total blending, tabletting, coating and packaging for being put in storage. The sticking problem of the tablets and the problem of being poor in content uniformity in the production process can be well solved.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a tablet dissolution test method with phosphodiesterase-4 (PDE-4) inhibitory effect. Background technique: [0002] Psoriasis, commonly known as psoriasis, is a chronic inflammatory skin disease with a long course of disease and a tendency to relapse, and some cases are almost unhealed throughout life. Psoriasis can be found all over the world, the highest prevalence in Europe is Denmark (2.9%) and the Faroe Islands (2.8%), and the average prevalence in Northern Europe is about 2%. The prevalence of psoriasis in the United States based on the demographic survey is between 2.2% and 2.6%, and there are about 150,000 newly diagnosed cases every year. The prevalence of psoriasis in Asia is low, with a prevalence of about 0.3% in demographic surveys. [0003] Apremilast is a small molecule phosphodiesterase 4 (PDE4) inhibitor that has specific effects on cyclic adenosi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/33A61K9/28A61K31/4035A61P17/06
CPCG01N33/15
Inventor 石文晶王华娟
Owner NANJING HEALTHNICE MEDICAL TECH
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