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Escitalopram oxalate tablet composition and quality control method

A technology for escitalopram oxalate and citalopram tablets, which is applied in the field of medicine and can solve the problems such as the limitation of escitalopram oxalate or its preparations.

Active Publication Date: 2018-06-22
HUNAN DONGTING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Unfortunately, however, existing methods are limited in the quality control of escitalopram oxalate or its preparations such as tablets, especially its optical isomers.

Method used

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  • Escitalopram oxalate tablet composition and quality control method
  • Escitalopram oxalate tablet composition and quality control method
  • Escitalopram oxalate tablet composition and quality control method

Examples

Experimental program
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Effect test

preparation example 1

[0077] Preparation Example 1: Preparation of Escitalopram Oxalate Tablet Composition

[0078] formula:

[0079]

[0080] Preparation method: Escitalopram oxalate API particle size median particle size D (V, 0.5) = 105 μm. Pass escitalopram oxalate and talcum powder through a 30-mesh sieve, and mix evenly with microcrystalline cellulose and croscarmellose sodium in a single-arm mixing tank. Add magnesium stearate through a 30-mesh sieve, and continue mixing for 3 minutes, and compress with a rotary tablet machine.

preparation example 2

[0081] Preparation Example 2: Preparation of Escitalopram Oxalate Tablet Composition

[0082] formula:

[0083]

[0084] Preparation method: Escitalopram oxalate API particle size median particle size D (V, 0.5) = 11 μm. Premix escitalopram oxalate, lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, and croscarmellose sodium in a high-shear granulator, add purified water to granulate, and use a rotary The granulator is wet sized, and the wet granules are dried in a fluidized bed. After drying, the granules are dried with a rotary granulator to obtain dry granules. The dry granules are mixed evenly with magnesium stearate in a single-arm hopper mixer, and the rotary tabletting is used. Machine tablet.

preparation example 3

[0085] Preparation Example 3: Preparation of Escitalopram Oxalate Tablet Composition

[0086] For the formula and preparation method, refer to Preparation Example 5 of the present invention, except that the polyethylene glycol-6000 is replaced by 0.75 g of magnesium stearate.

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Abstract

The invention relates to an escitalopram oxalate tablet composition and a quality control method and in particular relates to a method for controlling quality of an escitalopram oxalate tablet composition. The method comprises the following steps: carrying out limitation test on escitalopram R-enantiomeric impurities in the composition, measuring the content of the escitalopram R-enantiomeric impurities in the composition and testing related substances in the composition. Furthermore, the invention also relates to an escitalopram oxalate tablet composition. The escitalopram oxalate tablet composition comprises an effective dose of escitalopram oxalate, magnesium stearate and optional pharmaceutically acceptable carriers. The method can implement the excellent technical effect as described in the description.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a drug escitalopram oxalate tablet composition which can be used for treating depression and panic disorder with or without agoraphobia. The invention also relates to the escitalopram oxalate Quality control methods for citalopram tablet compositions. The method of the invention has excellent performance. Background technique [0002] Escitalopram Oxalate, its chemical name: S(+)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroiso Benzofuran-5-nitrile oxalate, molecular formula: C 20 h 21 FN 2 O·C 2 h 2 o 4 , molecular weight: 414.43, its chemical structural formula is: [0003] [0004] In the present invention, escitalopram can also be referred to as S-citalopram or S-isomer or citalopram S-isomer, and correspondingly, R-citalopram or R-isomer isomer or citalopram R-isomer as an impurity and in some embodiments of the present invention it is necessary to dete...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/343
CPCG01N30/02G01N2030/027
Inventor 侯奇伟李晓云余有付郭杰梁伟
Owner HUNAN DONGTING PHARMA
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