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Oral solid preparation of escitalopram oxalate and preparation method thereof

A technology of escitalopram oxalate and solid preparations, which is applied in the field of oral solid preparations of escitalopram oxalate and its preparation, and achieves the effect of solving the content uniformity of preparations

Active Publication Date: 2009-07-08
SICHUAN KELUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The oral solid preparation of escitalopram oxalate has not been reported so far, and each tablet of escitalopram oxalate only contains 12.78 mg of escitalopram oxalate. content uniformity and formulation stability

Method used

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  • Oral solid preparation of escitalopram oxalate and preparation method thereof
  • Oral solid preparation of escitalopram oxalate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1: the preparation of tablet

[0027] Weigh 12.78g of escitalopram oxalate and 25g of microcrystalline cellulose to pass through a 100-mesh sieve, mix 20g of starch with the remaining 25g of microcrystalline cellulose and 30g of lactose, pass through a 80-mesh sieve, and grind together The substance and the mixture are mixed through an 80 mesh sieve, stirred evenly, and 5% povidone K is added 30 Ethanol liquid, made into soft material, granulated with a 20-mesh sieve, dried in an oven at 60°C for 2 hours, then granulated with a 20-mesh sieve, added with 0.2g of magnesium stearate as an auxiliary material, mixed evenly to obtain granules, and pressed into tablets , that is.

Embodiment 2

[0028] Embodiment 2: the preparation of capsule

[0029] Weigh 25.56g of escitalopram oxalate and 60g of microcrystalline cellulose to grind through a 100-mesh sieve, mix 30g of starch with the remaining 50g of microcrystalline cellulose and 40g of lactose, pass through a 100-mesh sieve, and grind together Mix the material and the mixture through a 60-mesh sieve, stir evenly, add 1% hydroxyethyl methylcellulose ethanol solution to make a soft material, granulate with an 18-mesh sieve, dry in an oven at 70°C for 1.5 hours, and then use an 18-mesh cellulose Sieve for granulation, add 0.15 g of talcum powder as an auxiliary material, mix well to obtain granules, put them into empty capsule shells, and obtain.

Embodiment 3

[0030] Embodiment 3: the preparation of tablet

[0031] Weigh 12.78g of escitalopram oxalate and 40g of microcrystalline cellulose to grind through a 60-mesh sieve, mix 5g of starch with the remaining 80g of microcrystalline cellulose and 10g of lactose, pass through a 100-mesh sieve, and grind together The material and the mixture are mixed through a 100-mesh sieve, stirred evenly, and 8% methylcellulose aqueous solution is added to make a soft material, granulated with a 40-mesh sieve, dried in an oven at 40°C for 4 hours, and then granulated with a 30-mesh sieve. Add 0.2 g of stearic acid as an auxiliary material, mix well, obtain granules, and compress into tablets.

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Abstract

The invention discloses an oxalic acid esmolol citalopram oral solid preparation and a preparation method. The oral solid preparation comprises raw materials of: 2-40 parts by weight of oxalic acid esmolol citalopram, 5-60 parts by weight of starch, 5-200 parts by weight of microcrystalline cellulose, 5-60 parts by weight of lactose, 0.05-5 parts by weight of binding agent and 0.05-3 parts by weight of lubricant; the binding agent is one or a plurality of mixed aqueous solutions or alcoholic solutions from the group consisting of polyvinyl pyrrolidone, hydroxyethyl methylcellulose, methylcellulose, hydroxypropyl cellulose and ethyl cellulose, the concentration of the binding agent is 0.1-10.0%; and the lubricant is stearic acid, magnesium stearate, calcium stearate, talcum or superfine silica gel powder.

Description

field of invention [0001] The invention relates to a medicine, in particular to an oral solid preparation of escitalopram oxalate and a preparation method thereof. Background technique [0002] Escitalopram oxalate is an oral selective serotonin reuptake inhibitor (SSRI). Escitalopram oxalate is the S-isomer (single isomer) of racemic citalopram. Jointly developed by Forest Laboratories and Lundbeck, Denmark. [0003] Citalopram, manufactured by Forest Laboratories, has been sold as an antidepressant under various trade names (including Celexa, Cipramil, and Seropram) in 70 countries since its approval date of July 17, 1998. Since then, the company has submitted a new drug application for escitalopram to the US Food and Drug Administration (FDA), using escitalopram for the treatment of depression; it was approved on November 27, 2002. [0004] The Phase III clinical trial results of Forest Experimental Company's new antidepressant escitalopram showed that compared with ci...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/343A61K47/36A61K47/38A61K47/26A61K47/32A61K47/12A61K47/04A61J3/00A61K9/16A61K9/20A61K9/48A61P25/24
Inventor 张英平张永红梁隆程志鹏
Owner SICHUAN KELUN PHARMA CO LTD
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