Dapoxetine hydrochloride tablet and preparation method thereof

A technology for dapoxetine hydrochloride and cetine tablets, which can be applied in the fields of pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., and can solve problems such as complex preparation processes

Inactive Publication Date: 2020-04-10
SHANDONG HUBBLE KISEN BIOLOGICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Among the published patents, dapoxetine hydrochloride tablets mostly adopt wet granulation process or solid dispersion process, etc., and the preparation process is complicated, requiring the introduction of damp heat or organic solvents, etc.

Method used

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  • Dapoxetine hydrochloride tablet and preparation method thereof
  • Dapoxetine hydrochloride tablet and preparation method thereof
  • Dapoxetine hydrochloride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] prescription

[0018]

[0019]

[0020] Preparation Process:

[0021] ①Pretreatment: Put dapoxetine hydrochloride in a high-efficiency pulverizer to pulverize through a 0.6mm sieve, and colloidal silica through a 24-mesh sieve for treatment. ② Mixing: Mix dapoxetine hydrochloride, cellulose-lactose, croscarmellose sodium, and colloidal silicon dioxide for 5 minutes first, then add magnesium stearate, and mix for another 1 minute. ③ Tabletting: Compress the mixed powder into tablets. ④ Coating: adding the coating powder into purified water to prepare a coating liquid with a solid content of 12%, and then coating, the weight of the coating increases by 3-4%. ⑤Aluminum / plastic / aluminum packaging: the coated tablets are packaged in aluminum / plastic / aluminum.

Embodiment 2

[0023] prescription

[0024]

[0025] Preparation Process:

[0026] ①Pretreatment: Put dapoxetine hydrochloride in a high-efficiency pulverizer to pulverize through a 0.6mm sieve, and colloidal silica through a 24-mesh sieve for treatment. ② Mixing: Mix dapoxetine hydrochloride, cellulose-lactose, sodium carboxymethyl starch, and colloidal silicon dioxide for 5 minutes first, then add magnesium stearate, and mix for another 1 minute. ③ Tabletting: Compress the mixed powder into tablets. ④ Coating: adding the coating powder into purified water to prepare a coating liquid with a solid content of 12%, and then coating, the weight of the coating increases by 3-4%. ⑤Aluminum / plastic / aluminum packaging: the coated tablets are packaged in aluminum / plastic / aluminum.

Embodiment 3

[0028] prescription

[0029]

[0030] Preparation Process:

[0031] ①Pretreatment: Put dapoxetine hydrochloride in a high-efficiency pulverizer to pulverize through a 0.6mm sieve, and colloidal silica through a 24-mesh sieve for treatment. ② Mixing: Mix dapoxetine hydrochloride, cellulose-lactose, croscarmellose sodium, and colloidal silicon dioxide for 5 minutes first, then add magnesium stearate, and mix for another 1 minute. ③ Tabletting: Compress the mixed powder into tablets. ④ Coating: adding the coating powder into purified water to prepare a coating liquid with a solid content of 12%, and then coating, the weight of the coating increases by 3-4%. ⑤Aluminum / plastic / aluminum packaging: the coated tablets are packaged in aluminum / plastic / aluminum.

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PUM

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Abstract

The invention belongs to the field of pharmaceutical preparations. The dapoxetine hydrochloride tablet is composed of 33.6 mg of dapoxetine hydrochloride, less than 18 mg of microcrystalline cellulose, 40-45% of a filler, 2-8% of a disintegrating agent, 1-5% of a flow aid, 0.5-3% of a lubricant, 1-5% of coating powder and a special packaging material. The key composition auxiliary materials and the packaging material can greatly improve the stability of the medicine as well as the rate and degree of in-vivo absorption into blood, so that the curative effect is influenced.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a composition of dapoxetine hydrochloride tablets and packaging materials. [0002] technical background [0003] Dapoxetine hydrochloride, chemical name: (+)-(s)-N,N-dimethyl-(α)-[2-(1-naphthyloxy)ethyl]-benzylamine hydrochloride, Chemical formula: C 21 h 23 NO·HCl, molecular weight: 341.88, chemical structural formula: [0004] [0005] Dapoxetine is a selective serotonin reuptake inhibitor (SSRIs). The indication is the treatment of premature ejaculation. The recommended dose is 30 or 60 mg, taken as necessary about 1 to 3 hours before sex. The maximum recommended dose is 60 mg per day (24 hours). Dapoxetine was originally developed by Eli Lilly and Company for the treatment of major depressive disorder (MDD), but its pharmacokinetic properties (short half-life after oral administration, less accumulation in 24 hours) are not suitable for this indication, so ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K9/20A61K47/38A61K47/04A61K31/138A61P15/08
CPCA61K9/2009A61K9/2054A61K9/2095A61K9/28A61K31/138A61P15/08
Inventor 郭太明董鹏伟王秀红董晓玲王丽娟
Owner SHANDONG HUBBLE KISEN BIOLOGICAL TECH CO LTD
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