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Paroxetine hydrochloride orally disintegrating tablets and preparation technology thereof

A technology of paroxetine hydrochloride and orally disintegrating tablets, which is applied to medical preparations with no active ingredients, medical preparations containing active ingredients, drug combinations, etc., and can solve problems such as complicated preparation methods and difficulty in industrial scale-up

Pending Publication Date: 2020-12-29
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the preparation methods are relatively complicated, and it is not easy for industrial scale-up.

Method used

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  • Paroxetine hydrochloride orally disintegrating tablets and preparation technology thereof
  • Paroxetine hydrochloride orally disintegrating tablets and preparation technology thereof
  • Paroxetine hydrochloride orally disintegrating tablets and preparation technology thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017]

[0018] Note: The raw and auxiliary materials in the table are the dosage per 1000 preparation units

[0019] Preparation Process:

[0020] Pass paroxetine hydrochloride and silicon dioxide through a 60-mesh sieve and mix, and then mix the rest of the auxiliary materials. Add 30% ethanol to the mixture to make soft materials, granulate with a 24-mesh sieve, control the drying temperature at 50°C, control the moisture content of the granules below 3%, sieve the granules with a 24-mesh sieve, and mix the obtained granules with the prescription amount of additional materials. Compressed into 1000 tablets on the tablet press, and packed after passing the inspection.

Embodiment 2

[0022]

[0023] Note: The raw and auxiliary materials in the table are the dosage per 1000 preparation units

[0024] Preparation Process:

[0025] Pass paroxetine hydrochloride and silicon dioxide through a 60-mesh sieve and mix, and then mix the rest of the auxiliary materials. Add 30% ethanol to the mixture to make soft materials, granulate with a 24 mesh sieve, control the drying temperature at 50°C, control the moisture content of the granules below 3%, sieve the granules with a 24 mesh sieve, and coat the obtained granules with Eudragit NE30D. Compressed into 1000 pieces on a tablet machine, and packed after passing the inspection.

Embodiment 3

[0027]

[0028] Note: The raw and auxiliary materials in the table are the dosage per 1000 preparation units

[0029] Preparation Process:

[0030] Pass paroxetine hydrochloride and silicon dioxide through a 60-mesh sieve and mix, and then mix the rest of the auxiliary materials. Add 30% ethanol to the mixture to make soft materials, granulate with a 24 mesh sieve, control the drying temperature at 50°C, control the moisture content of the granules below 3%, sieve the granules with a 24 mesh sieve, and coat the obtained granules with Eudragit NE30D. Compressed into 1000 pieces on a tablet machine, and packed after passing the inspection.

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PUM

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Abstract

The invention discloses paroxetine hydrochloride orally disintegrating tablets and preparation method thereof. The invention is characterized in that the paroxetine hydrochloride orally disintegratingtablets are prepared by adopting a particle coating process after wet granulation. Through the process, the taste of the medicine can be remarkably improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to paroxetine hydrochloride orally disintegrating tablets and a preparation process thereof. Background technique [0002] Paroxetine hydrochloride is a selective serum reuptake inhibitor (SSRI) type antidepressant, its antidepressant effect is similar to that of tricyclic antidepressants (TCA), and its side effects are significantly less than TCA , which belongs to the third generation of new antidepressant drugs. GlaxoSmithKline (China) Investment Co., Ltd. has launched Paroxetine immediate-release tablets in China in 1996 for the treatment of major depressive disorder. [0003] Paroxetine hydrochloride is easy to absorb when taken orally, and is not affected by antacid drugs or food. After taking 30mg orally, the time to reach the peak concentration is 6.3h, the peak concentration is 17.6ug / ml, T1 / 2 is 24h, and the apparent volume is 3~28L / kg. The plasma protein bin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/38A61K9/50A61K47/32A61K47/26A61K31/4525A61P25/24
CPCA61K9/2095A61K9/2054A61K9/2081A61K9/5026A61K9/5042A61K9/5015A61K31/4525A61P25/24
Inventor 刘冲王宇杰
Owner BEIJING VENTUREPHARM BIOTECH
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