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Oral paroxetine disintegrating tablet and preparation process thereof

A technology of oral tablet and disintegrant, which is applied in the field of paroxetine oral tablet and its preparation, and can solve problems such as affecting the disintegration speed and the like

Inactive Publication Date: 2012-08-15
无锡万全医药技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, according to the current national conditions in our country, wet granulation is usually used to compress tablets, but it is found that the wet granulation process will affect the disintegration speed

Method used

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  • Oral paroxetine disintegrating tablet and preparation process thereof
  • Oral paroxetine disintegrating tablet and preparation process thereof
  • Oral paroxetine disintegrating tablet and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Dissolve paroxetine in the alcohol solution of acrylic resin, after all the dissolution, 60 ℃ rotary steaming for 4 hours, get paroxetine inclusion compound:

[0025]

[0026]

[0027] Preparation Process:

[0028] Pass the paroxetine inclusion compound in the prescription through 100 mesh and all the excipients through 80 mesh respectively.

[0029] The inclusion compound of paroxetine, mannitol, 1 / 2 crospovidone and 1 / 2 microcrystalline cellulose were mixed uniformly according to the method of equal volume addition.

[0030] Add the prepared starch slurry to make a soft material, extrude through a 18-mesh sieve and sieve to granulate.

[0031] The wet granules were dried at a constant temperature of 50 degrees for 3 hours.

[0032] Sieve the dry granules through a 24-mesh sieve, add the remaining auxiliary materials, and mix well.

[0033] A rotary tablet press produces 1000 tablets with the following properties:

[0034] The average tablet weight is between...

Embodiment 2

[0039] Dissolve paroxetine in the alcohol solution of acrylic resin, after all the dissolution, 60 ℃ rotary steaming for 4 hours, get paroxetine inclusion compound:

[0040]

[0041] Preparation Process:

[0042] The preparation method and detection method of embodiment 2 and embodiment 1 are the same.

[0043] The average tablet weight is between 257-266 mg; the hardness is 30-50 Newtons, the disintegration time in the oral cavity is less than 1 minute, and the disintegration time in the disintegration instrument is less than 30 seconds.

[0044] Mouth taste, no smell, no gritty feeling. Dissolution at 20 minutes was greater than 90%.

Embodiment 3

[0046] Dissolve paroxetine in the alcoholic solution of polacrilin potassium, after all the dissolution, 60 ℃ rotary steaming for 4 hours, to get paroxetine inclusion compound:

[0047]

[0048] Preparation Process:

[0049] The preparation method and detection method of embodiment 3 and embodiment 1 are the same.

[0050] The average tablet weight is between 255-264 mg; the hardness is 30-50 Newtons, the disintegration time in the oral cavity is less than 1 minute, and the disintegration time in the disintegration instrument is less than 30 seconds.

[0051] Mouth taste, no smell, no gritty feeling. Dissolution at 20 minutes was greater than 90%.

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Abstract

The invention relates to an oral paroxetine solid preparation capable of being rapidly disintegrated and dissolved and a preparation process thereof. The solid preparation has the characteristics of maintaining favorable taste in the condition of using a covering process and a taste masking agent, and rapidly expanding and dispersing in water to dissolve the paroxetine out, thus the dissolution rate and biological availability of the preparation are greatly enhanced, and the therapeutic effect can be more efficiently and rapidly achieved.

Description

technical field [0001] The invention relates to a pharmaceutical product and a preparation process, which is a rapidly disintegrating and dissolving paroxetine oral tablet and a preparation method thereof. Background technique [0002] Depression is a common mood disorder, which can be caused by various reasons. The main clinical feature is marked and persistent low mood, and the low mood is not commensurate with the situation. In severe cases, suicidal thoughts and behaviors may appear. Most cases have a tendency to relapse, and most of each attack can be relieved, and some may have residual symptoms or become chronic. [0003] Manic episodes can occur in at least 10% of patients with depression, at which point a diagnosis of bipolar disorder should be made. In addition, the depression we often talk about actually refers to clinical major depression, and 16% of the population will be affected by it at some point in their lives. In addition to the severe emotional and soci...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4525A61P25/24
Inventor 徐烨谌伦华华奕琳郭夏宋雪梅
Owner 无锡万全医药技术有限公司
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