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Pharmaceutical composition containing fesoterodine and preparation method thereof

A fesoterodine and composition technology, applied in the field of fesoterodine-containing pharmaceutical composition and its preparation, can solve the problems of fesoterodine's easy decomposition, gastrointestinal side effects, etc.

Inactive Publication Date: 2016-06-22
合肥信风科技开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to solve the problems in the above-mentioned prior art, the present invention proposes a fesoterodine-containing pharmaceutical composition and a preparation method thereof, which not only solves the problem of fesoterodine in high temperature and high humidity conditions. The problem of easy decomposition also solves the problem of the gastrointestinal side effects of the existing fesoterodine medicinal composition

Method used

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  • Pharmaceutical composition containing fesoterodine and preparation method thereof
  • Pharmaceutical composition containing fesoterodine and preparation method thereof
  • Pharmaceutical composition containing fesoterodine and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0041] With dextrin as stabilizer, prepare fesoterodine fumarate sustained-release tablet, its prescription is shown in Table 1 (1000 tablet quantity):

[0042] Table 1

[0043] Fesoterodine fumarate

4g

Dextrin

120g

lactose

65g

microcrystalline cellulose

25g

Hypromellose K15M

50g

Hypromellose K100M

50g

Glyceryl behenate

15g

[0044] Its preparation method is as follows:

[0045]Weigh the raw and auxiliary materials according to Table 1, mix fesoterodine fumarate and dextrin, pass through a 100-mesh sieve and mix evenly, then mix with lactose, microcrystalline cellulose, hypromellose and pass through a 100-mesh sieve to mix uniform. Mix the powder and add 95% ethanol as a wetting agent to make a soft material, pass through a 20-mesh sieve to make wet granules, and dry the wet granules at 45°C until the water content is less than 4.0%, to obtain dry granules. The dry granules are passed thro...

Embodiment 2

[0048] Do stabilizer with maltodextrin, prepare fesoterodine fumarate sustained release tablet, its prescription is shown in Table 2 (quantity of 1000):

[0049] Table 2

[0050] Fesoterodine fumarate

4g

Maltodextrin

100g

lactose

65g

microcrystalline cellulose

25g

Hypromellose K15M

50g

Hypromellose K100M

50g

Talc powder

9g

[0051] Its preparation method is as follows:

[0052] Refer to Table 2 to weigh the raw and auxiliary materials, mix fesoterodine fumarate and maltodextrin, pass through a 120-mesh sieve and mix evenly, then mix with lactose, microcrystalline cellulose, hypromellose and mix with a 40-mesh sieve Uniform; mixed with powder, 80% ethanol as wetting agent, made into soft material, passed through 14 mesh sieve to make wet granules, dried at 45°C until the moisture content was less than 4.0%, to obtain dry granules. The dry granules are passed through a 14-mesh sieve for gran...

Embodiment 3

[0055] Make stabilizer with mannitol, prepare fesoterodine fumarate sustained-release tablet, its prescription is shown in Table 3 (1000 tablet quantities):

[0056] table 3

[0057] Fesoterodine fumarate

4g

Mannitol

80g

lactose

65g

microcrystalline cellulose

25g

Hypromellose K15M

50g

Hypromellose K100M

50g

Glyceryl behenate

12g

Magnesium stearate

3g

[0058] Its preparation method is as follows:

[0059] Refer to Table 3 to weigh the raw and auxiliary materials, mix fesoterodine fumarate and mannitol, pass through a 40-mesh sieve and mix evenly, then mix with lactose, microcrystalline cellulose, hypromellose and mix evenly with a 100-mesh sieve ; Mix the powder and add 100% ethanol as a wetting agent to make soft materials, pass through a 20-mesh sieve to make wet granules, and dry the wet granules at 45°C until the water content is less than 4.0%. Obtain dry granules; pass the...

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Abstract

The invention brings forward a pharmaceutical composition containing fesoterodine and a preparation method thereof. The pharmaceutical composition also comprises a stabilizing agent, which is dextrin, maltodextrin, mannitol, propylene glycol and / or cane sugar. The preparation method of the pharmaceutical composition comprises steps of sieving, mixing, wetting, granulating, drying, tabletting and coating. According to the pharmaceutical composition, the problem that fesoterodine is easy to decompose under conditions of high temperature and high humidity is solved, and the problem that a medicinal excipient in an existing pharmaceutical composition containing fesoterodine has side effect on intestines and stomach is also solved.

Description

technical field [0001] The invention relates to a pharmaceutical composition of fesoterodine or a pharmaceutically acceptable salt thereof and a preparation method thereof. Background technique [0002] Fesoterodine fumarate, which may be known chemically as 2-[(R)-3-(diisopropylamino)-1-phenylpropyl]-4-(hydroxymethyl)phenyliso Butyrate hydrogen fumarate, its structural formula is as follows: [0003] [0004] Fesoterodine fumarate is used to treat overactive bladder (OAB). The sustained-release tablet developed by Pfizer was approved by the FDA in 2008. This product treats overactive bladder once a day, which can significantly reduce urgency Onset of incontinence and frequency of voiding in 24 hours. [0005] Fesoterodine fumarate is a competitive blocker of muscarinic receptors. After oral administration, it is rapidly and extensively hydrolyzed by non-specific esterases into the active metabolite 5-hydroxymethyl tolterodine, which exerts the anti-inflammatory effect ...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/222A61K47/36A61K47/26A61K47/10A61P13/10
Inventor 高嵩崔云龙宗国军章晓玲査大俊
Owner 合肥信风科技开发有限公司
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