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Azilsartan kaMedoxoMil solid dispersoid preparation and preparation method thereof

A technology of azilsartan medoxomil and solid dispersion, which is applied in the field of azilsartan medoxomil potassium salt solid dispersion preparation and its preparation, and can solve the problems that Edarbi cannot be replaced in terms of effectiveness, safety and tolerance

Inactive Publication Date: 2016-12-14
佛山市弘泰药物研发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although some of the current emerging antihypertensive drugs have certain potential, their own shortcomings in effectiveness, safety and tolerability, and / or administration methods may prevent them from replacing Edarbi

Method used

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  • Azilsartan kaMedoxoMil solid dispersoid preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1: Azilsartan medoxomil potassium salt solid dispersion tablet

[0041] prescription:

[0042] components

parts by weight

Azilsartan medoxomil potassium salt

40

Povidone K30

85

Microcrystalline Cellulose 102

50

Croscarmellose Sodium

20

Sodium dodecyl sulfate

8

silica

2

Sheet weight

215

[0043] Preparation process: solvent evaporation method

[0044] Dissolve the prescribed amount of azilsartan medoxomil potassium salt and povidone K30 in a solvent of acetone:methanol (1:3), volatilize under reduced pressure in a water bath at 60°C, vacuum degree 0.07-0.08MPa, reduce The organic solvent was recovered under pressure, and after it became viscous, it was dried under reduced pressure for 1 hour, transferred to a vacuum drying oven, dried at 40°C for 48 hours, and then crushed through an 80-mesh sieve to obtain a solid dispersion.

[0045] The prepared solid dispersion was ad...

Embodiment 2

[0046] Embodiment 2: Azilsartan medoxomil potassium salt solid dispersion tablet

[0047] prescription:

[0048] components

parts by weight

Azilsartan medoxomil potassium salt

80

Povidone K30

150

Microcrystalline Cellulose 102

90

Croscarmellose Sodium

20

Sodium dodecyl sulfate

7

talcum powder

3

Sheet weight

350

[0049] Preparation process: solvent evaporation method

[0050] Take the prescribed amount of azilsartan medoxomil potassium salt and povidone K30, dissolve in methanol: dichloromethane (4:1) solvent, put in water bath at 60°C, vacuum degree 0.07-0.08MPa, and recover organic After the solvent becomes viscous, continue vacuum drying under reduced pressure for 1 hour, transfer to a vacuum drying oven, dry at 40°C for 48 hours, and pass through an 80-mesh sieve to pulverize to obtain a solid dispersion.

[0051] The prepared solid dispersion is added into the prescribed amount of mi...

Embodiment 3

[0052] Embodiment 3: Azilsartan medoxomil potassium salt solid dispersion tablet

[0053] prescription:

[0054] components

parts by weight

Azilsartan medoxomil potassium salt

20

Povidone K30

60

Microcrystalline Cellulose 102

30

Croscarmellose Sodium

10

Sodium dodecyl sulfate

7

silica

3

Sheet weight

130

[0055] Preparation process: solvent evaporation method

[0056] Dissolve the prescribed amount of azilsartan medoxomil potassium salt and povidone K30 in a solvent of acetone:dichloromethane (3:1), in a water bath at 55°C, with a vacuum of 0.07-0.08MPa, and recover organic matter under reduced pressure. After the solvent becomes viscous, continue vacuum drying under reduced pressure for 3 hours, transfer to a vacuum drying oven, dry at 60°C for 48 hours, and pass through an 80-mesh sieve to pulverize to obtain a solid dispersion.

[0057] The prepared solid dispersion is added to the presc...

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Abstract

The invention relates to the field of pharmaceutical preparations and particularly discloses an Azilsartan kaMedoxoMil solid dispersoid preparation and a preparation method thereof. The Azilsartan kaMedoxoMil solid dispersoid preparation comprises Azilsartan kaMedoxoMil, povidone, specific lubricant, specific disintegrant and specific diluent. Industrial production of the Azilsartan kaMedoxoMil solid dispersoid preparation is promoted through the dissolution effect, bioavailability and stability of the preparation.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a solid dispersion preparation of azilsartan medoxomil potassium salt and a preparation method thereof. Background technique [0002] Azilsartan medoxomil was developed by Takeda, Japan. A prodrug of azilsartan that is hydrolyzed to azilsartan during absorption from the gastrointestinal tract. It was approved for marketing by FDA on February 22, 2011. The trade name is Edarbi, and the specifications are 40mg and 80mg. In April 2012, Azilsartan was launched in Japan, trade name: Azilva, specification: 20mg, 40mg. Azilsartan medoxomil is a selective AT1 subtype angiotensin II receptor antagonist. Azilsartan selectively blocks the binding of angiotensin II to the AT1 receptor (the affinity of azilsartan to the AT1 receptor is more than 10,000 times higher than that of the AT2 receptor), thereby blocking the vasoconstriction caused by angiotensin II , Aldosterone secret...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/48A61K9/16A61K47/38A61K47/32A61K47/20A61K47/04A61K47/12A61K31/4245A61P9/12
CPCA61K9/2054A61K9/1617A61K9/1635A61K9/2009A61K9/2013A61K9/2059A61K31/4245
Inventor 褚金涛王雪峰
Owner 佛山市弘泰药物研发有限公司
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