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Febuxostat solid dispersion preparation and preparation method thereof

A technology of solid dispersion and febuxostat, which can be used in medical preparations containing non-active ingredients, medical preparations containing active ingredients, and pill delivery, and can solve problems such as adverse reactions

Inactive Publication Date: 2018-05-15
FOSHAN TENGRUI MEDICINE TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This also brings serious and even fatal adverse reactions due to drug accumulation.

Method used

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  • Febuxostat solid dispersion preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Embodiment 1: febuxostat solid dispersion tablet

[0045] prescription:

[0046] components

parts by weight

febuxostat

1０0

Povidone K30

200

Microcrystalline Cellulose 102

50

Croscarmellose Sodium

20

Sodium dodecyl sulfate

10

silica

2

[0047] Preparation process: solvent evaporation method

[0048] Dissolve febuxostat and povidone K30 in the prescribed amount 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, and recover organic matter under reduced pressure. 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.

[0049] The prepared solid dispersion was added into the prescribed amount of microcrystalline cellulose pH102, croscarmellose sodium, ...

Embodiment 2

[0050] Embodiment 2: febuxostat solid dispersion tablet

[0051] prescription:

[0052] components

parts by weight

febuxostat

20

Povidone K30

100

Microcrystalline Cellulose 102

50

Croscarmellose Sodium

20

Sodium dodecyl sulfate

10

talcum powder

2

[0053] Preparation process: solvent evaporation method

[0054] Take the prescribed amount of febuxostat and povidone K30, dissolve them in a solvent of methanol:dichloromethane (4:1), put them in a water bath at 60°C, and vacuum the degree of 0.07-0.08MPa, and recover the organic solvent under reduced pressure. After becoming 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.

[0055] The prepared solid dispersion is added into the prescribed amount of microcrystalline cellulose pH102, crospovidone, sod...

Embodiment 3

[0056] Embodiment 3: febuxostat solid dispersion tablet

[0057] prescription:

[0058] components

parts by weight

febuxostat

30

Povidone K30

100

Microcrystalline Cellulose 102

50

Croscarmellose Sodium

20

Sodium dodecyl sulfate

10

silica

2

[0059] Preparation process: solvent evaporation method

[0060] Dissolve the prescribed amount of febuxostat 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 the organic solvent under reduced pressure. After becoming 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.

[0061] The prepared solid dispersion is added to the prescribed amount of pregelatinized starch, low-substituted hydroxypropyl cellulose, sodium lauryl sulfate, a...

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Abstract

The invention relates to the field of medical preparations, and particularly discloses a febuxostat solid dispersion preparation and a preparation method thereof. The febuxostat solid dispersion preparation disclosed by the invention comprises febuxostat, povidonem, a specific lubricating agent, a specific disintegrant and a diluent. The preparation disclosed by the invention is good in dissolvingeffect, and high in bioavailability and stability, and is beneficial to industrial production of the febuxostat solid dispersion preparation.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a febuxostat solid dispersion preparation and a preparation method thereof. Background technique [0002] Febuxostat first applied for listing in Japan at the beginning of 2004 by Japan's Teijin Corporation, and at the end of the year it applied for listing in the United States, and IPSEN applied for listing in Europe; febuxostat is a new generation of xanthine oxidase inhibitors, clinically used Treat hyperuricemia (gout). [0003] Gout is caused by the deposition of crystalline uric acid in the joints, causing an inflammatory response. The goal of treatment is to reduce the serum uric acid level to below 6 mg / dL. The current standard treatment drug is allopurinol, which belongs to xanthine oxidase inhibitors. [0004] The occurrence of gout is due to the excessive production of uric acid in the body and the decline in the ability of the kidneys to clear it. The accu...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/426A61K47/32A61K9/48A61K9/20A61P19/06
CPCA61K31/426A61K9/1635A61K9/2027
Inventor 欧泽桂
Owner FOSHAN TENGRUI MEDICINE TECH CO LTD
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