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Stable febuxostat tablet and preparation method thereof

A technology of Buxostat tablet, Febuxostat, applied in the field of medicine

Active Publication Date: 2013-05-01
HANGZHOU ZHUYANGXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The above-mentioned properties of febuxostat, such as solubility in water, make the drug a challenge in the preparation of solid formulations, especially tablets, especially in the preparation of tablets with good dissolution properties and / or stability properties

Method used

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  • Stable febuxostat tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0080] Embodiment 1: preparation contains the tablet of febuxostat

[0081] formula:

[0082] Element

Quantity (mg / tablet)

Febuxostat (Form A)

40

microcrystalline cellulose

50

pregelatinized starch

40

Sodium carboxymethyl starch

15

PVP K30

3＊

Magnesium stearate

2

[0083] *PVP K30 powder 3mg, prepared into a solution with water as a binder for granulation, the following have similar meanings.

[0084] Preparation:

[0085] i) each material is pulverized respectively and passed through a sieve with an aperture of less than 80 mesh;

[0086] ii) Mix the febuxostat, microcrystalline cellulose, and pregelatinized starch of the prescribed amount evenly;

[0087] iii) Using a binder to make soft materials from the above mixed materials, granulate, dry, and granulate;

[0088] iv) Add sodium carboxymethyl starch and magnesium stearate to the granules obtained in step iii), mix well...

Embodiment 2

[0090] Embodiment 2: preparation contains the tablet of febuxostat

[0091] formula:

[0092] Element

[0093] Preparation method: basically with embodiment 1.

Embodiment 3

[0094] Embodiment 3: preparation contains the tablet of febuxostat

[0095] formula:

[0096] Element

[0097] Preparation method: basically with embodiment 1.

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Abstract

The invention relates to a stable febuxostat tablet and a preparation method thereof. Specifically, the invention relates to a febuxostat tablet, which comprises: (i) febuxostat or a pharmaceutically-acceptable salt thereof, a solvent complex and multiple crystal forms, (ii) microcrystalline cellulose, (iii) pregelatinized starch, and (iv) sodium carboxymethyl starch and an optional bonding agent, a wetting agent, a lubricating agent and a flow aid. The febuxostat tablet disclosed by the invention has high dissolving performance and / or high stable performance, and an effective febuxostat oralsolid preparation, particularly a tablet is provided clinically.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a pharmaceutical composition of febuxostat, a xanthine oxidase inhibitor, in particular to a febuxostat tablet. It also relates to a process for the preparation of the tablet. The febuxostat tablet provided by the invention has excellent pharmaceutical properties. Background technique [0002] Hyperuricemia is caused by increased uric acid production and / or decreased renal uric acid secretion, and is the most risky factor for inducing gout. The use of drugs to reduce blood uric acid concentration is one of the common methods to prevent gout, such drugs include uricosuric drugs and xanthine oxidase / xanthine dehydrogenase inhibitors that can block the absorption of uric acid by the lumen of the renal tubules . However, uricosuric drugs are contraindicated in patients with renal dysfunction, and the use of such drugs in patients with normal renal function will lead to urine alka...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/426A61K47/38A61P19/06
Inventor 李阅东唐建飞沈如杰何海珍刘玉艳
Owner HANGZHOU ZHUYANGXIN PHARMA