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Ezetimibe and atorvastatin calcium tablet and preparation method thereof

A technology of atorvastatin calcium and ezetimibe, applied in the field of medicine, can solve problems such as unfavorable industrial production, and achieve the effects of improving uniform distribution and hydrophilicity, increasing stability and reducing dosage

Active Publication Date: 2016-08-10
ZHEJIANG JUTAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But the solvent used in this method is diethylene glycol monoethyl ether, a flammable and slightly toxic solvent, which is also unfavorable for suitability for industrialized production

Method used

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  • Ezetimibe and atorvastatin calcium tablet and preparation method thereof
  • Ezetimibe and atorvastatin calcium tablet and preparation method thereof
  • Ezetimibe and atorvastatin calcium tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Ezetimibe layer formulation and preparation

[0029] ingredient

Dosage (mg)

effect

Ezetimibe

10

Active ingredient

Povidone K30

120

Adhesive

Sodium dodecyl sulfate

8

Active agent

lactose

50

Water-soluble filler

Microcrystalline Cellulose 102

50

Water-insoluble filler

Croscarmellose Sodium

30

Disintegrant

Magnesium stearate

2

Lubricant

90% ethanol

0.06ml

lubricant

[0030] Mix the above-mentioned ezetimibe, sodium lauryl sulfate, lactose, microcrystalline cellulose 102, croscarmellose sodium, 3 / 4 amount of povidone K30 according to the prescription ratio, and use 20% The povidone K3090% ethanol solution is granulated with 40 meshes, dried, granulated, and magnesium stearate is added to prepare the ezetimibe layer.

[0031] Atorvastatin calcium layer prescription and preparation

[0032] ingredient

Dosage (mg)

effect

Atorvastatin calcium

11

Active ingredient

Microcrystalline Cellulose 102

100

Filler

Croscarmellose sodium

30

Disintegrant

Direct...

Embodiment 2

[0036] Ezetimibe layer formulation and preparation

[0037] In the top-drive granulator, ezetimibe and sodium lauryl sulfate were highly dispersed in a 20% povidone K30 90% ethanol solution according to the prescription ratio of Example 1, and then lactose was added. The crystalline cellulose 102 and the croscarmellose sodium are stirred evenly to form wet granules of 40-60 mesh, dried at 40 degrees, sizing, and adding an appropriate amount of lubricant to obtain.

[0038] Atorvastatin calcium layer prescription and preparation are the same as in Example 1

[0039] The two kinds of granules were respectively used in different feed hoppers, and pressed on a double-layer tablet press into upper and lower tablets, and then gastric-dissolved and coated to obtain double-layer tablets of Example 2.

Embodiment 3

[0041] Ezetimibe layer formulation and preparation

[0042] In the top drive granulator, ezetimibe and sodium lauryl sulfate were highly dispersed in a 20% povidone K30-90% ethanol solution according to the prescription ratio of Example 1, and then gradually added Stir the lactose evenly, add microcrystalline cellulose 102 and croscarmellose sodium to make wet granules of 40-60 mesh, dry at 40 degrees, sizing, and add appropriate amount of lubricant to get it.

[0043] Atorvastatin calcium layer prescription and preparation are the same as in Example 1

[0044] The two kinds of granules were respectively used in different feed hoppers, and pressed on a double-layer tablet press to form upper and lower tablets, and were gastric-dissolved and coated to obtain double-layer tablets of Example 3.

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PUM

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Abstract

The invention discloses an ezetimibe and atorvastatin calcium tablet and a preparation method thereof. The tablet is prepared from ezetimibe particles and atorvastatin calcium particles through double-layer tabletting, wherein the ezetimibe particles comprise the following components: ezetimibe, a binder, a surfactant, a water-soluble filling agent, a water-insoluble filling agent, a disintegrating agent and a lubricant; during pelletizing of the ezetimibe particles, the ezetimibe and the surfactant are dissolved or dispersed into a binder solution; the water-soluble filling agent is added to uniformly mix; and other auxiliary materials are added for pelletizing. During the preparation of the ezetimibe layer, the auxiliary materials are added in specific sequence, so that the in-vitro release problem of the ezetimibe is effectively solved.

Description

Technical field [0001] The invention relates to an ezetimibe atorvastatin calcium tablet and a preparation method thereof, and belongs to the technical field of medicine. Background technique [0002] Ezetimibe atorvastatin calcium tablets are compound preparations, mainly used to reduce total cholesterol (low density lipoprotein cholesterol and triglycerides) levels, and can increase high density lipoprotein cholesterol levels, developed by Merck The compound lipid-lowering drug, its trade name is "LIPTRZET", and the FDA approved this product on May 3, 2013. The compound preparation generally uses two active ingredients as separate entities in a single solid dosage form, that is, a double-layer tablet. The mechanism of action of the two active ingredients is different, and the compound prescription has better curative effect and patient adaptability, and has a broad market prospect. [0003] But unexpectedly, during the development of the compound preparation, it was discovered ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/397A61K31/40A61K9/24A61K9/30A61P3/06
CPCA61K9/2086A61K9/282A61K31/397A61K31/40
Inventor 易建勇祝方猛赵能选
Owner ZHEJIANG JUTAI PHARMA
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