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Efavirenz preparation adopting micronization technology

A technology for efavirenz and tablets, which is applied in the field of tableting or capsules to achieve the effects of improving solubility and reducing usage

Inactive Publication Date: 2013-01-16
FUKANGREN BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In some cases, the dissolution of the drug from the dosage form in the gastrointestinal tract may be the limiting factor in determining the rate and extent of drug absorption into the body

Method used

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  • Efavirenz preparation adopting micronization technology
  • Efavirenz preparation adopting micronization technology
  • Efavirenz preparation adopting micronization technology

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Embodiment 1: wet granulation 50mg capsule preparation

[0020] Preparation method: Mix efavirenz with sodium carboxymethyl starch whose particle size at 90% cumulative volume is controlled below 66um, then add sodium lauryl sulfate aqueous solution and carry out wet granulation. The wet material is then dried in a fluid bed, drying tray or other suitable desiccant. The dried granules can then be milled to a suitable particle size distribution prior to mixing with the other ingredients. The mixture is then filled into two hard gelatin capsule shells.

[0021]

[0022]

Embodiment 2

[0023] Embodiment 2: wet granulation 50mg capsule preparation

[0024] Preparation method: Mix efavirenz with a particle size above 66um at 90% cumulative volume and sodium carboxymethyl starch, then add sodium lauryl sulfate aqueous solution and carry out wet granulation. The wet material is then dried in a fluid bed, drying tray or other suitable desiccant. The dried granules can then be milled to a suitable particle size distribution prior to mixing with the other ingredients. The mixture is then filled into two hard gelatin capsule shells.

[0025]

Embodiment 3

[0026] Example 3: Wet Granulation 50mg Tablet Formulation

[0027] Preparation method: use sodium lauryl sulfate aqueous solution to granulate efavirenz, lactose, sodium carboxymethyl starch and microcrystalline cellulose whose particle size at 90% cumulative volume is controlled below 66um. The wet material is then dried in a fluid bed, drying pan or other suitable drying place. The dried granules can then be milled to achieve the desired particle size distribution, the magnesium stearate added and the mixture compressed to form tablets. Tablets may be coated, if desired.

[0028]

[0029]

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Abstract

The invention discloses an efavirenz preparation adopting a micronization technology. The invention provides a modified efavirenz orally-taken preparation which is used for inhibiting human immunodeficiency virus (HIV), preventing or treating HIV infection, and treating acquired immunodeficiency syndrome (AIDS) caused by the HIV infection, and in particular relates to tablets or a capsule which comprises efavirenz, wherein a micronization technology which can promote the dissolution velocity of the efavirenz in gastrointestinal tract, so that the absorption velocity and the absorption extent of the efavirenz in bodies is involved.

Description

technical field [0001] The present invention provides improved oral dosage formulations of efavirenz for transplantation of immunodeficiency virus (HIV), prophylaxis or treatment of HIV infection, and treatment of acquired immunodeficiency syndrome (AIDS) caused by HIV infection. In particular, the present invention relates to compressed tablets or capsules containing efavirenz, which contains a micronization technology that can accelerate the dissolution rate of efavirenz in the gastrointestinal tract, thereby improving the rate and degree of absorption of efavirenz in the body. Background technique [0002] This effect is particularly pronounced when efavirenz has relatively low water solubility, has hydrophobic properties, and / or is administered at high therapeutic doses. In some cases, the dissolution of the drug from the dosage form in the gastrointestinal tract may be the limiting factor in determining the rate and extent of drug absorption into the body. By changing ...

Claims

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Application Information

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IPC IPC(8): A61K31/536A61K9/20A61K9/48A61K47/32A61K47/36A61K47/38A61P31/18
Inventor 不公告发明人
Owner FUKANGREN BIO PHARMA
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