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Process for producing particles with converted amorphous and/or meta-stable drystalline region into crystalline state

A technology of amorphous and crystalline regions, applied in the direction of using atmospheric pressure to chemically change substances, organic chemistry methods, chemical instruments and methods, etc., can solve problems such as time-consuming and large space

Inactive Publication Date: 2005-04-27
ASTRAZENECA AB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, known methods for converting amorphous or metastable crystalline particles to crystalline particles are often time consuming and require considerable space

Method used

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  • Process for producing particles with converted amorphous and/or meta-stable drystalline region into crystalline state
  • Process for producing particles with converted amorphous and/or meta-stable drystalline region into crystalline state

Examples

Experimental program
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Embodiment

[0054] According to the present invention in figure 1 Tests were carried out in the apparatus shown in which carbon dioxide at a relative water saturation of 20-40% was used to crystallize amorphous lactose monohydrate.

[0055] 400-500 mg of amorphous lactose monohydrate was filled in a 50 ml volume conditioned container (CC, Keystone SFE).

[0056] Put the dry supercritical carbon dioxide pump through the conditioning container, using CO 2 Pump 1 until the desired pressure is reached.

[0057] By making dry supercritical carbon dioxide (using CO 2 Pump 2) passes through a water saturated vessel (WSC, Keystone SFE) used as a water reservoir to produce supercritical carbon dioxide fully saturated with water vapor. The water saturation vessel was filled with a chemically cleaned filter paper bed and 1-3ml of water was poured into the paper bed.

[0058] Both the water-saturated container (WSC) and the conditioning container (CC) are vertically placed in an oven (indicated b...

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Abstract

The invention provides a process for crystallization of amorphous and / or meta-stable crystalline regions of preformed particles by treating the particles with a supercritical or subcritical fluid containing an anti-solvent and a solvent. The invention further provides formulations comprising particles produced according to the present process containing one or more pharmacologically active substances and one or more pharmaceutically acceptable excipients, use of said formulations in the treatment of an allergic and / or inflammatory condition of the nose or lungs and methods for treatment of such conditions.

Description

field of invention [0001] The present invention relates to a method for converting microparticles of the amorphous and / or metastable crystalline region into a crystalline state, such that the resulting microparticles can be used, for example, for oral or nasal inhalation. Background of the invention [0002] The increasing production and use of fine powders in the pharmaceutical industry necessitates reliable methods for assessing their physicochemical and process handling. Microparticles obtained by spray drying, freeze drying, rapid solvent quenching or by controlled precipitation are often amorphous and / or metastable crystalline forms. For crystalline materials, a reduction process such as micronization will result in particles with amorphous regions. [0003] Amorphous and / or metastable crystalline microparticles are of limited utility because they are thermodynamically unstable. For example, such particles tend to melt in the presence of moisture...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07H3/02A61K9/14A61K31/00A61K31/57A61K38/00A61K45/00A61K47/10A61K47/26A61K47/36A61P1/00A61P1/04A61P11/00A61P11/02A61P11/06A61P29/00A61P37/08B01J3/00C07B63/00C07C31/18C07C31/27C07C43/30C07H3/04C07H3/06C08B37/00
CPCA61K47/26Y10S514/958A61P1/00A61P1/04A61P11/00A61P11/02A61P11/06A61P29/00A61P37/08A61K9/14
Inventor M·比斯拉特S·莫沙舍H·尼奎斯特M·德米尔比克
Owner ASTRAZENECA AB