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Composition containing fine particles and process for producing the same

A technology of composition and microparticles, which is applied in the direction of medical preparations of non-active ingredients, drug combinations, non-effective ingredients of polymer compounds, etc., can solve the problems of not being able to obtain freeze-dried agents, and achieve improved bioavailability and storage stability Excellent, absorption-promoting effect

Inactive Publication Date: 2007-09-05
EISIA R&D MANAGEMENT CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, using a solid composition of sugar alcohols such as mannitol or nonionic surfactants, the desired freeze-dried preparation cannot be obtained.

Method used

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  • Composition containing fine particles and process for producing the same
  • Composition containing fine particles and process for producing the same
  • Composition containing fine particles and process for producing the same

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no. 1 approach

[0056] FIG. 1 is a process explanatory diagram related to the first embodiment of the production method of the microparticle-containing composition of the present invention. The present embodiment is characterized in that the cyclic oligosaccharide is added to the microparticle dispersion after the poorly soluble drug is miniaturized. That is, (1) in the mixing process, the insoluble drug, surfactant and poor solvent are mixed to obtain a mixed solution. Then (II) in the miniaturization process, the above-mentioned mixed solution is miniaturized by a wet disperser to obtain a microparticle dispersion; and in the (III) addition process, a cyclic oligosaccharide is added to the above-mentioned microparticle dispersion and mixed, Next (IV) the fine particle dispersion liquid containing the above-mentioned cyclic oligosaccharide is dried by the first drying step, whereby the fine particle-containing composition of the present invention can be obtained.

no. 2 approach

[0058] Fig. 2 is a process explanatory diagram related to the second embodiment of the production method of the microparticle-containing composition of the present invention. A feature of this embodiment is that a poorly soluble drug is miniaturized in the presence of a cyclic oligosaccharide. That is (I) in the mixing process, mix insoluble drugs, surfactants, cyclic oligosaccharides and poor solvents to obtain a mixed solution; The mixed liquid of the above-mentioned insoluble drug is miniaturized to obtain a dispersion liquid of the above-mentioned insoluble drug particles. Further (III) the fine particle dispersion liquid containing the above-mentioned cyclic oligosaccharide is dried by a drying step to obtain the fine particle-containing composition of the present invention.

no. 3 approach

[0060] Fig. 3 is a process explanatory diagram related to a third embodiment of the production method of the microparticle-containing composition of the present invention. This embodiment is characterized in that after obtaining a composition containing poorly soluble drug particles and a surfactant, the cyclic oligosaccharide and a poor solvent are added and mixed. That is, (I) in the mixing step, the poorly soluble drug, the surfactant, and the first poor solvent are mixed to obtain a mixed solution. Then (II) through the miniaturization step, the above-mentioned mixed solution is miniaturized with a wet disperser to obtain a fine particle dispersion. (III) In the first drying step, the above-mentioned fine particle dispersion is dried to obtain a mixture containing the above-mentioned poorly soluble drug fine particles and the above-mentioned surfactant (hereinafter referred to as the first mixture). Next (IV) In the addition step, the cyclic oligosaccharide and the second...

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Abstract

The present invention provides a composition containing fine particles of a hardly-soluble drug which is stable and is not affected by storage environment conditions, as well as a manufacturing method therefor. The present invention provides a fine particle-containing composition containing fine particles of the hardly-soluble drug, a surfactant and a cyclic oligosaccharide, wherein an average particle size of the fine particles is at least 50 nm but not more than 1000 nm. The present invention also provides a method for manufacturing a fine particle-containing composition, comprising (I) a mixing step in which the hardly-soluble drug, the surfactant and a poor solvent are mixed to obtain a liquid mixture, (II) a pulverization step in which the liquid mixture is pulverized with a wet disperser to obtain a dispersion of fine particles, (III) an addition step in which the cyclic oligosaccharide is added to the dispersion of fine particles, and (IV) a drying step in which the dispersion of fine particles containing the cyclic oligosaccharide is dried.

Description

technical field [0001] The invention relates to a composition containing insoluble drug particles and a preparation method thereof. Background technique [0002] Since poorly soluble drugs have low solubility in water, they are generally difficult to formulate as injections. In addition, when compounded in a solid preparation, there are difficulties such as difficulty in elution from the solid preparation and easy reduction in bioavailability. Therefore, attempts have been made to solve the above-mentioned problems by miniaturizing poorly soluble drugs and improving their dispersibility in water. For example, it is known that an injection containing an anticancer agent or the like adjusted to a nanometer size exhibits low toxicity and high bioavailability. [0003] Wet pulverization using water or an organic solvent is the main method for producing poorly soluble drug particles, and surface modifiers such as surfactants are used in the wet pulverization. The reason is tha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K9/10A61K9/16A61K9/20A61K9/48A61K47/26A61K47/40
CPCA61K9/2054A61K9/1694A61K9/2018A61K9/1623A61K9/2059A61K9/1652A61P3/10A61K9/16A61K9/14A61K9/20A61K47/26
Inventor 植木洋祐
Owner EISIA R&D MANAGEMENT CO LTD