Pharmaceutical composition containing hardly water soluble medicament

A pharmaceutical composition, water-insoluble technology, applied in the direction of drug combination, medical preparations containing active ingredients, medical preparations without active ingredients, etc., can solve problems such as inability to preserve for a long time, insufficient effect, crystallization, etc. To achieve the effect of ensuring safety

Inactive Publication Date: 2008-03-05
OTSUKA PHARM FAB INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this method has disadvantages in that it cannot be stored for a long period of time when the obtained pharmaceutical preparation contains a pharmaceutical substance that is unstable even in a fat emulsion, or when the medicine or additional components are separated or crystallized easily out over time, etc.
However, since the solubility of paclitaxel in oil is also low (refer to Non-Patent Document 1), there is a concern that the above-mentioned emulsion also has stability problems such as crystallization during long-term storage.
[0005] Therefore, it can be said that the effect of pharmaceutical compositions capable of dissolving or dispersing poorly water-soluble drugs in liquid media such as fat emulsions is still insufficient.

Method used

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  • Pharmaceutical composition containing hardly water soluble medicament
  • Pharmaceutical composition containing hardly water soluble medicament
  • Pharmaceutical composition containing hardly water soluble medicament

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0089] The components shown in Table 1 below were mixed and dissolved, filtered through a filter with a pore size of 0.2 μm (manufactured by Pall Corporation) made of a polyethersulfone membrane, filled with 5 mL in a glass bottle with a capacity of 5 mL, sealed, and prepared as Pharmaceutical composition 1.

[0090] Table 1 Pharmaceutical composition 1

[0091] Element

Weight per 100mL

PTL

12.5g

Oleic acid

1g

PEG

Appropriate amount

[0092] After mixing the ingredients shown in Table 2 except glycerin, add glycerin dissolved in water for injection to make the final concentration of glycerol reach 2.21w / v%, and use a Polytron homogenizer (manufactured by KINEMATICA Co., Ltd. ), coarsely emulsified at 25000rpm for 10 minutes under nitrogen flow and heating.

[0093] Then, the obtained coarse emulsion was subjected to a high-pressure homogenizer (manufactured by APV Co., Ltd.), under a nitrogen flow at an emulsifica...

Embodiment 2

[0097] The components shown in the following Table 3 were mixed and dissolved, filtered, filled and sealed in the same way as the pharmaceutical composition 1 in preparation example 1, and the pharmaceutical composition 2 was prepared. As the liquid medium, the same liquid medium (liquid medium 1) as in Example 1 was prepared and used.

[0098] Element

Embodiment 3

[0100] The components shown in Table 4 below were mixed and dissolved, filtered, filled and sealed in the same way as the pharmaceutical composition 1 in preparation example 1, and pharmaceutical composition 3 was prepared. As the liquid medium, the same liquid medium (liquid medium 1) as in Example 1 was prepared and used.

[0101] Table 4 Pharmaceutical composition 3

[0102] Element

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PUM

PropertyMeasurementUnit
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Abstract

This invention provides a pharmaceutical composition for rendering a hardly water soluble medicament soluble or dispersible in a pharmaceutically acceptable liquid medium (for example, a fatty emulsifier). The pharmaceutical composition is characterized by comprising (i) a base (for example, polyethylene glycol), (ii) a hardly water soluble medicament, and (iii) a fatty acid or a pharmaceutically acceptable salt. For example, in preparing a pharmaceutical preparation for administration such as an injection by admixing with a pharmaceutically acceptable liquid medium, the pharmaceutical composition can be admixed in a short time and can render the hardly water soluble medicament soluble or dispersible homogeneously in the liquid medium.

Description

technical field [0001] The invention relates to a pharmaceutical composition for dissolving or dispersing poorly water-soluble drugs in liquid media such as fat emulsions and liposomes to prepare injections containing poorly water-soluble drugs. Pharmaceutical composition of dispersed poorly water soluble drug. Background technique [0002] When preparing injection preparations from chemically unstable drugs or poorly water-soluble drugs in aqueous solutions, there are known methods of mixing these drugs with fat emulsions, liposomes, etc. to prepare injection preparations. However, this method has disadvantages in that it cannot be stored for a long time when the obtained pharmaceutical preparation contains a pharmaceutical substance that is unstable even in a fat emulsion, or when the medicine or additional components separate or crystallize easily over time. As a method to solve this shortcoming, it is known that the fat emulsion and the medicinal substance composition a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/12A61K31/337A61K9/107A61K47/10A61K9/127A61K47/34
CPCA61K9/127A61K31/337A61K9/1075A61K9/0019A61P35/00A61K47/12A61K9/107
Inventor 武田光市松田宪治寺尾敏光井上忠昭今川昂
Owner OTSUKA PHARM FAB INC
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