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Oil-in-water emulsion composition containing difluprednate and tobramycin

A technology of difluprednate and oil-in-water type, which is applied in the field of compositions containing difluprednate and tobramycin, which can solve the problems of storage stability without tobramycin and achieve storage stability good effect

Inactive Publication Date: 2013-07-31
SENJU PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is no background art on the storage stability of tobramycin in an aqueous solution in the presence of a nonionic surfactant in the compounding agent of a steroid drug and tobramycin

Method used

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  • Oil-in-water emulsion composition containing difluprednate and tobramycin
  • Oil-in-water emulsion composition containing difluprednate and tobramycin
  • Oil-in-water emulsion composition containing difluprednate and tobramycin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0083] The preparation method of embodiment 1

[0084] 1) According to the above prescription, add and dissolve polysorbate 80 and sodium acetate in purified water.

[0085] 2) Add hydrochloric acid to adjust the pH to 5.4-5.6.

[0086] 3) Separately, difluprednate was added to castor oil (manufactured by NOF), and dissolved in a water bath (85 to 95° C.) (liquid A).

[0087] 4) Slowly add Liquid A to the liquid (65-75°C) in 2) to roughly emulsify it (mixer: Robo Mics, TOKUSHU KIKA KOGYO, rotation speed: about 8000 rpm, stirring time: 1 hour after adding Liquid A).

[0088] 5) Allow to cool to room temperature, and check the pH (pH 5.4 to 5.6).

[0089] 6) Add purified water and make the volume to 50% of the specified amount.

[0090] 7) Use a high-pressure emulsification machine (micro jet machine, Microfluidics Corporation) to process a pressure of about 1500 kgf / cm 2 1. The temperature of the sample cooling water bath is about 35-45°C, and the number of passes is 20 tim...

Embodiment 2

[0094] The preparation method of embodiment 2

[0095] 1) According to the above prescription, add and dissolve polysorbate 80, sodium acetate, sodium edetate, boric acid and tobramycin in purified water.

[0096] 2) Separately add difluprednate to castor oil, and dissolve in a water bath (85-95° C.) (liquid A).

[0097] 3) Slowly add Liquid A to the liquid (65-75°C) in 1) to roughly emulsify it (mixer: Robo Mics, TOKUSHU KIKA KOGYO, rotation speed: about 8000 rpm, stirring time: 1 hour after adding Liquid A).

[0098] 4) Allow to cool to room temperature, add hydrochloric acid, and adjust the pH to 5.4-5.6.

[0099] 5) Add purified water, set the volume to the specified amount, and check the pH (pH 5.4 to 5.6).

[0100] 6) Use a high-pressure emulsification machine (micro jet machine, Microfluidics Corporation) to process a pressure of about 1500 kgf / cm 2 1. The temperature of the sample cooling water bath is about 35-45°C, and the number of passes is 20 times to prepare t...

Embodiment 3

[0101] The preparation method of embodiment 3

[0102] 1) According to the above prescription, add and dissolve polysorbate 80, sodium acetate, sodium edetate and tobramycin in purified water.

[0103] 2) Add hydrochloric acid to adjust the pH to 5.4-5.6.

[0104] 3) Separately add difluprednate to castor oil, and dissolve in a water bath (85-95° C.) (liquid A).

[0105] 4) Slowly add Liquid A to the liquid (65-75°C) in 2) to roughly emulsify it (mixer: Robo Mics, TOKUSHU KIKA KOGYO, rotation speed: about 8000 rpm, stirring time: 1 hour after adding Liquid A).

[0106] 5) Allow to cool to room temperature, and check the pH (pH 5.4 to 5.6).

[0107] 6) Add purified water and make the volume to the specified amount.

[0108] 7) Use a high-pressure emulsification machine (micro jet machine, Microfluidics Corporation) to process a pressure of about 1500 kgf / cm 2 1. The temperature of the sample cooling water bath is about 35-45°C, and the number of passes is 20 times to prepar...

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PUM

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Abstract

The present invention provides an oil-in-water emulsion composition for topical administration, which contains (a) tobramycin, (b) difluprednate, (c) water, (d) oil and (e) an emulsifying agent. The present invention also provides a method for stabilizing tobramycin, which includes the formation of an oil-in-water emulsion composition by mixing (a) tobramycin, (b) difluprednate, (c) water, (d) oil and (e) an emulsifying agent. The present invention is capable of providing an oil-in-water emulsion composition that contains tobramycin and is capable of stably maintaining the tobramycin content even in cases where a nonionic surfactant is added thereto.

Description

technical field [0001] The invention relates to a composition containing difluprednate and tobramycin with good storage stability. Background technique [0002] Combinations of anti-inflammatory steroids and antibiotics are useful for inflammatory diseases caused by infectious diseases, and there have been many reports on the combination (Patent Documents 1 to 4). Tobramycin is an aminoglycoside antibiotic with a broad antibacterial spectrum, and can cooperate well with steroid drugs (Patent Documents 2-4). Most steroidal drugs are poorly soluble in water and are usually developed as suspensions or ointments. Nonionic surfactants such as polysorbate 80 and tyloxapol are widely used as suspending or dispersing agents as additives necessary for suspending agents or ointments. However, there is no background art on the storage stability of tobramycin in an aqueous solution in the presence of a nonionic surfactant in the compounding agent of a steroid drug and tobramycin. Dif...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7036A61K9/107A61K31/573A61K47/34A61K47/44A61P11/02A61P27/02A61P27/14A61P27/16A61P29/00A61P31/04A61P37/08
CPCA61K31/7036A61K9/08A61K47/44A61K9/1075A61K47/26A61K31/573A61K9/0014A61K9/10A61P11/02A61P27/02A61P27/14A61P27/16A61P29/00A61P31/04A61P37/08A61K2300/00
Inventor 鹿村悠子
Owner SENJU PHARMA CO LTD
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