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Non-aqueous composition having drug carried therein, and method for producing same

A composition, non-aqueous technology, applied in the directions of non-active ingredients medical preparations, active ingredients-containing medical preparations, drug delivery, etc., can solve the problems of time and cost, etc.

Inactive Publication Date: 2020-01-17
技术防卫株式会社
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, as a method of removing the water phase from the emulsion, when the method of freeze-drying the emulsion at minus tens of degrees Celsius proposed so far is adopted, it takes time and cost.

Method used

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  • Non-aqueous composition having drug carried therein, and method for producing same
  • Non-aqueous composition having drug carried therein, and method for producing same
  • Non-aqueous composition having drug carried therein, and method for producing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Example 1: loaded with prostaglandin E 1 of non-aqueous compositions (one of them)

[0036] Collect prostaglandin E in a 50 mL beaker 1 900 μg, medium-chain fatty acid triglyceride (ODO: manufactured by Nissin Oilio (Oillio) Co., Ltd., hereinafter the same) 900 mg, refined egg yolk lecithin (PC-98N: manufactured by キユーピー Corporation, hereinafter the same) 3.6 g, polysorbate (polysorbate) Sorbitate 80) 3.6g, propylene glycol 30g, by heating to 45°C in a water bath, dissolving and processing with a mixing mixer under nitrogen flow for about 10 minutes, to obtain the target prostaglandin E 1 non-aqueous composition (colorless transparent viscous liquid). Collect 200 mg of this viscous liquid into a test tube, dilute it 10 times with pure water, and shake it by hand for 1 minute to prepare a colorless, cloudy prostaglandin E-containing 1 fat emulsion (refer to Table 1, 2).

Embodiment 2

[0037] Example 2: Non-aqueous composition loaded with tocopheryl acetate

[0038] In a 50 mL beaker, 60 mg of tocopheryl acetate, 300 mg of medium-chain fatty acid triglyceride (ODO), 3 g of refined egg yolk lecithin (PL-100M: manufactured by キユーピー company, the same below) and 2.4 g of polysorbate (polysorbate 80) were collected in a 50 mL beaker. g, 30 g of propylene glycol, while being heated to 60° C. in a water bath, dissolve and process with a mixer for about 30 minutes to obtain the target non-aqueous composition (yellow transparent viscous liquid) loaded with tocopheryl acetate. Collect 200 mg of this viscous liquid into a test tube, dilute it 10 times with pure water, and shake it by hand for 1 minute to prepare a yellow, thin, turbid tocopheryl acetate-containing fat emulsion (see Tables 1 and 2).

Embodiment 3

[0039] Embodiment 3: non-aqueous compositions loaded with dexamethasone palmitate (one of them)

[0040] Collect 30 mg of dexamethasone palmitate, 300 mg of refined soybean oil, 3 g of refined egg yolk lecithin (PL-100M), 6 g of polysorbate (polysorbate 80), and 30 g of propylene glycol in a 50 mL beaker. 60° C. for about 15 minutes while dissolving with a mixer to obtain the target dexamethasone palmitate-loaded non-aqueous composition (pale yellow transparent viscous liquid). Collect 200 mg of this viscous liquid into a test tube, dilute it 10 times with pure water, and shake it by hand for 1 minute to prepare a colorless and transparent fat emulsion containing dexamethasone palmitate (see Tables 1 and 2).

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Abstract

The present invention addresses the problem of providing: a non-aqueous composition having a drug carried therein, which can be prepared by mixing a drug-containing fat emulsion that can be used as aninjectable solution, an eye drop, a nasal spray, an inhalant and the like with an aqueous medium upon use without needing to produce a drug-containing fat emulsion in advance; and a method for producing the non-aqueous composition. The non-aqueous composition having a drug carried therein according to the present invention, which is a solution for the problem, is characterized in that componentsare dissolved in a polyhydric alcohol that serves as a water-soluble carrier in such a manner that the content of an oil or fat can be 0.05 to 250 mg / g, the ratio of the content of a poorly-water-soluble drug to the content of the oil or fat (i.e., (poorly-water-soluble drug) / (oil or fat)) can be 0.0001 to 50 by weight (provided that the total content of the poorly-water-soluble drug and the oil or fat is up to 300 mg / g) and the content of an emulsifying agent can be 20 to 500 mg / g.

Description

【Technical field】 [0001] The invention relates to a drug-loaded non-aqueous composition capable of preparing a drug-containing fat emulsion by mixing with an aqueous medium such as water for injection or physiological saline when used, and a preparation method thereof. 【Background technique】 [0002] Those skilled in the art are familiar with the fact that fat emulsions containing drugs, such as those containing steroids (dexamethasone palmitate) and those containing prostaglandins (PGE 1 ) and several emulsions headed by fat emulsions have been listed and widely used. However, among them, there is a limitation that storage in a cold place is required due to poor stability. [0003] As a method of improving the storage stability of a drug-containing fat emulsion, a method of removing the water phase from the emulsion and maintaining it in a dry state is known. However, as a method of removing the water phase from the emulsion, when the method of freeze-drying the emulsion ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/44A61K9/08A61K31/337A61K31/5575A61K31/573A61K47/10
CPCA61K31/337A61K31/5575A61K31/573A61K9/107A61K47/14A61K47/26A61K47/24A61K47/10A61K47/44A61K9/0019A61K9/06
Inventor 锅田喜一郎
Owner 技术防卫株式会社
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