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Anti-aggregation agent, and pharmaceutical composition and medical device using same

A technology of aggregating agent and composition, which can be used in drug combinations, pharmaceutical formulations, medical preparations of inactive ingredients, etc., and can solve problems such as difficulty in aggregation

Pending Publication Date: 2022-07-22
NIPRO CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, even with the above-mentioned technology, the mixing of silicone oil cannot be completely avoided, and it is difficult to say that the aggregation of poorly water-soluble chemicals can be sufficiently suppressed.

Method used

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  • Anti-aggregation agent, and pharmaceutical composition and medical device using same
  • Anti-aggregation agent, and pharmaceutical composition and medical device using same
  • Anti-aggregation agent, and pharmaceutical composition and medical device using same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] (Example 1: Test suspension containing aripiprazole)

Embodiment 1-1-1

[0076] (Example 1-1-1: Preparation and evaluation of test suspension using polyoxyethylene cetyl ether)

[0077] Aripiprazole hydrate, sodium carboxymethyl cellulose, mannitol, and sodium dihydrogen phosphate monohydrate, which are poorly water-soluble drugs, were added to purified water to achieve the following concentrations to prepare an aripiprazole suspension.

[0078] ・Aripiprazole hydrate: 30% by mass (as anhydrous);

[0079] ・Sodium carboxymethylcellulose: about 1.248% by mass;

[0080] ・Mannitol: about 6.24% by mass;

[0081] ・Sodium dihydrogen phosphate monohydrate: about 0.111% by mass.

[0082] To 1 g of the aripiprazole suspension, only an amount equivalent to 4 parts by mass of polyoxyethylene cetyl ether was added as an anti-aggregation agent with respect to 100 parts by mass of aripiprazole contained in the suspension, and the Stir. To the suspension was added 1% silicone oil emulsion (Dow Corning (registered trademark) 365, 35% dimethicone NF Elusion; here...

Embodiment 1-1-2～1-1-7

[0083] (Examples 1-1-2 to 1-1-7: Preparation and evaluation of test suspensions using polyoxyethylene cetyl ether)

[0084] To the test suspension (E1-1-1) (suspension before ultrasonic treatment) obtained in Example 1-1-1, 1% of silicone oil emulsion was added, respectively, so that the silicone oil contained in the suspension was adjusted to 100% by mass. Part of aripiprazole was in the amount shown in Table 1, and the test suspensions (E1-1-2) to (E1-1-7) were prepared to obtain the test suspensions (E1-1-2) to (E1 -1-7). The particle sizes of particles contained in the test suspensions before (a) and after (b) ultrasonication were measured for each test suspension. The results are shown in Table 1.

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PUM

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Abstract

This anti-aggregation agent contains, as an anti-aggregation component, at least one substance selected from the group consisting of polyoxyethylene cetyl ether, polyoxyethylene sorbitan fatty acid ester, and polyoxyethylene polyoxypropylene glycol (ether) having an average molecular weight of 3000-13000. According to the present invention, it is possible to prevent the poorly water-soluble agent from aggregating by silicone oil in a container whose inner wall has been treated by the silicone oil.

Description

technical field [0001] The present invention relates to an anti-aggregation agent and a pharmaceutical composition and medical device using the same. Background technique [0002] When a poorly water-soluble drug such as aripiprazole hydrate for the treatment of schizophrenia is administered in the form of an injection, the drug is dispersed in water in advance to prepare an aqueous suspension, which is then directly administered to the The patient is injected, or it is in the form of a solid (freeze-dried product, etc.) such as powder or cake, and it is suspended in water for immediate use and injected into the patient. Here, the aqueous suspension or solid matter (lyophilized matter, etc.) is stored and distributed in a vial or in a so-called prefilled syringe (prefilled syringe) such as a double-chamber syringe. When stored in a vial, it is drawn out with a general-purpose syringe and administered to a patient immediately before use. [0003] However, in the above-menti...

Claims

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Application Information

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IPC IPC(8): A61K47/10A61K47/26A61K47/34A61M5/28A61P25/18A61K9/10A61K9/19A61K31/496
CPCA61K47/10A61K9/10A61K47/34A61K47/26A61P25/18A61K9/19A61K31/496A61K31/44A61K31/55A61K47/02A61K47/38A61L31/10
Inventor 藤田瑞乃守谷美友纪佐藤慎吉初鹿稔
Owner NIPRO CORP
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