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Difluprednate emulsion composition containing antimicrobial metal

The technology of an emulsion composition and difluprednate, which is applied in the directions of drug combination, emulsion delivery, medical preparations containing active ingredients, etc., can solve the problem of high risk of contamination of the drug solution by opening the cap.

Inactive Publication Date: 2016-01-06
SENJU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Since eye drops, nasal drops, and ear drops are repeated-use preparations rather than single-use preparations, even if they are sterilized before opening the cap, there is a risk of contamination of the drug solution with microorganisms such as bacteria, etc. after opening the cap still extremely high

Method used

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  • Difluprednate emulsion composition containing antimicrobial metal
  • Difluprednate emulsion composition containing antimicrobial metal
  • Difluprednate emulsion composition containing antimicrobial metal

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preparation example Construction

[0080] In the preparation step of the composition of the present invention, antimicrobial metals (except zinc) and additives such as tonicity agents, buffers, etc. can be dissolved in the water phase, or added to the emulsion after emulsification.

[0081] The composition of the present invention is preferably used as a topical preparation for the eyes, nose, ear or skin, and further used as an ophthalmic composition such as eye drops, nasal drops, ear drops or lotions.

[0082] The composition of the present invention has excellent anti-inflammatory effect, excellent anti-allergic effect and excellent antimicrobial effect. Therefore, the composition can be used to prevent or treat various inflammatory diseases or allergic diseases, such as allergic conjunctivitis, vernal conjunctivitis, blepharitis, catarrhal conjunctivitis, uveitis, and those caused by eye surgery Inflammation or pain, macular edema, etc. In addition, the composition can also be advantageously used for topical a...

Embodiment

[0103] The antiseptic effect of the difluprednisolone emulsion composition was studied.

[0104] 1.1 Test method

[0105] As the test microorganisms, Staphylococcus aureus (ATCC6538), Escherichia coli (ATCC8739), and Pseudomonas aeruginosa (ATCC9027) were used. Each test microorganism was inoculated on the surface of the inclined agar medium and pre-cultured. The pre-cultivation is carried out at 30-35°C for 18-24 hours using soybean casein digested agar medium.

[0106] Using the emulsion composition to be tested as a sample, the sample was dispensed into 5 sterile capped test tubes, each of 10 mL. Add pre-cultured test microorganisms to the sample so that the cell count is 10 5 -10 6 Cells / mL to obtain a mixed sample. The test microorganisms are added separately to the sample. Store the mixed sample under light protection at 20-25°C.

[0107] At 6 hours and 24 hours from the start of storage, 1 mL of each mixed sample was measured, and the solution was diluted with saline (9 mL)...

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Abstract

The present invention provides a difluprednate emulsion composition showing immediate effectiveness of preservative efficacy. The immediate effectiveness of preservative efficacy is achieved by adding an antimicrobial metal (excluding zinc). The present invention also provides a method of conferring immediate effectiveness of the preservative efficacy to an emulsion composition comprising difluprednate, the method includes preparing an emulsion composition comprising difluprednate and an antimicrobial metal (excluding zinc).

Description

Technical field [0001] The present invention relates to a difluprednisolone emulsion composition containing antimicrobial metals. More particularly, the present invention relates to an emulsion composition containing difluprednisolone, which exhibits an immediate effect of antiseptic efficacy due to the antimicrobial metal content. Background of the invention [0002] Since eye drops, nose drops, and ear drops are repetitive preparations, not single-use formulations, even if they are sterilized before opening the cap, there is a risk that the uncapped drug solution will be contaminated by microorganisms such as bacteria. Still extremely high. Therefore, in order to prevent this secondary pollution, preservatives such as benzalkonium chloride, chlorhexidine gluconate, and parabens are usually added to aqueous preparations. However, compared with aqueous liquids, it is difficult to impart antiseptic effects to emulsions, and the use of sorbic acid, boric acid and sodium edetate a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/573A61K9/107A61K33/34A61K33/38A61P27/14A61P37/08
CPCA61K9/107A61K33/34A61K33/38A61K9/0048A61K47/26A61K47/44A61K31/573A61P27/02A61P27/14A61P29/00A61P37/08A61K2300/00A61K33/00A61K47/02
Inventor 山口正纯西畑秀一家本凉香安枝真一
Owner SENJU PHARMA CO LTD
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