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Topical otic compositions and methods of topical treatment of prevention of otic infections

A kind of composition, the technology of topical application, be used in the field of azalide antibiotic in the treatment and/or prevention of ear infection

Inactive Publication Date: 2007-02-28
INSITE VISION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Oral antibiotics for ear infections in children have limited efficacy and serious risk of developing pathogen resistance to oral antibiotics

Method used

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  • Topical otic compositions and methods of topical treatment of prevention of otic infections
  • Topical otic compositions and methods of topical treatment of prevention of otic infections
  • Topical otic compositions and methods of topical treatment of prevention of otic infections

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-2

[0074] Hydroxypropylmethylcellulose, sodium chloride, edetate sodium (EDTA), BAK, and surfactant were dissolved in a beaker containing about 1 / 3 final weight of water and stirred with an overhead stirrer for 10 minutes. Add azithromycin and stir to disperse for 30 minutes. The solution was autoclaved at 121°C for 20 minutes. As an alternative, azithromycin can be dry heat sterilized and added as a sterile powder after sterilization. Mannitol, Poloxamer 407 and boric acid were each dissolved in about 1 / 2 final weight of water and added via sterile filtration (0.22 μm filter) and stirred for 10 minutes to form a mixture. The mixture is adjusted to the desired pH with 10 N sodium hydroxide with stirring, brought to final weight with water, sterile filtered and aseptically filled into multi-dose containers.

Embodiment 3-6

[0076] Slowly disperse Noveon AA-1 into a beaker containing about 1 / 3 final weight of water and stir with an overhead stirrer for 1.5 hours. Noveon AA-1 is an acrylic polymer available from B.F. Goodrich. Edetate sodium (EDTA), sodium chloride, BAK and surfactants were then added to the polymer solution and stirred for 10 minutes after each addition. The pH of the polymer suspension is about 3.0-3.5. Add azithromycin and stir to disperse for 30 minutes. The mixture was autoclaved at 121°C for 20 minutes. As an alternative, azithromycin can be dry heat sterilized and added as a sterile powder after sterilization. Mannitol and boric acid, or sodium perborate, Dequest, mannitol, and boric acid were each dissolved in approximately 1 / 2 final weight of water, sterile filtered (0.22 μm filter) and added to the polymer mixture and stirred for 10 minutes. The mixture is adjusted to the desired pH with 10 N sodium hydroxide with stirring, brought to final weight with water, sterile ...

Embodiment 7

[0078] Noveon AA-1 was slowly dispersed into a beaker containing about 1 / 2 final weight of water and stirred with an overhead stirrer for 1.5 hours. Noveon AA-1 is an acrylic polymer available from B.F. Goodrich. Edetate sodium (EDTA), Poloxamer 407 and sodium chloride were then added to the polymer suspension and stirred for 10 minutes. The pH of the polymer suspension is about 3.0-3.5. Add azithromycin and stir to disperse for 30 minutes. The mixture was autoclaved at 121°C for 20 minutes. As an alternative, azithromycin can be dry heat sterilized and added as a sterile powder after sterilization. Mannitol was dissolved in 1 / 10 final weight of water and sterile filtered (0.22 μm filter) was added to the polymer suspension and stirred for 10 minutes. The mixture is adjusted to the desired pH with 10 N sodium hydroxide with stirring, brought to final weight with water, sterile filtered and aseptically filled into unit dose containers.

[0079] ...

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Abstract

A topical otic composition containing an azalide antibiotic. A topical otic composition containing an azalide antibiotic and a medicament. A topical otic composition containing an azalide antibiotic and a polymer suspending agent. And methods for treating of preventing infections in the ear using azalide antibiotic compositions.

Description

1. Technical field [0001] The present invention relates to topical otic compositions comprising an azalide antibiotic and to the use of an azalide antibiotic in a method of treating and / or preventing ear infections. 2. Background technology [0002] Azalide antibiotic preparations are known for the treatment of ocular infections. See US Patents 6,239,113 B1 and 6,569,443 B1 and US Patent Application Publication 2003 / 0206956 Al and 2003 / 0143259 Al to InSite Vision, Inc. [0003] Ear infections can be treated with local injections, systemic administration, or topical administration of antibiotics. However, treating infections in ear tissue remains challenging and / or problematic due to difficulties in delivering antibiotics to infected tissue. [0004] The simple and direct method of topical administration of antibiotics to the ear has several benefits, including avoiding side effects and reducing the chance of developing resistant bacterial strains compared to systemic admin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7048A61P27/16
CPCA61K9/0046A61K31/7048A61K31/192A61K31/195A61P27/16A61P31/00A61P31/04A61K31/7042
Inventor 莱尔·M·鲍曼桑托什·库马尔·钱德拉塞克兰埃尔温·C·西
Owner INSITE VISION
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