Ophthalmic or otic and nasal composition containing difluprednate and lavo-ofloxacin and application thereof

A technology of levofloxacin and difluprednate, which is applied in the field of ophthalmic or ear-nasal pharmaceutical compositions, can solve problems such as inability to speculate on the compatibility effect of levofloxacin and difluprednate, incomparability of chemical properties and physical properties, etc.

Inactive Publication Date: 2009-10-28
SHANDONG INST OF PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, dexamethasone and difluprednate are not comparable in terms of chemical and physical properties, and the compatibility effect of levofloxacin and difluprednate cannot be speculated

Method used

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  • Ophthalmic or otic and nasal composition containing difluprednate and lavo-ofloxacin and application thereof
  • Ophthalmic or otic and nasal composition containing difluprednate and lavo-ofloxacin and application thereof
  • Ophthalmic or otic and nasal composition containing difluprednate and lavo-ofloxacin and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Difluprednate 0.05g

[0039] Levofloxacin 0.5g

[0040] Castor oil 5.0g

[0041] Tween 80 4.0g

[0042] Glycerin 2.0g

[0043] Sodium acetate 0.01g

[0044] Boric acid 0.1g

[0045] Disodium ethylenediaminetetraacetic acid 0.02g

[0046] Sorbic acid 0.1g

[0047] Sodium hydroxide amount

[0048] Sterile distilled water, add water to 100ml

[0049] Heat sterile distilled water to 70°C, then add levofloxacin, Tween 80, medicinal glycerin, sodium acetate, boric acid, disodium edetate and sorbic acid of the above formula and dissolve them. The pH is adjusted to 6.0 with sodium hydroxide to obtain an aqueous phase. In addition, the castor oil is heated to about 70° C., and difluprednisolone is added and stirred to dissolve to obtain an oil phase. A homomixer is used to stir the water phase while adding the oil phase to obtain the emulsified crude oil, and finally the emulsified crude oil is split in the microfluidizer, and finally, the pharmaceutical composition of the present i...

example 2

[0051] Difluprednate 0.005g

[0052] Levofloxacin 0.3g

[0053] Castor oil 1.0g

[0054] Tween 80 0.5g

[0055] Glycerin 2.2g

[0056] Sodium acetate 0.05g

[0057] Hydroxypropyl methylcellulose 0.1g

[0058] Chlorobutanol 0.3g

[0059] Sorbic acid 0.1g

[0060] Hydrochloric acid

[0061] Sterile distilled water, add water to 100ml

[0062] Heat sterile distilled water to about 70°C, then add levofloxacin, Tween 80, medicinal glycerin, hydroxypropyl methylcellulose, sodium acetate and chlorobutanol in the above formula and dissolve them. The pH was adjusted to 4.0 with hydrochloric acid to obtain an aqueous phase. In addition, the castor oil is heated to 70° C., difluprednisolone is added, and the mixture is stirred and dissolved to obtain an oil phase. While mixing the water phase with a homomixer, the oil phase is added to obtain the emulsified crude oil. Finally, the emulsified crude oil is split in a microfluidizer, and finally, the pharmaceutical composition of the present in...

example 3

[0064] Difluprednate 0.01g

[0065] Levofloxacin 0.3g

[0066] Miglyol 10.0g

[0067] Polysorbate 5.0g

[0068] Concentrated glycerin 2.2g

[0069] Amino boric acid 0.1g

[0070] Chlorhexidine Gluconate 0.005g

[0071] Sodium hydroxide amount

[0072] Sterile purified water is added to the total amount of 100ml

[0073] Heat sterile purified water to about 70°C, then add levofloxacin, polysorbate, concentrated glycerin, aminoboronic acid and chlorhexidine gluconate of the above formula and dissolve them, and adjust the pH to 5.5 with sodium hydroxide to obtain water box. In addition, Miglyol was heated to about 70°C, and difluprednisolone was added and dissolved to obtain an oil phase. While mixing the water phase with a homomixer, the oil phase is added to obtain the emulsified crude oil. Finally, the emulsified crude oil is split in a microfluidizer, and then filtered and sterilized to obtain the composition of the present invention. The average particle size of the oil droplets...

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PUM

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Abstract

The invention provides an ophthalmic or otic and nasal pharmaceutical composition, which comprises lavo-ofloxacin and salts thereof and difluprednate, wherein the weight ratio of the difluprednate to the lavo-ofloxacin is 1:1-1:10. The ophthalmic or otic and nasal medicament composition is applied to treating conjunctivitis, keratitis, eyelid inflammation, dacryocystitis, hordeolum, corneal ulcer and eye infections with inflammations of eyes or surrounding tissues, or preventing increased risk of bacterial infections and tissue inflammations of infected parts after ophthalmic surgeries or eye injuries, or treating or relieving the bacterial infections combined with tissue inflammations of the infected parts after the ophthalmic surgeries, or treating otitis media, otitis externa and infectious rhinitis.

Description

Technical field [0001] The present invention relates to a pharmaceutical composition for ophthalmology or ear and nose, and more specifically, to a pharmaceutical composition comprising levofloxacin or a pharmaceutically acceptable salt thereof and difluprednate. The invention also relates to the preparation and use of the composition. Background technique [0002] Eye infections are often accompanied by inflammation of the eye and even surrounding tissues. Eye surgery or eye trauma often increases the risk of bacterial infection and inflames the tissues of the infected site. Therefore, it is very important to have one or more antibiotics with anti-infective effects and one or more steroidal or non-steroidal anti-inflammatory drugs with anti-inflammatory effects in the form of a single preparation compound preparation. [0003] The drug marketed in the United States is a single preparation of difluprednisolone, the trade name is Durezol, and it is an ophthalmic emulsion of 0.05% ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/573A61K31/5383A61P27/02A61P27/16A61P11/02A61P31/04
Inventor 刘宪华宋海波张岱州王功霞曹冲
Owner SHANDONG INST OF PHARMA IND
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