COMPOSITION COMPRISING AN ANTIBIOTIC AND A CORTICOSTEROID

• US 20100087409A1
• Filed: 06/02/2009
• Published: 04/08/2010
• Est. Priority Date: 06/02/2008
• Status: Abandoned Application

• Current Assignee: Intervet Incorporated
• Original Assignee: Intervet International BV (Merck & Co., Inc.)
• Inventors: Tully, Roger, Brumfield, Jay, Freehauf, Keith A.
• Application Number:
  US12/476,783
• Publication Number:
  US 20100087409A1
• Time in Patent Office: Days
• US Class Current: 514/171
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/496 Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 9/0046 Ear
• CPC Class Codes: A61K 9/10 Dispersions; Emulsions A61K9/06 takes precedence; composition of dispersions, emulsions A61K47/00
• CPC Class Codes: A61K 9/14 Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51
• CPC Class Codes: A61P 27/16 Otologicals
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/10 Antimycotics

Abstract

This invention relates to compositions (e.g., otic compositions) comprising an antibiotic (generally a quinolone or naphthyridinone), corticosteroid, and organic acid (generally a fatty acid). This invention also relates to treatment methods using such a composition, uses of such a composition to make medicaments, and therapeutic kits comprising such a composition.

Claims

1. A pharmaceutical composition, wherein:

the composition comprises;

a corticosteroid,

an antibiotic, and

a fatty acid;

the antibiotic comprises;

a fluoroquinolone, a salt of the fluoroquinolone, or a solvate of the fluoroquinolone or its salt, or

a fluoronaphthyridinone, a salt of the fluoronaphthyridinone, or a solvate of the fluoronaphthyridinone or its salt;

the fatty acid;

comprises from about 3 to about 18 carbon atoms, and has a melting point of no greater than about 60°

C.

2. A composition according to claim 1, wherein the composition is in the form of a suspension.

3. A composition according to claim 1, wherein the corticosteroid comprises mometasone, mometasone furoate, or a solvate of mometasone or mometasone furoate.

4. A composition according to claim 3, wherein the corticosteroid comprises mometasone furoate monohydrate.

5. A composition according to claim 1, wherein the antibiotic comprises a 6-fluoroquinolin-4(1H)-one, a salt of the 6-fluoroquinolin-4(1H)-one, or a solvate of the 6-fluoroquinolin-4(1H)-one or its salt.

6. A composition according to claim 5, wherein the 6-fluoroquinolin-4(1H)-one comprises a 6-fluoroquinolin-4(1H)-one selected from the group consisting of amifloxacin, balofloxacin, ciprofloxacin, clinafloxacin, fleroxacin, garenoxacin, gatifloxacin, grepafloxacin, lomefloxacin, moxifloxacin, norfloxacin, pefloxacin, pradofloxacin, sitafloxacin, sparfloxacin, temafloxacin, danofloxacin, difloxacin, enrofloxacin, sarafloxacin, flumequine, ibafloxacin, levofloxacin, nadifloxacin, ofloxacin, pazufloxacin, prulifloxacin, rufloxacin, and marbofloxacin.

7. A composition according to claim 5, wherein the 6-fluoroquinolin-4(1H)-one comprises orbifloxacin.

8. A composition according to claim 1, wherein the composition further comprises an antifungal agent.

9. A composition according to claim 8, wherein the antifungal agent comprises a triazole, a salt of triazole, or a solvate of the triazole or its salt.

10. A composition according to claim 9, wherein the triazole comprises a triazole selected from the group consisting of fluconazole, itraconazole, saperconazole, terconazole, and voriconazole.

11. A composition according to claim 9, wherein the triazole comprises posaconazole.

12. A composition according to claim 1, wherein the fatty acid comprises lauric acid.

13. A composition according to claim 1, wherein the fatty acid comprises oleic acid.

14. A composition according to claim 1, wherein the composition further comprises mineral oil.

15. A method for treating an infection in an animal, wherein the method comprises administering a composition according to any one of claims 1 to 14 to the animal.

16. A method according to claim 15, wherein the infection comprises an otic infection in a dog.

17. A therapeutic kit, wherein the kit comprises:

a composition according to any one of claims 1 to 14, and

an additional component selected from the group consisting of;

a diagnostic tool,

an otic cleaning solution,

an apparatus for cleaning an ear,

instructions for administering the composition to an animal, and

a device for administering the composition to an animal.