WO2011094504A4

WO2011094504A4 - Antimicrobial sinus irrigation compositions, methods, and devices

Info

Publication number: WO2011094504A4
Application number: PCT/US2011/022874
Authority: WO
Inventors: Aron M. Shapiro; Peter N. Friedensohn; Leo P. Menard; Stephanie K. Lynch; George E. Minno; Jacquelyn M. Nice
Original assignee: Ora, Inc.
Priority date: 2010-01-28
Filing date: 2011-01-28
Publication date: 2012-02-16
Also published as: WO2011094504A3; WO2011094504A2

Abstract

This application discloses topical sinus irrigation formulations, uses thereof, and delivery devices thereof.

Claims

AMENDED CLAIMS received by the International Bureau on 23 December 2011 (23.12.2011 )

1. A single-use nasal irrigation delivery device comprising;

a single-use reservoir and an irrigator tip, wherein the single-use reservoir is configured for controlled collapsing to dispense nasal irrigation fluid from the reservoir through a reservoir outlet at the irrigator tip, wherein the irrigator tip is configured to create a seal to the nostril in order to direct a stream of antimicrobial fluid into the sinuses.

2. The single-use nasal irrigation delivery device of claim 1 , wherein the reservoir has a volume capacity of from about 1 ml to about 500 ml.

3. The single-use nasal irrigation delivery device of claim 1 , wherein the irrigator tip has an extension so that the intranasal release of liquid occurs more proximal to the sinuses than with traditional sinus rinse bottles.

4. The single-use nasal irrigation delivery device of claim 1 , wherein the reservoir is shaped like a bellows to allow for controlled collapsing and for the expulsion of the total liquid volume contained in the device without the need for a Straw.

5. The single-use nasal irrigation delivery device of claim 1 , wherein the device is

manufactured so that its liquid contents are sterile.

6. The single-use nasal irrigation delivery device of claim 1 , wherein the device contains a substance comprising one or more pharmaceutical substances selected from the group consisting of an antihistamine agent, a decongestant (vasoconstrictor), an anti-allergy agent, an anti-inflammatory agent (e.g., non-steroidal anti-inflammatory (NSAID) or

corticosteroid), or any combination or mixture thereof,

7. The single-use nasal irrigation delivery device of any one of claims 1 to 5 or any combination of claims 1 to 5, wherein the reservoir contains an antimicrobial nasal irrigation fluid useful for treatment of sinusitis, wherein the antimicrobial nasal irrigation fluid comprises an antimicrobial agent in a therapeutically effective amount, a buffered isotonic, hypertonic, or hypertonic solution having a pH between about 4 and 9, and one or more tastemasking agents selected from the group consisting of sweeteners, a flavoring agents and fragrances.

8. An antimicrobial nasal irrigation fluid useful for treatment of sinusitis, comprising:

an antimicrobial agent in a therapeutically effective amount, a buffered isotonic, hypotonic, or hypertonic solution having a pH between about 4 and 9, and one or more tastemasking agents selected from the group consisting of sweeteners, flavoring agents and fragrances.

9. The antimicrobial nasal irrigation fluid of claim 8, wherein the antimicrobial agent is selected from the group consisting of cephalosporins, penicillins, penicillins, beta lactamase inhibitors, carbepenems, monobactams, macrolides, lincosamines, lipopeptide,

glycopeptides, lipoglycopeptides, carbapenem, rifampin, oxazolidonones, tetracyclines, aminoglycosides, streptogramins, and sulfonamides and combinations thereof.

10. The antimicrobial nasal irrigation fluid of claim 8, wherein the antimicrobial agent is a

quinolone, fluoroquinolone, heteroaryl isothiazolone, or a isothiazoloquinolone,

1 1. The antimicrobial nasal irrigation fluid of claim 8, wherein the antimicrobial agent is

levofloxacin.

12. The antimicrobial nasal irrigation fluid of claim 8, wherein the antimicrobial agent has a concentration from about 0.1% to about 30%.

13. The antimicrobial nasal irrigation fluid of any one of claims 7 to 12, further comprising one or more pharmaceutical substances selected from the group consisting of an antihistamine agent, a decongestant (vasoconstrictor), an anti-allergy agent, an anti-inflammatory agent (e.g., non-steroidal anti-inflammatory (NSAID) οτ corticosteroid), or any combination or mixture thereof.

14. A method of treating a patient with sinusitis comprising intranasally administering to said patient a therapeutically effective amount of the antimicrobial nasal irrigation fluid of any one of claims 7 to 13 using the device of any one of claims 1 to 5 or any combinations of claims 1 to 5.

15. The method of claim 14, wherein the sinusitis is the result of microbial infection.

16. The method of claim 14, wherein the sinusitis is the result of bacterial infection.

17. A nasal irrigation fluid useful for treatment of a medical condition of the sinonasal tract, comprising: one or more pharmaceutical substances selected from the group consisting of an antimicrobial, an antihistamine agent, a decongestant (vasoconstrictor), an anti-allergy agent, a fibrotic agent, an anti-inflammatory agent {e.g., non-steroidal anti-inflammatory (NSAID) or corticosteroid), a pro-coagulant agent, an anti-fibrotic agent, an anti -metabolite agent, an anti-cancer agent, a surfactant or any combination or mixture thereof in a therapeutically effective amount, a buffered isotonic, hypotonic, or hypertonic solution having a pH between about 4 and 9, and one or more tastemasking agents selected from the group consisting of sweeteners, flavoring agents and fragrances.

18. A method of treating a patient with a medical condition of the sinonasal tract comprising intranasally administering to said patient a therapeutically effective amount of the nasal irrigation fluid of claim 17.

19. A method of treating a patient with a medical condition of the sinonasal tract comprising intranasally administering to said patient a therapeutically effective amount of the nasal irrigation fluid of claim 18 using the device of any one of claims 1 to 5 or any combination of claims 1 to 5.

20. The single-use nasal irrigation delivery device of any one of claims 1 to 5 or any combination of claims 1 to 5, wherein the reservoir contains a nasal irrigation fluid useful for treatment of a medical condition of the sinonasal tract, comprising: one or more pharmaceutical substances selected from the group consisting of an antimicrobial, an antihistamine agent, a decongestant (vasoconstrictor), an anti-allergy agent, a fibrotic agent, an anti-inflammatory agent (e.g., non-steroidal anti-inflammatory (NSAID) or corticosteroid), a pro-coagulant agent, an anti-fibrotic agent, an anti-metabolite agent, an anti-cancer agent, a surfactant or any combination or mixture thereof in a therapeutically effective amount, a buffered isotonic, hypotonic, or hypertonic solution having a pH between about 4 and 9, and one or more tastemasking agents selected from the group consisting of sweeteners, flavoring agents and fragrances.