Claims for Patent: 8,337,814

Summary for Patent: 8,337,814

Title:	Treatment of active infections, sinusitis, rhinitis, and related neurological disorders and related compositions
Abstract:	The present invention is directed to the treatment of infections and the associated symptoms of sinusitis, rhinitis and related neurological disorders of the cranial cavity and facial tissue. More specifically, the present invention is directed to aerosols that are used to treat infections and the associated symptoms of sinusitis, rhinitis and related neurological disorders of the cranial cavity and facial tissue, compositions from which the aerosols are generated and methods of generating the aerosols. In an aerosol aspect of the present invention, an aerosol for delivery to the sinus cavity of a patient is provided. The aerosol includes at least: a) one or more compounds selected from antibiotics, antifungals, leukotriene antagonists, anti-TNF compounds, antihistamines, steroidal antiinflammatories, mucolytics, estrogen, progesterone and related hormones; and, b) water The compounds are present in the water at a concentration ranging from 0.01 mg/kg to 1000 mg/kg, and the aerosol does not contain a surfactant.
Inventor(s):	Osbakken; Robert Scott (Camarillo, CA), Reitz; Russell N. (Camarillo, CA), Tarrant; John C. (Camarillo, CA)
Assignee:	Topical Sinus Therapeutics, Inc. (Camarillo, CA)
Application Number:	12/097,230
Patent Claims:	1. A method of delivering a medication aerosol for treating sinusitis or rhinitis, and related neurological disorders of the cranial cavity and facial tissue, wherein the method comprises creating the medication aerosol by passing a liquid composition through a filter, wherein: the filter comprises pores; the medication aerosol and the liquid composition do not contain a surfactant: and the liquid composition comprises one or more compounds selected from the group consisting of antifungals, leukotriene antagonists, anti-TNF compounds, antihistamines, mucolytics, estrogen and progesterone. 2. The method according to claim 1, wherein the filter pores range in size from 1 .mu.m to 6 .mu.m. 3. The method according to claim 2, wherein the filter pores are placed such that the distance between filter pore centers ranges from 15 .mu.m to 150 .mu.m. 4. The method according to claim 3, wherein the liquid composition comprises an antibiotic, and wherein the antibiotic is selected from the group of antibiotic classes consisting of: cephalosporins, penicillins, aminoglycocides, quinolones, tetracyclines and macrolides. 5. The method according to claim 3, wherein the liquid composition comprises an antiviral, and wherein the antiviral is selected from the group consisting of oseltamivir, acyclovir and rimantadine. 6. The method according to claim 3, wherein the liquid composition comprises an antifungal, and wherein the antifungal is selected from the group consisting of amphotericin B, fluconazole, itraconazole and liposomal amphotericin. 7. The method according to claim 3, wherein the liquid composition comprises a leukotriene antagonist, and wherein the leukotriene antagonist is selected from the group consisting of montelukast and zafirlukast. 8. The method according to claim 3, wherein the liquid composition comprises an antihistamine, and wherein the antihistamine is azelastin. 9. The method according to claim 3, wherein the liquid composition comprises a steroidal anti-inflammatory and wherein the anti-inflammatory is selected from the group consisting of budesonide, betamethasone and mometasone. 10. The method according to claim 3, wherein the liquid composition comprises a mucolytic, and wherein the mucolytic is selected from the group consisting of acetylcysteine and dornase alpha. 11. The method according to claim 1, wherein the liquid composition is stored in a reservoir being sealed and pressurized. 12. The method according to claim 11, wherein the reservoir is pressurized between 30 psi and 300 psi. 13. The method according to claim 11, wherein the reservoir is pressurized by a pump or by a mechanical piston. 14. The method according to claim 1, wherein the liquid composition comprises one or more compounds selected from the group consisting of anti-TNF compounds, estrogen, and progesterone. 15. A medication aerosol for delivery to the sinus cavity of a patient, wherein the aerosol comprises: (a) one or more compounds selected from antifungals, leukotriene antagonists, anti-TNF compounds, antihistamines, mucolytics, estrogen and progesterone; and (b) water; wherein: the compounds are present in the water at a concentration ranging from 0.01 mg/ml to 1000 mg/ml; the medication aerosol is made using a method comprising creating the medication aerosol by passing a liquid composition through a filter, and wherein the filter comprises pores, thereby forming the aerosol; and the medication aerosol and the liquid composition do not contain a surfactant. 16. The aerosol according to claim 15, wherein the filter pores range in size from 1.mu.m to 6.mu.m. 17. The aerosol according to claim 16, wherein the filter pores are placed such that the distance between filter pore centers ranges from 15 .mu.m to 150 .mu.m. 18. The aerosol according to claim 17, wherein the aerosol comprises an antiviral, and wherein the antiviral is selected from the group consisting of oseltamivir, acyclovir and rimantadine. 19. The aerosol according to claim 17, wherein the aerosol comprises an antifungal, and wherein the antifungal is selected from the group consisting of amphotericin B, fluconazole, itraconazole and liposomal amphotericin. 20. The aerosol according to claim 17, wherein the aerosol comprises a leukotriene antagonist, and wherein the leukotriene antagonist is selected from the group consisting of montelukast and zafirlukast. 21. The aerosol according to claim 17, wherein the aerosol comprises an anti-TNF compound, and wherein the anti-TNF compound is selected from the group consisting of infliximab, etanercept, adalimumab. 22. The aerosol according to claim 17, wherein the aerosol comprises an antihistamine, and wherein the antihistamine is azelastin. 23. The aerosol according to claim 17, wherein the aerosol comprises a steroidal antiinflammatory, and wherein the anti-inflammatory is selected from the group consisting of budesonide, betamethasone and mometasone. 24. The aerosol according to claim 17, wherein the aerosol comprises a mucolytic, and wherein the mucolytic is selected from the group consisting of acetylcysteine and dornase alpha. 25. The aerosol according to claim 15, wherein the liquid composition is stored in a reservoir being sealed and pressurized. 26. The aerosol according to claim 25, wherein the reservoir is pressurized between 30 psi and 300 psi. 27. The aerosol according to claim 25, wherein the reservoir is pressurized by a pump or by a mechanical piston. 28. The aerosol according to claim 15, wherein the liquid composition comprises one or more compounds selected from the group consisting of anti-TNF compounds, estrogen, and progesterone.

Details for Patent 8,337,814

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2039-02-26
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2039-02-26
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2039-02-26