Details for Patent: 7,902,208

Title:	Treating allergic and inflammatory conditions
Abstract:	A method of treating and/or preventing allergic and inflammatory conditions of the skin or upper and lower airway passages, e.g. seasonal allergic rhinitis, perennial allergic rhinitis, or chronic idopathic urticaria, in a human more 12 years old, by administering an amount of desloratadine, e.g. 2.times.2.5 mg or 5 mg/day for a time sufficient to produce a geometric mean steady state maximum plasma concentration of desloratadine in the range of about 2.90 ng/mL to about 4.54 ng/mL, or a arithmetic mean steady state maximum plasma concentration of desloratadine in the range of about 3.2 ng/mL to about 5.0 ng/mL is disclosed.
Inventor(s):	Affrime; Melton B. (Warren, NJ), Banfield; Christopher R. (High Bridge, NJ), Gupta; Samir K. (East Brunswick, NJ), Padhi; Desmond (Thousand Oaks, CA)
Assignee:	Schering Corporation (Kenilworth, NJ)
Filing Date:	May 30, 2008
Application Number:	12/155,250
Claims:	1. A method of treating seasonal or perennial allergic rhinitis in a human of 12 years and older which comprises administering an effective amount of desloratadine for a time sufficient to produce a geometric mean steady state maximum plasma concentration of 3-OH-desloratadine in the range of about 1.50 ng/mL to about 2.34 ng/mL, or an arithmetic mean steady state maximum plasma concentration of 3-OH-desloratadine in the range of about 1.60 ng/mL to about 2.50 ng/mL. 2. The method of claim 1 wherein a geometric mean T.sub.max is in the range of about 4.00 to about 6.25 hours. 3. The method of claim 1 wherein an arithmetic mean steady state maximum plasma concentration of 3-OH-desloratadine in the range of about 1.60 ng/mL to about 2.50 ng/mL is produced. 4. The method of claim 1 wherein an arithmetic mean T.sub.max is in the range of about 3.80 to about 5.95 hours. 5. The method of claim 1 wherein the amount of desloratadine is about 5.0 mg/day, in single or divided doses. 6. The method of claim 1 wherein a geometric mean AUC(0-24 hr) for 3-OH-desloratadine is in the range of about 24.3 ng.hr/mL to about 38.0 ng.hr/mL. 7. The method of claim 1 wherein an arithmetic mean AUC(0-24 hr) for 3-OH-desloratadine is in the range of about 25.8 ng.hr/mL to about 40.4 ng.hr/mL. 8. A method of treating atopic dermatitis or urticaria in a human of 12 years and older which comprises administering an effective amount of desloratadine for a time sufficient to produce a geometric mean steady state maximum plasma concentration of 3-OH-desloratadine in the range of about 1.50 ng/mL to about 2.34 ng/mL, or an arithmetic mean steady state maximum plasma concentration of 3-OH-desloratadine in the range of about 1.6 ng/mL to about 2.50 ng/mL. 9. The method of claim 8 wherein a geometric mean T.sub.max, of 3-OH-desloratadine is in the range of about 4.00 to about 6.25 hours. 10. The method of claim 8 wherein an arithmetic mean T.sub.max of 3-OH-desloratadine is in the range of about 3.80 to about 5.95 hours. 11. The method of claim 8 wherein the amount of desloratadine is about 5.0 mg/day, in single or divided doses. 12. The method of claim 8 wherein a geometric mean AUC(0-24 hr) for 3-OH-desloratadine is in the range of about 24.3 ng.hr/mL to about 38.0 ng.hr/mL. 13. The method of claim 8 wherein an arithmetic mean AUC(0-24 hr) for 3-OH-desloratadine is in the range of about 25.8 ng.hr/mL to about 40.4 ng.hr/mL. 14. A method of treating the nasal and non-nasal symptoms of seasonal and perennial allergic rhinitis and for treating chronic idiopathic urticaria in a human which comprises administering to said human about 5.0 mg of desloratadine once a day for about 10 days to produce a mean time to maximum plasma concentration (T.sub.max) of about 3 hours post dose, a steady state maximum plasma concentration (C.sub.max) of desloratadine of about 4 ng/mL, and an area under the concentration-time curve of about 56.9 ng.hr/mL of desloratadine, wherein a mean steady state maximum plasma concentration (C.sub.max) of 3-OH-desloratadine produced post dose at a mean time to maximum plasma concentration (T.sub.max) of about 4.8 hours, is about 2 ng/mL, and an area under the concentration-time curve of 3-OH-desloratadine is in the range of about 25.8 ng.hr/mL to about 40.4 ng.hr/mL. 15. The method of claim 14 wherein a mean AUC(0-24 hr) for 3-OH-desloratadine is about 32.3 ng.hr/mL. 16. A method of treating the nasal and non-nasal symptoms of seasonal and perennial allergic rhinitis and/or of treating chronic idiopathic urticaria in a human which comprises administering an effective amount of desloratadine for a time sufficient to produce a steady state geometric mean plasma concentration of desloratadine in the range of about 2.90 ng/mL to about 4.54 ng/mL, or a steady state arithmetic mean maximum plasma concentration of desloratadine in the range of about 3.2 ng/mL to about 5.0 ng/mL, wherein an arithmetic mean steady state maximum plasma concentration (C.sub.max) of 3-OH-desloratadine produced post dose at arithmetic mean time to maximum plasma concentration (T.sub.max) in the range of about 3.80 hours to about 5.95 hours, is in the range about 1.60 ng/mL to about 2.50 ng/mL, and an area under the concentration-time curve of 3-OH-desloratadine was in the range of about 25.8 ng.hr/mL to about 40.4 ng.hr/mL. 17. A method of treating chronic idiopathic urticaria in a human of 12 years and older which comprises administering to said human about 5.0 mg of desloratadine once a day for about 10 days to produce at a mean time to maximum plasma concentration (T.sub.max) of about 3 hours post dose, a mean steady state maximum plasma concentration (C.sub.max) of desloratadine of about 4 ng/mL, and an area under the concentration-time curve of about 56.9 ng.hr/mL of desloratadine, wherein a mean steady state maximum plasma concentration (C.sub.max) of 3-OH-desloratadine produced at a mean time to maximum plasma concentration (T.sub.max) of about 4.80 hours post dose, is about 2.0 ng/mL, and an area under the concentration-time curve of 3-OH-desloratadine is about 32.3 ng.hr/mL. 18. A method of treating the nasal and non-nasal symptoms of seasonal and perennial allergic rhinitis in a human of 12 years and older which comprises administering to said human about 5.0 mg of desloratadine once a day for about 10 days to a produce at a mean time to maximum plasma concentration (T.sub.max), of about 3 hours post dose, a mean steady state maximum plasma concentration (C.sub.max) of desloratadine of about 4 ng/mL, and an area under the concentration-time curve of about 56.9 ng.hr/mL of desloratadine, wherein a mean steady state maximum plasma concentration (C.sub.max) of 3-OH-desloratadine produced at a mean time to maximum plasma concentration (T.sub.max) of about 4.80 hours post dose, is about 2.0 ng/mL, and an area under the concentration-time curve of 3-OH-desloratadine is about 32.3 ng.hr/mL.