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Claims for Patent: 7,405,223

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Claims for Patent: 7,405,223

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)
Application Number:09/760,588
Patent Claims: 1. A method of administering a pharmaceutical composition, wherein the method comprises: administering the pharmaceutical composition, comprising desloratadine and a suitable, inert pharmaceutically acceptable carrier or diluent, to target a pharmacokinetic (pK) profile for desloratadine comprising an arithmetic or geometric mean steady state maximum plasma concentration (C.sub.max) of desloratadine of about 4 ng/mL, and an arithmetic or geometric mean time to maximum plasma concentration (T.sub.max) of desloratadine of about 3 hours post dose.

2. The method of claim 1, wherein the pharmaceutical composition comprises about 5.0 mg of desloratadine.

3. The method of claim 2, wherein the pharmaceutical composition is administered once a day.

4. The method of claim 1 wherein the desloratadine is in a free base form.

5. A method of administering a pharmaceutical composition, comprising: administering the pharmaceutical composition, comprising desloratadine and a suitable, inert pharmaceutically acceptable carrier or diluent, once a day for about 10 days, wherein said administering is carried out to target a pharmacokinetic (pK) profile comprising an arithmetic or geometric mean steady state maximum plasma concentration (C.sub.max) of desloratadine of about 4 ng/mL, and an arithmetic or geometric mean time to maximum plasma concentration (T.sub.max) of desloratadine of about 3 hours post dose.

6. The method of claim 5, wherein the pharmaceutical composition comprises about 5.0 mg of desloratadine.

7. The method of claim 5, wherein the desloratadine is in a free base form.

8. A method of administering a pharmaceutical composition comprising: administering the pharmaceutical composition, comprising desloratadine and a suitable, inert pharmaceutically acceptable carrier or diluent, for a period of time to target the establishment of a steady-state pharmacokinetic (pK) profile in the bloodstream of a patient comprising an arithmetic or geometric mean steady state maximum plasma concentration (C.sub.max) of desloratadine of about 4 ng/mL, and an arithmetic or geometric mean time to maximum plasma concentration (T.sub.max) of desloratadine of about 3 hours post dose.

9. The method of claim 8, wherein the pharmaceutical composition comprises about 5.0 mg of desloratadine.

10. The method of claim 8, wherein the desloratadine is in a free base form.

11. A method of achieving a pharmacokinetic (pK) profile of desloratadine that is safe and effective for treating nasal and non-nasal symptoms of seasonal and perennial allergic rhinitis and for treating symptoms of chronic idiopathic urticaria in a human 12 years or older, comprising: administering a dosage form comprising desloratadine and a suitable, inert pharmaceutically acceptable carrier or diluent, wherein said administering is carried out to target the pK profile and wherein the pK profile comprises an arithmetic or geometric mean steady state maximum plasma concentration (C.sub.max) of desloratadine of about 4 ng/mL, and an arithmetic or geometric mean time to maximum plasma concentration (T.sub.max) of desloratadine of about 3 hours post dose.

12. A method of treating nasal and non-nasal symptoms of seasonal and perennial allergic rhinitis in a human of 12 years and older comprising: administering a dosage form comprising desloratadine and a suitable, inert pharmaceutically acceptable carrier or diluent, wherein said administering is carried out to target a pharmacokinetic (pK) profile that is safe and effective for treating the allergic rhinitis symptoms, and wherein the pK profile comprises an arithmetic or geometric mean steady state maximum plasma concentration (C.sub.max) of desloratadine of about 4 ng/mL, and an arithmetic or geometric mean time to maximum plasma concentration (T.sub.max) of desloratadine of about 3 hours post dose.

13. A method of treating symptoms of chronic idiopathic urticaria in a human of 12 years and older comprising: administering a dosage form comprising desloratadine and a suitable, inert pharmaceutically acceptable carrier or diluent, wherein said administering is carried out to target a pharmacokinetic (pK) profile that is safe and effective for treating the chronic idiopathic urticaria symptoms, and wherein the pK profile comprises an arithmetic or geometric mean steady state maximum plasma concentration (C.sub.max) of desloratadine of about 4 ng/mL, and an arithmetic or geometric mean time to maximum plasma concentration (T.sub.max) of desloratadine of about 3 hours post dose.

14. The method of any of claims 11, 12 or 13, wherein said administering is carried out according to a dosage regimen comprising administering the dosage form once a day for about 10 days.

15. The method of any of claims 11, 12 or 13, wherein said dosage form comprises about 5.0 mg of desloratadine.

16. The method of any of claims 11, 12 or 13, wherein the desloratadine is in a free base form.
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