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Claims for Patent: 8,187,630

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Claims for Patent: 8,187,630

Title:Extended release oral dosage composition
Abstract: A bilayer solid composition comprising (a) an immediate release first layer comprising an anti-allergic effective amount of desloratadine and at least one pharmaceutically acceptable excipient and (b) a sustained release second layer comprising an effective amount of a nasal decongestant, e.g. pseudoephedrine sulfate and a pharmaceutically acceptable sustained release agent wherein the composition contains less than about 2% of desloratadine decomposition products is disclosed. A solid composition comprising an anti-allergic effective amount of desloratadine and at least one, and preferably two pharmaceutically acceptable antioxidants is also disclosed.
Inventor(s): Cho; Wing-Kee Philip (Princeton, NJ)
Assignee: Schering-Plough Corporation (Kenilworth, NJ)
Application Number:12/573,022
Patent Claims: 1. A solid composition comprising: (1) an immediate release layer comprising an anti-allergic effective amount of desloratadine and a desloratadine-protective amount of two pharmaceutically acceptable antioxidants; and (2) a sustained release layer comprising an effective amount of pseudoephedrine or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable sustained release agent; wherein the total amount of desloratadine degradation products in the solid composition is less than or equal to about 2% by weight, and wherein at least about 80% of the desloratadine dissolves in a 0.1N HCl solution at 37.degree. C. in about 45 minutes.

2. The solid composition of claim 1 wherein the two pharmaceutically acceptable antioxidants are edetate disodium and citric acid.

3. A solid composition comprising: (1) an immediate release first layer comprising an anti-allergic effective amount of desloratadine and at least one pharmaceutically acceptable antioxidant; and (2) a sustained release second layer comprising an effective amount of pseudoephedrine or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable sustained release agent; wherein the total amount of desloratadine degradation products in the solid composition is less than or equal to about 2% by weight, and wherein at least about 80% of the desloratadine dissolves in a 0.1N HCl solution at 37.degree. C. in about 45 minutes.

4. A solid composition comprising: (1) an immediate release first layer comprising about 2.5 mg of desloratadine and a desloratadine-protective amount of at least one pharmaceutically acceptable antioxidant; (2) a sustained release second layer comprising about 120 mg of pseudoephedrine or a pharmaceutically acceptable salt thereof; and (3) a pharmaceutically acceptable excipient, wherein at least about 80% of the desloratadine dissolves in a 0.1N HCl solution at 37.degree. C. in about 45 minutes.

5. The solid composition of claim 4 wherein the total amount of desloratadine degradation products is less than or equal to about 2% by weight.

6. The solid composition of claim 4 wherein a desloratadine-protective amount of a pharmaceutically acceptable binder is present in the sustained release second layer.

7. The solid composition comprising a first and a second layer wherein the first layer is an immediate release layer comprising: TABLE-US-00021 INGREDIENT mg/composition Desloratadine, micronized 5.0 Corn Starch 36.0 Microcrystalline Cellulose 140.7 Edetate Disodium 10.0 Citric Acid 2.0 Talc 6.0 Dye 0.30 TOTAL 200.00

and wherein the second layer is a sustained release layer comprising: TABLE-US-00022 INGREDIENT mg/composition Pseudoephedrine Sulfate 120.0 Hydroxypropyl Methylcellulose 2208, 100,000 cps 105.0 Microcrystalline Cellulose 103.5 Hydroxypropyl Methylcellulose 2910 10.5 Edetate Disodium 3.5 Silicon Dioxide 5.0 Magnesium Stearate (Non-Bovine) 2.5 TOTAL 350.0 TOTAL Tablet Weight 550.0

wherein the total amount of desloratadine degradation products in the solid composition is less than or equal to about 2% by weight.

8. A solid composition comprising a first layer and a second layer, wherein the first layer is an immediate release first layer comprising: TABLE-US-00023 INGREDIENT mg/composition Desloratadine, micronized 2.5 Corn Starch 18.0 Microcrystalline Cellulose 71.22 Edetate Disodium 5.0 Citric Acid 1.0 Talc 3.0 Dye 0.28 TOTAL 100.00

and wherein the second layer is a sustained release layer comprising: TABLE-US-00024 INGREDIENT mg/composition Pseudoephedrine Sulfate 120.0 Hydroxypropyl Methylcellulose 2208 105.0 Microcrystalline cellulose 103.5 Edetate Disodium 3.5 Hydroxypropyl Methylcellulose 2910 10.5 Silicon Dioxide 5.0 Magnesium stearate 2.5 TOTAL 350.0

and wherein total amount of desloratadine degradation products in the solid composition is less than or equal to about 2% by weight.

9. The solid composition of claim 8 wherein at least about 80% of the desloratadine dissolves in a 0.1N HCl solution at 37.degree. C. in about 45 minutes.

10. A method of treating allergic or inflammatory conditions of the upper and lower airway passages and skin which comprises administering to a patient in need of such treating an effective amount of the solid composition of claim 1.

11. A method of treating the signs and symptoms of nasal congestion associated with allergic and inflammatory conditions of the upper or lower airway passages and skin which comprises administering to a patient in need of such treating an effective amount of the solid composition of claim 1.

12. A method of treating the signs and symptoms of nasal congestion associated with allergic or inflammatory conditions of the upper and lower airway passages and skin which comprises administering to a patient in need of such treating an effective amount of the solid composition of claim 3.

13. A method of treating the signs and symptoms of nasal congestion associated with allergic or inflammatory conditions of the upper and lower airway passages and skin which comprises administering to a patient in need of such treating an effective amount of the solid composition of claim 4.

14. A method of treating the signs and symptoms of nasal congestion associated with allergic or inflammatory conditions of the upper and lower airway passages and skin which comprises administering to a patient in need of such treating an effective amount of the solid composition of claim 8.

15. A method of treating the signs and symptoms of urticaria which comprises administering to a patient in need of such treating an effective amount of the solid composition of claim 1.

16. A method of treating the signs and symptoms of urticaria which comprises administering to a patient in need of such treating an effective amount of the solid composition of claim 3.

17. A method of treating the signs and symptoms of urticaria which comprises administering to a patient in need of such treating an effective amount of the solid composition of claim 4.

18. A method of treating the signs and symptoms of urticaria which comprises administering to a patient in need of such treating an effective amount of the solid composition of claim 7.

19. A method of treating the signs and symptoms of urticaria which comprises administering to a patient in need of such treating an effective amount of the solid composition of claim 8.

20. A method of treating the nasal and non-nasal symptoms of perennial or seasonal allergic rhinitis which comprises administering to a patient in need of such treating an effective amount of the solid composition of claim 1.

21. A method of treating the nasal and non-nasal symptoms of perennial or seasonal allergic rhinitis which comprises administering to a patient in need of such treating an effective amount of the solid composition of claim 3.

22. A method of treating the nasal and non-nasal symptoms of perennial or seasonal allergic rhinitis which comprises administering to a patient in need of such treating an effective amount of the solid composition of claim 4.

23. A method of treating the nasal and non-nasal symptoms of perennial or seasonal allergic rhinitis which comprises administering to a patient in need of such treating an effective amount of the solid composition of claim 7.

24. A method of treating the nasal and non-nasal symptoms of perennial or seasonal allergic rhinitis which comprises administering to a patient in need of such treating an effective amount of the solid composition of claim 8.

25. A method of treating allergic or inflammatory conditions of the upper and lower airway passages and skin which comprises administering to a patient in need of such treating an effective amount of the solid composition of claim 3.

26. A method of treating allergic or inflammatory conditions of the upper and lower airway passages and skin which comprises administering to a patient in need of such treating an effective amount of the solid composition of claim 4.

27. A method of treating allergic or inflammatory conditions of the upper and lower airway passages and skin which comprises administering to a patient in need of such treating an effective amount of the solid composition of claim 7.

28. A method of treating allergic or inflammatory conditions of the upper and lower airway passages and skin which comprises administering to a patient in need of such treating an effective amount of the solid composition of claim 8.

29. A method of treating the signs and symptoms of nasal congestion associated with allergic and inflammatory conditions of the upper or lower airway passages and skin which comprises administering to a patient in need of such treating an effective amount of the solid composition of claim 7.
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