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Claims for Patent: 7,618,649

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Claims for Patent: 7,618,649

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 Corporation (Kenilworth, NJ)
Application Number:10/699,987
Patent Claims: 1. A solid composition comprising an anti-allergic effective amount of desloratadine in a free base form and a desloratadine-protective amount of at least one pharmaceutically acceptable antioxidant, wherein: the desloratadine does not form a pharmaceutically acceptable salt with the antioxidant; about 0.1% to about 10% of the at least one pharmaceutically acceptable antioxidant is present; at least 80% of the desloratadine dissolves in a 0.1N HCl solution at 37.degree. C. in about 45 minutes; and the total amount of desloratadine degradation products in the solid composition is less than or equal to 2% by weight.

2. A solid composition comprising about 5 mg of desloratadine in a free base form and a desloratadine-protective amount of at least one pharmaceutically acceptable antioxidant, wherein: the desloratadine does not form a pharmaceutically acceptable salt with the antioxidant; about 0.1% to about 10% of the at least one pharmaceutically acceptable antioxidant is present; at least 80% of the desloratadine dissolves in a 0.1N HCl solution at 37.degree. C. in about 45 minutes; and the total amount of desloratadine degradation products in the solid composition is less than or equal to 2% by weight.

3. A solid composition comprising: TABLE-US-00013 INGREDIENT mg/composition Desloratadine, micronized 5.0 Corn Starch 36.0 Microcrystalline Cellulose 132.7 Edetate Disodium 10.0 Citric Acid Anhydrous 10.0 Stearic Acid 6.0 Dye 0.3 TOTAL 200.0

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

4. The solid composition of claim 3 wherein at least 80% of the desloratadine dissolves in a 0.1N HCl solution at 37.degree. C. in about 45 minutes.

5. A solid composition comprising: TABLE-US-00014 INGREDIENT mg/composition Desloratadine, micronized 2.5 Corn Starch 18.0 Microcrystalline Cellulose 66.35 Edetate Disodium 5.0 Citric Acid 5.0 Stearic Acid 3.0 Dye 0.15 TOTAL 100.00

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

6. The solid composition of claim 5 wherein at least 80% of the desloratadine dissolves in a 0.1N HCl solution at 37.degree. C. in about 45 minutes.

7. 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 2.

8. A solid composition comprising an anti-allergic effective amount of desloratadine in a free base form and a desloratadine-protective amount of two pharmaceutically acceptable antioxidants, wherein the two pharmaceutically acceptable antioxidants are edetate disodium and citric acid, and wherein: the desloratadine does not form a pharmaceutically acceptable salt with the antioxidant; about 0.1% to about 10% of the two pharmaceutically acceptable antioxidants is present; at least 80% of the desloratadine dissolves in a 0.1N HCl solution at 37.degree. C. in about 45 minutes; and the total amount of desloratadine degradation products in the solid composition is less than or equal to 2% by weight.

9. A solid composition comprising about 2.5 mg desloratadine in a free base form and a desloratadine-protective amount of at least one pharmaceutically acceptable antioxidant, wherein: the desloratadine does not form a pharmaceutically acceptable salt with the antioxidant; about 0.1% to about 10% of the at least one pharmaceutically acceptable antioxidant is present; at least 80% of the desloratadine dissolves in a 0.1N HCl solution at 37.degree. C. in about 45 minutes; and the total amount of desloratadine degradation products in the solid composition is less than or equal to 2% by weight.

10. A solid composition comprising: TABLE-US-00015 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 0.3 TOTAL 200.0

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

11. The solid composition of claim 10 wherein at least 80% of the desloratadine dissolves in a 0.1N HCl solution at 37.degree. C. in about 45 minutes.

12. A solid composition comprising: TABLE-US-00016 INGREDIENT mg/composition Desloratadine, micronized 2.5 Corn Starch 18.0 Microcrystalline Cellulose 70.35 Edetate Disodium 5.0 Citric Acid 1.0 Talc 3.0 Dye 0.28 TOTAL 100.00

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

13. The solid composition of claim 12 wherein at least 80% of the desloratadine dissolves in a 0.1N HCl solution at 37.degree. C. in about 45 minutes.

14. 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.

15. 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 9.

16. 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 10.

17. 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 12.

18. 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.
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