Extended release oral dosage composition
First Claim
1. A bilayer solid composition comprising (1) a first layer comprising an anti-allergic effective amount of desloratadine and a desloratadine-protective amount of a pharmaceutically acceptable water insoluble basic calcium, magnesium or aluminum salt, or of a desloratadine-protective amount of at least one pharmaceutically acceptable antioxidant;
- and (2) a second layer comprising an effective amount of pseudoephedrine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient, and optionally, a desloratadine-protective amount of at least one pharmaceutically acceptable antioxidant.
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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.
2 Citations
41 Claims
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1. A bilayer solid composition comprising (1) a first layer comprising an anti-allergic effective amount of desloratadine and a desloratadine-protective amount of a pharmaceutically acceptable water insoluble basic calcium, magnesium or aluminum salt, or of a desloratadine-protective amount of at least one pharmaceutically acceptable antioxidant;
- and (2) a second layer comprising an effective amount of pseudoephedrine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient, and optionally, a desloratadine-protective amount of at least one pharmaceutically acceptable antioxidant.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 38, 39, 40, 41)
- 11. A bilayer solid composition comprising (1) a first layer comprising an anti-allergic effective amount of desloratadine and desloratadine-protective amount of a pharmaceutically acceptable water insoluble basic calcium, magnesium or aluminum salt, and (2) a second layer comprising an effective amount of pseudoephedrine or a pharmaceutically acceptable salt thereof.
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17. A bilayer solid composition comprising (1) a first layer comprising an anti-allergic effective amount of desloratadine and a desloratadine-protective amount of at least one pharmaceutically acceptable antioxidant;
- and (2) a second layer comprising an effective amount of pseudoephedrine or a pharmaceutically acceptable salt thereof, a pharmaceutically acceptable excipient, and a desloratadine-protective amount of at least one pharmaceutically acceptable antioxidant, and wherein total amount of desloratadine degradation products is less than or equal to about 2.0% by weight.
- View Dependent Claims (18, 19, 20, 21, 22, 23)
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24. 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 pseudoephedrine, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient, and wherein total amount of desloratadine degradation products 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°
- C. in about 45 minutes.
- View Dependent Claims (25)
- 26. A bilayer solid composition comprising a first layer and a second layer, wherein the first layer is an immediate release layer comprising:
- 28. A bilayer solid composition comprising (1) a first layer comprising 2.5 mg of desloratadine and desloratadine-protective amount of a pharmaceutically acceptable water insoluble basic calcium, magnesium or aluminum salt, and (2) a second layer comprising 120 mg of pseudoephedrine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient, and wherein total amount of desloratadine degradation products is less than or equal to about 2% by weight
- 30. A bilayer solid composition comprising (1) a first layer comprising 5 mg of desloratadine and desloratadine-protective amount of at least one pharmaceutically acceptable antioxidant, and (2) a second layer comprising 120 mg of pseudoephedrine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient, and wherein total amount of desloratadine degradation products is less than or equal to about 2% by weight.
- 32. A bilayer solid composition comprising a first layer and a second layer, wherein the first layer is an immediate release layer comprising:
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34. A bilayer solid composition comprising a first layer and a second layer, wherein the first layer is an immediate release layer comprising:
- 36. A bilayer solid composition comprising a first and second layer, wherein the first layer is an immediate release first layer comprises:
Specification