摘要 |
PURPOSE: Provided is a bilayer sustained release oral dosage composition containing a nasal decongestant, for example, pseudoephedrine in one layer and the non-sedating antihistamine, desloratadine in a second layer and having less than about 2% of desloratadine degradation products. CONSTITUTION: The compressed bilayer solid composition comprises: (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 salt thereof, and a pharmaceutically acceptable excipient, and optionally a desloratadine-protective amount of a pharmaceutically acceptable antioxidant.
|