Therapeutic compositions for intranasal administration which include KETOROLAC
View Patent ↗An analgesic/anti-inflammatory pharmaceutical dosage form which comprises an effective amount of an active ingredient selected from the group consisting of racemic 5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, optically active forms thereof and pharmaceutically acceptable salts thereof, in combination with a pharmaceutically acceptable excipient or diluent, said dosage form being an intranasally administrable dosage form.
1. An aqueous pharmaceutical formulation in the form of a nasal spray comprising an effective amount of an analgesic comprising ketorolac, an optical isomer thereof, or a salt thereof admixed with a bioadhesive polymer, wherein said spray when administered to a human subject intranasally generates plasma levels of ketorolac in the subject within the range of 0.3-5 mg/liter of plasma.
2. The pharmaceutical nasal spray of claim 1 wherein the analgesic is ketorolac tromethamine.
3. The nasal spray of claim 1 wherein the analgesic is present in the formulation in an amount of between 5 to 20% by weight based on total weight of the formulation.
4. The nasal spray of claim 3 wherein the analgesic is present in the formulation in an amount of 15% by weight based on total weight of the formulation.
5. The nasal spray of claim 1 wherein the bioadhesive polymer is selected from the group consisting of polyacrylics, cellulosics, and gums.
6. The nasal spray of claim 1 , said spray being free of absorption enhancers.
7. A pharmaceutical formulation in the form of a nasal spray comprising an effective amount of an analgesic comprising ketorolac, an optical isomer thereof, or a salt thereof admixed with a bioadhesive polymer, wherein said spray when administered to a human subject intranasally forms a gel and generates plasma levels of ketorolac in the subject within the range of 0.3-5 mg/liter of plasma.
8. The nasal spray of claim 7 wherein the analgesic is ketorolac tromethamine.
9. The nasal spray of claim 7 wherein the analgesic is present in the formulation in an amount of between 5 to 20% by weight based on total weight of the formulation.
10. The nasal spray of claim 9 wherein the analgesic is present in the formulation in an amount of 15% by weight based on total weight of the formulation.
11. The nasal spray of claim 7 wherein the bioadhesive polymer is selected from the group consisting of polyacrylics, cellulosics, and gums.
12. The nasal spray of claim 7 , said spray being free of absorption enhancers.