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Details for Patent: 7,267,827

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Details for Patent: 7,267,827

Title:Therapeutic compositions for intranasal administration which include KETOROLAC
Abstract: 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.
Inventor(s): Santus; Giancarlo (Milan, IT), Bottoni; Giuseppe (Bergamo, IT), Bilato; Ettore (Padova, IT)
Assignee: Recordati S.A. (Chiasso, CH)
Filing Date:Jul 13, 2001
Application Number:09/903,665
Claims: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.
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