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Claims for Patent: 7,476,689

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Claims for Patent: 7,476,689

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 Ireland Limited (IE)
Application Number:10/792,457
Patent Claims: 1. An analgesic pharmaceutical aqueous dosage form that 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, of the formula ##STR00002## optically active forms thereof and pharmaceutically acceptable salts thereof, said form being a solution containing 5-20% (weight/volume) of said active ingredient in combination with a pharmaceutically acceptable excipient or diluent, wherein the aqueous dosage form is adapted for treating pain by providing a systemic effect through intranasal administration by spraying into a nasal cavity and wherein the aqueous dosage form when administered to a human subject intranasally at 0.5-40 mg generates plasma levels of the active ingredient in the subject within the range of 0.3-5 mg/liter of plasma.

2. The dosage form of claim 1 comprising 5-30 mg of said active ingredient.

3. The dosage form of claim 1 in a single-dose form.

4. The dosage form of claim 1 containing 15% (weight/volume) of said active ingredient.

5. The dosage form of claim 1 wherein said excipient comprises a bioadhesive.

6. The dosage form of claim 1 wherein said excipient comprises a polymer that provides a lower vehicle viscosity at room temperature, but after spraying into the nasal cavity increases said viscosity at body temperature.

7. The dosage form of claim 1 further comprising as an excipient an intranasal absorption promoter.

8. The dosage form of claim 7 wherein said promoter is selected from the group consisting of polyoxyethylene (9) lauryl alcohol, sodium glycocholate and lysophosphatidyl choline.

9. A method for the treatment of pain in a patient in need thereof, which method comprises spraying into a nasal cavity of the patient an aqueous composition comprising a systemically effective amount of 0.5-40 mg of the active ingredient 5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, in a racemic or optically active form or in the form of a pharmaceutically acceptable salt, wherein said composition is a solution containing 5-20% (weight/volume) of the active ingredient and wherein said effective amount is sufficient to generate a plasma concentration of the active ingredient within the range between 0.3 and 5 mg/liter of plasma.

10. The method according to claim 9 wherein said effective amount is within the range of 5-30 mg.

11. The method according to claim 9 wherein said composition a 15% (weight/volume) solution of the active ingredient.

12. The method according to claim 9 wherein said patient is a human.

13. An article of manufacture comprising an atomizer containing an aqueous analgesic pharmaceutical composition that comprises 0.5-40 mg per dose of an active ingredient selected from the group consisting of racemic 5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid of the formula ##STR00003## optically active forms therefor and pharmaceutically acceptable salts thereof, in combination with a pharmaceutically acceptable excipient or diluent, said composition being a solution containing 5-20% (weight/volume) of said active ingredient which is intranasally administrable for systemically effective treatment of pain.

14. The article of claim 13, wherein the composition comprises 5-30 mg per dose of said active ingredient.

15. The article of claim 13 which comprises a single-dose form.

16. The article of claim 13, wherein the composition contains 15% (weight/volume) of said active ingredient.

17. The article of claim 13 wherein said excipient comprises a bioadhesive.

18. The article of claim 13, wherein said excipient comprises a polymer that provides a lower composition viscosity at room temperature, but after spraying into the nasal cavity increases said viscosity at body temperature.

19. The article of claim 13, wherein the composition comprises an excipient that is an intranasal absorption promoter.

20. The article of claim 19, wherein said promoter is selected from the group consisting of polyoxyethylene (9) lauryl alcohol, sodium glycocholate and lysophosphatidyl choline.

21. The article of claim 13 in combination with written instructions for treating pain by intranasal administration to a patient.

22. The dosage form of claim 1 in the form of a spray.
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