Therapeutic compositions for intranasal administration which include KETOROLAC®
AssigneeRecordati S.A., Chemical and Pharmaceutical Company
InventorsGiancarlo Santus, Giuseppe Bottoni, Ettore Bilato
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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.
Claims51
An analgesic/anti-inflammatory pharmaceutical liquid dosage form which comprises a systemically 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
- optically active forms thereof and pharmaceutically acceptable salts thereof, in combination with a pharmaceutically acceptable excipient or diluent, said dosage form being a non-thermosetting intranasally administrable transmucosally rapidly absorbable dosage form that achieves blood levels in a host effective for analgesic or anti-inflammatory use after intranasal administration.
A method for the treatment of inflammatory processes and pain of a traumatic or pathologic origin, which comprises the administration by the intranasal route of a dosage form comprising a systemically effective amount 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, said dosage form being a non-thermosetting intranasally administrable transmucosally rapidly absorbable dosage form that achieves blood levels for said active ingredient effective for analgesic or anti-inflammatory use after intranasal administration.
An analgesic/anti-inflammatory pharmaceutical liquid dosage form which comprises a systemically effective amount for a human of an active ingredient selected from the group consisting of racemic 5-benzoyl-2,3-dihyro-1H-pyrrolizine-1-carboxylic acid, of the formula
- 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 transmucosally rapidly absorbable dosage form that achieves blood levels in a host effective for analgesic or anti-inflammatory use after intranasal administration, wherein the dosage form is free of polymers providing a low viscosity composition at room temperature but an increased viscosity composition at body temperature.
A method for the treatment of inflammatory processes and pain of a traumatic or pathologic origin in human, which method comprises the administration by the intranasal route of a dosage form comprising a systemically effective amount of an active ingredient selected from the group consisting of racemic 5-benzoyl-2,3-dihyro-1H-pyrrolizine-1-carboxylic acid, of the formula
- optically active forms thereof and pharmaceutically acceptable salts thereof, said dosage form being an intranasally-administrable dosage form that achieves blood levels in a host effective for analgesic or anti-inflammatory use after intranasal administration, wherein the dosage form is free of polymers providing a low viscosity at room temperature but an increased viscosity composition at body temperature.
An analgesic/anti-inflammatory aqueous solution as an intranasally administrable pharmaceutical dosage form in a bottle suitable for delivering a spray of the solution, which dosage form comprises about 5% to about 20% (weight/volume) ketorolac tromethamine, optionally less than about 0.1% (weight/volume) sodium ethylenediaminetetretraacetic acid, and optionally a preservative, wherein the dosage form is free of any polymer providing a low viscosity composition at room temperature but an increased viscosity composition at body temperature.
Dependencies are inferred from the claim text.