Stabilized composition comprising at least one adrenergic compound
AssigneeAlk AG
InventorsAlan J. Baillie, Kenneth MacDonald, Pamela Porteous, Simon Hendry
Life of this patent
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Abstract
A stabilised composition comprising at least one adrenergic compound and at least one antioxidant selected from the group consisting of a bisulfite, a metabisulfite and a sulfite compound.
Claims20
A liquid pharmaceutical composition comprising an adrenergic compound wherein the adrenergic compound is epinephrine or a physiologically acceptable salt thereof, and at least one antioxidant selected from the group consisting of a bisulfite, a meta bisulfite and a sulfite compound, wherein the molar ratio of the adrenergic compound to the at least one antioxidant, measured as sulfite-equivalents, is in the range 0.70-1.30, and wherein the pH of said liquid composition is in the range of about 2.0-5.0.
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A method for stabilizing a liquid pharmaceutical composition comprising an adrenergic compound, comprising the steps of i) providing a solution of an adrenergic compound, wherein the adrenergic compound is epinephrine or a physiologically acceptable salt thereof, ii) adding at least one antioxidant selected from the group consisting of a bisulfite, a metabisulfite, and a sulfite compound, iii) adjusting the pH thereof to a value in the range 2.0-5.0 optionally by addition of an acid or a base, wherein the molar ratio of the adrenergic compound to the at least one antioxidant, measured as sulfite-equivalents, is in the range 0.70-1.30.
The method of stabilizing a liquid pharmaceutical composition which comprises combining at least one antioxidant selected from the group consisting of a bisulfite, a metabisulfite, and a sulfite compound and epinephrine or a physiologically acceptable salt thereof, wherein the molar ratio of the epinephrine or a physiologically acceptable salt thereof to the at least one antioxidant, measured as sulfite-equivalents, is in the range 0.70-1.30, and wherein the pH of said liquid composition is in the range of about 2.0-5.0.
A kit comprising:
- i) a liquid pharmaceutical composition comprising an adrenergic compound, wherein the adrenergic compound is epinephrine or a physiologically acceptable sale thereof, and at least one antioxidant selected from the group consisting of a bisulfite, a metabisulfite and a sulfite compound, wherein the molar ratio of the adrenergic compound to the at least one antioxidant, measured as sulfite-equivalents, is in the range 0.70-1.30, and wherein the pH of said liquid composition is in the range of about 2.0-5.0, and
- ii) an administration device.
A method of improving at least one symptom of a medical condition requiring an adrenergic compound in an individual in need thereof, which comprises administering to the individual a liquid pharmaceutical composition comprising an adrenergic compound, wherein the adrenergic compound is epinephrine or a physiologically acceptable salt thereof, and at least one antioxidant selected from the group consisting of a bisulfite, a metabisulfite and a sulfite compound, wherein the molar ratio of the adrenergic compound to the at least one antioxidant, measured as sulfite-equivalents, is in the range 0.70-1.30, and wherein the pH of said liquid composition is in the range of about 2.0-5.0.
A method of treating anaphylaxis in an individual comprising administering to the individual a liquid pharmaceutical composition comprising an adrenergic compound, wherein the adrenergic compound is epinephrine or a physiologically acceptable salt thereof, and at least one antioxidant selected from the group consisting of a bisulfite, a metabisulfite and a sulfite compound, wherein the molar ratio of the adrenergic compound to the at least one antioxidant, measured as sulfite-equivalents, is in the range 0.70-1.30, and wherein the pH of said liquid composition is in the range of about 2.0-5.0.
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A liquid medicament comprising an adrenergic compound wherein the adrenergic compound is epinephrine or a physiologically acceptable salt thereof, and at least one antioxidant selected from the group consisting of a bisulfite, a metabisulfite and a sulfite compound, wherein the molar ratio of the adrenergic compound to the at least one antioxidant, measured as sulfite-equivalents, is in the range 0.70-1.30, and wherein the pH of said medicament is 2.0 and 5.0.
Dependencies are inferred from the claim text.