Tetracycline compositions
AssigneeRempex Pharmaceuticals, Inc.
InventorsDavid C. Griffith, Serge Boyer, Scott Hecker, Michael N. Dudley
Life of this patent
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Abstract
The present invention relates to compositions, pharmaceutical compositions, and methods for preparing the same, comprising a tetracycline with improved stability and solubility. Some embodiments include a tetracycline with an excess of a divalent or trivalent cation.
Claims96
A method of treating or preventing a bacterial infection in a subject, comprising administering a pharmaceutical composition to the subject via an intravenous route, wherein the pharmaceutical composition comprises an aqueous solution of a 7-dimethylamino-tetracycline antibiotic and a divalent or trivalent cation, wherein the molar ratio of divalent or trivalent cation to 7-dimethylamino-tetracycline antibiotic is greater than 2:1 and wherein the solution does not comprise a pharmaceutically acceptable oil, has a pH greater than 4 and less than 7.
A method of treating or preventing a bacterial infection in a subject, comprising administering a pharmaceutical composition to the subject via an intravenous route, wherein the pharmaceutical composition is prepared by a method comprising dissolving a water-soluble solid composition in water to form a solution, wherein the water-soluble composition comprises a 7-dimethylamino-tetracycline antibiotic or a salt thereof and a salt comprising a divalent or trivalent cation, wherein the molar ratio of divalent or trivalent cation to 7-dimethylamino-tetracycline is greater than 1:1 and wherein upon dissolution of the solid composition in water to make a solution having a pH greater than 4 and less than 7 is formed.
A method of treating or preventing a bacterial infection in a subject, comprising administering a pharmaceutical composition to the subject via an intravenous route, wherein the pharmaceutical composition is prepared by a method comprising dissolving a 7-dimethylamino-tetracycline in a solution comprising a divalent or trivalent cation, wherein the molar ratio of divalent or trivalent cation to 7-dimethylamino-tetracycline in the solution is greater than 1:1 and wherein after dissolving the 7-dimethylamino-tetracycline, the solution has a pH greater than 4 and less than 7.
A method of treating or preventing a bacterial infection in a subject, comprising administering a pharmaceutical composition to the subject via an intravenous route, wherein the pharmaceutical composition is prepared by a method comprising:
- dissolving a 7-dimethylamino-tetracycline in a solution comprising a divalent or trivalent cation, wherein the molar ratio of divalent or trivalent cation to 7-dimethylamino-tetracycline in the solution is greater than 1:1;
- adjusting the pH of the solution to be greater than 4 and less than 7;
- and
- lyophilizing the composition.
Dependencies are inferred from the claim text.