Process for the preparation of ketorolac tromethamine
AssigneeAbbott Laboratories
InventorsGrant L. Esser, Marazban H. Vandrevala, Madhup K. Dhaon, Ameen F. Ghannam, Dragan Obradovich
Life of this patent
Estimating the term…
Abstract
The present invention provides an improved process for producing ketorolac tromethamine. The preferred method utilizes a three-part solvent system, comprising isopropanol, ethyl acetate and water.
Claims31
A process for making ketorolac tromethamine comprising the steps of:
- a. combining a first solution comprising ketorolac acid in a suitable solvent with a second solution comprising tromethamine in water;
- b. distilling the resulting solution until about one half the volume remains;
- c. adding an amount of solvent equal to the volume remaining after step (b) and repeating step (b);
- d. adding an amount of organic solvent equal to the volume remaining after step (c) and repeating step (b);
- e. repeating step (d) one or more times;
- f. precipitating and collecting the ketorolac tromethamine.
A process for making ketorolac tromethamine comprising the steps of:
- a. combining a ketorolac acid in a lower alkyl alcohol with tromethamine in water;
- b. distilling the resulting solution under conditions of temperature and vacuum until about one half the volume remains;
- c. adding an amount of solvent equal to the volume remaining after step (b) and repeating step (b);
- d. adding an amount of lower alkyl acetate equal to the volume remaining after step (c) and repeating step (b);
- e. repeating step (d) one or more times;
- f. precipitating and collecting the ketorolac tromethamine.
A process for making ketorolac tromethamine comprising the steps of:
- a. combining ketorolac acid and isopropanol (1:4 to 8 (w/w)) with tromethamine in water (1:2 (w/w));
- b. distilling the resulting solution until about one half the volume remains;
- c. adding an amount of isopropanol equal to the volume remaining after step (b) and repeating step (b);
- d. adding an amount of ethyl acetate equal to the volume remaining after step (c) and repeating step (b);
- e. repeating step (d) one or more times;
- f. cooling the resulting distillate to 10° C. and collecting the ketorolac tromethamine by filtration.
A process for making ketorolac tromethamine comprising the steps of:
- a. combining a first solution comprising ketorolac acid in a suitable solvent, with a second solution comprising tromethamine in water, and with a third solution comprising an organic solvent;
- b. distilling the resulting solution until about one half the volume remains;
- c. adding an amount of organic solvent equal to the volume remaining after step (b) and repeating step (b);
- d. repeating step (c) one or more times;
- e. precipitating and collecting the ketorolac tromethamine.
A process for making ketorolac tromethamine comprising the steps of:
- a. combining a first solution comprising ketorolac acid in a lower alkyl alcohol, with a second solution comprising tromethamine in water, and with a third solution comprising a lower alkyl acetate;
- b. distilling the resulting solution until about one half the volume remains;
- c. adding an amount of said equal to the volume remaining after step (b) and repeating step (b);
- d. repeating step (c) one or more times;
- e. precipitating and collecting the ketorolac tromethamine.
A process for making ketorolac tromethamine comprising the steps of:
- a. combining ketorolac acid and isopropanol (1:4 to 8 w/w)), with tromethamine in water (1:2 w/w)), and with ethyl acetate (14 parts w/w)
- b. distilling the resulting solution until about one half the volume remains;
- c. adding an amount of ethyl acetate equal to the volume remaining after step (b) and repeating step (b);
- d. repeating step (co one or more times;
- e. cooling the resulting distillate to 10° C. and collecting the ketorolac tromethamine by filtration.
Dependencies are inferred from the claim text.