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US 10,478,434 B2Granted
Crystallization process of aripiprazole derivatives in extended release formulations for treatment of schizophrenia
AssigneeAlkermes Pharma Ireland Limited
InventorsWilfredo Morales, Tarek A. Zeidan, Renato A. Chiarella, Steven G. Wright, Jason M. Perry
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Abstract
Processes for providing depot injections of recrystallized aripiprazole lauroxil in which particles of the aripiprazole lauroxil have a surface area of about 0.50 to about 3.3 m2/g; and crystals of aripiprazole lauroxil produced by such processes.
Claims23
A process for making a compound of Formula (A) in crystal form:
- wherein Ra is CH2OC(O)R1 and wherein R1 is a substituted or unsubstituted aliphatic moiety;
- the process comprising the steps of:
- (a) dissolving the compound of Formula (A) or a salt or solvate thereof in a first solvent to form a homogeneous drug solution;
- (b) optionally combining the drug solution with a second solvent;
- (c) cooling the solution;
- and
- (d) when the temperature of the solution is within the range of about 31-38° C., further homogenizing the solution to induce formation of the compound of Formula (A) in crystal form.
4 more elements
Dependencies are inferred from the claim text.