Continuous production of active pharmaceutical ingredients
AssigneeNew Jersey Institute of Technology
InventorKamalesh Sirkar
Life of this patent
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Abstract
The present invention is directed to a method of producing active pharmaceutical ingredients (APIs). The method includes subjecting a reaction mixture with an API precursor to solvent extraction to produce a reactant stream with the API precursor. The method includes concentrating the API precursor in the reactant stream using at least one membrane. The method includes carrying out a reaction in a membrane reactor. The method includes separating the API precursor from the reaction stream using a separator. The method includes crystallizing the API precursor using a crystallizer to produce APIs.
Claims15
A method for continuous manufacturing of prexasertib monolactate monohydrate, said method comprising the steps of:
- (a) combining compound 7 with hydrazine in the presence of acetic acid in methanol and THF at the temperature of about 130° C. to produce compound 8:
- (b) combining compound 8 with compound 9 in the presence of N-ethylmorpholine in DMSO at the temperature of about 85° C. to produce compound 10:
- (c) deprotecting compound 10 by combining it with formic acid at the temperature of about 25° to produce compound 1:
- and
- (d) subjecting compound 1 to lactic acid distillation in THF/water to produce compound 12:
- wherein each of steps (a)-(d) is carried out in a series of units connected to each other to support continuous flow;
- and
- wherein said series of units comprises at least one membrane-based unit, wherein after step (a), combining compound 8 with toluene and carrying out countercurrent solvent extraction using the membrane-based unit to yield compound 8 in a mixture of toluene, methanol, water and THF, wherein the membrane-based unit is a pervaporation membrane device.
Dependencies are inferred from the claim text.