Assisted particle size reduction process
AssigneeHovione International Ltd.
InventorsEunice Costa, Marcio Temtem, Luis Sobral, Constanca Cacela, Peter Villax
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Abstract
A new scalable process to control the particle size and the particle size distribution, comprising 5 steps: (i) suspension preparation in a mixture of solvents in which the API and/or excipient is partially soluble in one of the solvents; (ii) particle size reduction of the suspension; (iii) aging; (iv) stopping the aging by solvent removal; and (v) optionally, a step of isolating the processed ingredients in the form of powder.
Claims25
A process for controlling the particle size, while controlling the particle size distribution, of one or more active pharmaceutical ingredients (APIs), or one or more APIs with one or more excipients, which process comprises:
- a) suspending particles of the one or more APIs and optionally one or more excipients in a mixture of at least two solvents that comprise at least a first solvent and a second solvent;
- wherein at least the first solvent partially dissolves at least one of the APIs and/or excipients, wherein the API and/or excipient are soluble in the first solvent in an amount of 5,000 volumes or more of solvent per gram of solute, and wherein the API and/or excipient are substantially insoluble in the second solvent;
- b) reducing the size of the particles in the suspension produced in step a);
- c) aging the suspension by allowing the suspension to stand over a period of time of at least one hour so as to allow particle size growth to occur via Ostwald ripening;
- d) stopping the aging by removing the first solvent.
Dependencies are inferred from the claim text.