Process for particle processing of active pharmaceutical ingredients
AssigneeHovione Inter Ltd.
InventorsMarco Gil, Constanca Cacela, Ricardo Mendonca, Filipe Gaspar
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Abstract
A process for reducing the particle size of an active pharmaceutical ingredient (API) while maintaining its polymorphic form, comprises the step of processing the active pharmaceutical ingredient by cavitation at elevated pressure. The process preferably comprises the step of isolating the processed active ingredient in the form of powder, wherein the isolation step comprises filtration or spray drying. Particles produced by the process of the invention typically have a span value of less than 2.5.
Claims24
A process for micronizing particles of an active pharmaceutical ingredient (API) while maintaining its polymorphic form, which process comprises the steps of:
- suspending the API at a concentration between 2 and 60% w/v in a solvent in which it is insoluble to produce a suspension;
- processing the suspension of the active pharmaceutical ingredient by cavitation at a pressure in the range of 300 to 3500 bar with a high pressure cavitation apparatus;
- rinsing the high pressure cavitation apparatus with the solvent to produce a wash;
- adding the wash to the suspension;
- and
- subjecting the suspension to an isolation step to produce a processed active pharmaceutical ingredient in the form of powder;
- wherein the process is performed on the active pharmaceutical ingredient in the absence of any excipients other than the suspending solvent, the resulting particle size distribution of the processed active pharmaceutical ingredient comprises a span ((Dv90−Dv10)/Dv50) of less than 2.5, and the processed active pharmaceutical ingredient comprises microparticles suitable for topical delivery to the lungs or nose.
A process for micronizing particles of an active pharmaceutical ingredient (API) while maintaining its polymorphic form, which process comprises the steps of:
- suspending the API at a concentration between 2 and 60% w/v in a solvent in which it is insoluble to produce a suspension;
- processing the suspension of the active pharmaceutical ingredient by cavitation at a pressure in the range of 300 to 3500 bar with a high pressure cavitation apparatus;
- and
- subjecting the suspension to an isolation step to produce a processed active pharmaceutical ingredient in the form of powder;
- wherein the process is performed on the active pharmaceutical ingredient in the absence of any excipients other than the suspending solvent, the resulting particle size distribution of the processed active pharmaceutical ingredient comprises a span ((Dv90−Dv10)/Dv50) of less than 2.5, and the processed active pharmaceutical ingredient comprises microparticles suitable for topical delivery to the lungs or nose.
Dependencies are inferred from the claim text.