Process for preparing pharmaceutical compositions
AssigneeMerck Sharp & Dohme Corp.
InventorsLuke R. Schenck, David J. Lamberto, Joseph L. Kukura, II, Francisco J. Guzman, Aaron Cote, Athanas Koynov
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Abstract
A process for preparing and isolating pharmaceutical active ingredient particles having a particle size of between about 0.1 and 30 microns, wherein a slurry comprising the active ingredient and one or more pharmaceutically acceptable excipients is fed into a thin film evaporator under suitable conditions for less than 10 minutes sufficient to generate solid matrix particles comprising active ingredient and one or more excipients, wherein the particles have less than 5% residual solvent.
Claims24
A process for preparing and isolating pharmaceutical active ingredient particles having a particle size of between about 0.1 and 30 microns, wherein a dried solids-containing slurry comprising:
- (a) a pharmaceutical active ingredient, and one or more of:
- (b) a steric stability polymer, (c) an electrostatic stability surfactant, and (d) a redispersibility excipient is fed into a thin film evaporator comprising shear rates exceeding 4,000 s−1, temperature between about 50° C. and 100° C., vacuum from 10 mbar to 75 mbar pressure, and Reynolds Numbers above 200,000, to provide turbulent mixing for less than 10 minutes and sufficient to generate solid matrix particles comprising the pharmaceutical active ingredient and the one or more excipients, wherein the particles have less than 5% residual solvent.
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Dependencies are inferred from the claim text.