A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/14 (2006.01) A61K 9/16 (2006.01) A61K 9/51 (2006.01) B01D 9/00 (2006.01) B01J 2/06 (2006.01)
Patent
CA 2458889
A process for preparing crystalline particles of a drug substance is disclosed, said process comprising recirculating an anti-solvent through a mixing zone, dissolving the drug substance in a solvent to form a solution, adding the solution to the mixing zone to form a article slurry in the anti- solvent, and recirculating at least a portion of the particle slurry back through the mixing zone. Particles produced from the process are also disclosed. The present invention has the ability to be operated in a continuous fashion, resulting in a more efficient process and a more uniform product. The present invention has the additional advantage of having the ability to operate at a relatively low solvent ratio, thereby increasing the drug to excipient ratio.
L'invention concerne un procédé de préparation de particules cristallines d'une substance médicamenteuse. Ce procédé consiste à : procéder à la recirculation d'un anti-solvant dans une zone de mélange, dissoudre la substance médicamenteuse dans un solvant pour former une solution, ajouter la solution à la zone de mélange pour former une suspension particulaire dans l'anti-solvant, et enfin, réinjecter au moins une partie de la suspension particulaire vers la zone de mélange. L'invention concerne en outre les particules obtenues par ce procédé. Par ailleurs, l'invention peut être exploitée selon un mode continu qui permet d'améliorer l'efficacité du procédé et l'uniformité du produit. Un autre avantage de l'invention consiste en ce qu'elle peut être réalisée avec un rapport de solvant relativement faible, ce qui permet d'augmenter le rapport entre le médicament et l'excipient.
Curtis Cathy A.
Evans Jonathan C.
Hitt James E.
Svenson Sonke
Tucker Christopher J.
Dow Global Technologies Inc.
Smart & Biggar
The Board Of Regents Of The University Of Texas System
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