Crystalline drug particles prepared using a controlled...

A - Human Necessities – 61 – K

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A61K 9/14 (2006.01)

Patent

CA 2494280

Drug particles which are essentially crystalline and have a mean particle size below 2 microns, when dispersed in water, are described. When added to an aqueous medium at 25-95% of the equilibrium solubility of the drug substance, the drug particles show complete dissolution, as characterized by a 95% reduction in turbidity, in less than 5 minutes. Using a controlled precipitation process to prepare such drug particles is also described. Such drug particles exhibit an enhanced dissolution rate and better stability as compared to particles prepared according to processes described in the prior art.

L'invention concerne des particules médicamenteuses cristallines possédant une dimension moyenne inférieure à 2 microns quand elles sont dispersées dans de l'eau. Quand on les ajoute à un milieu aqueux à 25-95 % de la solubilité d'équilibre de la substance médicamenteuse, ces particules sont complètement dissoutes en moins de 5 mn comme le démontre une diminution de 95 % de la turbidité. Elle concerne également la mise en application d'une opération de précipitation contrôlée pour préparer ces particules médicamenteuses. Ces dernières présentent une vitesse de dissolution améliorée et une stabilité accrue par rapport à des particules préparées selon des méthodes décrites dans l'état actuel de la technique.

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