Crystalline micropowder particles

Details Crystalline micropowder particles Crystalline micropowder particles

A - Human Necessities

61

K

A61K 31/485 (2006.01) A61K 9/14 (2006.01) A61P 13/10 (2006.01) A61P 17/04 (2006.01) A61P 25/04 (2006.01) C07D 489/08 (2006.01)

Patent

CA 2687955

Crystalline particles of N-(17-cyclopropylmethyl-4,5.alpha.-epoxy-3,14-dihydroxy-morphinan-6.beta.-yl)-phthalimide or a pharmaceutically acceptable salt thereof. Theses crystalline particles have a particle diameter distribution, wherein the particle diameter (D50) at the point attaining a cumulative frequency of 50% in volume distribution counted from the smallest particle diameter ranges from 1 to 30 µm while the particle diameter (D90) at the point attaining a cumulative frequency of 90% in volume distribution counted from the smallest particle diameter is not more than 90 µm, and a degree of crystallization of 80% or more. These crystalline particles make it possible to improve the biological availability of the active ingredient while ensuring the storage stability of the above-described compound.

L'invention concerne des particules cristallines de N-(17-cyclopropylméthyl-4,5.alpha.-époxy-3,14-dihydroxy-morphinan-6.beta.-yl)-phthalimide ou un sel de ce composé pharmaceutiquement acceptable. Ces particules cristallines ont une répartition du diamètre particulaire, ce diamètre particulaire (D50) au point atteignant une fréquence cumulative de 50% en répartition de volume compté à partir du diamètre particulaire le plus petit se situe entre 1 et 30 µm, alors que le diamètre particulaire (D90) au point atteignant une fréquence cumulative de 90% en répartition de volume compté à partir du diamètre particulaire le plus petit ne dépasse pas 90 µm, ainsi qu'un degré de cristallisation de 80% ou plus. Ces particules cristallines permettent d'améliorer la disponibilité biologique du principe actif, tout en assurant la stabilité de conservation du composé décrit ci-dessus.

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