A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/16 (2006.01)
Patent
CA 2732952
A method for producing crystalline microparticles of active substance is provided, comprising the steps in which a suspension is prepared from primary particles of the active substance, a solution of the active substance, non-solvent for the active substance and inert formed pieces, the suspension is mixed, whereupon the active substance crystallizes out of the suspension, the active substance is separated in the form of product particles and the product particles are then dried, wherein the primary particles and the product particles are crystalline, are in the most stable crystal modification of the active substance, have a crystal surface area of 3-10 m2/g and the size distribution of the primary and product particles is each d50 = 1-2 µm, d99 < 6 µm and d100 < 12 µm. Furthermore, microparticles of active substance and a solid form of particles of active substance obtainable according to the method are provided.
L'invention concerne un procédé de fabrication de microparticules de substance active cristalline, comprenant les étapes selon lesquelles une suspension est préparée à partir de particules primaires de la substance active, d'une solution de la substance active, d'un agent ne dissolvant pas la substance active et de corps moulés inertes, la suspension est mélangée, la substance active est cristallisée, la substance active sous forme de particules de produit est séparée de la suspension et les particules de produit sont ensuite séchées, les particules primaires et les particules de produit étant cristallines, étant présentes dans la modification cristalline la plus stable de la substance active, présentant une surface cristalline de 3 - 10 m2/g et la distribution dimensionnelle des particules primaires et des particules de produit étant respectivement d50 = 1 - 2 µm, d99 < 6 µm et d100 < 12 µm. Des microparticules de substance active et un corps moulé solide de particules de substance active pouvant être obtenus selon le procédé sont également préparés.
Eilers Robert
Gliesing Sabine
Grawe Detlef
Fetherstonhaugh & Co.
Jesalis Pharma Gmbh
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