Method and apparatus for producing ultrafine drug particles

Details Method and apparatus for producing ultrafine drug particles Method and apparatus for producing ultrafine drug particles

A - Human Necessities

61

K

A61K 9/16 (2006.01) A61K 47/18 (2006.01) A61K 47/34 (2006.01) A61K 47/44 (2006.01) A61P 1/00 (2006.01) A61P 3/02 (2006.01) A61P 3/06 (2006.01) A61P 3/10 (2006.01) A61P 5/00 (2006.01) A61P 9/10 (2006.01) A61P 9/12 (2006.01) A61P 19/10 (2006.01) A61P 25/04 (2006.01) A61P 25/08 (2006.01) A61P 25/20 (2006.01) A61P 29/00 (2006.01) A61P 31/04 (2006.01) A61P 35/00 (2006.01) A61P 37/08 (2006.01) B01F 5/10 (2006.01) B01F 17/14 (2006.01) B01F 17/42 (2006.01) B01F 17/52 (2006.01)

Patent

CA 2534471

Drug fine particles of submicron size excelling in long-term dispersibility. In particular, there is provided a process for producing drug ultramicroparticles of 10 to 1000 nm average diameter, comprising (1) dissolving a drug in at least one type of good solvent or good mixed solvent to thereby obtain a drug-containing solution; (2) mixing the drug-containing solution with a, to the drug, poor solvent or poor mixed solvent that is miscible with the drug-containing solution prepared with the good solvent or good mixed solvent; and (3) without any pretreatment step for adjusting the average particle diameter of the drug to 100 µm or less, directly emulsifying the resultant mixed solution at given treating pressure by the use of high-pressure homogenizer. There is further provided an apparatus therefor.

L'invention se rapporte à des particules médicamenteuses fines de dimension sous-micronique qui présentent une excellente dispersibilité à long terme. En particulier, l'invention concerne un procédé de production de particules ultramicroscopiques médicamenteuses ayant un diamètre moyen compris entre 10 et 1000 nm, consistant (1) à dissoudre un médicament dans au moins un type de bon solvant ou de bon solvant mélangé de manière à obtenir une solution contenant le médicament; (2) à mélanger la solution contenant le médicament avec, relativement audit médicament, un solvant pauvre ou un solvant pauvre mélangé qui n'est pas miscible avec la solution contenant le médicament préparée avec le bon solvant ou le bon solvant mélangé; et (3) sans aucune étape de prétraitement pour ajuster le diamètre moyen des particules du médicament à une valeur inférieure ou égale à 100 µm, à émulsifier directement la solution mélangée résultante, à une pression de traitement donnée, au moyen d'un homogénéisateur haute pression. L'invention se rapporte également à un appareil permettant la mise en oeuvre dudit procédé.

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