Processes for making lactose utilizing pre-classification...

A - Human Necessities – 61 – K

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A61K 9/14 (2006.01) A61J 3/02 (2006.01) A61K 31/137 (2006.01) A61K 31/56 (2006.01) A61K 47/26 (2006.01) C13K 5/00 (2006.01) C07H 3/00 (2006.01)

Patent

CA 2597557

A process for forming lactose suitable for use in a pharmaceutical formulation comprises providing a plurality of lactose particles containing no more than 10% w/w of lactose particles having a volume average particle size of about 70 microns or less; milling the plurality of lactose particles to yield a plurality of milled lactose particles with an average particle size, (D50), ranging from about 50 microns to about 100 microns; and classifying the plurality of milled lactose particles into at least two fractions comprising a fine fraction and a coarse fraction wherein the fine fraction has an average particle size, (D50), ranging from about 3 microns to about 50 microns, and the coarse fraction has an average particle size, (D50), ranging from about 40 microns to about 250 microns.

Procédé de fabrication de lactose convenant pour préparations pharmaceutiques, qui englobe les opérations suivantes: utilisation de particules de lactose contenant pas plus de 10 % en poids de particules dont la taille moyenne en volume est de 70 microns ou moins; broyage de la pluralité de particules de lactose pour l'obtention de particules de lactose broyées d'une taille moyenne (D50) comprise entre 50 et 100 microns environ; et regroupement de la pluralité des particules broyées en au moins deux fractions, l'une fine, d'une taille moyenne de particules (D50) comprise entre 3 et 50 microns environ, l'autre grossière d'une taille moyenne de particules (D50) comprise entre 40 et 250 microns environ.

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