Processes for making particle-based pharmaceutical...

A - Human Necessities – 61 – K

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A61K 9/14 (2006.01)

Patent

CA 2631494

A method is provided for making a parenteral dosage form of a pharmaceutical agent which Includes (a) providing particles of a pharmaceutical agent; (b) blending the particles with particles of at least one bulking agent to form a first powder blend, which does not include a surfactant; (c) milling the first powder blend to form a milled blend which comprises microparticles or nanopartides of the pharmaceutical agent; and (d) reconstituting the milled blend with a liquid vehicle, which includes at least one surfactant, for parenteral administration. A method also is provided which includes (a) providing particles of a pharmaceutical agent; (b) blending these particles with particles of an excipient to form a first blend; and (c) milling the first blend to form a milled blend that includes microparticles or tianopart~cles, which exhibits a greater dispersibility, wettability, and suspendability as compared to the particles of step (a) or the first blend.

L'invention concerne un procédé de préparation d'une forme galénique parentérale d'un agent pharmaceutique, consistant: (a) à prendre des particules d'un agent pharmaceutique; (b) à mélanger les particules avec au moins un agent gonflant, de manière à former un premier mélange de poudres ne comportant pas de tensio-actif; (c) à broyer le premier mélange de poudres, de manière à former un mélange broyé comprenant des microparticules ou des nanoparticules de l'agent pharmaceutique; et (d) à reconstituer le mélange broyé avec un véhicule liquide, comprenant au moins un tensioactif, aux fins d'administration parentérale. L'invention concerne également un procédé consistant: (a) à prendre des particules d'un agent pharmaceutique; (b) à mélanger ces particules avec les particules d'un excipient, afin de former un premier mélange; et (c) à broyer le premier mélange, afin de former un mélange broyé comprenant des microparticules ou des nanoparticules possédant des dispersabilité, mouillabilité et capacité de suspension supérieures, comparativement aux particules de l'étape (a) ou du premier mélange.

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