Processes for making particle-based pharmaceutical...

Details Processes for making particle-based pharmaceutical... Processes for making particle-based pharmaceutical...

A - Human Necessities

61

K

A61K 9/14 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01)

Patent

CA 2631492

A method is provided for making an oral dosage form of a pharmaceutical agent which includes the steps of (a) providing particles which include a pharmaceutical agent; (b) blending the particles with particles of a pre- processed excipient to form a primary blend, wherein the pre-processed excipient is prepared by (i) dissolving a bulking agent (e.g., a sugar) and at least one non-friable excipient (e.g., a waxy or liquid surfactant) in a solvent to form an excipient solution, and (ii) removing the solvent from the excipient solution to form the pre-processed excipient in dry powder form; (c) milling the primary blend to form a milled pharmaceutical formulation blend that includes microparticles or nanoparticles of the pharmaceutical agent; and (d) processing the milled pharmaceutical formulation blend into a solid oral dosage form or liquid suspension for oral administration. The process yields formulations having improved wettability or dispersibility.

L'invention concerne un procédé permettant de préparer une forme galénique orale d'un agent pharmaceutique et comprenant les étapes consistant: (a) à utiliser des particules renfermant un agent pharmaceutique; (b) à mélanger les particules avec des particules d'un excipient traité au préalable, de manière à former un mélange principal, l'excipient traité au préalable étant préparé par: (i) dissolution d'un agent de gonflement (par exemple, un sucre) et au moins d'un excipient non friable (par exemple, un tensio-actif cireux ou liquide) dans un solvant, afin de former une solution d'excipient, et (ii) élimination du solvant de la solution d'excipient, afin de former l'excipient traité au préalable sous la forme d'une poudre sèche; (c) à broyer le mélange principal de manière à former un mélange de formulation pharmaceutique broyé comprenant des micro-particules ou des nanoparticules de l'agent pharmaceutique; et (d) à traiter le mélange de formulation pharmaceutique broyé en une forme galénique orale solide ou une suspension liquide destinée à une administration orale. Le procédé permet d'obtenir des formulations possédant une mouillabilité ou une dispersabilité améliorée.

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