Device and method for producing pharmaceutically highly...

A - Human Necessities – 61 – K

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A61K 9/14 (2006.01) A61K 9/16 (2006.01) A61K 31/00 (2006.01)

Patent

CA 2751625

The invention relates to pharmaceutical active substance particles having small particle size, wherein said particles are produced by combining a solvent-non-solvent precipitate with an in-situ spray drying process. A pharmaceutical active substance is dispersed in a water-soluble solvent, in particular ethanol, and heated in an infeed line under pressure to above the boiling point of the solvent until solubilization. Said solution collides as a fine fluid jet with a fine water jet in a gas-permeated microreactor, and the fine mist so arising is thereby very rapidly vaporized. The organic solvent vaporizes first, then the water. The water can comprise surface modifiers.

L'invention concerne des particules pharmaceutiques de principe actif ayant une taille de particule minime qui sont fabriquées en combinant une précipitation de solvant et non-solvant avec un séchage par pulvérisation in situ. Un principe actif pharmaceutique est dispersé dans un solvant miscible dans l'eau, notamment de l'éthanol, et est chauffé dans un conduit d'alimentation sous pression au-delà du point d'ébullition du solvant jusqu'à dissolution. Cette solution entre en collision sous la forme d'un fin jet de liquide dans un microréacteur rincé par du gaz avec un fin jet d'eau et le fin brouillard qui en résulte est très rapidement évaporé. Le solvant organique s'évapore tout d'abord et ensuite l'eau. L'eau peut contenir des modificateurs de surface.

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