Production of dosage forms comprising a solid dispersion of...

Details Production of dosage forms comprising a solid dispersion of... Production of dosage forms comprising a solid dispersion of...

A - Human Necessities

61

K

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

Patent

CA 2597549

Disclosed is a method for producing dosage forms comprising a solid dispersion of a microcrystalline agent. According to said method, a thermoplastic polymer having a minimum glass transition temperature Tg of 40oC is melted, and an agent is homogeneously dissolved in the melt; crystallization of the agent is initiated in the obtained mass; and the mass is cooled. Crystallization of the agent can be initiated by adding a nonsolvent, seed crystals of the agent, or a derivatization reagent. Crystallization can also be initiated by maintaining the mass at a certain temperature for a sufficient amount of time, said temperature being lower than the temperature at which the agent can be fully dissolved in the mass.

La présente invention concerne un procédé pour produire des formes posologiques qui comprennent une dispersion solide d'une substance active microcristalline. Ce procédé consiste à faire fondre un polymère thermoplastique présentant une température de transition vitreuse Tg d'au moins 40 °C, à dissoudre de façon homogène une substance active dans la masse fondue, à amorcer une cristallisation de la substance active dans la masse obtenue, puis à refroidir ladite masse. La cristallisation de la substance active peut être amorcée en ajoutant un non solvant, des cristaux germes de la substance active ou un réactif de dérivation. On peut également amorcer la cristallisation en maintenant la masse pendant un temps adéquat à une température qui est inférieure à la température à laquelle la substance active est complètement soluble dans la masse.

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