PRODUCTION OF DOSAGE FORMS COMPRISING A SOLID DISPERSION OF A MICROCRYSTALLINE AGENT

摘要

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 40^oC 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.