Process for the preparation of a solid dosage form, in particular a tablet, for pharmaceutical use and process for the preparation of a precursor for a solid dosage form, in particular a tablet

摘要

Process for preparing a powder comprising the steps of providing at least one first component in liquid form at ambient temperature, providing at least one second component having a melting point or melting range in the range from above ambient temperature to below the degradation temperature of said first component, forming a homogenous liquid mixture comprising the at least one first component and the at least one second component by stirring and heating the mixture to or keeping the mixture at a temperature in the range from above the melting point or melting range of the second component and below the degradation temperature of the first component, transferring the liquid mixture to at least one spray congealing unit, spray congealing the mixture, and isolating the powder obtained upon spray congealing.

主权项

1. Process for preparing a powder comprising the steps of:
i) providing from 0.1 wt-% to 8 wt-% of at least one first component selected from the group consisting of tocopherol and tocopherol derivatives, said at least one first component:
being in liquid form at ambient temperature; orbeing a solid or semi-solid at ambient temperature and having an onset of melting in the temperature range from 15° C. to 40° C., ii) providing from 92 wt-% to 99.9 wt-% of at least one second component having a melting point or melting range above ambient temperature and comprising polyalkylene glycol, iii) forming a homogenous liquid mixture comprising said at least one first component and said at least one second component by stirring and heating the mixture to or keeping the mixture at a temperature in the range from above the melting point or melting range of said second component to 120° C., iv) transferring the liquid mixture to at least one spray congealing unit by at least one transfer unit, which is adapted to keep the mixture in its liquid form during its transfer, v) spray congealing said mixture, and vi) isolating the powder obtained upon spray congealing.