首页> 外国专利> 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

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

机译:制备用于药物用途的特别是片剂的固体剂型的过程,以及制备特别是片剂的用于固体剂型的前体的过程

摘要

The present invention refers to a process for preparing a powder comprising the steps of providing at least one first component being in liquid form at ambient temperature, in particular having a viscous liquid consistency, such as for example an oil; or having a waxy consistency at ambient temperature, in particular a component which is a solid or semi-solid at ambient temperature and which has an onset of melting in the temperature range from 15 0 C to 40 0 C, 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, in particular in the range from above ambient temperature to 120 0 C, more in particular in the range from 40 °C to 120°C, even more in particular in the range from 50°C to 120°C, even further in particular in the range from 55°C to 120°C, 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 and below the degradation temperature of said first component, in particular in the range from above the melting point or melting range of said second component to 120 0 C, 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, spray congealing said mixture, and isolating the powder obtained upon spray congealing. Further, the present invention refers to a process for the preparation of a solid dosage form comprising the powder resulting from the above process.
机译:本发明涉及一种制备粉末的方法,该方法包括以下步骤:提供至少一种在环境温度下为液体形式的第一组分,特别是具有粘性液体稠度的第一组分,例如油;或在环境温度下具有蜡质稠度,特别是在环境温度下为固体或半固体并且在15 0 C至40 0 C的温度范围内具有开始熔化的组分,从而提供至少一种第二组分具有高于或高于所述环境温度至低于所述第一组分的降解温度的熔点或熔点范围,特别是高于或高于环境温度至120 0 C,更特别地高于或高于40℃至120℃,甚至更特别地在50℃至120℃的范围内,甚至更特别地在55℃至120℃的范围内,形成包含所述至少一种第一组分和所述至少一种第一组分的均质液体混合物。通过将混合物搅拌并加热至混合物或将混合物保持在从高于所述第二组分的熔点或熔融范围至低于所述第一组分的降解温度的范围内的温度下的至少一个第二组分,i n特别是在从所述第二组分的熔点或熔点范围以上至120 0 C的范围内,通过至少一个转移单元将液体混合物转移到至少一个喷雾凝结单元,该转移单元适于将混合物保持在其液体中在其转移过程中形成粉末,将所述混合物喷雾凝结,并分离通过喷雾凝结获得的粉末。此外,本发明涉及包含上述方法得到的粉末的固体剂型的制备方法。

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