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PROCESS FOR THE PREPARATION OF AN INTERMEDIATE POWDER FORMULATION AND A FINAL SOLID DOSAGE FORM UNDER USAGE OF A SPRAY CONGEALING STEP
专利权人:
GRUENENTHAL GMBH
发明人:
FAURE, ANNE,VOORSPOELS, JODY FIRMIN MARCELINE,MERTENS, ROEL JOS M.,KIEKENS, FILIP RENE IRENA
申请号:
CA2723438
公开号:
CA2723438C
申请日:
2009.05.08
申请国别(地区):
CA
年份:
2016
代理人:
摘要:
The present invention refers to a process for preparing a powder comprisingthe steps of providing at least one firstcomponent being in liquid form at ambient temperature, in particular having aviscous liquid consistency, such as for example anoil or having a waxy consistency at ambient temperature, in particular acomponent which is a solid or semi-solid at ambienttem-perature and which has an onset of melting in the temperature range from15 °C to 40 °C, providing at least one second componenthaving a melting point or melting range in the range from above ambienttemperature to below the degradation temperature of saidfirst component, in particular in the range from above ambient temperature to120 °C, more in particular in the range from >40 °Cto 120°C, even more in particular in the range from 50°C to120°C, even further in particular in the range from 55°C to120°C,forming a homogenous liquid mixture comprising said at least one firstcomponent and said at least one second component bystir-ring and heating the mixture to or keeping the mixture at a temperaturein the range from above the melting point or melting rangeof said second component and below the degradation temperature of said firstcomponent, in particular in the range from abovethe melting point or melting range of said second component to 120 °C,transferring the liquid mixture to at least one spraycon-gealing unit by at least one transfer unit, which is adapted to keep themixture in its liquid form during its transfer, spraycongeal-ing said mixture, and isolating the powder obtained upon spraycongealing. Further, the present invention refers to a process forthe preparation of a solid dosage form comprising the powder resulting fromthe above process.
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