Laura Restrepo Uribe;Claudia Andrea Silva Blanco;Maria del Pilar Noriega Escobar;Carlos Arturo Salazar Altamar;Marco Enrique Sanjuan Mejia
发明人:
Maria del Pilar Noriega Escobar,Laura Restrepo Uribe,Marco Enrique Sanjuan Mejia,Carlos Arturo Salazar Altamar,Claudia Andrea Silva Blanco
申请号：
US14849571
公开号：
US20160193151A1
申请日:
2015.09.09
申请国别(地区):
US
年份:
2016
代理人:
摘要：
The dissolution of Active Pharmaceutical Ingredients in polymeric melts plays an important role in the manufacturing of drugs that use polymers as excipients. The dissolution kinetics is essential for designing the processing equipment, describing the operating conditions, and defining material properties, for example, the appropriate API-polymer(s) pair. In one embodiment of the invention, the solubility of ketoprofen (KTO) in Soluplus®, Kollidon® VA64, Kollidon® SR and a combination of three； was analyzed under Hot Melt Extrusion (HME) processing conditions. Thermal characterization techniques show that a single phase amorphous solid solution (only one Tg) was achieved by HME at 120° C. and 70 rpm. The sample's stability was analyzed for 4 weeks and the single phase amorphous solid solution was maintained during that time. An extended release profile of KTO was achieved, releasing 100% of KTO in 12 h. The invention is particularly useful to target a specific release profile.
