| abstract |
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. |