Preparation, Physical Characterization and Solubility-Dissolution Testing of Loratidine Hot Melt Extrudates Prepared on a Laboratory Mixing Extruder

Purpose.  To prepare and test hot melt extrudates of Loratidine with Copovidone at 30% and 40% drug loading using a bench-top Dynisco laboratory mixing extruder (LME) at various temperatures. Dissolution behavior and solubility enhancement was tested using a small-volume in situ UV dissolution apparatus μDISS Profiler to collect concentration-time profiles in biorelevant media (e.g., FaSSIF and FeSSIF).

Conclusion. Temperature was an important process parameter in preparing amorphous solid dispersions of Loratidine with Copovidone at 30% or 40% API loading on the Dynisco LME. The μDISS Profiler allowed real-time concentration monitoring in small volumes of media thus providing a valuable tool for studying meta-stable solubility of amorphous form of API.