Hot Melt Extrusion
An increasing challenges faced today by the pharmaceutical industry is approximately 40% of currently marketed drugs are classified as poorly soluble (BCS Class II/IV), and more than 90% of drugs in development are also poorly soluble, especially when the molecule has both low solubility and a high dose.
The mechanism of HME is to disperse APIs in the polymer matrix at the molecular level to form amorphous solid dispersions. Amorphous solid dispersions can improve bioavailability in more than 80% of cases. The advantage of HME technology is the capability of continuous manufacturing with solvent-less processing and friendly downstream processing of extrudates into final dosage forms (tablets, capsules, controlled release forms etc.). HME is increased use in the pharmaceutical industry.