Optimelt™ Technology: Unique Approach To Development & Scale-up Of Melt Extruded Oral Dosage Forms
Summary: An estimated 60 percent of compounds in early developmenthave poor solubility. Hot melt extrusion (HME) is increasinglybeing used for development of oral dosage forms ofwater-insoluble compounds with amorphous soliddispersions. Amorphous dispersions made by HME involveco-melting of the drug substance and an appropriatepolymeric excipient in a co-rotating twin screw extruder. Uponcooling, the extrudate generally consists of a single-phaseamorphous glassy matrix that can be milled to the desiredparticle size and incorporated into traditional tablet or capsuledosage forms. HME serves as a continuous manufacturingsolvent-less process technology.