Hot-melt extrusion of orally disintegrating films

Manufacturing methods for ODF Typical manufacturing methods for ODFs include solvent casting and hot-melt extrusion (HME) [1]. Solvent casting is a very common method for first studies and excipient screening. It is well-suited for thermolabile APIs but requires the handling of a solvent and can create problems during scale-up. HME offers a better alternative. In comparison to solvent casting, HME is a solvent-free, environmentally friendly technology. It is highly reproducible, and it shows better content uniformity with fewer processing steps and decreased production costs [2]. Furthermore, API and excipients are mixed on a molecular level with HME, resulting in a more uniform dispersion of the API in the ODF which increases the bioavailability of the drug. Scale-up in HME has been well established [4], and it can be easily done with Thermo Scientific extruders. With a suitable range of excipients, HME is the method of choice for innovative ODF formulation [2]. N o. LR 85 N o. LR 85 N o. LR 85 N o. LR 85 N o. LR 85