Continuous manufacturing via hot-melt extrusion and scale up: regulatory matters.

Hot-Melt Extrusion Technique: A Review

Hot-melt extrusion is one of the most widely applied processing technologies in the plastic, rubber and food industry. Today this technology has found its place in the array of pharmaceutical manufacturing operations. Melt extrusion process are currently applied in the pharmaceutical field for the manufacture of a variety of dosage forms and formulations such as granules, pellets, tablets, supp...

Hot-Melt Extrusion Technique: A Review

Hot-melt extrusion is one of the most widely applied processing technologies in the plastic, rubber and food industry. Today this technology has found its place in the array of pharmaceutical manufacturing operations. Melt extrusion process are currently applied in the pharmaceutical field for the manufacture of a variety of dosage forms and formulations such as granules, pellets, tablets, supp...

Development and optimization of ketoconazole oral strips by means of continuous hot-melt extrusion processing.

OBJECTIVES The aim of this study was to develop mucoadhesive oral strips using hot-melt extrusion as a continuous manufacturing process. METHODS Powder blends of ketoconazole, a water-insoluble drug - either hydroxypropyl methylcellulose (HPMC) or soluplus (SOL), sorbitol (SRB) and magnesium aluminometasilicate (MAS) were extruded to manufacture thin strips with 0.5-mm thickness. The presence...

Development of Continuous Manufacturing of Filaments for Pharmaceutical 3D Print Dosage Forms Utilizing Hot Melt Extrusion Technology

Hot Melt Extrusion Technique

Various approaches have been adopted to address this including preparation of solid dispersions and solid solutions. Hot-melt extrusion is an efficient technology for producing solid molecular dispersions with considerable advantages over solvent-based processes such as spray drying and co-precipitation. Hot-melt extrusion has been demonstrated to provide sustained, modified, and targeted drug ...