>> Gentle, homogenous and innovative: continuous mixing of pharmaceutical active ingredients.
Pharmaceutical Hot Melt Extrusion
With its special versions of the ZSK twin-screw extruder suitable for the production of pharmaceutical compounds, Coperion, formerly Werner & Pfleiderer, is one of the pioneers in the development of Pharmaceutical Hot Melt Extrusion. In this continuous production process, polymers are mixed with binding materials, carrier materials and active pharmaceutical ingredients (API’s). This innovative, flexibly applicable process has recently become increasingly important.
Typical Application Areas of Pharmaceutical Hot Melt Extrusion
| Production of pharmaceutical melt extrudates (tablets, pellets, capsules, micropellets) |
| Incorporation of difficult to dissolve active ingredients in a polymer matrix (BCS class 2 & 4) |
| Production of medicines with delayed/exactly timed release of active ingredients |
| Production of active ingredient compounds for transdermal plasters |
| Production of adhesives for medical applications such as stoma |
| Encapsulation and taste masking |
| Implants/biodegradable implants |
| Medical plastics (wound plasters/butterfly closures) |
| Orodispersible tablets |
| Potent extrusion (processing of active ingredients under protective conditions) |
| Wet extrusion |
Advantages of Pharmaceutical Hot Melt Extrusion
| Excellent integration of difficult to dissolve API´s (Active Pharmaceutical Ingredients) into a polymer matrix |
| Production of solid dispersions and solid solutions possible |
| Greatly improved bio-availability of the pharmaceutically active ingredients |
| Exactly timed and delayed release profiles can be realized |
| Solvent-free process in which production steps such as drying are omitted completely |
| Continuous process/reproducibility |
| Intensive mixing behavior of the twin-screw extruder |
| Production method which is kind on the product due to short residence time in the process section at low temperature |
Coperion has references for pharmaceutical extruders in the sizes ZSK 18 to ZSK 70. The good mixing behaviour and the devolatilization possibilities of the co-rotating twin screws make it particularly suitable for hot melt extrusion.
Special Features of the Pharmaceutical Extruder from Coperion
| Manufactured in GMP design |
| Use of tested, certified materials |
| Use of FDA-conformant oils/lubricants |
| Compact design and therefore low space requirement |
| Self cleaning of the twin screws enables fast recipe and product changes |
| Clear arrangement of the lines with easy operation, easy access for cleaning and maintenance |
| Special control system which can be designed for the requirements of laboratory operation and clean-room production |
Engineering Know-how
| Long years of experience in project management for pharmaceutical plants, 1994 realization of the first extrusion project according to GMP regulations |
| Qualification and validation of the plants by the experienced Coperion pharmaceutical team |
| FAT (factory acceptance test) and SAT (site acceptance test) |
