>> 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)
ZSK 18 MEGAlab in GMP design
ZSK 18 MEGAlab in GMP design, suited for laboratory use as well as for production
Process section of the ZSK extruder in pharmaceutical design
Process section of the ZSK extruder in pharmaceutical design
Completely clad in stainless steel and equipped with leak-proof cooling water couplings
Completely clad in stainless steel and equipped with leak-proof cooling water couplings
Gravimetric feeder with tri-clamp connection
Gravimetric feeder with tri-clamp connection