To successfully develop and manufacture your polymer-based delivery systems, like implants and intra-vaginal rings, we have advanced extrusion capabilities in Malmö (Sweden) and Putnam (US Connecticut). The US site is also a center of expertise for Hot Melt Extrusion (HME), a technology used to manufacture amorphous solid dispersions enabling the solubilization of poorly water-soluble drugs.
Extrusion is a suitable technology for continuously manufacturing polymer-based delivery systems with a fixed cross-sectional profile by pushing material through a die. A classic example is a cylindrical strand, which can be cut into pieces of defined length, and the resulting rods can be implantable dosage forms.
Next to using extruders for manufacturing delivery systems, the twin-screw extrusion capabilities in Putnam are also utilized for Hot Melt Extrusion (HME), a technology used to improve the bioavailability of poorly water-soluble drugs (BCS II and IV). During HME, crystalline API is dissolved in a suitable polymer using heat and shear generated in a twin-screw extruder. The US facility has various twin-screw extruders and an extensive library of over 100 screw designs to support technical and GMP development.
It is within the scope of our capabilities and knowledge base to support your development process from start to finish, including manufacturing supplies for all clinical phases of development and a seamless transition to commercial manufacturing. Moreover, our equipment is fully contained, warranting the safe handling of the highest potency APIs.
Book a meeting at CPHI with one of our experienced and knowledgeable hot melt extrusion experts. Our scientists are ready to consult you on how to make your project come alive in the best way possible.