Pharma-compounding, often referred to as “hot melt extrusion,” is the integration of drugs, antimicrobials, or active pharmaceutical ingredients (API) with biopolymers for implantation or ingestion. Biomerics’ chemists and engineers have the compounding and feeding technologies available to incorporate these agents into a wide range of bioabsorable and bioimplantable polymers including PEEK, polyurethane (TPU), polylactide (PLA), polyglycolide (PGA), and other blends. In some cases, we can incorporate the agent during the polymerization process using our in-house reactors.
We will partner with you during the development phase of the product to establish the formulation (including release and absorption kinetics), polymer chemistry, and the compounding or extrusion process. Once developed, we have the quality systems to guide the project through all phases including: trials, scale-up, validation, and final production.
Polymerization and hot melt extrusion are completed in a controlled environment under FDA quality requirements. Biomerics operates a variety of twin screw compounders including a Leistritz Pharma-compounder with air cooling extrusion belts and cutting lines to produce the desired product form.