RESOMER® and LACTEL® biodegradable polymers for parenteral controlled release

Our RESOMER® portfolio has been delivering safety, biocompatibility and supply security to companies with complex parenteral drug products for more than 30 years. In 2020, Evonik acquired the LACTEL® absorbable polymers portfolio—first commercialized in 1987— from DURECT Corporation. Together, these absorbable polymers have been defining polymer quality for decades and find application in numerous FDA-approved pharmaceutical products.

Both portfolios are 100 percent bioresorbable, completely metabolized by the body (hence, bioabsorbable), and ideal for terminal sterilization. With a shelf life exceeding five years, RESOMER® and LACTEL® are highly suitable for use with small molecules, peptides, proteins and other substances. Both are supplied from modern, established manufacturing sites in the U.S. and Germany – ensuring extensive options for dual sourcing and supply security.

The standard RESOMER® catalog of biodegradable polymers for controlled release includes high and low molecular weight homo-polymers, co-polymers and block co-polymers. Standard compositions include Poly (D,L-lactide) and Poly (D,L-lactide-co-glycolide) polymers with acid and ester end group chemistries. The RESOMER® portfolio also includes specialized co-polymers manufactured via polycondensation and di-block co-polymers made of PLA and mPEG. A variety of molecular weights are available to help modulate degradation times from weeks to years. 

All polymers are purified as part of the standard manufacturing process to achieve low residual monomer content and avoid possible interaction of any remaining monomer with an API. RESOMER® polymers are typically produced in conformance with the Joint IPEC- PQG Good Manufacturing Practice Guide for Bulk Pharmaceutical Excipients 2017 and USP-NF General Chapter GMPs for Bulk Pharmaceutical Excipients via validated manufacturing processes in large batch sizes from production sites in Germany or the U.S.

The standard LACTEL® portfolio boasts of more than 20 polymers available as a cost effective supply due to streamlined manufacturing processes. Common application areas for LACTEL standard polymers include veterinary medicine, where bioresorbable polymers are used in long-acting injectable formulations, and generic drug formulations, which require price-sensitive planning and quick shipment to support demanding, fast-paced markets. These non-solvent purified polymers are appropriate for many formulation applications, from existing generic products to novel therapeutics. For development projects, LACTEL® is available in small volumes that can then be scaled and optimized as a project progresses from small-scale research to full-scale commercial batches.