Allows for more precise control of release kinetics
Merck is expanding its excipients portfolio following the signing of an agreement with PCAS, based in Longjumeau, France.
Under the agreement, Merck will be the exclusive, global distributor of the Expansorb line of biocompatible and biodegradable polymers.
The portfolio will include 38 polymers for sustained release of small molecule and selected peptide injectables, allowing release kinetics of the final drug products to be optimised and precisely controlled. This ability allows for drug delivery through fewer numbers of injections with the same therapeutic efficacy, improving patient comfort and compliance.
'The pharmaceutical industry is increasingly interested in controlling the release of small molecules and selected peptides delivered via injection,' said Andrew Bulpin, Head of Process Solutions at the life science business of Merck.
'The addition of the Expansorb polymers to our broad portfolio of excipients improves drug developers’ ability to protect molecules with short in vivo half-lives and achieve the desired therapeutic effect while enhancing patient comfort and compliance.'
Poly lactic acid (PLA) and poly lactic-co-glycolic acid (PLGA) polymers are biocompatible and biodegradable synthetic substances that have already been approved by the US FDA and the EMA. Several drug products are on the market with many more in clinical development.
Expansorb PLA and PLGA polymers are manufactured under cGMP conditions by PCAS and are expected to be sold under Merck’s Emprove programme once evaluations and certifications are complete.
Nanosphere and microsphere formulations based on PLGA polymers have been studied extensively for use in the delivery of peptides, therapeutic proteins, hormones and antibiotics. Future applications are expected to include the development of targeted drug-containing nanoparticles using site-specific ligands.