Meeting the unmet: from traditional to cutting-edge techniques for poly lactide and poly lactide-co-glycolide microparticle manufacturing

Abstract

Background: Polylactides (PLA) and poly lactide-co-glycolides (PLGA) undoubtedly are among the major drivers in the pharmaceutical market. Their relevance in pharmaceutics and biomedicine is well established in light of their sustainability, safety, tunable biodegradability, and versatility. However, polymer degradability and plasticity can somehow restrain industrial developability of PLA and PLGA formulations, especially in the form of microparticles (MP). Area covered: This review wants to deal with the known manufacturing issues of PLA/PLGA MP, debating the potential contribution of modern and cutting-edge manufacturing technologies to the solution of unmet production needs. Technological and regulatory aspects will be considered outlining the potential role of advanced manufacturing techniques in the advancement of PLA/PLGA MP production processes. Expert opinion: The multifaceted complexity of PLA/PLGA MP manufacturing processes demands adequate standardization and updated guidelines covering the so far unmet industrialization requirements. Novel and evolving manufacturing technologies will surely support the future development of bench-to-production plant transfer for such products. Careful evaluation of production costs is demanded in order to ensure process sustainability and patient’s outreach.