Scale-up, Preclinical and Clinical Status of Poly (Lactide-Co-Glycolide) and its Copolymers based Drug Delivery Systems

Poly(lactide-co-glycolide) or PLGA is a kind of a synthetic polymer that has been approved by USFDA for its use in humans. PLGA nano/microparticles have proved to offer controlled as well as the sustained release of several medicinal moieties. PLGA is chemically synthesized by direct polycondensation of glycolic acid (GA) with lactic acid (LA) and different factors like LA: GA ratio, storage temperature, the initial molecular weight of the monomers, and exposure time to water influences the physical properties of PLGA. Similarly, various factors like morphology, crystallinity, molecular weight, shape, size molecular, hydrophobicity, chemical structure, physicochemical properties, glass transition temperature are some of the crucial factors responsible for the biodegradation of PLGA. PLGA based micro/nanoparticles are generally prepared by the oil-in-water emulsification process. On the other hand, spray drying is one of the industrial methods for the production of PLGA particles. In this chapter, we have summarized the extensive applications, laboratory, and industrial-scale methods for the production of PLGA nano/microparticles, preclinical, and clinical status PLGA based drug delivery systems.

Keywords: Industrial scale-up, Microparticles, Nanoparticles, Physicochemical properties, Poly(lactide-co-glycolide), Preclinical and clinical status, Scaffolds, Vaccine adjuvant.