A comparative assessment of continuous production techniques to generate sub-micron size PLGA particles.
Authors of this article are:
Operti MC, Fecher D, van Dinther EAW, Grimm S, Jaber R, Figdor CG, Tagit O.
A summary of the article is shown below:
The clinical and commercial development of polymeric sub-micron size formulations based on poly(lactic-co-glycolic acid) (PLGA) particles is hampered by the challenges related to their good manufacturing practice (GMP)-compliant, scale-up production without affecting the formulation specifications. Continuous process technologies enable large-scale production without changing the process or formulation parameters by increasing the operation time. Here, we explore three well-established process technologies regarding continuity for the large-scale production of sub-micron size PLGA particles developed at the lab scale using a batch method. We demonstrate optimization of critical process and formulation parameters for high-shear mixing, high-pressure homogenization and microfluidics technologies to obtain PLGA particles with a mean diameter of 150-250 nm and a small polydispersity index (PDI, ≤0.2). The most influential parameters on the particle size distribution are discussed for each technique with a critical evaluation of their suitability for GMP production. Although each technique can provide particles in the desired size range, high-shear mixing is found to be particularly promising due to the availability of GMP-ready equipment and large throughput of production. Overall, our results will be of great guidance for establishing continuous process technologies for the GMP-compliant, large-scale production of sub-micron size PLGA particles, facilitating their commercial and clinical development.
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This article is a good source of information and a good way to become familiar with topics such as:
Continuous process technology;Homogenization;Microfluidics;Poly(lactic-co-glycolic acid);Scale-up production;Sub-micron particles
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