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Surface Characterization of PLGA Particles by Atomic Force Microscope

The Tosca AFM is used to characterize PLGA polymer in qualitative and quantitative manner for an FDA approval for a generic injectable PLGA formulation

Introduction

Poly (lactide-co-glycolide) (PLGA) is a copolymer, containing polylactic acid (PLA) and polyglycolic acid (PEG). Due to its biocompatibility and biodegradability, it has been used for making injectable, long term formulations in the last three decades. An in depth understanding of PLGA polymers is critical for development of depot formulations as their properties control drug release kinetics. To date, about 20 PLGA-based formulations have been approved by the U.S. Food and Drug Administration (FDA) through new drug applications. However, none of these FDA approved formulations have generic counterparts on the market yet. A generic injectable PLGA product needs to establish qualitative and quantitative sameness of PLGA to that of a reference listed drug to obtain approval from FDA. Conventional characterizations of PLGA used in a formulation rely on measuring the molecular weight by gel permeation chromatography (GPC) based on polystyrene molecular weight standards, and determining the lactide: glycolide (L: G) ratio by 1H NMR and the end-group by 13C NMR. 

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