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PREPARATION OF DRUG-LOADED PLGA NANOPARTICLES BY SPRAY-DRYING USING A BUCHI SPRAY DRYER B-90

M. A. Merkulova

Abstract

Previously we have developed the PLGA nanoparticles loaded with doxorubicin (PLGA-DOX NP) that demonstrated a high anti-tumor effect against the rat glioblastoma in the preclinical studies and is now being evaluated in the clinical phase II study. This formulation was obtained by a generally accepted homogenization ? solvent evaporation technique followed by freeze-drying. The purpose of the present study was to explore the feasibility to simplify the process of the nanoparticle preparation by replacing a freeze drying step with spray drying using a BUCHI Nano Spray Dryer B-90. The NP were prepared using the low molecular weight PLGA (Resomer® RG 502H) as a core polymer. The drug-to-polymer ratio was maintained at 1:10 w/w. The new process optimization involved variation of the following parameters: velocity of the air flow; inlet temperature; concentration of solid ingredients, ratio of aqueous and organic phases (w1:o:w2) in the initial emulsion; concentration of polyvinyl alcohol (PVA) used as stabilizer. Evaluation of the significance of the process parameters carried out by the Taguchi method revealed that the formulation factors had a greater impact on the nanoparticle parameters than technological ones. This result points to a comparatively easy configuration of the spray drying process for the PLGA nanoparticle-based formulations. Importantly, the characteristics of the nanoparticles were not affected by the drying gas at the temperatures required for efficient drying (80°C). The physicochemical parameters of the doxorubicin-loaded PLGA nanoparticles obtained by the optimized spray drying process (average size 230 ± 16 nm, PDI 0.213 ± 0.090, encapsulation efficiency of 85%) were similar to the parameters of the nanoparticles obtained by a conventional homogenization ? solvent evaporation - freeze-drying technique.

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DOI resolver: doi.org/10.5593/sgem2019/6.1/s24.047

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