Identification of Factors of Importance for Spray Drying of Small Interfering RNA-Loaded Lipidoid-Polymer Hybrid Nanoparticles for Inhalation

Pharmaceutical Research
Cypriane DormenvalCamilla Foged

Abstract

With the recent approval of the first small interfering RNA (siRNA) therapeutic formulated as nanoparticles, there is increased incentive for establishing the factors of importance for the design of stable solid dosage forms of such complex nanomedicines. The aims of this study were: (i) to identify factors of importance for the design of spray-dried siRNA-loaded lipidoid-poly(DL-lactic-co-glycolic acid) hybrid nanoparticles (LPNs), and (ii) to evaluate their influence on the resulting powders by using a quality-by-design approach. Critical formulation and process parameters were linked to critical quality attributes (CQAs) using design of experiments, and an optimal operating space (OOS) was identified. A series of CQAs were identified based on the quality target product profile. The loading (ratio of LPNs to the total solid content) and the feedstock concentration were determined as critical parameters, which were optimized systematically. Mannitol was chosen as stabilizing excipient due to the low water content of the resulting powders. The loading negatively affected the colloidal stability of the LPNs, whereas feedstock concentration correlated positively with the powder particle size. The optimal mannitol-based solid form...Continue Reading

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Citations

May 29, 2020·Journal of Receptor and Signal Transduction Research·Nan ZhengDongkai Shan
Nov 13, 2020·Journal of Controlled Release : Official Journal of the Controlled Release Society·Ling DingDavid Oupický
Mar 2, 2021·Acta Pharmaceutica Sinica. B·Yuanyuan ChenSen Zhang
Mar 12, 2021·Advanced Drug Delivery Reviews·Rachel Yoon Kyung ChangHak-Kim Chan
Aug 10, 2021·Molecular Aspects of Medicine·Alysia CoxEun Ji Chung
Aug 18, 2021·Acta Pharmaceutica Sinica. B·Makhloufi ZoulikhaWei He

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Methods Mentioned

BETA
dynamic light scattering
scanning electron microscopy
X-ray
fluorescence spectroscopy
scraping
PCR
electrophoresis
transfection
flow filtration

Software Mentioned

’ Pert HighScore Plus
Zetasizer
PANalytical
Aerosol Instrument Manager®
’ Pert Data Collector
LightCycler® 480
GraphPad Prism
Modde

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