Formulation of High-Performance Dry Powder Aerosols for Pulmonary Protein Delivery

Pharmaceutical Research
Erin M WilsonJoseph M DeSimone

Abstract

Pulmonary delivery of biologics is of great interest, as it can be used for the local treatment of respiratory diseases or as a route to systemic drug delivery. To reach the full potential of inhaled biologics, a formulation platform capable of producing high performance aerosols without altering protein native structure is required. A formulation strategy using Particle Replication in Non-wetting Templates (PRINT) was developed to produce protein dry powders with precisely engineered particle morphology. Stability of the incorporated proteins was characterized and the aerosol properties of the protein dry powders was evaluated in vitro with an Andersen Cascade Impactor (ACI). Model proteins bovine serum albumin (BSA) and lysozyme were micromolded into 1 μm cylinders composed of more than 80% protein, by mass. Extensive characterization of the incorporated proteins found no evidence of alteration of native structures. The BSA formulation produced a mass median aerodynamic diameter (MMAD) of 1.77 μm ± 0.06 and a geometric standard deviation (GSD) of 1.51 ± 0.06 while the lysozyme formulation had an MMAD of 1.83 μm ± 0.12 and a GSD of 1.44 ± 0.03. Protein dry powders manufactured with PRINT could enable high-performance delivery ...Continue Reading

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Citations

Dec 10, 2019·Expert Opinion on Drug Delivery·Nivedita ShettyQi Tony Zhou
Oct 30, 2020·Pharmaceutics·Wanling LiangJenny K W Lam
Jun 9, 2020·Advanced Drug Delivery Reviews·Michael Y T ChowHak-Kim Chan
Mar 12, 2021·Advanced Drug Delivery Reviews·Rachel Yoon Kyung ChangHak-Kim Chan
Sep 22, 2021·International Journal of Pharmaceutics·Ashutosh SharmaHelen Hughes

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Methods Mentioned

BETA
Assay
light scattering
Electrophoresis
circular dichroism
Fluorescence
scanning electron microscopy

Software Mentioned

GraphPad Prism
PRINT
GraphPad

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