An Overview on Spray-Drying of Protein-Loaded Polymeric Nanoparticles for Dry Powder Inhalation

Abstract

The delivery of therapeutic proteins remains a challenge, despite recent technological advances. While the delivery of proteins to the lungs is the gold standard for topical and systemic therapy through the lungs, the issue still exists. While pulmonary delivery is highly attractive due to its non-invasive nature, large surface area, possibility of topical and systemic administration, and rapid absorption circumventing the first-pass effect, the absorption of therapeutic proteins is still ineffective, largely due to the immunological and physicochemical barriers of the lungs. Most studies using spray-drying for the nanoencapsulation of drugs focus on the delivery of conventional drugs, which are less susceptible to bioactivity loss, compared to proteins. Herein, the development of polymeric nanoparticles by spray-drying for the delivery of therapeutic proteins is reviewed with an emphasis on its advantages and challenges, and the techniques to evaluate their in vitro and in vivo performance. The protein stability within the carrier and the features of the carrier are properly addressed.

Casein-Based Nanoparticles: A Potential Tool for the Delivery of Daunorubicin in Acute Lymphocytic Leukemia

“…Thanks to the innovative piezoelectric vibrating spray mesh head, which allows for the formation of fine droplets, and the novel electrostatic particle collector, it is possible to generate particles in the size range from 300 nm to 5 μm. Spray-drying of protein nanoparticles has been reported in numerous scientific papers [ 28 , 29 , 30 , 31 ], but no data were found in the literature on the nano spray-drying of casein nanoparticles loaded with chemotherapeutic agents. In this study, the encapsulation of the chemotherapeutic agent daunorubicin hydrochloride (DRB) in casein nanoparticles was demonstrated using a nanospray-drying technique.…”

Recombinant Alpha-1 Antitrypsin as Dry Powder for Pulmonary Administration: A Formulative Proof of Concept

“…More recently, Kamada (Rehovot, Israel) filed a patent application (EP3565584) [22] detailing the preparation of an inhalable AAT powder by spray drying. Nevertheless, to our knowledge, no peer-reviewed work has been published, and no data on AAT stability and activity upon formulation are available, a piece of crucial information considering the well-known effects of spray drying on protein stability [23]. In particular, hAAT is known to undergo oxidation at a specific methionine residue, an inactivating modification also observed in cigarette smokers with AATD [24].…”

Development of Solid Lipid Nanoparticles as Dry Powder: Characterization and Formulation Considerations

“…Multiple studies in the scientific literature have provided many examples regarding the importance of spray-drying in nanotechnological processes [ 29 , 30 ]. This technique has demonstrated its ability to optimize the particle size, shape, surface roughness, and surface composition of polymeric nanoparticles by modifying critical process parameters and formulation variables.…”