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Published on: April 6, 2017
Engineering High-Performance Inhalable Monoclonal Antibody Powders via Spray Freeze Drying
Lorena Pasero1, Adamo Sulpizi2, Elettra Pinetti2
1Department of Applied Science and Technology, Politecnico di Torino, 24 Corso Duca Degli Abruzzi, 10129 Torino, Italy.
Summary
Spray freeze-drying produces stable, inhalable biologic powders for drug delivery. Formulation strategies using excipients like trehalose with leucine or HPβCD optimize monoclonal antibody stability and aerodynamic performance.
Area of Science:
- Pharmaceutical Sciences
- Biotechnology
- Materials Science
Background:
- Spray freeze-drying (SFD) is a promising technique for creating dry powders for pulmonary drug delivery.
- SFD's low-temperature process is suitable for sensitive biologics like monoclonal antibodies (mAbs).
- Potential challenges include mAb denaturation due to processing stresses.
Purpose of the Study:
- To investigate how formulation excipients affect mAb stability and delivery performance during SFD.
- To identify optimal excipients for preserving mAb integrity and powder properties.
- To evaluate the efficacy of SFD-processed mAb powders for pulmonary delivery.
Main Methods:
- A model mAb was spray freeze-dried with various stabilizing excipients (sugars, amino acids, cyclodextrins, surfactants).
- mAb chemical stability was assessed using size exclusion chromatography post-SFD.
- Aerodynamic properties, dissolution rates, and storage stability of the resulting powders were evaluated.
- In vivo studies in rats assessed lung deposition and systemic exposure after inhalation.
Main Results:
- Formulation significantly modulated mAb stability and powder characteristics during SFD.
- Trehalose combined with leucine or HPβCD demonstrated superior stabilization of the mAb.
- Optimized powders exhibited favorable aerodynamic properties (50-60% fine particle fraction) and rapid dissolution.
- Inhaled optimized powders showed effective lung deposition and systemic exposure in rats.
Conclusions:
- Rational excipient selection is crucial for producing stable, inhalable biologic dry powders via SFD.
- Optimized formulations enable the successful pulmonary delivery of mAbs using SFD technology.
- This approach supports the development of novel inhaled mAb-based therapeutics.
