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Protein inhalation powders: spray drying vs spray freeze drying
Y F Maa1, P A Nguyen, T Sweeney
1Genentech, Inc., South San Francisco, California 94080, USA. yuh-fun_maa@powderject.com
Pharmaceutical Research
|April 1, 1999
Summary
Spray freeze drying creates porous protein powders with superior aerosol performance compared to traditional spray drying. This new technique enhances delivery of inhaled therapeutics.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- Protein aerosol powders are crucial for inhaled drug delivery.
- Optimizing powder properties is essential for effective aerosol performance.
Purpose of the Study:
- To develop spray freeze drying (SFD) for protein aerosol powders.
- To compare SFD powders with spray-dried (SD) powders regarding physical characteristics and aerosol delivery.
Main Methods:
- Characterization of powders using particle size analysis, thermal analysis, microscopy, X-ray diffraction, and surface area measurement.
- Evaluation of aerosol performance using multi-stage liquid impinger and Anderson cascade impactor.
- Formulation of recombinant deoxyribonuclease (rhDNase) and anti-IgE monoclonal antibody (anti-IgE MAb) with carbohydrate excipients.
Main Results:
- SFD produced large (8-10 microns), porous particles, while SD yielded small (3 microns), dense particles.
- SFD powders exhibited significantly higher fine particle fraction (FPF) due to improved aerodynamic properties.
- Protein formulation, particularly carbohydrate excipient crystallization tendency, impacted aerosol performance.
Conclusions:
- Spray freeze drying yields light, porous protein particles.
- SFD offers superior aerosol performance compared to spray drying, attributed to favorable aerodynamic properties.
- SFD is a promising technique for preparing protein powders for inhalation.