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Biopharmaceutical powders: particle formation and formulation considerations
1PowderJect Technologies, Fremont, CA 94555, USA. yuh-fun_maa@powderject.com
Current Pharmaceutical Biotechnology
|July 27, 2001
Summary
Protein/peptide drugs are more stable as powders, offering advantages for storage and delivery. This review details various powder preparation techniques, aiding in selecting the best method for specific applications.
Area of Science:
- Pharmaceutical Sciences
- Biotechnology
- Materials Science
Background:
- Protein/peptide drugs exhibit enhanced stability in solid-state formulations compared to liquid forms.
- Solid-state protein formulations offer significant advantages for ambient temperature storage, shipping, and extended shelf life.
- Emerging powder-based drug delivery systems, including sustained release and inhalation, further enhance the value of solid protein dosage forms.
Purpose of the Study:
- To systematically review and summarize available protein powder preparation techniques.
- To evaluate common and novel methods for protein powder production.
- To assess these methods based on their impact on protein stability, process versatility, and scalability.
Main Methods:
- Lyophilization
- Spray drying
- Pulverization
- Precipitation
- Supercritical fluid precipitation
- Spray-freeze drying
- Fluidized-bed spray coating
- Emulsion precipitation
Main Results:
- Each protein powder preparation method possesses unique advantages and disadvantages.
- The choice of method is highly dependent on the specific drug formulation and intended application.
- Understanding the principles and benefits of each technique is crucial for effective selection.
Conclusions:
- No single method is universally superior; selection is application-specific.
- A comprehensive understanding of various protein powder preparation techniques facilitates optimal formulation development.
- This review provides a practical guide for scientists to choose appropriate methods for desired protein powder formulations.
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