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Feasibility of protein spray coating using a fluid-bed Würster processor
1Department of Pharmaceutical Research and Development, Genentech, Inc, 460 Point San Bruno Boulevard, South San Francisco, California 94080, USA. maa.yuh-fun@gene.com
Biotechnology and Bioengineering
|March 20, 1997
Summary
Spray coating fine powders with proteins is feasible. Formulating proteins with calcium ions significantly reduced aggregation caused by thermal stress during the process.
Area of Science:
- Pharmaceutical Technology
- Materials Science
- Biotechnology
Background:
- Developing stable, dried pharmaceutical proteins is crucial for drug formulation.
- Traditional methods for protein coating can be complex and costly.
- Spray coating offers a potential alternative for protein encapsulation.
Purpose of the Study:
- To evaluate the feasibility of using a Würster spray coater for coating fine powders with protein solutions.
- To investigate the impact of process parameters on protein loading and coating integrity.
- To identify strategies for mitigating protein aggregation during spray coating.
Main Methods:
- Utilized a Würster spray coater (GPCG-1) for fluid-bed spray coating.
- Employed lactose powders (53-125 and 125-250 microm) as microcarriers.
- Used recombinant human deoxyribonuclease (rhDNase) as the model protein.
- Varied protein application amounts and formulated rhDNase with calcium ions.
Main Results:
- Achieved consistent rhDNase loading, matching theoretical values and confirmed by SEM.
- Demonstrated strong coating integrity under mechanical stress.
- Observed significant protein aggregation due to thermal stress, reduced by calcium formulation.
- Confirmed Ca(2+) thermal stabilization of rhDNase via scanning microcalorimetry.
Conclusions:
- Spray coating is a viable method for preparing coated pharmaceutical proteins.
- Rational formulation strategies, such as calcium addition, are essential to prevent protein aggregation.
- This technique offers a promising alternative for dried protein preparation.
