Ensuring Scalable Filling of Engineered Powders: Quality by Design
Boeckl AJ, Lord JD.
Respiratory Drug Delivery 2014. Volume 1, 2014: 267-276.
Abstract:
The large number of capsules or blisters required for commercial unit dose drug products necessitates the utilization of high throughput powder filling technology. Historically, this has been achieved using volumetric filling techniques but this approach presents unique challenges for dry powder inhaler (DPI) products and poses risks to their critical quality attributes (CQAs). For example, volumetric filling methods subject the powder to compressive forces that can adversely affect subsequent powder dispersion and, thereby, aerosol performance. Volumetric powder filling equipment are reviewed and a case study for drum filling feasibility trials using AeroVanc, an investigational DPI drug product for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) infections in cystic fibrosis patients, is presented.
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