This week, I was in New Orleans attending the 2010 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting. The AAPS Meeting combines a large trade show with technical presentation and poster sessions running in parallel.
At the 2010 AAPS meeting, hot topics included Quality by Design (QbD), Process Analytical Technology (PAT) and the drive towards real-time release for pharmaceutical products. FBRM and PVM technologies were well represented with numerous posters and presentations focusing on their use to understand, optimize and control particle size distribution during drug product formulation.
Two posters of note came from Novartis and Bristol-Myers Squibb and focused on the use of FBRM C35 during high shear wet granulation. The Novartis paper – Evaluation of PAT Tools for the Monitoring and Endpoint Detection of the High Shear Wet Granulation: NIR, FBRM, PVM, ARS – outlined a case study where FBRM was used to track granule growth and fine particle disappearance. The authors concluded: “FBRM’s sensitivity to fine the particle population allowed the root cause of variability to be understood and addressed”. The Bristol-Myers Squibb paper – Resolution and Sensitivity of FBRM C35 Probe for Real-Time Chord Length Distribution Measurement During High Shear Wet Granulation and Correlation with Other Particle Size Distribution Techniques – showed how FBRM provided adequate sensitivity to differentiate between different grades of MCC during a dry blend and how the FBRM data correlated well with offline particle size measurement techniques. BMS also presented innovative methods for FBRM data representation where changes in the chord length distribution were visualized as a heat map changing over time.
Other AAPS posters of interest included:
- Process Analytical Technology: Online Monitoring of PLGA Microparticles Formation Using FBRM and PVM – Food and Drug Administration (FDA)
- Quality-by-Design (QbD) Case Study: Seeking Linkage Between Real-Time PAT Process Monitoring and Offline Product Characterization – Food and Drug Administration (FDA)
- Application of QbD Principles for the Evaluation of Various Hypromellose Grades for a Sustained Release Formation – GlaxoSmithKline
- Predicting High Shear Wet Milling Behaviors of Pharmaceutical Solids – Pfizer
- A Mechanistic Study Using Polymers to Sustain Supersaturation upon In-vitro Dissolution of Liquid Filled Capsule Formulations of a Poorly Soluble Drug Molecule – Amgen Inc.
On a personal note, I was lucky enough to have a poster accepted that focused on the use of FBRM and PVM to improve liquid formulations such as suspensions, emulsions and dispersions. The poster – Improving Liquid Formulations Using In Situ Particle and Droplet Characterization – reviewed recent work in this area and included examples of how FBRM can track wet-milling endpoint, improve emulsion scale-up and screen for suspension stability under changing temperature and agitation. For those who could not attend AAPS this year, this work is also available in the On-Demand Webinar: Gain Control of Liquid Formulations with Inline Particle and Droplet Measurements.
New Orleans provided the perfect backdrop for the AAPS conference and I was lucky enough to learn the difference between Creole and Cajun cuisine! For those interested, I prefer Creole!