I recently had the pleasure of collaborating with a group of very talented scientists at EMS and International Institute of Pharmaceutical Research (IIPF). EMS and IIPF are two pharmaceutical companies based in Hortolândia, a city roughly 100 miles northwest of Sao Paulo, Brazil. We worked on an interesting project where FBRM was used to track Active Pharmaceutical Ingredient (API) particle size reduction during wet milling. Traditionally, offline laser diffraction had been used to track this process; however this approach proved to be time consuming, prone to inaccuracy and potentially hazardous. Continue reading
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. Continue reading
The 2010 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting will be held November 14 to 18 in New Orleans. As thousands of pharmaceutical scientists from around the world prepare to gather for the AAPS conference that is being held in conjunction with the International Pharmaceutical Federation’s (FIP) Pharmaceutical Sciences World Congress (PSWC), I wanted to highlight some papers that will discuss how to track particle distribution in real-time:
One presentation that will be given at the Quality by Design Session at the 2010 American Institute of Chemical Engineers (AIChE) Annual Meeting will be: Optimizing and Controlling High Value Processes Using the Principles of Quality by Design (QbD) Advanced Tools Such as Real-Time In Situ Particle Characterization, In Situ Mid-Infrared Spectrometry and Reaction Calorimetry.
1. Reduce fines generation
2. Identify crystallization problems at small scale
3. Optimize seeding protocol
4. Target an appropriate endpoint during wet milling
5. Identify and monitor polymorph transformation
For additional details to improve laboratory crystallization, view the online seminar I presented: Top Five High Impact Ways In Situ Particle Characterization Can Improve Laboratory Crystallization.
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Add your comments below if you have any additional crystallization resources or thoughts you would like to highlight.