Tag Archives: Raman

Polymorph Form Control: Why Care About Seeding and Cooling Rates?

In Situ Monitoring of Supersaturation and Polymorphic Form of Piracetam during Batch Cooling Crystallization

Mark Barrett and others at the University College Dublin (UCD) recently published a paper Continue reading

AIChE征集结晶技术报告

美国化学工程师学会(AIChE)2011年会将在十月16-21 日于Minneapolis, MN 举行,有几个分会将重点讨论结晶于蒸发。

2011 AIChE
Bing-Shiou Yang (Principal Engineer, Boehringer Ingelheim) 和我将主持用于结晶开发与生产的PAT 分会。本分会欢迎新进的把工艺过程分析技术(PAT)应用于结晶工艺过程开发和生产的技术报告。 PAT应用技术可包括各种光谱分析法(FTIR, NIR, Raman)、颗粒与计数技术、以及其它不同在线监测或传感技术。尤其感兴趣的是驱动结晶过程开发的创新性途径和手段。 Continue reading

AIChE Call For Crystallization Papers

The 2011 American Institute of Chemical Engineers (AIChE) Annual Meeting – to be held October 16-21 in Minneapolis, MN – features a number of sessions on crystallization and evaporation.  Continue reading

Scale-up of API crystallization using Raman and FBRM Process Analytical Technology (PAT) to ensure Quality by Design (QbD)

scale-up-active-pharmaceutical-ingredients-api-american-pharmaceutical-reviewIn this recent paper published in American Pharmaceutical Review (Nov/Dec 2009) , the authors describe a comprehensive approach to QbD throughout the development and scale-up of a final crystallization step for an active pharmaceutical ingredient.

“The use of the QbD approach throughout the life-cycle of a drug product is an efficient tool for faster and more focused process development”

The paper describes the use of various tools, including:

  • Phase diagrams for a complete understanding of system thermodynamics, and determination of operating conditions to ensure production of the desired anhydrous form
  • The use of factorial design of experiments to map the operating design space, understand the effect of process variations and ensure robust operation
  • Real-time monitoring of the crystal product with FBRM (focused beam reflectance measurement) to monitor crystal nucleation and growth for optimization of seeding protocol and detection of undesirable events upon scale-up
  • In-line Raman to detect the presence of a metastable undesirable solvated form of the API, and to confirm its complete conversion to the desired stable form

Citation:

http://www.americanpharmaceuticalreview.com/ViewArticle.aspx?ContentID=4504?crel=US_AC_eAdv_Blog or New Developments in Scale-Up and QbD to Ensure Control Over Product Quality, by Martin Bohlin Ph.D., Helen Jones Ph.D., & Simon Black Ph.D. Global Process R&D, AstraZeneca, American Pharmaceutical Review, Volume 12, Issue 7, November/December 2009.