Can you envisage the impact of physical transformations of the active drug substances on the final dosage form during late development?

It is huge!

How can this be prevented and controlled? The first step is to understand the process and the drug substance. Process conditions such as temperature, solvents and mechanical stress play an important role on the physical properties of the drug substance. Sometimes the solid-state transformations that may occur are subtle, so the analytical methods used to monitor these changes have to be able to detect and quantify very low levels of different solid phases. It is, therefore, important to control the physical attributes of the drug substance during the different stages of the process. This can be a real challenge; nevertheless, the use of orthogonal solid state and particle characterization techniques, such as XRD, DSC, IR, Raman and SEM, are tools of paramount relevance for this purpose.

Learn more with this webinar, where practical cases that focus on how Hovione overcomes some of these challenges are presented.  

Key Learning objectives:

• To use common solid state characterization analytical techniques to detect low amounts of solid phases impurities
• The impact of physical transformations on the solid dosage performance
• Linking between process and physical attributes of drugs

Watch On-demand. 

You might be also interested in:

• PAT Toolbox (PDF)
• Process Analytical Technologies (PDF)