(295c) Improving Drug Delivery By Employing Terahertz Technologies to Monitor Manufacturing Processes

Terahertz spectroscopy and imaging are powerful new techniques for monitoring of pharmaceutical manufacturing processes.  A number of parameters that critically affect drug delivery are able to be measured and continuously evaluated by these methods.  These include bulk physical properties such as density, porosity, solid fraction and hardness as well as chemical properties such as crystalline/amorphous state of an API or blend uniformity.  Furthermore, the unique ability of terahertz light to penetrate deeply into opaque materials allows one to determine the thickness and uniformity of functional coatings on tablets.

Such methods are easily integrated into the pharmaceutical manufacturing process.  Their rapid and non-destructive nature enables them to be employed in-line to assess and monitor key Critical Quality Attributes (CQAs) and maintain product quality.

This talk gives an overview of a number of applications where CQAs critical to effective drug delivery have been measured using these techniques.  These include:

-       Continuous, in-line monitoring of roller compaction ribbon density

-       Measurement of tablet porosity and hardness and their correlation to dissolution properties

-       Rapid and precise quantification of percent crystallinity of API in a mixture

-       Determination of coating thickness and uniformity in functionally coated tablets

Due to these diverse applications and simplicity of use, Terahertz Process Analytical Technology (PAT) is rapidly becoming a powerful and effective tool for obtaining optimal and consistent drug delivery characteristics.