Coatings are a vital part of a pharmaceutical tablet as they control the release of active pharmaceutical ingredients (API) to ensure the bioavailability, safety and efficacy of the drug product. However, if there is an issue with the coating, if it isn’t uniform or contains defects, then these functions may be severely compromised.
This makes it critical that coating integrity for tablets is assessed, for both individual tablets and across an entire batch to ensure product quality and monitor and control coating operations.
Terahertz Pulsed Imaging (TPI™)
A new method of rapid, non-destructive analysis of tablet coating thickness and quality is Terahertz Pulsed Imaging (TPI™). As it is non-destructive, tablets can be re-examined further on through the process to assess continuing coating stability or used for further functional studies with prior knowledge of the coating uniformity.
TeraView's TPI™ imaga 2000 can probe any position on a tablet in less than 20 ms, making it ideal for determining Critical Quality Attributes in support of PAT initiatives in laboratory and manufacturing environments.
The TPI imaga 2000 is optimized for non-destructive determination of heterogeneity and integrity of pharmaceutical cores and coatings, and can be used as a routine part of your product and process development to:
- Enable rational product design and control
- Build ICH compliant product registration
- Mitigate risk of product failure
- Optimize manufacturing costs
Assessment of Product Performance
TeraView has the necessary expertise to investigate and assess vital attributes that affect the product performance such as:
- Density variation in tablet cores
- Crack propagation leading to tablet failure such as capping and de-lamination
- Coating thickness, density, integrity and uniformity
- Core – coat interaction to establish impact of coating process on the tablet core
- Interaction between multiple coatings or core layers
Generation of Predictive Models
TeraView can use chemometric software to generate predictive models that support you across product and process development, and optimization, as well as suggesting the additional manufacturing space required for successful scale-up and process transfer.
This information has been sourced, reviewed and adapted from materials provided by TeraView Ltd.
For more information on this source, please visit TeraView Ltd.