A vital component of pharmaceutical tablets are coatings, which control the release of active pharmaceutical ingredients (APIs), thus ensuring the bioavailability, safety and efficacy of the drug. However, issues with the coating, such as non-uniformity or defects, can severely damage these functions.
Thus, it is critical to assess the tablets’ coating integrity – both for individual tablets and across an entire batch – to ensure product quality in addition to monitor and control coating operations.
Introducing Terahertz Pulsed Imaging (TPI™)
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Terahertz Pulsed Imaging (TPI™) is a new technique enabling the rapid, non-destructive analysis of tablets in terms of coating thickness and quality. Being non-destructive, tablets can be re-examined repeatedly through the process, in order to assess coating stability on a continuous basis. Similarly, they can also be used for further functional studies with prior knowledge of the coating uniformity.
The TPI™ Imaga 2000 by TeraView is powerful in that it can probe any position on a tablet in less than 20 ms, thus making it ideal to determine Critical Quality Attributes and support PAT initiatives in the laboratory and manufacturing environments.
TeraView tablet scanning using TPI imaga 2000
A Method of Non-Destructive Analysis
TeraView’s TPI™ Imaga 2000 is optimized for non-destructive determination of heterogeneity and integrity of pharmaceutical cores and coatings. The technology can be used as a routine part of the product and process development to:
- Enable rational product design and control
- Build product registration that is ICH compliant
- Mitigate the risk of product failure
- Streamline manufacturing costs
Assessing Product Performance
TeraView has the necessary expertise to investigate and assess vital attributes affecting 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 optimization and product and process development, as well as suggesting the additional manufacturing space required for successful scale-up and process transfer.
About TeraView Ltd.
TeraView’s patented terahertz technology and instruments can generate, detect and manipulate terahertz radiation to characterise a wide range of materials. Our technology generates spectroscopic information and 3D images using the unique signatures of terahertz light not found at other wavelengths.
Using our TPS Spectra 3000 turn-key system, we have already successfully demonstrated that terahertz spectroscopy has the major advantage of being a non-contact analytical method. It can be applied in the study of semiconductors, pharmaceutical products, medical imaging, novel materials research and non-destructive evaluation of ceramics, composites and more.
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