Analysis of sustained-release tablet film coats using terahertz pulsed imaging

• Published in: Journal of controlled release 2007-06, Vol.119 (3), p.253-261
• Main Authors: Ho, L., Müller, R., Römer, M., Gordon, K.C., Heinämäki, J., Kleinebudde, P., Pepper, M., Rades, T., Shen, Y.C., Strachan, C.J., Taday, P.F., Zeitler, J.A.
• Format: Article
• Language: English
• Subjects: Biological and medical sciences; Coating uniformity; Drug Compounding; Film coating; General pharmacology; Image Processing, Computer-Assisted; Imaging, Three-Dimensional; Medical sciences; Microscopy, Confocal; Pharmaceutical technology. Pharmaceutical industry; Pharmacology. Drug treatments; Process analytical technology (PAT); Radio Waves; Refractive index; Spectrum Analysis - methods; Surface Properties; Tablets, Enteric-Coated - chemistry; Tablets, Enteric-Coated - standards; Terahertz pulsed imaging
• ISSN: 0168-3659; 1873-4995
• DOI: 10.1016/j.jconrel.2007.03.011

The coating quality of a batch of lab-scale, sustained-release coated tablets was analysed by terahertz pulsed imaging (TPI). Terahertz radiation (2 to 120 cm − 1 ) is particularly interesting for coating analysis as it has the capability to penetrate through most pharmaceutical excipients, and hence allows non-destructive coating analysis. Terahertz pulsed spectroscopy (TPS) was employed for the determination of the terahertz refractive indices (RI) on the respective sustained-release excipients used in this study. The whole surface of ten tablets with 10 mg/cm 2 coating was imaged using the fully-automated TPI imaga2000 system. Multidimensional coating thickness or signal intensity maps were reconstructed for the analysis of coating layer thickness, reproducibility, and uniformity. The results from the TPI measurements were validated with optical microscopy imaging and were found to be in good agreement with this destructive analytical technique. The coating thickness around the central band was generally 33% thinner than that on the tablet surfaces. Bimodal coating thickness distribution was detected in some tablets, with thicker coatings around the edges relative to the centre. Aspects of coating defects along with their site, depth and size were identified with virtual terahertz cross-sections. The inter-day precision of the TPI measurement was found to be within 0.5%.