Analysis of coating structures and interfaces in solid oral dosage forms by three dimensional terahertz pulsed imaging.
Three dimensional terahertz pulsed imaging (TPI) was evaluated as a novel tool for the nondestructive characterization of different solid oral dosage forms. The time-domain reflection signal of coherent pulsed light in the far infrared was used to investigate film-coated tablets, sugar-coated tablets, multilayered controlled release tablets, and soft gelatin capsules. It is possible to determine the spatial and statistical distribution of coating thickness in single and multiple coated products using 3D TPI. The measurements are nondestructive even for layers buried underneath other coating structures. The internal structure of coating materials can be analyzed. As the terahertz signal penetrates up to 3 mm into the dosage form interfaces between layers in multilayered tablets can be investigated. In soft gelatin capsules it is possible to measure the thickness of the gelatin layer and to characterize the seal between the gelatin layers for quality control. TPI is a unique approach for the nondestructive characterization and quality control of solid dosage forms. The measurements are fast and fully automated with the potential for much wider application of the technique in the process analytical technology scheme.
Zeitler
J Axel
JA
TeraView Limited, Platinum Building, St John's Innovation Park, Cambridge, CB4 0WS, United Kingdom.
Shen
Yaochun
Y
Baker
Colin
C
Taday
Philip F
PF
Pepper
Michael
M
Rades
Thomas
T
D002214:Capsules / Q000032:analysis*; D003692:Delayed-Action Preparations; D019422:Dietary Sucrose; D005079:Excipients; D005780:Gelatin; D007091:Image Processing, Computer-Assisted; D021621:Imaging, Three-Dimensional; D013499:Surface Properties; D013607:Tablets / Q000032:analysis*; D013678:Technology, Pharmaceutical
D002214:Capsules; D003692:Delayed-Action Preparations; D019422:Dietary Sucrose; D005079:Excipients; D013607:Tablets; D005780:Gelatin