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978-3-8439-1262-4, Reihe Pharmazeutische Technologie
Terahertz Pulsed Imaging for Quality by Design Driven Development of Active-Coated OROS Tablets
143 Seiten, Dissertation Heinrich-Heine-Universität Düsseldorf (2013), Softcover, A5
The aim of this work was the nondestructive evaluation of coating thickness distributions on active-coated OROS® tablets using Terahertz Pulsed Imaging (TPI). The use of TPI in the quality by design driven development of coated dosage forms should be evaluated.
It was shown that TPI is a useful technique to reveal the microstructure of this sophisticated dosage form and to monitor the progress of an active coating process via off-line measurements.
Subtle changes in the physical properties, here the refractive index of the active coating at different process conditions were identified. As the refractive index is a crucial parameter for the calculation of absolute coating thickness values using TPI, a new method was developed that enables the determination of the refractive index directly on the coated tablet. This allows accounting for process related changes in the refractive index in the film thickness calculation.
Furthermore, the feasibility of TPI to determine both intra- and inter-tablet coating uniformity was demonstrated. Critical process parameters for intra- and inter-tablet coating uniformity were identified with TPI and encourage to use TPI for the quality by design driven development of coated dosage forms.
In summary, TPI showed high potential as a process analytical tool to nondestructively quantify coating thickness distributions on coated tablets.