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Terahertz Pulsed Imaging and Magnetic Resonance Imaging as Tools to Probe Formulation Stability
Department of Chemical and Biological Engineering, Zhejiang University, Hangzhou 310027, China
Department of Chemical Engineering & Biotechnology, University of Cambridge, Cambridge CB2 3RA, UK
Merck Sharp & Dohme Ltd., Hoddesdon EN11 9BU, UK
* Author to whom correspondence should be addressed.
Received: 3 August 2013; Accepted: 21 September 2013 / Published: 25 October 2013
Abstract: Dissolution stability over the entire shelf life duration is of critical importance to ensure the quality of solid dosage forms. Changes in the drug release profile during storage may affect the bioavailability of drug products. This study investigated the stability of a commercial tablet (Lescolr XL) when stored under accelerated conditions (40 oC/75% r.h.). Terahertz pulsed imaging (TPI) was used to investigate the structure of the tablet coating before and after the accelerated aging process. The results indicate that the coating was reduced in thickness and exhibited a higher density after being stored under accelerated conditions for four weeks. In situ magnetic resonance imaging (MRI) of the water penetration processes during tablet dissolution in a USP-IV dissolution cell equipped with an in-line UV-vis analyzer was carried out to study local differences in water uptake into the tablet matrix between the stressed and unstressed state. The drug release profiles of the Lescolr XL tablet before and after the accelerated storage stability testing were compared using a “difference” factor ∫1 and a “similarity” factor ∫2. The results reveal that even though the physical properties of the coating layers changed significantly during the stress testing, the coating protected the tablet matrix and the densification of the coating polymer had no adverse effect on the drug release performance.
Keywords: magnetic resonance imaging; terahertz pulsed imaging; formulation stability; drug release; controlled release
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MDPI and ACS Style
Zhang, Q.; Gladden, L.F.; Avalle, P.; Zeitler, J.A.; Mantle, M.D. Terahertz Pulsed Imaging and Magnetic Resonance Imaging as Tools to Probe Formulation Stability. Pharmaceutics 2013, 5, 591-608.
Zhang Q, Gladden LF, Avalle P, Zeitler JA, Mantle MD. Terahertz Pulsed Imaging and Magnetic Resonance Imaging as Tools to Probe Formulation Stability. Pharmaceutics. 2013; 5(4):591-608.
Zhang, Qilei; Gladden, Lynn F.; Avalle, Paolo; Zeitler, J. A.; Mantle, Michael D. 2013. "Terahertz Pulsed Imaging and Magnetic Resonance Imaging as Tools to Probe Formulation Stability." Pharmaceutics 5, no. 4: 591-608.