Journal
JOURNAL OF PHARMACY AND PHARMACOLOGY
Volume 67, Issue 2, Pages 199-208Publisher
WILEY
DOI: 10.1111/jphp.12332
Keywords
bio-relevant dissolution testing; burst release mesalazine; carbonate buffer; dissolution stress test; dose dumping
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Funding
- German Federal Ministry of Education and Research [BMBF FKZ 03IPT612C]
- Innovative Medicines Initiative [115369]
- European Union's Seventh Framework Programme (FP7)
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ObjectivesFor the treatment of inflammatory bowel disease, the development of pH responsive modified release dosage forms is one of the most common approaches to achieve targeted drug delivery. In this study, the dissolution behaviour of eight different modified release (MR) products containing 800mg mesalazine was investigated. MethodsThe performance of the products was compared under simulated fasted state conditions using the paddle apparatus as well as the dissolution stress test device mimicking mechanical stress events of bio-relevant intensity. Key findingsThe dissolution behaviour of the eight tested different pH-responsive MR tablets containing 800mg mesalazine was dependent on the test conditions. Phases of mechanical stress with physiological intensity influenced the dissolution characteristics and caused in some cases accelerated drug release indicating possible dose dumping. ConclusionThe study demonstrates that besides the investigation of the pH dependency of drug release, the characterisation of the mechanical robustness of the dosage forms is an essential factor determining the dissolution characteristics of such pH-dependent targeted modified release tablets. The susceptibility of 800mg mesalazine MR tablets towards mechanical stress may be one reason for undesired drug delivery in vivo.
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