Stability of Benzocaine Formulated in Commercial Oral Disintegrating Tablet Platforms
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Pharmaceutical excipients contain reactive groups and impurities due to manufacturing processes that can cause decomposition of active drug compounds. The aim of this investigation was to determine if commercially available oral disintegrating tablet (ODT) platforms induce active pharmaceutical ingredient (API) degradation. Benzocaine was selected as the model API due to known degradation through ester and primary amino groups. Benzocaine was either compressed at a constant pressure, 20 kN, or at pressure necessary to produce a set hardness, i.e., where a series of tablets were produced at different compression forces until an average hardness of approximately 100 N was achieved. Tablets were then stored for 6 months under International Conference on Harmonization recommended conditions, 25°C and 60% relative humidity (RH), or under accelerated conditions, 40°C and 75% RH. Benzocaine degradation was monitored by liquid chromatography–mass spectrometry. Regardless of the ODT platform, no degradation of benzocaine was observed in tablets that were kept for 6 months at 25°C and 60% RH. After storage for 30 days under accelerated conditions, benzocaine degradation was observed in a single platform. Qualitative differences in ODT platform behavior were observed in physical appearance of the tablets after storage under different temperature and humidity conditions.
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- Stability of Benzocaine Formulated in Commercial Oral Disintegrating Tablet Platforms
Volume 14, Issue 4 , pp 1333-1340
- Cover Date
- Online ISSN
- Springer US
- Additional Links
- oral disintegrating tablet
- Industry Sectors
- Author Affiliations
- 1. Department of Biopharmaceutical Sciences, University of Illinois, Chicago, Illinois, 60612-7231, USA
- 2. Roquette America Inc., Geneva, Illinois, 60134, USA
- 3. Department of Pharmaceutics, University of Mississippi, University, Mississippi, 38677, USA
- 4. Department of Bioengineering, University of Illinois, Chicago, Illinois, 60607-7052, USA
- 5. Department of Ophthalmology and Visual Sciences, University of Illinois, Chicago, Illinois, 60612-4319, USA