Accelerated degradation of ibuprofen in tablets

Abstract

The forced degradation of 11 ibuprofen tablet brands was carried out according to current industry best practices. The results indicated an incompatibility between ibuprofen and two common tablet excipients (polyethylene glycol and polysorbate 80) that were observed to accelerate the degradation of ibuprofen in tablets stored for three weeks at 70°C/75% RH. Studies of binary drug/excipient samples supported the conclusion. One degradant that was observed at increased levels was 4-isobutylacetophenone (4-IBAP), which is a known toxin.

Keywords::

• Ibuprofen
• excipients
• degradation
• 4-isobutylacetophenone

Acknowledgements

Thanks to B. Smith, I. Reiners, H. Root and J. Wyatt for procuring international ibuprofen tablets.

Declaration of interest

This report is based upon work supported by the National Science Foundation under CHE-0821426 and the National Institutes of Health under NIH-INBRE RR-03-010. We would like to thank the College of Charleston 4th Century Initiative SURF (Summer Undergraduate Research with Faculty) and Faculty Research and Development Committee grant programs for their funding of this research. The authors declare no conflicts of interest.