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Accelerated degradation of ibuprofen in tablets.
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.
Anti-Inflammatory Agents, Non-Steroidal
Pub Type(s)Comparative Study
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, Non-P.H.S.