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.
Cory
Wendy Clevenger
WC
Department of Chemistry and Biochemistry, College of Charleston, Charleston, South Carolina 29424, USA. coryw@cofc.edu
Harris
Corbyn
C
Martinez
Sabrina
S
D000098:Acetophenones / Q000737:chemistry; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000737:chemistry*; D004355:Drug Stability; D004356:Drug Storage; D005079:Excipients / Q000737:chemistry*; D006813:Humidity; D007052:Ibuprofen / Q000008:administration & dosage / Q000737:chemistry*; D011092:Polyethylene Glycols / Q000737:chemistry; D011136:Polysorbates / Q000737:chemistry; D013607:Tablets
D000098:Acetophenones; D000894:Anti-Inflammatory Agents, Non-Steroidal; D005079:Excipients; D011136:Polysorbates; D013607:Tablets; D011092:Polyethylene Glycols; C524006:4-isobutylacetophenone; D007052:Ibuprofen