Unbound MEDLINE

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.

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  • Publisher Full Text
  • Authors

    Cory WC, Harris C, Martinez S

    Source

    Pharmaceutical development and technology 15:6 2010 Dec pg 636-43

    MeSH

    Acetophenones
    Anti-Inflammatory Agents, Non-Steroidal
    Drug Stability
    Drug Storage
    Excipients
    Humidity
    Ibuprofen
    Polyethylene Glycols
    Polysorbates
    Tablets

    Pub Type(s)

    Comparative Study
    Journal Article
    Research Support, N.I.H., Extramural
    Research Support, U.S. Gov't, Non-P.H.S.

    Language

    eng

    PubMed ID

    19941407