2-Pyrrolidone derivatives are provided as preservatives for topical
formulations, particularly for ophthalmic, otic, and nasal formulations.
N-octyl-2-pyrrolidone, without any other preservative or preservative aid
in an isotonic pH 7.5 formulation, provided sufficient preservation to
comply with the European Pharmacopoeia 5.0 standards in addition to the
United States Pharmacopoeia 24 standards for parenteral and ophthalmic
preparations. On the other hand, N-dodecyl-2-pyrrolidone requires a
second anti-microbial agent to achieve such preservation standards.