Abstract: 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.

Abstract: The present invention is directed to the provision of multi-dose, self-preserved ophthalmic compositions. The compositions possess sufficient antimicrobial activity to satisfy USP preservative efficacy requirements, as well as similar preservative standards (e.g., EP and JP), without requiring the presence of conventional anti-microbial preservative agents, such as benzalkonium chloride. The compositions are effectively preserved by a balanced ionic buffer system containing zinc ions at a concentration of 0.04 to 0.9 mM, preferably 0.04 to 0.4 mM. One aspect of the balanced buffer system is limitation of the amount of buffering anions present to a concentration of 15 mM or less, preferably 5 mM or less. In a preferred embodiment, the compositions also contain borate or, most preferably, one or more borate/polyol complexes. The use of propylene glycol as the polyol in such complexes is strongly preferred.

Abstract: Solid or semi-solid intraocular implant compositions are disclosed. The compositions contain a lipophilic compound but lack a polymeric ingredient.

Abstract: The present invention provides stable ophthalmic solutions comprising a compound with serotonergic 5-HT2 receptor activity and at least one stabilizer, together with methods of using such solutions to treat glaucoma and to lower intraocular pressure.