Low dose ophthalmic solution of difluprednate for the management of pain and inflammation

Difluprednate is available as a 0.05% w/v ophthalmic emulsion formulation approved for the treatment of ocular surgery-related inflammation and pain. The milky white emulsion is administered four times per day. An oil-free, clear, aqueous Difluprednate formulation with a lower strength (0.04%w/v) was developed for twice-daily (b.i.d) administration. Difluprednate, a poorly water-soluble molecule, was dissolved in water using a mixed micellar system composed of non-ionic, cationic, and anionic surfactants. The resulting clear and colorless solution had a pH of 4.5–5.5 and a viscosity of