Stabilization and solubilization of difluprednate in aqueous cyclodextrin solution and its characterization for ophthalmic delivery

Difluprednate is a synthetic glucocorticoid used for the treatment of postoperative inflammation and pain associated with endogenous uveitis. It very lipophilic limited aqueous solubility stability. The only available marketed formulation an oil-in-water ophthalmic emulsion that has many drawbacks. Cyclodextrin (CD) molecules are widely to increase stability hydrophobic drugs through formation drug/CD complexes. This study aims investigate degradation kinetics, difluprednate in CD solutions effort develop eye drop vehicle delivery. Phase-solubility kinetics studies were performed presence different CDs polymers. Characterization complexes was done using techniques like NMR, DSC, FTIR. results show maximum at pH 5 solution. HPγCD found be best solubilizer stabilizer among all tested. further improved combination difluprednate/HPγCD complex solid solution state confirmed complex. possible solubilize 0.1% stabilize drug polymer