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The goal of this study was to develop and characterize an ion-activated  in situ  gel-forming estradiol (E 2 ) solution eye drops intended for the prevention of age-related cataracts. Accordingly,  in situ  gelling eye drops were made using gellan gum as an ion-activated gel-forming polymer, polysorbate-80 as drug solubilizing agent, mannitol as tonicity agent, and combination of potassium sorbate and edetate disodium dihydrate (EDTA) as preservatives. The formulations were tested for the following characteristics: pH, clarity, osmolality, antimicrobial efficacy, rheological behavior, and  in vitro  drug release. Stability of the formulation was also monitored for 6 months at multiple storage conditions per ICH  Q1A (R2)  guidelines. The solution eye drops resulted in an i n-situ  phase change to gel-state when mixed with simulated tear fluid (STF). The gel structure formation was confirmed by viscoelastic measurements. Drug release from the gel followed non-fickian mechanism with 80% of drug released in 8 hr. The formulations were found to be clear, isotonic with suitable pH and viscoelastic behavior and stable at accelerated and long-term storage conditions for 6 months.  In vitro  results suggest that the developed formulation is suitable for further investigation in animal models to elucidate the ability of estrogen to prevent and delay cataracts.

Development of topical ophthalmic In Situ gel-forming estradiol delivery system intended for the prevention of age-related cataracts