NanoMiLens (Nano-Micelle Loaded Hydrogel Contact Lenses) of Tofacitinib Citrate: Amalgamation, Development,...

Dry eye disease (DED) is a multifactorial inflammatory eye disease caused mainly by immune dysregulation through JAK/STAT, which leads to a turbulent tear film, damage to the corneal epithelia, and poor visualization. Topical therapies of the conventional type show less ocular bioavailability with quick precorneal excretion. This research was done to design and test a new NanoMiLens system loaded with Tofacitinib Citrate (TFC), which is a selective JAK inhibitor, in order to have a controlled and prolonged contact lens delivery manageable with DED. TFC Polymeric Nano-Micelles (PoT-PNMs) were prepared using a thin-film hydration method employing Poloxamer 407 as the amphiphilic polymer and Tween 80 as the stabilizing surfactant in acetone, then rehydrated with simulated tear fluid. PBD ANOVA confirmed polymer concentration and surfactant concentration as dominant factors for EE%. CCD quadratic modelling yielded R² = 0.9904 for EE%, 0.9789 for CDR%, and 0.9408 for particle size, with model validation errors < 1%. The optimized PoT-PNMs (200 mg Poloxamer 407, 0.30 mL Tween 80) achieved particle size 92 ± 2.6 nm, PDI 0.246, EE% 90.60 ± 0.44%, and CDR% 93.10 ± 1.2% over 12 h. FTIR, DSC, and XRD confirmed drug amorphization and drug-excipient compatibility. The optimized PoT-PNMs were loaded into freeze-thaw-crosslinked PVA/pHEMA hydrogel contact lenses via soak-loading. The optimized PoT-PNMs -loaded contact lens (NMCL12) showed % transmittance 96.11 ± 0.22%, swelling index 96.48 ± 0.24%, drug content 90.60 ± 0.44%, in-vitro CDR% 96.50 ± 0.30% over 12 h, and mechanical strength 142 ± 6 folds. This system is an effective, scalable method of topical immunomodulatory treatment of inflammatory dry eye disease.