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Formulation and Evaluation of Atorvastatin Calcium-Poly- ε- Caprolactone Nanoparticles Loaded Ocular Inserts for Sustained Release Anti-inflammatory Efficacy.

PURPOSE
The work was performed to investigate the feasibility of preparing ocular inserts loaded with Poly- ε - Caprolactone (PCL) nanoparticles as sustained ocular delivery system.


METHOD
First, Atorvastatin Calcium-Poly- ε -Caprolactone (ATC-PCL) nanoparticles were prepared and characterized. Then the optimized nanoparticles were loaded within inserts formulated with methylcellulose (MC) and polyvinyl alcohol (PVA) by solvent casting technique and evaluated physically, and for in- vitro drug release profile. Finally, in- vivo study was performed on selected formulation to prove non-irritability and sustained ocular anti-inflammatory efficacy compared with free drug loaded ocuserts.


RESULTS
The results revealed (ATC-PCL) nanoparticles prepared with 0.5% pluronic F127 were the optimized with 181.72±3.6 nm particle size, 0.12±0.02 (PDI) analysis, -27.4± 0.69 mV zeta potential and 62.41%±4.7% entrapment efficiency. Nanoparticles loaded ocuserts manifested compatibility between drug and formulations polymers. Moreover, formulations were complied with average weight 0.055±0.002 to 0.143±0.023 mg, and accepted pH. ATC-PCL nanoparticles loaded inserts prepared by 5% MC showed more sustained, prolonged in- vitro release over 24h. In-vivo study emphasized non-irritability, ocular anti-inflammatory effectiveness represented by smaller lid closure scores, statistically significant lowering in PMN count after 3h.


CONCLUSION
These findings proposed a possible simple, new and affordable price technique to prepare promising (ATC-PCL) nanoparticles loaded inserts to achieve sustained release with prolonged anti-inflammatory efficacy.