RT Journal Article
T1 Topical insulin eye drops: stability and safety of two compounded formulations for treating persistent corneal epithelial defects
A1 Vicario De La Torre, Marta
A1 Herrero Vanrell, María Del Rocío
A1 Díaz Valle, David
A1 Benítez Del Castillo Sánchez, José Manuel
A1 Gegúndez Fernández, José Antonio
A1 González-Cela Casamayor, Miriam Ana
A1 Burgos Blasco, Bárbara
A1 Brugnera, Marco
A1 López Cano, José Javier
A1 Ybañez García, Lidia
A1 Puebla García, Virginia
AB Compounded insulin eye drops were prepared at 1 IU/mL from commercially available subcutaneous insulin by dilution in saline solution or artificial tears. Physicochemical characterization and in vitro tolerance testing in human and conjunctival cells were followed by a 28-day short-term stability study under various conditions. The formulations were isotonic (280–300 mOsm/L), had a pH close to neutral (7–8), medium surface-tension values (<56 MN/m−1), and low (≈1 mPa·s) and medium (≈5 mPa·s) viscosities (compounded normal saline solution and artificial tear-based preparation, respectively). These values remained stable for 28 days under refrigeration. Microbiological stability was also excellent. Insulin potency remained in the 90–110% range in the compounded formulations containing normal saline solution when stored at 2–8 ◦C for 28 days, while it decreased in those based on artificial tears. Although both formulations were well tolerated in vitro, the compounded insulin diluted in a normal saline solution exhibited better cell tolerance. Preliminary data in humans showed that insulin in saline solution was an effective and safe treatment for persistent corneal epithelial defects. Compounded insulin eye drops diluted in normal saline solution could, therefore, constitute an emergent therapy for the treatment of persistent corneal epithelial defects.
PB MDPI
YR 2024
FD 2024-04-24
LK https://hdl.handle.net/20.500.14352/115534
UL https://hdl.handle.net/20.500.14352/115534
LA eng
NO Vicario-de-la-Torre, M.; Puebla-García, V.; Ybañez-García, L.; López-Cano, J.J.; González-Cela- Casamayor, M.A.; Brugnera, M.; Burgos-Blasco, B.; Díaz-Valle, D.; Gegúndez-Fernández, J.A.; Benítez-del-Castillo, J.M.; et al. Topical Insulin Eye Drops: Stability and Safety of Two Compounded Formulations for Treating Persistent Corneal Epithelial Defects. Pharmaceutics 2024, 16, 580. https://doi.org/10.3390/ pharmaceutics16050580
NO Universidad Complutense de Madrid. Research Group UCM 920415 “Innovation, Therapy and Pharmaceutical Development in Ophthalmology"
NO Instituto de Salud Carlos III
NO Fondos FEDER
DS Docta Complutense
RD 12 abr 2025