Topical insulin eye drops: stability and safety of two compounded formulations for treating persistent corneal epithelial defects
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 st...
| Autores: | ; ; ; ; ; ; ; ; ; ; |
|---|---|
| Tipo de documento: | Artículo |
| Fecha de publicación: | 2024 |
| País: | España |
| Institución: | Universidad Complutense de Madrid (UCM) |
| Repositorio: | Docta Complutense |
| Lenguaje: | Inglés |
| OAI Identifier: | oai:docta.ucm.es:20.500.14352/115534 |
| Acceso en línea: | https://hdl.handle.net/20.500.14352/115534 |
| Nivel de acceso: | Acceso abierto |
| Palabra clave: | 617.7 615.4 Topical insulin Eye drops Compounding stability In vitro tolerance Persistent epithelial corneal defects Oftalmología Tecnología farmaceútica 32 Ciencias Médicas 2407 Biología Celular |
| _version_ | 1878739137718124544 |
|---|---|
| author | Vicario De La Torre, Marta |
| author2 | Herrero Vanrell, María Del Rocío Díaz Valle, David Benítez Del Castillo Sánchez, José Manuel Gegúndez Fernández, José Antonio González-Cela Casamayor, Miriam Ana Burgos Blasco, Bárbara Brugnera, Marco López Cano, José Javier Ybañez García, Lidia Puebla García, Virginia |
| author2_role | author author author author author author author author author author |
| author_browse | Benítez Del Castillo Sánchez, José Manuel Brugnera, Marco Burgos Blasco, Bárbara Díaz Valle, David Gegúndez Fernández, José Antonio González-Cela Casamayor, Miriam Ana Herrero Vanrell, María Del Rocío López Cano, José Javier Puebla García, Virginia Vicario De La Torre, Marta Ybañez García, Lidia |
| author_facet | Vicario De La Torre, Marta Herrero Vanrell, María Del Rocío Díaz Valle, David Benítez Del Castillo Sánchez, José Manuel Gegúndez Fernández, José Antonio González-Cela Casamayor, Miriam Ana Burgos Blasco, Bárbara Brugnera, Marco López Cano, José Javier Ybañez García, Lidia Puebla García, Virginia |
| author_role | author |
| collection | Docta Complutense |
| description | 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. |
| eu_rights_str_mv | openAccess |
| format | article |
| id | ES_bbcdf4e17a15747a71e045253be8a129 |
| institution | Universidad Complutense de Madrid (UCM) |
| instname_str | Universidad Complutense de Madrid (UCM) |
| language | eng |
| network_acronym_str | ES |
| network_name_str | España |
| oai_identifier_str | oai:docta.ucm.es:20.500.14352/115534 |
| publishDate | 2024 |
| publishDateSort | 2024 |
| publisher | MDPI |
| publisherStr | MDPI |
| reponame_str | Docta Complutense |
| spelling | Topical insulin eye drops: stability and safety of two compounded formulations for treating persistent corneal epithelial defects Vicario De La Torre, Marta Herrero Vanrell, María Del Rocío Díaz Valle, David Benítez Del Castillo Sánchez, José Manuel Gegúndez Fernández, José Antonio González-Cela Casamayor, Miriam Ana Burgos Blasco, Bárbara Brugnera, Marco López Cano, José Javier Ybañez García, Lidia Puebla García, Virginia 617.7 615.4 Topical insulin Eye drops Compounding stability In vitro tolerance Persistent epithelial corneal defects Oftalmología Tecnología farmaceútica 32 Ciencias Médicas 2407 Biología Celular 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. MDPI https://hdl.handle.net/20.500.14352/115534 |
| spellingShingle | Topical insulin eye drops: stability and safety of two compounded formulations for treating persistent corneal epithelial defects Vicario De La Torre, Marta 617.7 615.4 Topical insulin Eye drops Compounding stability In vitro tolerance Persistent epithelial corneal defects Oftalmología Tecnología farmaceútica 32 Ciencias Médicas 2407 Biología Celular |
| title | Topical insulin eye drops: stability and safety of two compounded formulations for treating persistent corneal epithelial defects |
| title_full | Topical insulin eye drops: stability and safety of two compounded formulations for treating persistent corneal epithelial defects |
| title_fullStr | Topical insulin eye drops: stability and safety of two compounded formulations for treating persistent corneal epithelial defects |
| title_full_unstemmed | Topical insulin eye drops: stability and safety of two compounded formulations for treating persistent corneal epithelial defects |
| title_short | Topical insulin eye drops: stability and safety of two compounded formulations for treating persistent corneal epithelial defects |
| title_sort | Topical insulin eye drops: stability and safety of two compounded formulations for treating persistent corneal epithelial defects |
| topic | 617.7 615.4 Topical insulin Eye drops Compounding stability In vitro tolerance Persistent epithelial corneal defects Oftalmología Tecnología farmaceútica 32 Ciencias Médicas 2407 Biología Celular |
| topic_facet | 617.7 615.4 Topical insulin Eye drops Compounding stability In vitro tolerance Persistent epithelial corneal defects Oftalmología Tecnología farmaceútica 32 Ciencias Médicas 2407 Biología Celular |
| url | https://hdl.handle.net/20.500.14352/115534 |