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...

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Authors: 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
Format: article
Publication Date:2024
Country:España
Institution:Universidad Complutense de Madrid (UCM)
Repository:Docta Complutense
Language:English
OAI Identifier:oai:docta.ucm.es:20.500.14352/115534
Online Access:https://hdl.handle.net/20.500.14352/115534
Access Level:Open access
Keyword: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
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oai_identifier_str oai:docta.ucm.es:20.500.14352/115534
network_acronym_str ES
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repository_id_str
spelling Topical insulin eye drops: stability and safety of two compounded formulations for treating persistent corneal epithelial defectsVicario De La Torre, MartaHerrero Vanrell, María Del RocíoDíaz Valle, DavidBenítez Del Castillo Sánchez, José ManuelGegúndez Fernández, José AntonioGonzález-Cela Casamayor, Miriam AnaBurgos Blasco, BárbaraBrugnera, MarcoLópez Cano, José JavierYbañez García, LidiaPuebla García, Virginia617.7615.4Topical insulinEye dropsCompounding stabilityIn vitro tolerancePersistent epithelial corneal defectsOftalmologíaTecnología farmaceútica32 Ciencias Médicas2407 Biología CelularCompounded 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.MDPIUniversidad Complutense de Madrid20242024-01-0120242024-01-01journal articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/20.500.14352/115534reponame:Docta Complutenseinstname:Universidad Complutense de Madrid (UCM)Inglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:docta.ucm.es:20.500.14352/1155342026-06-02T12:44:21Z
dc.title.none.fl_str_mv Topical insulin eye drops: stability and safety of two compounded formulations for treating persistent corneal epithelial defects
title Topical insulin eye drops: stability and safety of two compounded formulations for treating persistent corneal epithelial defects
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_short 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_sort Topical insulin eye drops: stability and safety of two compounded formulations for treating persistent corneal epithelial defects
dc.creator.none.fl_str_mv 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 Vicario De La Torre, Marta
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
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
dc.contributor.none.fl_str_mv Universidad Complutense de Madrid
dc.subject.none.fl_str_mv 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 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
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.
publishDate 2024
dc.date.none.fl_str_mv 2024
2024-01-01
2024
2024-01-01
dc.type.none.fl_str_mv journal article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/20.500.14352/115534
url https://hdl.handle.net/20.500.14352/115534
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv MDPI
publisher.none.fl_str_mv MDPI
dc.source.none.fl_str_mv reponame:Docta Complutense
instname:Universidad Complutense de Madrid (UCM)
instname_str Universidad Complutense de Madrid (UCM)
reponame_str Docta Complutense
collection Docta Complutense
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869418057748709376
score 15,811543

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