Dexamethasone PLGA Microspheres for Sub-Tenon Administration: Influence of Sterilization and Tolerance Studies

Many diseases affecting the posterior segment of the eye require repeated intravitreal injections with corticosteroids in chronic treatments. The periocular administration is a less invasive route attracting considerable attention for long-term therapies. In the present work, dexamethasone-loaded po...

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Detalles Bibliográficos
Autores: Barbosa Alfaro, Deyanira, Andrés Guerrero, Vanesa, Fernández Bueno, Iván, García Gutiérrez, María Teresa, Gil Alegre, María Esther, Molina Martínez, Irene Teresa, Pastor Jimeno, José Carlos, Herrero Vanrell, María Del Rocío, Bravo Osuna, Irene
Tipo de recurso: artículo
Fecha de publicación:2021
País:España
Institución:Universidad Complutense de Madrid (UCM)
Repositorio:Docta Complutense
Idioma:inglés
OAI Identifier:oai:docta.ucm.es:20.500.14352/7071
Acceso en línea:https://hdl.handle.net/20.500.14352/7071
Access Level:acceso abierto
Palabra clave:615.4
Dexamethasone
Poly(lactic-co-glycolic) acid
Ophthalmology
Microspheres
Periocular administration
Gamma sterilization
Tolerance
Tecnología farmaceútica
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network_acronym_str ES
network_name_str España
repository_id_str
spelling Dexamethasone PLGA Microspheres for Sub-Tenon Administration: Influence of Sterilization and Tolerance StudiesBarbosa Alfaro, DeyaniraAndrés Guerrero, VanesaFernández Bueno, IvánGarcía Gutiérrez, María TeresaGil Alegre, María EstherMolina Martínez, Irene TeresaPastor Jimeno, José CarlosHerrero Vanrell, María Del RocíoBravo Osuna, Irene615.4DexamethasonePoly(lactic-co-glycolic) acidOphthalmologyMicrospheresPeriocular administrationGamma sterilizationToleranceTecnología farmaceúticaMany diseases affecting the posterior segment of the eye require repeated intravitreal injections with corticosteroids in chronic treatments. The periocular administration is a less invasive route attracting considerable attention for long-term therapies. In the present work, dexamethasone-loaded poly(lactic-co-glycolic) acid (PLGA) microspheres (Dx-MS) were prepared using the oil-in-water (O/W) emulsion solvent evaporation technique. MS were characterized in terms of mean particle size and particle size distribution, external morphology, polymer integrity, drug content, and in vitro release profiles. MS were sterilized by gamma irradiation (25 kGy), and dexamethasone release profiles from sterilized and non-sterilized microspheres were compared by means of the similarity factor (f2). The mechanism of drug release before and after irradiation exposure of Dx-MS was identified using appropriate mathematical models. Dexamethasone release was sustained in vitro for 9 weeks. The evaluation of the in vivo tolerance was carried out in rabbit eyes, which received a sub-Tenon injection of 5 mg of sterilized Dx-MS (20–53 µm size containing 165.6 ± 3.6 µg Dx/mg MS) equivalent to 828 µg of Dx. No detectable increase in intraocular pressure was reported, and clinical and histological analysis of the ocular tissues showed no adverse events up to 6 weeks after the administration. According to the data presented in this work, the sub-Tenon administration of Dx-MS could be a promising alternative to successive intravitreal injections for the treatment of chronic diseases of the back of the eye.MDPIUniversidad Complutense de Madrid20212021-02-0620212021-02-06journal articlehttp://purl.org/coar/resource_type/c_6501info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/20.500.14352/7071reponame:Docta Complutenseinstname:Universidad Complutense de Madrid (UCM)Inglésengopen accesshttp://purl.org/coar/access_right/c_abf2Atribución 3.0 Españahttps://creativecommons.org/licenses/by/3.0/es/info:eu-repo/semantics/openAccessoai:docta.ucm.es:20.500.14352/70712026-06-02T12:44:21Z
dc.title.none.fl_str_mv Dexamethasone PLGA Microspheres for Sub-Tenon Administration: Influence of Sterilization and Tolerance Studies
title Dexamethasone PLGA Microspheres for Sub-Tenon Administration: Influence of Sterilization and Tolerance Studies
spellingShingle Dexamethasone PLGA Microspheres for Sub-Tenon Administration: Influence of Sterilization and Tolerance Studies
Barbosa Alfaro, Deyanira
615.4
Dexamethasone
Poly(lactic-co-glycolic) acid
Ophthalmology
Microspheres
Periocular administration
Gamma sterilization
Tolerance
Tecnología farmaceútica
title_short Dexamethasone PLGA Microspheres for Sub-Tenon Administration: Influence of Sterilization and Tolerance Studies
title_full Dexamethasone PLGA Microspheres for Sub-Tenon Administration: Influence of Sterilization and Tolerance Studies
title_fullStr Dexamethasone PLGA Microspheres for Sub-Tenon Administration: Influence of Sterilization and Tolerance Studies
title_full_unstemmed Dexamethasone PLGA Microspheres for Sub-Tenon Administration: Influence of Sterilization and Tolerance Studies
title_sort Dexamethasone PLGA Microspheres for Sub-Tenon Administration: Influence of Sterilization and Tolerance Studies
dc.creator.none.fl_str_mv Barbosa Alfaro, Deyanira
Andrés Guerrero, Vanesa
Fernández Bueno, Iván
García Gutiérrez, María Teresa
Gil Alegre, María Esther
Molina Martínez, Irene Teresa
Pastor Jimeno, José Carlos
Herrero Vanrell, María Del Rocío
Bravo Osuna, Irene
author Barbosa Alfaro, Deyanira
author_facet Barbosa Alfaro, Deyanira
Andrés Guerrero, Vanesa
Fernández Bueno, Iván
García Gutiérrez, María Teresa
Gil Alegre, María Esther
Molina Martínez, Irene Teresa
Pastor Jimeno, José Carlos
Herrero Vanrell, María Del Rocío
Bravo Osuna, Irene
author_role author
author2 Andrés Guerrero, Vanesa
Fernández Bueno, Iván
García Gutiérrez, María Teresa
Gil Alegre, María Esther
Molina Martínez, Irene Teresa
Pastor Jimeno, José Carlos
Herrero Vanrell, María Del Rocío
Bravo Osuna, Irene
author2_role author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universidad Complutense de Madrid
dc.subject.none.fl_str_mv 615.4
Dexamethasone
Poly(lactic-co-glycolic) acid
Ophthalmology
Microspheres
Periocular administration
Gamma sterilization
Tolerance
Tecnología farmaceútica
topic 615.4
Dexamethasone
Poly(lactic-co-glycolic) acid
Ophthalmology
Microspheres
Periocular administration
Gamma sterilization
Tolerance
Tecnología farmaceútica
description Many diseases affecting the posterior segment of the eye require repeated intravitreal injections with corticosteroids in chronic treatments. The periocular administration is a less invasive route attracting considerable attention for long-term therapies. In the present work, dexamethasone-loaded poly(lactic-co-glycolic) acid (PLGA) microspheres (Dx-MS) were prepared using the oil-in-water (O/W) emulsion solvent evaporation technique. MS were characterized in terms of mean particle size and particle size distribution, external morphology, polymer integrity, drug content, and in vitro release profiles. MS were sterilized by gamma irradiation (25 kGy), and dexamethasone release profiles from sterilized and non-sterilized microspheres were compared by means of the similarity factor (f2). The mechanism of drug release before and after irradiation exposure of Dx-MS was identified using appropriate mathematical models. Dexamethasone release was sustained in vitro for 9 weeks. The evaluation of the in vivo tolerance was carried out in rabbit eyes, which received a sub-Tenon injection of 5 mg of sterilized Dx-MS (20–53 µm size containing 165.6 ± 3.6 µg Dx/mg MS) equivalent to 828 µg of Dx. No detectable increase in intraocular pressure was reported, and clinical and histological analysis of the ocular tissues showed no adverse events up to 6 weeks after the administration. According to the data presented in this work, the sub-Tenon administration of Dx-MS could be a promising alternative to successive intravitreal injections for the treatment of chronic diseases of the back of the eye.
publishDate 2021
dc.date.none.fl_str_mv 2021
2021-02-06
2021
2021-02-06
dc.type.none.fl_str_mv journal article
http://purl.org/coar/resource_type/c_6501
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/20.500.14352/7071
url https://hdl.handle.net/20.500.14352/7071
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
Atribución 3.0 España
https://creativecommons.org/licenses/by/3.0/es/
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
Atribución 3.0 España
https://creativecommons.org/licenses/by/3.0/es/
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_ 1869410275607707649
score 15,300719

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