RT info:eu-repo/semantics/article T1 Dexamethasone PLGA Microspheres for Sub-Tenon Administration: Influence of Sterilization and Tolerance Studies A1 Barbosa-Alfaro, Deyanira A1 Andrés-Guerrero, Vanessa A1 Fernández Bueno, Iván A1 García-Gutiérrez, María Teresa A1 Gil-Alegre, Esther A1 Molina-Martínez, Irene Teresa A1 Pastor Jimeno, José Carlos A1 Herrero-Vanrell, Rocío A1 Bravo-Osuna, Irene AB Many diseases affecting the posterior segment of the eye require repeated intravitrealinjections with corticosteroids in chronic treatments. The periocular administration is a less invasiveroute 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 meanparticle 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 dexamethasonerelease profiles from sterilized and non-sterilized microspheres were compared by means of thesimilarity factor (f2). The mechanism of drug release before and after irradiation exposure of Dx-MS was identified using appropriate mathematical models. Dexamethasone release was sustainedin vitro for 9 weeks. The evaluation of the in vivo tolerance was carried out in rabbit eyes, whichreceived a sub-Tenon injection of 5 mg of sterilized Dx-MS (20–53 µm size containing 165.6 ±3.6 µgDx/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 weeksafter the administration. According to the data presented in this work, the sub-Tenon administrationof Dx-MS could be a promising alternative to successive intravitreal injections for the treatment ofchronic diseases of the back of the eye. SN 1999-4923 YR 2021 FD 2021 LK https://uvadoc.uva.es/handle/10324/71460 UL https://uvadoc.uva.es/handle/10324/71460 LA eng NO Pharmaceutics 2021;13:228 NO Producción Científica DS UVaDOC RD 27-dic-2024