Título:
Sustained-release biodegradable intracameral implants containing dexamethasone and moxifloxacin :development and in vivo primary assessment
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Autor:
Miranda, Pablo
Tártara, Luis Ignacio
Castro, Analía
Zimet, Patricia
Faccio, Ricardo
Palma, Santiago Daniel
Mombrú, Álvaro W.
Pardo, Helena
Tártara, Luis Ignacio
Castro, Analía
Zimet, Patricia
Faccio, Ricardo
Palma, Santiago Daniel
Mombrú, Álvaro W.
Pardo, Helena
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Tipo de documento:
Artículo
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Palabras clave:
Implantes intraoculares
Cataratas
Endoftalmitis
Dexametasona
Moxifloxacino
Cataratas
Endoftalmitis
Dexametasona
Moxifloxacino
Descriptores:
Año de publicación:
2025
Contenido:
Resumen:
Background/Objectives: We report the development of a novel intraocular sustainedrelease
implantable pharmaceutical formulation, designed to be placed in the anterior
chamber of the eye after cataract surgery. The device is intended to reduce postoperative
inflammation, and to prevent opportunistic bacterial infections that may lead to
endophthalmitis. Methods: The implants were produced via hot-melt extrusion, using
a twin-screw extruder to process a homogeneous mixture of polylactide-co-glycolic acid,
moxifloxacin hydrochloride (MOX HCl) and dexamethasone (DEX). Quality control tests
included drug content determination, release rate profile evaluation, and several instrumental
characterization techniques (scanning electron microscopy (SEM), confocal Raman
microscopy, differential scanning calorimetry, and X-ray diffraction). Long-term and accelerated
stability tests were also performed, following ICH guidelines. Sterilization was
achieved by exposing samples to gamma radiation. In vivo exploratory studies were
carried out in healthy rabbits to evaluate the safety and overall performance of the implantable
formulation. Results: In terms of quality control, drug content was found to
be homogeneously distributed throughout the implants, and it also met the label claim.
In vitro release rate was constant for MOX HCl, but non-linear for DEX, increasing over
time. In vivo preliminary tests showed that the inserts completely biodegraded within
approximately 20 days. No clinical signs of anterior segment toxic syndrome or statistically
significant intraocular pressure differences were found between treatment and
control groups. Conclusions: The implants developed in this study can act as sustainedrelease
depots for the delivery of both DEX and MOX HCl, and are biocompatible with
ocular structures.
Descripción:
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MDPI
EN:
Pharmaceutics, v. 17, n°9, 2025.-- e1191
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Citación:
Miranda, P., Tártara, L., Castro, A. y otros. "Sustained-release biodegradable intracameral implants containing dexamethasone and moxifloxacin :development and in vivo primary assessment". Pharmaceutics [en línea] v. 17, n°9, 2025.-- e1191. 22 p.
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Licencia Creative Commons Atribución (CC - By 4.0)
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| Ficheros | Descripción | Tamaño | Formato | ||
|---|---|---|---|---|---|
| Sustained-Release.pdf | — | 2.97 MB | Adobe PDF |