Formulation and stability study of a pediatric 2% phenylephrine hydrochloride eye drop solution Formulation et étude de stabilité d'un collyre pédiatrique de chlorhydrate de phényléphrine à 2 %

Summary Introduction. — We present formulation and stability evaluation of a 2% (w/v) phenylephrinehydrochloride biocompatible eye drop solution, routinely prepared in hospital pharmacy underaseptic conditions, for retinal examination of neonates and premature infants. Materials and methods.— Eye drop solution was formulated by dissolution of phenylephrinehydrochloride and disodium hydrogen phosphate as buffering agent in sterile water for injectionand sodium chloride for injection as isotonic agent. The previous solution was sterile filteredthrough under aseptic conditions, in an iso class 5 air quality clean room under horizontallaminar airflow hood. Physical stability (visual inspection, osmolality measurements), chemicalstability (pH measurement, phenylephrine assay by liquid chromatography coupled with an ∗ Corresponding author. E-mail addresses: gilles.dollo@univ-rennes1.fr, gilles.dollo@chu-rennes.fr (G. Dollo).http://dx.doi.org/10.1016/j.pharma.2014.06.0060003-4509/© 2014 Elsevier Masson SAS. All rights reserved.