title: Preparation and characterization of spironolactone-loaded nano-emulsions for extemporaneous applications.
abstract: In neonates as well as in adults having swallowing difficulty, oral medication is given through a nasogastric tube making liquid formulations preferable. In this study, we present the high potential of nanometric emulsions formulated by spontaneous surfactant diffusion, as extemporaneous formulations of hydrophobic drug. Spironolactone used as hydrophobic drug model, was incorporated in oil before formulation at a concentration of 13.5mg/g oil. Then, all formulations were evaluated from pharmacotechnical and clinical standpoints, for their use in hospital or community pharmacy. The strength of this new liquid formulation lies on the simplicity, efficiency and reproducibility of their low energy process as on clinical aspects: high dose uniformity, facility to be administered through in nasogastric tube without any retention and a stability of 2 months at least compatible for an extemporaneous use. Moreover, this emulsion presented spironolactone content of 3.75 mg/ml among the most concentrated formulations published.
authors.affiliation: Université de Rennes I, Laboratoire de Pharmacie Galénique, Biopharmacie et Pharmacie Clinique, Rennes, France.
authors.forename: François
authors.initials: F
authors.lastname: Hallouard
authors.affiliation: Université de Rennes I, Laboratoire de Pharmacie Galénique, Biopharmacie et Pharmacie Clinique, Rennes, France; Centre Hospitalo-Universitaire de Rennes, Pôle Pharmacie, Rennes, France. Electronic address: gilles.dollo@univ-rennes1.fr.
authors.forename: Gilles
authors.initials: G
authors.lastname: Dollo
authors.affiliation: Université de Rennes I, Laboratoire de Pharmacie Galénique, Biopharmacie et Pharmacie Clinique, Rennes, France.
authors.forename: Nolwenn
authors.initials: N
authors.lastname: Brandhonneur
authors.affiliation: Université de Rennes I, Institut des Sciences Chimiques de Rennes, UMR/CNRS 6226, Rennes, France; CNRS, UMI 3629CNRS/Saint-Gobain, Laboratory for Innovative Key Materials and Structures-Link, National Institute of Material Science (NIMS), GREEN/MANA Room 512, 1-1 Namiki, 305-0044 Tsukuba, Japan.
authors.forename: Fabien
authors.initials: F
authors.lastname: Grasset
authors.affiliation: Université de Rennes I, Laboratoire de Pharmacie Galénique, Biopharmacie et Pharmacie Clinique, Rennes, France; Centre Hospitalo-Universitaire de Rennes, Pôle Pharmacie, Rennes, France.
authors.forename: Pascal Le
authors.initials: PL
authors.lastname: Corre
mesh_terms: D004355:Drug Stability; D004655:Emulsions; D007441:Intubation, Gastrointestinal; D053758:Nanoparticles / Q000737:chemistry*; D009821:Oils / Q000737:chemistry; D012995:Solubility; D013148:Spironolactone / Q000737:chemistry*; D013501:Surface-Active Agents / Q000737:chemistry; D014783:Viscosity
chemical_list: D004655:Emulsions; D009821:Oils; D013501:Surface-Active Agents; D013148:Spironolactone
keywords: Nano-emulsions; Nasogastric tube; Spironolactone; Spontaneous surfactant diffusion; Swallowing difficulty