title: Development of a Discriminative In Vitro Release Test for Rivastigmine Transdermal Patches Using Pharmacopeial Apparatuses: USP 5 and USP 6.
abstract: The aim of this study was to develop and validate a discriminating in vitro release test to evaluate rivastigmine transdermal patches. The Exelon® Patch was chosen as a model transdermal product. The studies of in vitro release were designed to determine the impact of the official apparatus chosen (USP apparatus 5 and USP apparatus 6), the rotation speed, and the dissolution medium characteristics on the rivastigmine release profile from transdermal patches. Patches with different drug release profiles were tested in order to evaluate the discriminating power of the in vitro release test developed and validated. Variables such as the apparatus type, the dissolution medium, and the rotation speed have a significant influence on the drug release characteristics from a transdermal patch. The in vitro release methodologies using the USP apparatus 5 at 50 rpm and USP apparatus 6 at 25 rpm using the medium phosphate-buffered saline pH 7.4 were considered discriminative and adequate to characterize the rivastigmine (RV) release from a commercial transdermal patch, Exelon® Patch.
authors.affiliation: Department of Drugs and Pharmaceutics, Faculty of Pharmacy, Federal University of Rio de Janeiro, Av. Carlos Chagas Filho, 373, CCS, Bss, Sala 15, Rio de Janeiro, RJ, 21941-902, Brazil.
authors.forename: Alice
authors.initials: A
authors.lastname: Simon
authors.affiliation: School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin 2, Ireland.
authors.forename: Maria Inês
authors.initials: MI
authors.lastname: Amaro
authors.affiliation: School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin 2, Ireland.
authors.forename: Anne Marie
authors.initials: AM
authors.lastname: Healy
authors.affiliation: Department of Drugs and Pharmaceutics, Faculty of Pharmacy, Federal University of Rio de Janeiro, Av. Carlos Chagas Filho, 373, CCS, Bss, Sala 15, Rio de Janeiro, RJ, 21941-902, Brazil.
authors.forename: Lucio Mendes
authors.initials: LM
authors.lastname: Cabral
authors.affiliation: Department of Drugs and Pharmaceutics, Faculty of Pharmacy, Federal University of Rio de Janeiro, Av. Carlos Chagas Filho, 373, CCS, Bss, Sala 15, Rio de Janeiro, RJ, 21941-902, Brazil. valeria@pharma.ufrj.br.
authors.forename: Valeria Pereira
authors.initials: VP
authors.lastname: de Sousa
mesh_terms: D065546:Drug Liberation; D010602:Pharmacopoeias as Topic; D000068836:Rivastigmine / Q000008:administration & dosage* / Q000737:chemistry; D012995:Solubility; D057968:Transdermal Patch
chemical_list: D000068836:Rivastigmine
keywords: Franz diffusion cell; dissolution test; patch; pharmacopeial apparatus; rivastigmine