The role of SeDeM for characterizing the active substance and polyvinyilpyrrolidone eliminating metastable forms in an oral lyophilizate-A preformulation study.

A preformulation study of an oral lyophilisate with cetirizine dihydrochloride (CTZ) as active ingredient, mannitol and PVP K30 as bulking agents is presented. CTZ shown a humidity content of 0.150% and a spontaneous hygroscopicity of 0.200% (both determined by SeDeM diagram), demonstrating an adequ...

Full description

Bibliographic Details
Main Authors: Paloma Flórez Borges, Encarna García-Montoya, Pilar Pérez-Lozano, Enric Jo, Montserrat Miñarro, Albert Manich, Josep Maria Suñé-Negre
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2018-01-01
Series:PLoS ONE
Online Access:http://europepmc.org/articles/PMC5916852?pdf=render