Flórez Borges, PalomaPérez Lozano, PilarGarcía Montoya, EncarnaMiñarro Carmona, MontserratJo, EnricManich Bou, AlbertSuñé i Negre, Josep M. (Josep Maria)2019-03-082019-03-082018-04-241932-6203https://hdl.handle.net/2445/129964A 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 adequate stability behavior in solid form. A design of experiments (DoE) performed with both mannitol and PVP K30, followed by a simple factorial design (32) has determined the optimum combination of excipients and CTZ, and showed that a higher proportion of PVP K30 was able to prevent metastable forms generated by mannitol.application/pdfengcc-by (c) Flórez Borges, Paloma et al., 2018http://creativecommons.org/licenses/by/3.0/esAdministració de medicamentsMedicació oralMedicamentsDisseny de medicamentsAdministration of drugsOral medicationDrugsDrug designinfo:eu-repo/semantics/article6813122019-03-08info:eu-repo/semantics/openAccess29689061