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Title: The Role of SeDeM Characterizing the Active Substance and Polyvynilpyrrolidone Eliminating Metastable Forms in an Oral Lyophilizate - A Preformulation Study.
Author: Flórez Borges, Paloma
Pérez Lozano, Pilar
García Montoya, Encarna
Miñarro Carmona, Montserrat
Jo, Enric
Manich Bou, Albert
Suñé i Negre, Josep M. (Josep Maria)
Keywords: Administració de medicaments
Medicació oral
Disseny de medicaments
Administration of drugs
Oral medication
Drug design
Issue Date: 24-Apr-2018
Publisher: Public Library of Science (PLoS)
Abstract: 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 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.
Note: Reproducció del document publicat a:
It is part of: PLoS One, 2018, vol. 13, num. 4, p. e0196049
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ISSN: 1932-6203
Appears in Collections:Articles publicats en revistes (Farmàcia, Tecnologia Farmacèutica i Fisicoquímica)

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