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

Paloma Flórez Borges, Encarna García-Montoya, Pilar Pérez-Lozano, Enric Jo, Montserrat Miñarro, Albert Manich and Josep Maria Suñé-Negre

PLOS ONE, 2018, vol. 13, issue 4, 1-17

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.

Date: 2018
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0196049

DOI: 10.1371/journal.pone.0196049

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