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The role of SeDeM for characterizing the active substance and polyvinyilpyrrolidone eliminating metastable forms in an oral lyophilizate-A preformulation study.
Flórez Borges, Paloma; García-Montoya, Encarna; Pérez-Lozano, Pilar; Jo, Enric; Miñarro, Montserrat; Manich, Albert; Suñé-Negre, Josep Maria.
Afiliación
  • Flórez Borges P; Pharmacy and Pharmaceutical Technology Department, Faculty of Pharmacy, University of Barcelona. Barcelona, Spain.
  • García-Montoya E; Reig Jofre Group. Sant Joan Despí, Spain.
  • Pérez-Lozano P; Pharmacy and Pharmaceutical Technology Department, Faculty of Pharmacy, University of Barcelona. Barcelona, Spain.
  • Jo E; Pharmacy and Pharmaceutical Technology Department, Faculty of Pharmacy, University of Barcelona. Barcelona, Spain.
  • Miñarro M; Reig Jofre Group. Sant Joan Despí, Spain.
  • Manich A; Pharmacy and Pharmaceutical Technology Department, Faculty of Pharmacy, University of Barcelona. Barcelona, Spain.
  • Suñé-Negre JM; IQAC-CSIC. Institute of Advanced Chemistry of Catalonia. Barcelona, Spain.
PLoS One ; 13(4): e0196049, 2018.
Article en En | MEDLINE | ID: mdl-29689061
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pirrolidinonas / Cetirizina / Manitol Idioma: En Revista: PLoS One Asunto de la revista: CIENCIA / MEDICINA Año: 2018 Tipo del documento: Article País de afiliación: España Pais de publicación: Estados Unidos
Texto completo
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Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pirrolidinonas / Cetirizina / Manitol Idioma: En Revista: PLoS One Asunto de la revista: CIENCIA / MEDICINA Año: 2018 Tipo del documento: Article País de afiliación: España Pais de publicación: Estados Unidos