The Role of SeDeM Characterizing the Active Substance and Polyvynilpyrrolidone Eliminating Metastable Forms in an Oral Lyophilizate - A Preformulation Study

Autor: Pilar Pérez-Lozano, Montserrat Miñarro, Encarna García-Montoya, Enric Jo, Albert M. Manich, Josep M. Suñé-Negre, Paloma Flórez Borges
Přispěvatelé: Manich, A. M. [0000-0002-9835-2850], Universitat de Barcelona, Manich, A. M.
Rok vydání: 2018
Předmět:
Polymers
lcsh:Medicine
Administration
Oral
02 engineering and technology
030226 pharmacology & pharmacy
Cetirizine dihydrochloride
0302 clinical medicine
Spectrum Analysis Techniques
Oral lyophilisate
Mannitol
lcsh:Science
Polyvinyl Chloride
Administration of drugs
Active ingredient
Multidisciplinary
Factorial Design
Calorimetry
Differential Scanning
Chemistry
Organic Compounds
Experimental Design
Physics
Oral medication
Magnetism
Drugs
Factorial experiment
021001 nanoscience & nanotechnology
Condensed Matter Physics
Cetirizine
Pyrrolidinones
Pharmaceutical Preparations
Macromolecules
Research Design
Physical Sciences
Administració de medicaments
Powders
0210 nano-technology
Medicaments
medicine.drug
Tablets
Research Article
Materials by Structure
Drug Compounding
Nuclear Magnetic Resonance
Materials Science
Medicació oral
Dissolving tablets
Geometry
Research and Analysis Methods
Crystals
Drug design
03 medical and health sciences
medicine
Disseny de medicaments
Chromatography
lcsh:R
Organic Chemistry
Chemical Compounds
Polymer Chemistry
Freeze Drying
Radii
Alcohols
Wettability
Ultraviolet-Visible Spectroscopy
lcsh:Q
Mathematics
Zdroj: Dipòsit Digital de la UB
Universidad de Barcelona
PLoS ONE
Digital.CSIC. Repositorio Institucional del CSIC
instname
Recercat. Dipósit de la Recerca de Catalunya
PLoS ONE, Vol 13, Iss 4, p e0196049 (2018)
Popis: 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. © 2018 Flórez Borges et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Reig Jofré Group has provided the active substance and the Freeze-Drying Centre of Excellence (Reig Jofré Group) for the FDM analysis.
Databáze: OpenAIRE
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