Comparative physical-chemical characterization of encapsulated lipid-based isotretinoin products assessed by particle size distribution and thermal behavior analyses

Comparative physical-chemical characterization of encapsulated lipid-based isotretinoin products assessed by particle size distribution and thermal behavior analyses

Author Guimaraes, Carla Aiolfi Google Scholar
Menaa, Farid Google Scholar
Menaa, Bouzid Google Scholar
Quenca-Guillen, Joyce S. Google Scholar
Matos, Jivaldo do Rosario Google Scholar
Mercuri, Lucildes Pita Autor UNIFESP Google Scholar
Braz, Andre Borges Google Scholar
Rossetti, Fabia Cristina Google Scholar
Maria Kedor-Hackmann, Erika Rosa Google Scholar
Rocha Miritello Santoro, Maria Ines Google Scholar
Institution Universidade de São Paulo (USP)
Sch Med Wuerzburg
Fluorotronics Inc
Universidade Federal de São Paulo (UNIFESP)
Abstract Isotretinoin is the drug of choice for the management of severe recalcitrant nodular acne. Nevertheless, some of its physical-chemical properties are still poorly known. Hence, the aim of our study consisted to comparatively evaluate the particle size distribution (PSD) and characterize the thermal behavior of the three encapsulated isotretinoin products in oil suspension (one reference and two generics) commercialized in Brazil. Here, we show that the PSD, estimated by laser diffraction and by polarized light microscopy, differed between the generics and the reference product. However, the thermal behavior of the three products, determined by thermogravimetry (TGA), differential thermal (DTA) analyses and differential scanning calorimetry (DSC), displayed no significant changes and were more thermostable than the isotretinoin standard used as internal control.Thus, our study suggests that PSD analyses in isotretinoin lipid-based formulations should be routinely performed in order to improve their quality and bioavailability. (C) 2010 Elsevier B.V. All rights reserved.
Keywords Isotretinoin
Particle size distribution
Thermal analysis
Quality control
Polarized light microscopy
Laser diffraction
Language English
Sponsor Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
Date 2010-06-10
Published in Thermochimica Acta. Amsterdam: Elsevier B.V., v. 505, n. 1-2, p. 73-78, 2010.
ISSN 0040-6031 (Sherpa/Romeo, impact factor)
Publisher Elsevier B.V.
Extent 73-78
Origin http://dx.doi.org/10.1016/j.tca.2010.04.001
Access rights Closed access
Type Article
Web of Science ID WOS:000278961700010
URI http://repositorio.unifesp.br/handle/11600/32629

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