Development and validation of an intrinsic dissolution method for nimodipine polymorphs

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dc.contributor.authorRiekes, Manoela K.
dc.contributor.authorKuminek, Gislaine
dc.contributor.authorRauber, Gabriela S.
dc.contributor.authorCuffini, Silvia L. [UNIFESP]
dc.contributor.authorStulzer, Hellen K.
dc.contributor.institutionUniversidade Federal de Santa Catarina (UFSC)
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.date.accessioned2016-01-24T14:37:17Z
dc.date.available2016-01-24T14:37:17Z
dc.date.issued2014-05-01
dc.description.abstractThe polymorphs of nimodipine, Modification I (Mod I), the metastable racemate, and Modification II (Mod II), the stable conglomerate, were evaluated by means of the intrinsic dissolution procedure. for this purpose, a hydro alcoholic solution (ethanol:water, 50:50, v/v) was selected as the dissolution medium, maintained at 37 +/- 0.5A degrees C. Different rotation speeds were tested (50, 75 and 100 rpm) and the lower one was chosen for the test validation. Although the sample initially characterized as polymorph Mod I presented higher intrinsic dissolution rates in all the conditions tested, no statistical differences were noticed between the two polymorphs. This result can be attributed to the partial solution-mediated phase transformation from Mod I to Mod II, detected through X-ray powder diffraction and differential scanning calorimetry. Also, reliable intrinsic dissolution rate data were acquired for the polymorph Mod II. the dissolution method was validated, being considered stable, specific, linear, sensible, accurate and precise.en
dc.description.affiliationUniv Fed Santa Catarina, Postgrad Program Pharm, BR-88040970 Florianopolis, SC, Brazil
dc.description.affiliationUniversidade Federal de São Paulo, BR-12231280 Sao Jose Dos Campos, SP, Brazil
dc.description.affiliationUnifespUniversidade Federal de São Paulo, BR-12231280 Sao Jose Dos Campos, SP, Brazil
dc.description.sourceWeb of Science
dc.description.sponsorshipConselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)
dc.description.sponsorshipFundacao de Amparo a Pesquisa do Estado de Santa Catarina (FAPESC)
dc.description.sponsorshipCoordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
dc.format.extent549-556
dc.identifierhttp://dx.doi.org/10.2478/s11532-014-0511-9
dc.identifier.citationCentral European Journal of Chemistry. Warsaw: Versita, v. 12, n. 5, p. 549-556, 2014.
dc.identifier.doi10.2478/s11532-014-0511-9
dc.identifier.issn1895-1066
dc.identifier.urihttp://repositorio.unifesp.br/handle/11600/37758
dc.identifier.wosWOS:000331644400002
dc.language.isoeng
dc.publisherVersita
dc.relation.ispartofCentral European Journal of Chemistry
dc.rightsinfo:eu-repo/semantics/restrictedAccess
dc.subjectNimodipineen
dc.subjectPolymorphismen
dc.subjectIntrinsic dissolution rateen
dc.titleDevelopment and validation of an intrinsic dissolution method for nimodipine polymorphsen
dc.typeinfo:eu-repo/semantics/article
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