Pharmaceutical and Pharmacokinetic Evaluation of a Novel Fast Dissolving Film Formulation of Flupentixol Dihydrochloride

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dc.AffiliationOctober University for modern sciences and Arts (MSA)
dc.contributor.authorAbdelbary A.
dc.contributor.authorBendas E.R.
dc.contributor.authorRamadan A.A.
dc.contributor.authorMostafa D.A.
dc.contributor.otherDepartment of Pharmaceutics and Industrial Pharmacy
dc.contributor.otherFaculty of Pharmacy
dc.contributor.otherCairo University
dc.contributor.otherKasr El-Ainy Street
dc.contributor.otherCairo
dc.contributor.other11562
dc.contributor.otherEgypt; Department of Pharmaceutics
dc.contributor.otherAl-Azhar University
dc.contributor.otherCairo
dc.contributor.otherEgypt; Department of Pharmaceutics
dc.contributor.otherModern Sciences and Arts University
dc.contributor.otherCairo
dc.contributor.otherEgypt
dc.date.accessioned2020-01-09T20:42:17Z
dc.date.available2020-01-09T20:42:17Z
dc.date.issued2014
dc.descriptionScopus
dc.description.abstractThe objective of the present study was to develop fast dissolving oral film of the antipsychotic drug, flupentixol dihydrochloride, to enhance its bioavailability, optimize its therapeutic effect when used to treat depression with anxiety, and increase the convenience and compliance by the mentally ill, developmentally disable, elderly, and pediatric patients. Six formulae were prepared with different concentrations of water-soluble polymers vis. hydroxypropyl methylcellulose (HPMC E5) and carboxymethyl cellulose (CMC) by solvent casting technique. The prepared films were subjected to characterization for folding endurance, weight variations, thickness, disintegration time, drug release pattern, and drug content. Physical compatibility between the drug and excipients was guaranteed in the selected formulation (2% HPMC) by means of differential scanning calorimetry analysis and Fourier-transform infrared spectroscopy. This formulation revealed high stability after testing according to the International Conference on Harmonisation guidelines. In vivo studies based on single phase parallel design were carried out for the optimized formulation in healthy human volunteers. The concentration of flupentixol dihydrochloride in plasma samples was analyzed by a developed validated LC-MS/MS assay method and the pharmacokinetic parameters of the established formulation were compared with the commercially available oral tablets. Faster rate of absorption of flupentixol could be obtained from the oral film formulation and the relative bioavailability was found to be 151.06% compared to the marketed product. � 2014, American Association of Pharmaceutical Scientists.en_US
dc.description.urihttps://www.scimagojr.com/journalsearch.php?q=28473&tip=sid&clean=0
dc.identifier.doihttps://doi.org/10.1208/s12249-014-0186-8
dc.identifier.doiPubMed ID 25142820
dc.identifier.issn1635158
dc.identifier.otherhttps://doi.org/10.1208/s12249-014-0186-8
dc.identifier.otherPubMed ID 25142820
dc.identifier.urihttps://t.ly/AXJBm
dc.language.isoEnglishen_US
dc.publisherSpringer New York LLCen_US
dc.relation.ispartofseriesAgeing International
dc.relation.ispartofseries15
dc.subjectOctober University for Modern Sciences and Arts
dc.subjectجامعة أكتوبر للعلوم الحديثة والآداب
dc.subjectUniversity of Modern Sciences and Arts
dc.subjectMSA University
dc.subjectfast dissolvingen_US
dc.subjectflupentixol dihydrochlorideen_US
dc.subjectLC-MS/MS analysisen_US
dc.subjectoral filmen_US
dc.subjectpharmacokineticsen_US
dc.subjectcarboxymethylcelluloseen_US
dc.subjectexcipienten_US
dc.subjectflupentixolen_US
dc.subjecthydroxypropylmethylcelluloseen_US
dc.subjectneuroleptic agenten_US
dc.subjecttableten_US
dc.subjectadulten_US
dc.subjectbioavailabilityen_US
dc.subjectblooden_US
dc.subjectchemistryen_US
dc.subjectcomparative studyen_US
dc.subjectcontrolled studyen_US
dc.subjectdifferential scanning calorimetryen_US
dc.subjecthumanen_US
dc.subjectinfrared spectroscopyen_US
dc.subjectliquid chromatographyen_US
dc.subjectmaleen_US
dc.subjectmedicinal chemistryen_US
dc.subjectoral drug administrationen_US
dc.subjectpharmaceuticsen_US
dc.subjectproceduresen_US
dc.subjectrandomized controlled trialen_US
dc.subjectreproducibilityen_US
dc.subjectsolubilityen_US
dc.subjecttableten_US
dc.subjecttandem mass spectrometryen_US
dc.subjectyoung adulten_US
dc.subjectAdministration, Oralen_US
dc.subjectAdulten_US
dc.subjectAntipsychotic Agentsen_US
dc.subjectBiological Availabilityen_US
dc.subjectCalorimetry, Differential Scanningen_US
dc.subjectCarboxymethylcellulose Sodiumen_US
dc.subjectChemistry, Pharmaceuticalen_US
dc.subjectChromatography, Liquiden_US
dc.subjectExcipientsen_US
dc.subjectFlupenthixolen_US
dc.subjectHumansen_US
dc.subjectHypromellose Derivativesen_US
dc.subjectMaleen_US
dc.subjectReproducibility of Resultsen_US
dc.subjectSolubilityen_US
dc.subjectSpectroscopy, Fourier Transform Infrareden_US
dc.subjectTabletsen_US
dc.subjectTandem Mass Spectrometryen_US
dc.subjectTechnology, Pharmaceuticalen_US
dc.subjectYoung Adulten_US
dc.titlePharmaceutical and Pharmacokinetic Evaluation of a Novel Fast Dissolving Film Formulation of Flupentixol Dihydrochlorideen_US
dc.typeArticleen_US
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