Quality by Design approach for developmentand characterization of gabapentin-loaded solid lipid nanoparticles for intranasal delivery: In vitro, ex vivo , and histopathological evaluation [2]

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dc.contributor.authorToksoy, Mahmut Ozan
dc.contributor.authorAsir, Firat
dc.contributor.authorGuzel, Mert Can
dc.date.accessioned2025-02-22T14:08:44Z
dc.date.available2025-02-22T14:08:44Z
dc.date.issued2024
dc.departmentDicle Üniversitesien_US
dc.description.abstractObjective(s): Quality by Design (QbD) is a novel approach to product development that involves understanding the product and process, as well as the relationship between critical quality attributes (CQA) and critical process parameters (CPP). This study aimed to optimize the gabapentin-loaded solid lipid nanoparticle formulation (GP-SLN) using a QbD approach and evaluate in vitro and ex vivo performance. Materials and Methods: The GP-SLN formulation was created using the microemulsion method by combining Gelucire 48/16, Tween 80, and Plurol Oleique CC 497. The Box-Behnken experimental design was adopted to investigate the effects of independent factors on dependent factors. The GPSLN formulation was assessed based on particle size and distribution, zeta potential, morphology, entrapment efficiency, release kinetics, permeation parameters, stability, and nasal toxicity. Results: The nanoparticles had a cubical shape with a particle size of 185.3 +/- 45.6 nm, a zeta potential of -24 +/- 3.53 mV, and an entrapment efficiency of 82.57 +/- 4.02%. The particle size and zeta potential of the GP-SLNs remained consistent for 3 months and followed Weibull kinetics with a significantly higher ex vivo permeability (1.7 fold) than a gabapentin solution (GP-SOL). Histopathology studies showed that intranasal administration of the GP-SLN formulation had no harmful effects. Conclusion: The current study reports the successful development of a GP-SLN formulation using QbD. A sustained release of GP was achieved and its nasal permeability was increased. Solid lipid nanoparticles with optimum particle size and high entrapment efficiency may offer a promising approach for the intranasal delivery of drugs.en_US
dc.description.sponsorshipDicle University Scientific Research Projects Coordinatorship (DUBAP) [ECZACILIK.22.005]en_US
dc.description.sponsorshipThis study was supported by Dicle University Scientific Research Projects Coordinatorship (DUBAP, Project code: ECZACILIK.22.005) . The graphical abstract was created BioRender.en_US
dc.identifier.doi10.22038/IJBMS.2024.76281.16511-2
dc.identifier.endpage913en_US
dc.identifier.issn2008-3866
dc.identifier.issn2008-3874
dc.identifier.issue7en_US
dc.identifier.scopusqualityQ2en_US
dc.identifier.startpage904en_US
dc.identifier.urihttps://doi.org/10.22038/IJBMS.2024.76281.16511-2
dc.identifier.urihttps://hdl.handle.net/11468/29609
dc.identifier.volume27en_US
dc.identifier.wosWOS:001223071800014
dc.identifier.wosqualityQ3
dc.indekslendigikaynakWeb of Science
dc.language.isoenen_US
dc.publisherMashhad Univ Med Sciencesen_US
dc.relation.ispartofIranian Journal of Basic Medical Sciencesen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.snmzKA_WOS_20250222
dc.subjectBox-Behnken designen_US
dc.subjectGabapentinen_US
dc.subjectHistopathologyen_US
dc.subjectNasal deliveryen_US
dc.subjectPermeationen_US
dc.subjectRelease kineticsen_US
dc.subjectSolid lipid nanoparticleen_US
dc.titleQuality by Design approach for developmentand characterization of gabapentin-loaded solid lipid nanoparticles for intranasal delivery: In vitro, ex vivo , and histopathological evaluation [2]en_US
dc.typeArticleen_US

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