Formulation and Evaluation of Orally Disintegrating Tablet Containing Aripiprazole in the Context of Quality by Design Approach

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dc.contributor.authorKalayı, Mehmet
dc.contributor.authorBarbar, Arkan Yashar
dc.contributor.authorAksu, Buket
dc.date.accessioned2025-08-14T14:37:56Z
dc.date.available2025-08-14T14:37:56Z
dc.date.issued2025
dc.departmentFakülteler, Eczacılık Teknolojisi Bilimleri Bölümü, Farmasötik Teknoloji Ana Bilim Dalı
dc.description.abstractAim/Background: The objective of this research is to develop and enhance the formulation of aripiprazole rapid disintegrating tablets utilizing the Quality by Design (QbD) methodology. Materials and Methods: A full factorial experimental design with three levels was employed to analyze the influence of key factors, namely the concentration of the filler (starch), ludipress concentration and disintegrant concentration, on important quality attributes such as disintegration time, friability and hardness. The formulation's drug-excipients interaction was examined using FTIR. Research was conducted to assess the stability of the product in accelerated conditions of 40ºC and 75% relative humidity. Results: FTIR analysis indicated that there was no notable chemical interaction seen in the solid form. The Aripiprazole fast disintegrating tablet formulations demonstrated satisfactory friability (0.77±0.16%), rapid disintegration time (66±0.58 sec) and appropriate hardness (48.35±3.22 N). The research revealed that the most favorable combination of independent components consisted of 15.8% filler (starch), 76% ludipress and 1.3% disintegrant. Conclusion: The accelerated stability experiments demonstrated that the hardness, friability, disintegration durations and drug release rate were within the permissible limits defined by the compendial standards. Implementing the Quality by Design (QbD) method may facilitate a comprehensive comprehension of how the Critical Material Attributes (CMAs) impact the Critical Quality Attributes (CQAs) of the final product of aripiprazole rapid disintegrating tablets.
dc.identifier.citationKalayı, M., Barbar, A. Y., Aksu, B. (2025). Formulation and Evaluation of Orally Disintegrating Tablet Containing Aripiprazole in the Context of Quality by Design Approach. Indian Journal of Pharmaceutical Education and Research, 59(3), s825-s836. 10.5530/ijper.20256989
dc.identifier.doi10.5530/ijper.20256989
dc.identifier.endpages836
dc.identifier.issn0019-5464
dc.identifier.issue3
dc.identifier.scopus2-s2.0-105011722025
dc.identifier.scopusqualityQ3
dc.identifier.startpages825
dc.identifier.urihttps://hdl.handle.net/20.500.12939/5849
dc.identifier.volume59
dc.indekslendigikaynakScopus
dc.institutionauthorKalayı, Mehmet
dc.institutionauthorBarbar, Arkan Yashar
dc.institutionauthorAksu, Buket
dc.language.isoen
dc.publisherAssociation of Pharmaceutical Teachers of India
dc.relation.ispartofIndian Journal of Pharmaceutical Education and Research
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectAripiprazole
dc.subjectFast disintegrating tablets
dc.subjectQuality by design QBD
dc.subjectStability
dc.subjectSuper-disintegrants
dc.titleFormulation and Evaluation of Orally Disintegrating Tablet Containing Aripiprazole in the Context of Quality by Design Approach
dc.typeArticle

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