The effect of different granulation amounts of kollicoat MAE 30DP® on ODT CQAs using risk assessment

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dc.authorid0000-0001-6915-0283
dc.authorid0000-0003-2838-1688
dc.authorid0000-0003-4176-0308
dc.authorid0000-0002-9110-3704
dc.contributor.authorPirinçci Tok, Yağmur
dc.contributor.authorDemiralp, Burcu
dc.contributor.authorAl-Mohaya, Mazen
dc.contributor.authorÖzsoy, Yıldız
dc.date.accessioned2026-06-05T12:27:43Z
dc.date.available2026-06-05T12:27:43Z
dc.date.issued2026
dc.departmentFakülteler, Eczacılık Fakültesi, Eczacılık Teknoloji Bölümü, Farmasötik Teknoloji Ana Bilim Dalı
dc.description.abstractOrally disintegrating tablets (ODTs) improve patient compliance, but they present challenges in terms of masking the bitter taste of active pharmaceutical ingredients such as dexketoprofen trometamol (DEX). The study aimed to develop palatable DEX ODTs by granulating drug with Kollicoat MAE 30DP® to create a physical barrier. Using a quality by design (QbD) approach, an initial risk assessment identified Prosolv® ODT G2, Emdex®, and Magnasweet® MM100 and tablet compression pressure as critical variables. A Box-Behnken design was employed to prepare 26 formulations, systematically evaluating the impact of these variables across low and high polymer concentrations. The results showed that although high concentrations of Kollicoat MAE 30DP initially delayed the dissolution rate, this barrier effect did not affect the final extent of drug release. Disintegration was predominantly governed by compression pressure, which altered tablet porosity, whereas PROSOLV® ODT G2 significantly influenced the overall dissolution profile. By optimizing the superdisintegrant-to-binder ratio, high-polymer formulations successfully overcame the initial retardation, consistently exceeding an 85% cumulative release at 30 minutes.
dc.identifier.citationPirinçci Tok, Y., Demiralp, B., Al-Mohaya, M., & Özsoy, Y. (2026). The effect of different granulation amounts of kollicoat MAE 30DP® on ODT CQAs using risk assessment. Journal of Research in Pharmacy, 30(3), pp. 957-974. https://doi.org/10.12991/jrespharm.1835939
dc.identifier.doi10.12991/jrespharm.1835939
dc.identifier.endpage974
dc.identifier.issn2630-6344
dc.identifier.issue3
dc.identifier.scopus2-s2.0-105039492949
dc.identifier.scopusqualityQ3
dc.identifier.startpage957
dc.identifier.urihttps://doi.org/10.12991/jrespharm.1835939
dc.identifier.urihttps://hdl.handle.net/20.500.13055/1503
dc.identifier.volume30
dc.identifier.wosWOS:001767194600001
dc.identifier.wosqualityQ4
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakTR-Dizin
dc.indekslendigikaynak.otherESCI - Emerging Sources Citation Index
dc.institutionauthorPirinçci Tok, Yağmur
dc.institutionauthorid0000-0001-6915-0283
dc.language.isoen
dc.publisherMarmara University
dc.relation.ispartofJournal of Research in Pharmacy
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectOrally Disintegrating Tablet
dc.subjectDexketoprofen Trometamol
dc.subjectQuality by Design Box-Behnken Design
dc.subjectMinitab
dc.subjectGranulation
dc.titleThe effect of different granulation amounts of kollicoat MAE 30DP® on ODT CQAs using risk assessment
dc.typeArticle
dspace.entity.typePublication

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