Critical tools in tableting research: Using compaction simulator and quality by design (QbD) to evaluate lubricants’ effect in direct compressible formulation

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dc.authorid0000-0003-0427-8918en_US
dc.authorid0000-0001-7555-0603en_US
dc.contributor.authorJiwa, Nailla
dc.contributor.authorÖzalp, Yıldız
dc.contributor.authorYeğen, Gizem
dc.contributor.authorAksu, Buket
dc.date.accessioned2022-01-19T09:25:15Z
dc.date.available2022-01-19T09:25:15Z
dc.date.issued2021en_US
dc.departmentFakülteler, Eczacılık Meslek Bilimleri Bölümü, Farmasötik Kimya Ana Bilim Dalıen_US
dc.description.abstractAs commonly known, the product development stage is quite complex, requires intensive knowledge, and is time-consuming. The selection of the excipients with the proper functionality and their corresponding levels is critical to drug product performance. The objective of this study was to apply quality by design (QbD) principles for formulation development and to define the desired product quality profile (QTPP) and critical quality attributes (CQA) of a product. QbD is a risk- and science-based holistic approach for upgraded pharmaceutical development. In this study, Ibuprofen DC 85W was used as a model drug, Cellactose® 80 along with MicroceLac® 100 as a filler, and magnesium stearate, stearic acid, and sodium stearyl fumarate as lubricants. By applying different formulation parameters to the filler and lubricants, the QbD approach furthers the understanding of the effect of critical formulation and process parameters on CQAs and the contribution to the overall quality of the drug product. An experimental design study was conducted to determine the changes of the obtained outputs of the formulations, which were evaluated using the Modde Pro 12.1 statistical computer program that enables optimization by modeling complex relationships. The results of the optimum formulation revealed that MicroceLac® 100 was the superior filler, while magnesium stearate at 1% was the optimum lubricant. A design space that indicates the safety operation limits for the process and formulation variables was also created. This study enriches the understanding of the effect of excipients in formulation and assists in enhancing formulation design using experimental design and mathematical modeling methods in the frame of the QbD approach.en_US
dc.identifier.citationJiwa, N., Ozalp, Y., Yegen, G., & Aksu, B. (2021). Critical Tools in Tableting Research: Using Compaction Simulator and Quality by Design (QbD) to Evaluate Lubricants’ Effect in Direct Compressible Formulation. AAPS PharmSciTech, 22(4), 1-15.en_US
dc.identifier.endpage15en_US
dc.identifier.issue4en_US
dc.identifier.scopus2-s2.0-85105769538
dc.identifier.scopusqualityN/A
dc.identifier.startpage1en_US
dc.identifier.urihttps://hdl.handle.net/20.500.12939/2208
dc.identifier.volume22en_US
dc.identifier.wosWOS:000655551700001
dc.identifier.wosqualityN/A
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.institutionauthorYeğen, Gizem
dc.institutionauthorAksu, Buket
dc.language.isoen
dc.publisherAAPS PharmSciTechen_US
dc.relation.ispartofAmerican Association of Pharmaceutical Scientists
dc.relation.isversionof10.1208/s12249-021-02004-yen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjectQuality By Designen_US
dc.subjectCompaction Simulatoren_US
dc.subjectLubricantsen_US
dc.subjectDirect Compressionen_US
dc.subjectLactose-Based Fillersen_US
dc.titleCritical tools in tableting research: Using compaction simulator and quality by design (QbD) to evaluate lubricants’ effect in direct compressible formulation
dc.typeArticle

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