A quality by design study of the use of microfluidic nanoprecipitation for the generation of sub-100 nm drug nanocrystals

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dc.authorid0000-0001-6915-0283
dc.authorid0000-0001-6682-9610
dc.authorid0000-0003-4309-2155
dc.authorid0000-0003-2838-1688
dc.authorid0000-0002-9110-3704
dc.authorid0000-0003-1294-8993
dc.contributor.authorPirinçci Tok, Yağmur
dc.contributor.authorAbukhamees, Shorooq
dc.contributor.authorFitaihi, Rawan
dc.contributor.authorDemiralp, Burcu
dc.contributor.authorÖzsoy, Yıldız
dc.contributor.authorCraig, Duncan
dc.date.accessioned2026-02-20T18:01:32Z
dc.date.available2026-02-20T18:01:32Z
dc.date.issued2026
dc.departmentFakülteler, Eczacılık Fakültesi, Eczacılık Teknoloji Bölümü, Farmasötik Teknoloji Ana Bilim Dalı
dc.description.abstractAlthough drug nanocrystals have attracted considerable interest within the pharmaceutical industry, there remain issues with the production of nanocrystals with a size below 100 nm. The aim of the present study is to develop a stable, reproducible Canagliflozin (CFZ) sub-100 nm nanosuspension system using microfluidic nanoprecipitation and Quality by Design (QbD) techniques. By means of the circumscribed central composite design (CCCD), critical parameters of the microfluidic nanoprecipitation process and nanosuspension formula tion components were optimised. Optimal CFZ nanosuspension with Z-average of 89.52 ± 3.30 nm, PDI of 0.12 ± 0.01 and drug content of 92.49 ± 0.03 % was successfully fabricated using Soluplus as a stabiliser. An increase in saturation solubility corresponding to approximately 250 times the value of the pure CFZ in water was noted. The optimised CFZ nanosuspension was solidified by freeze-drying and electrospraying. Overall, the study has demonstrated that by using a combination of microfluidics and QbD it is promising to generate stable sub-100 nm nanocrystals with high yield, and narrow size distribution and favourable stability.
dc.description.sponsorshipThe authors declare the following financial interests/personal re lationships which may be considered as potential competing interests: Yagmur Pirincci Tok reports a relationship with The Scientific and Technological Research Council of Türkiye (TUBITAK) that includes: funding grants. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Yazarlar, potansiyel çıkar çatışması olarak değerlendirilebilecek aşağıdaki mali çıkarları/kişisel ilişkileri beyan ederler: Yagmur Pirincci Tok, Türkiye Bilim ve Teknolojik Araştırma Konseyi (TÜBİTAK) ile aşağıdaki ilişkileri bildirmektedir: finansman hibeleri. Başka yazarlar varsa, bu makalede bildirilen çalışmayı etkilemiş olabilecek bilinen herhangi bir mali çıkar çatışması veya kişisel ilişkileri olmadığını beyan ederler.
dc.identifier.citationPirinçci Tok, Y., Abukhamees, S., Fitaihi, R., Demiralp, B., Özsoy, Y., & Craig, D. (2026). A quality by design study of the use of microfluidic nanoprecipitation for the generation of sub-100 nm drug nanocrystals. Colloids and Surfaces B: Biointerfaces, 262, pp. 1-16. https://doi.org/10.1016/j.colsurfb.2026.115515
dc.identifier.doi10.1016/j.colsurfb.2026.115515
dc.identifier.endpage16
dc.identifier.issn1873-4367
dc.identifier.issn0927-7765
dc.identifier.pmidPMID: 41653577
dc.identifier.scopus2-s2.0-105029470216
dc.identifier.scopusqualityQ1
dc.identifier.startpage1
dc.identifier.urihttps://doi.org/10.1016/j.colsurfb.2026.115515
dc.identifier.urihttps://hdl.handle.net/20.500.13055/1342
dc.identifier.volume262
dc.identifier.wosWOS:001686347400001
dc.identifier.wosqualityQ1
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.indekslendigikaynak.otherSCI-E - Science Citation Index Expanded
dc.institutionauthorPirinçci Tok, Yağmur
dc.institutionauthorid0000-0001-6915-0283
dc.language.isoen
dc.publisherElsevier
dc.relation.ispartofColloids and Surfaces B: Biointerfaces
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectAntisolvent Crystallization
dc.subjectMicrofluidic Nanoprecipitation
dc.subjectQuality by Design
dc.subjectSolidification
dc.subjectNanocrystal
dc.titleA quality by design study of the use of microfluidic nanoprecipitation for the generation of sub-100 nm drug nanocrystals
dc.typeArticle
dspace.entity.typePublication

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