Bottom-up production of injectable itraconazole suspensions using membrane technology

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dc.contributor.authorAnjum, Fatima
dc.contributor.authorViville, Thaïsa
dc.contributor.authorNandi, Snehashis
dc.contributor.authorWessner, Maximilian
dc.contributor.authorWitte, Bruno De
dc.contributor.authorCollas, Alain
dc.contributor.authorSadowski, Gabriele
dc.date.accessioned2025-12-05T12:09:29Z
dc.date.available2025-12-05T12:09:29Z
dc.date.issued2024-03-06
dc.description.abstractBottom-up production of active pharmaceutical ingredient (API) crystal suspensions offers advantages in surface property control and operational ease over top-down methods. However, downstream separation and concentration pose challenges. This proof-of-concept study explores membrane diafiltration as a comprehensive solution for downstream processing of API crystal suspensions produced via anti-solvent crystallization. It involves switching the residual solvent (N-methyl-2-pyrrolidone, NMP) with water, adjusting the excipient (d-α-Tocopherol polyethylene glycol 1000 succinate, TPGS) quantity, and enhancing API loading (solid concentration) in itraconazole crystal suspensions. NMP concentration was decreased from 9 wt% to below 0.05 wt% (in compliance with European Medicine Agency guidelines), while the TPGS concentration was decreased from 0.475 wt% to 0.07 wt%. This reduced the TPGS-to-itraconazole ratio from 1:2 to less than 1:50 and raised the itraconazole loading from 1 wt% to 35.6 wt%. Importantly, these changes did not adversely affect the itraconazole crystal stability in suspension. This study presents membrane diafiltration as a one-step solution to address downstream challenges in bottom-up API crystal suspension production. These findings contribute to optimizing pharmaceutical manufacturing processes and hold promise for advancing the development of long-acting API crystal suspensions via bottom-up production techniques at a commercial scale.en
dc.identifier.urihttp://hdl.handle.net/2003/44430
dc.language.isoen
dc.relation.ispartofseriesInternational journal of pharmaceutics; 654
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectMembrane filtrationen
dc.subjectDownstream processingen
dc.subjectBottom-up productionen
dc.subjectLong-acting injectablesen
dc.subjectPharmaceutical crystal suspensionsen
dc.subject.ddc660
dc.titleBottom-up production of injectable itraconazole suspensions using membrane technologyen
dc.typeText
dc.type.publicationtypeArticle
dcterms.accessRightsopen access
eldorado.dnb.deposittrue
eldorado.doi.registerfalse
eldorado.secondarypublicationtrue
eldorado.secondarypublication.primarycitationFatima Anjum, Thaïsa Viville, Snehashis Nandi, Maximilian Wessner, Bruno De Witte, Alain Collas, Gabriele Sadowski, Bottom-up production of injectable itraconazole suspensions using membrane technology, International Journal of Pharmaceutics, Volume 654, 2024, 123977, https://doi.org/10.1016/j.ijpharm.2024.123977
eldorado.secondarypublication.primaryidentifierhttps://doi.org/10.1016/j.ijpharm.2024.123977

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