Itraconazole Nanosuspensions via Dual Centrifugation Media Milling: Impact of Formulation and Process Parameters on Particle Size and Solid-State Conversion as Well as Storage Stability
Nanocrystal suspensions proved to be a potent enabling principle for biopharmaceutics classification system class II drugs with dissolution limited bioavailability. In the example of itraconazole (ITZ) as a model drug combined with electrosteric stabilization using hydroxypropyl cellulose (HPC-SL),...
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Published in | Pharmaceutics Vol. 14; no. 8; p. 1528 |
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Language | English |
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Abstract | Nanocrystal suspensions proved to be a potent enabling principle for biopharmaceutics classification system class II drugs with dissolution limited bioavailability. In the example of itraconazole (ITZ) as a model drug combined with electrosteric stabilization using hydroxypropyl cellulose (HPC-SL), sodium dodecyl sulfate (SDS) and polysorbate 80 (PS80), the impacts of formulation and process parameters of a dual centrifugal mill on material attributes such as particle size, zeta potential, particle morphology, storage stability and especially solid-state characteristics were evaluated. A minimal concentration of 0.9% (w/w) HPC-SL, 0.14% (w/w) SDS and 0.07% (w/w) PS80 was necessary for sufficient nanoparticle stabilization. Despite the minor effect of PS80, its presence was beneficial for electrosteric stabilization. Choosing lower stabilizer concentrations resulted in a pronounced increase in particle size due to agglomeration, which was confirmed by SEM imaging and a decrease in zeta potential in combination with an amorphization of the particles. Milling temperature had no significant impact on the particle size, whereas milling speed and the size of the milling beads used were found to have a strong impact on the critical material attributes such as particle size and polydispersity index. The smallest particle sizes could be obtained by using the smallest milling bead size. However, the smallest obtainable particle size could only be achieved by using two-fold stabilizer concentrations, as smaller particles exhibit a larger specific surface area. |
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AbstractList | Nanocrystal suspensions proved to be a potent enabling principle for biopharmaceutics classification system class II drugs with dissolution limited bioavailability. In the example of itraconazole (ITZ) as a model drug combined with electrosteric stabilization using hydroxypropyl cellulose (HPC-SL), sodium dodecyl sulfate (SDS) and polysorbate 80 (PS80), the impacts of formulation and process parameters of a dual centrifugal mill on material attributes such as particle size, zeta potential, particle morphology, storage stability and especially solid-state characteristics were evaluated. A minimal concentration of 0.9% (w/w) HPC-SL, 0.14% (w/w) SDS and 0.07% (w/w) PS80 was necessary for sufficient nanoparticle stabilization. Despite the minor effect of PS80, its presence was beneficial for electrosteric stabilization. Choosing lower stabilizer concentrations resulted in a pronounced increase in particle size due to agglomeration, which was confirmed by SEM imaging and a decrease in zeta potential in combination with an amorphization of the particles. Milling temperature had no significant impact on the particle size, whereas milling speed and the size of the milling beads used were found to have a strong impact on the critical material attributes such as particle size and polydispersity index. The smallest particle sizes could be obtained by using the smallest milling bead size. However, the smallest obtainable particle size could only be achieved by using two-fold stabilizer concentrations, as smaller particles exhibit a larger specific surface area. Nanocrystal suspensions proved to be a potent enabling principle for biopharmaceutics classification system class II drugs with dissolution limited bioavailability. In the example of itraconazole (ITZ) as a model drug combined with electrosteric stabilization using hydroxypropyl cellulose (HPC-SL), sodium dodecyl sulfate (SDS) and polysorbate 80 (PS80), the impacts of formulation and process parameters of a dual centrifugal mill on material attributes such as particle size, zeta potential, particle morphology, storage stability and especially solid-state characteristics were evaluated. A minimal concentration of 0.9% ( w / w ) HPC-SL, 0.14% ( w / w ) SDS and 0.07% ( w / w ) PS80 was necessary for sufficient nanoparticle stabilization. Despite the minor effect of PS80, its presence was beneficial for electrosteric stabilization. Choosing lower stabilizer concentrations resulted in a pronounced increase in particle size due to agglomeration, which was confirmed by SEM imaging and a decrease in zeta potential in combination with an amorphization of the particles. Milling temperature had no significant impact on the particle size, whereas milling speed and the size of the milling beads used were found to have a strong impact on the critical material attributes such as particle size and polydispersity index. The smallest particle sizes could be obtained by using the smallest milling bead size. However, the smallest obtainable particle size could only be achieved by using two-fold stabilizer concentrations, as smaller particles exhibit a larger specific surface area. |
Audience | Academic |
Author | Wagner, Karl G Willmann, Ann-Cathrin Berkenfeld, Kai Faber, Thilo Wachtel, Herbert Boeck, Georg |
AuthorAffiliation | 1 Pharmaceutical Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach, Germany; ann-cathrin.willmann@boehringer-ingelheim.com 2 Department of Pharmaceutical Technology, University of Bonn, Gerhard-Domagk-Straße 3, 53121 Bonn, Germany; kaib@uni-bonn.de (K.B.); thilo.faber@uni-bonn.de (T.F.) 3 Device Development, Boehringer Ingelheim GmbH & Co. KG, Binger Straße 173, 55216 Ingelheim am Rhein, Germany; herbert.wachtel@boehringer-ingelheim.com 4 Department Discovery Research, Boehringer Ingelheim RCV GmbH & Co. KG, Dr.-Boehringer-Gasse 5-11, 1121 Vienna, Austria; georg.boeck@boehringer-ingelheim.com |
AuthorAffiliation_xml | – name: 4 Department Discovery Research, Boehringer Ingelheim RCV GmbH & Co. KG, Dr.-Boehringer-Gasse 5-11, 1121 Vienna, Austria; georg.boeck@boehringer-ingelheim.com – name: 2 Department of Pharmaceutical Technology, University of Bonn, Gerhard-Domagk-Straße 3, 53121 Bonn, Germany; kaib@uni-bonn.de (K.B.); thilo.faber@uni-bonn.de (T.F.) – name: 1 Pharmaceutical Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach, Germany; ann-cathrin.willmann@boehringer-ingelheim.com – name: 3 Device Development, Boehringer Ingelheim GmbH & Co. KG, Binger Straße 173, 55216 Ingelheim am Rhein, Germany; herbert.wachtel@boehringer-ingelheim.com |
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CitedBy_id | crossref_primary_10_1016_j_ijpharm_2023_123455 crossref_primary_10_3390_ph16111519 crossref_primary_10_3390_pharmaceutics15020706 crossref_primary_10_1016_j_ejps_2023_106417 crossref_primary_10_1016_j_jddst_2024_105605 crossref_primary_10_1016_j_ijpharm_2023_123733 crossref_primary_10_3390_pharmaceutics15051520 |
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SubjectTerms | agglomeration Cellulose acetate Centrifugation Chemical properties Dosage and administration Drug delivery systems Drugs dual centrifugation Investigations Itraconazole media milling nanocrystals Nanoparticles nanosuspension Particle size Pharmaceuticals Stabilizing agents Surfactants Suspensions (Chemistry) Vehicles |
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Title | Itraconazole Nanosuspensions via Dual Centrifugation Media Milling: Impact of Formulation and Process Parameters on Particle Size and Solid-State Conversion as Well as Storage Stability |
URI | https://www.proquest.com/docview/2706272462 https://search.proquest.com/docview/2695285773 https://pubmed.ncbi.nlm.nih.gov/PMC9332252 https://doaj.org/article/289b207588534f169dfcc8136745e571 |
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