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Naji, M. |
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Motta, Antonella |
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Aletan, Dirar |
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Mohamed, Tarek |
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Ertürk, Emre |
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Taccardi, Nicola |
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Kononenko, Denys |
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Petrov, R. H. | Madrid |
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Alshaaer, Mazen | Brussels |
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Bih, L. |
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Casati, R. |
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Muller, Hermance |
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Kočí, Jan | Prague |
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Šuljagić, Marija |
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Kalteremidou, Kalliopi-Artemi | Brussels |
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Azam, Siraj |
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Ospanova, Alyiya |
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Blanpain, Bart |
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Ali, M. A. |
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Popa, V. |
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Rančić, M. |
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Ollier, Nadège |
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Azevedo, Nuno Monteiro |
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Landes, Michael |
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Rignanese, Gian-Marco |
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Rantanen, Jukka
University of Copenhagen
in Cooperation with on an Cooperation-Score of 37%
Topics
Publications (43/43 displayed)
- 2024Leucine as a Moisture-Protective Excipient in Spray-Dried Protein/Trehalose Formulationcitations
- 2024Compaction behavior of freeze-dried and spray-dried trypsin/lactose particulate systems
- 2023Co-administration of Intravenous Drugscitations
- 2023Coating of Primary Powder Particles Improves the Quality of Binder Jetting 3D Printed Oral Solid Productscitations
- 2022Structured approach for designing drug-loaded solid products by binder jetting 3D printingcitations
- 2021Enabling formulations of aprepitantcitations
- 2020Fabrication of Mucoadhesive Buccal Films for Local Administration of Ketoprofen and Lidocaine Hydrochloride by Combining Fused Deposition Modeling and Inkjet Printingcitations
- 2020Exploring the Complexity of Processing-Induced Dehydration during Hot Melt Extrusion Using In-Line Raman Spectroscopycitations
- 2019Determining Thermal Conductivity of Small Molecule Amorphous Drugs with Modulated Differential Scanning Calorimetry and Vacuum Molding Sample Preparationcitations
- 2019Exploring the chemical space for freeze-drying excipientscitations
- 2019Roadmap to 3D printed oral pharmaceutical dosage formscitations
- 2018The use of molecular descriptors in the development of co-amorphous formulationscitations
- 2017Investigation of nanocarriers and excipients for preparation of nanoembedded microparticlescitations
- 2017Correlation between calculated molecular descriptors of excipient amino acids and experimentally observed thermal stability of lysozymecitations
- 2017The flow properties and presence of crystals in drug-polymer mixturescitations
- 2017The effect of poly (lactic-co-glycolic) acid composition on the mechanical properties of electrospun fibrous matscitations
- 2017The effect of poly (lactic-co-glycolic) acid composition on the mechanical properties of electrospun fibrous matscitations
- 2016Oscillatory Shear Rheology in Examining the Drug-Polymer Interactions Relevant in Hot Melt Extrusioncitations
- 2016Properties of the Sodium Naproxen-Lactose-Tetrahydrate Co-Crystal upon Processing and Storagecitations
- 2015Three-Dimensional Printing of Drug-Eluting Implantscitations
- 2015Well-plate freeze-dryingcitations
- 2015Rheology as a tool for evaluation of melt processability of innovative dosage formscitations
- 2014Evaluation of ring shear testing as a characterization method for powder flow in small-scale powder processing equipmentcitations
- 2014Near-Infrared Imaging for High-Throughput Screening of Moisture-Induced Changes in Freeze-Dried Formulationscitations
- 2013A step toward development of printable dosage forms for poorly soluble drugscitations
- 2013Interpreting the Disordered Crystal Structure of Sodium Naproxen Tetrahydratecitations
- 2013Designing CAF-adjuvanted dry powder vaccinescitations
- 2013Investigation of the phase separation of PNIPAM using infrared spectroscopy together with multivariate data analysiscitations
- 2013Fast-track to a solid dispersion formulation using multi-way analysis of complex interactionscitations
- 2013Foreign matter identification from solid dosage formscitations
- 2013Exploring the solid-form landscape of pharmaceutical hydratescitations
- 2012Complementing high-throughput X-ray powder diffraction data with quantum-chemical calculationscitations
- 2012Crystal morphology modification by the addition of tailor-made stereocontrolled poly(N-isopropyl acrylamide)citations
- 2012Atomic pairwise distribution function analysis of the amorphous phase prepared by different manufacturing routescitations
- 2011Assessment of crystalline disorder in cryo-milled samples of indomethacin using atomic pair-wise distribution functionscitations
- 2006Understanding processing-induced phase transformations in erythromycin-PEG 6000 solid dispersionscitations
- 2005Physical changes of beta-sitosterol crystals in oily suspensions during heatingcitations
- 2005IR spectroscopy together with multivariate data analysis as a process analytical tool for in-line monitoring of crystallization process and solid-state analysis of crystalline productcitations
- 2005Pellet manufacturing by extrusion-spheronization using process analytical technologycitations
- 2005Characterization of polymorphic solid-state changes using variable temperature X-ray powder diffractioncitations
- 2004Role of excipients in hydrate formation kinetics of theophylline in wet masses studied by near-infrared spectroscopycitations
- 2003Dehydration studies using a novel multichamber microscale fluid bed dryer with in-line near-infrared measurementcitations
- 2002Hydrate formation during wet granulation studied by spectroscopic methods and multivariate analysis
Places of action
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article
Leucine as a Moisture-Protective Excipient in Spray-Dried Protein/Trehalose Formulation
Abstract
<p>The incorporation of leucine (Leu), a hydrophobic amino acid, into pharmaceutically relevant particles via spray-drying can improve the physicochemical and particulate properties, stability, and ultimately bioavailability of the final product. More specifically, Leu has been proposed to form a shell on the surface of spray-dried (SD) particles. The aim of this study was to explore the potential of Leu in the SD protein/trehalose (Tre) formulation to control the water uptake and moisture-induced recrystallization of amorphous Tre, using lysozyme (LZM) as a model protein. LZM/Tre (1:1, w/w) was dissolved in water with varied amounts of Leu (0 - 40%, w/w) and processed by spray-drying. The solid form, residual moisture content (RMC), hygroscopicity, and morphology of SD LZM/Tre/Leu powders were evaluated, before and after storage under 22°C/55% RH conditions for 90 and 180 days. The X-ray powder diffraction results showed that Leu was in crystalline form when the amount of Leu in the formulation was at least 20% (w/w). Thermo-gravimetric analysis and scanning electron microscopy results showed that 0%, 5%, and 10% (w/w) Leu formulations led to comparable RMC and raisin-like round particles. In contrast, higher Leu contents resulted in a lower RMC and increased surface corrugation of the SD particles. Dynamic vapor sorption analysis showed that partial recrystallization of amorphous Tre to crystalline Tre·dihydrate occurred in the 0% Leu formulation. However, adding as little as 5% (w/w) Leu inhibited this recrystallization during the water sorption/desorption cycle. In addition, after storage, the formulations with higher Leu contents showed reduced water uptake. Instead of observing recrystallization of amorphous Tre in 0%, 5%, and 10% (w/w) Leu formulations, recrystallization of amorphous Leu was noted in the 5% and 10% (w/w) Leu formulations after storage. In summary, our study demonstrated that the addition of Leu has the potential to reduce water uptake and inhibit moisture-induced recrystallization of amorphous Tre in the SD protein/Tre powder system.</p>