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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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Hinrichs, Wouter
University of Groningen
in Cooperation with on an Cooperation-Score of 37%
Topics
Publications (17/17 displayed)
- 2024Combinations of arginine and pullulan reveal the selective effect of stabilization mechanisms on different lyophilized proteinscitations
- 2018The mechanism behind the biphasic pulsatile drug release from physically mixed poly(DL-lactic(-co-glycolic) acid)-based compactscitations
- 2016Compacted Solid Dosage Form
- 2015Protein release from water-swellable poly(d,l-lactide-PEG)-b-poly(ϵ-caprolactone) implantscitations
- 2015Protein Stability during Hot Melt Extrusion
- 2015Size and molecular flexibility of sugars determine the storage stability of freeze-dried proteinscitations
- 2015Protein Stability during Hot Melt Extrusion: The Effect of Extrusion Temperature, Hydrophilicity of Polymers and Sugar Glass Pre-stabilization
- 2015Polymeric formulations for drug release prepared by hot melt extrusioncitations
- 2013Designing CAF-adjuvanted dry powder vaccinescitations
- 2013Unraveling protein stabilization mechanismscitations
- 2012Preparation and physicochemical evaluation of a new tacrolimus tablet formulation for sublingual administrationcitations
- 2010Effect of drug-carrier interaction on the dissolution behavior of solid dispersion tabletscitations
- 2006Characterization of the molecular distribution of drugs in glassy solid dispersions at the nano-meter scale, using differential scanning calorimetry and gravimetric water vapour sorption techniquescitations
- 2005Inulin is a promising cryo- and lyoprotectant for PEGylated lipoplexescitations
- 2004Incorporation of lipophilic drugs in sugar glasses by lyophilization using a mixture of water and tertiary butyl alcohol as solventcitations
- 2003Investigations into the stabilization of drugs by sugar glassescitations
- 2001Inulin glasses for the stabilization of therapeutic proteinscitations
Places of action
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article
Investigations into the stabilization of drugs by sugar glasses
Abstract
<p>PURPOSE: To study the effect of the high-pH buffers ammediol, borax, CHES, TRIS, and Tricine on the glass transition temperature of the freeze concentrated fraction (Tg') of trehalose/buffer and inulin/buffer solutions at pH 6.0 and pH 9.8. Also, the glass transition temperature (Tg) of sugar glasses obtained after freeze drying of these solutions was elucidated. Additionally, the effect occurring during the freezing process on the pH of the various buffers was investigated. Furthermore, the stability of alkaline phosphatase (AP) incorporated in these sugar glasses prepared from solutions at pH 9.8 was evaluated.</p><p>METHODS: The Tg' and Tg were measured using differential scanning calorimetry (DSC), and the change of pH during freezing was estimated by using an indicator solution added to the respective solutions. The enzymatic activity of AP after freeze drying and storage at 60 degrees C was evaluated by an enzymatic activity assay.</p><p>RESULTS: It was found that the Tg' and Tg of the samples investigated are strongly influenced by the presence of the buffer. On freezing, only minor changes of the pH were observed. The samples with the lowest Tg and the samples containing buffers that formed complexes with the sugars showed the poorest stability of the AP.</p><p>CONCLUSIONS: The stabilizing capacities of sugars that are currently recognized as excellent stabilizers for proteins during drying and storage can be completely lost if certain high-pH buffers such as ammediol, borax, and TRIS are used at high concentrations. Loss of stabilizing capacities can be ascribed to strong depression of the Tg' and Tg or to complex formation.</p>