References of "Krier, Fabrice"
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See detailA Review of Pharmaceutical Extrusion: Critical Process Parameters and Scaling-up
Thiry, Justine ULg; Krier, Fabrice ULg; Evrard, Brigitte ULg

in International Journal of Pharmaceutics (2015), 479(1), 227-240

Hot melt extrusion has been a widely used process in the pharmaceutical area for three decades. In this field, it is important to optimize the formulation in order to meet specific requirements. However ... [more ▼]

Hot melt extrusion has been a widely used process in the pharmaceutical area for three decades. In this field, it is important to optimize the formulation in order to meet specific requirements. However, the process parameters of the extruder should be as much investigated as the formulation since they have a major impact on the final product characteristics. Moreover, a design space should be defined in order to obtain the expected product within the defined limits. This gives some freedom to operate as long as the processing parameters stay within the limits of the design space. Those limits can be investigated by varying randomly the process parameters but it is recommended to use design of experiments. An examination of the literature is reported in this review to summarize the impact of the variation of the process parameters on the final product properties. Indeed, the homogeneity of the mixing, the state of the drug (crystalline or amorphous), the dissolution rate, the residence time, can be influenced by variations in the process parameters. In particular, the impact of the following process parameters: temperature, screw design, screw speed and feeding, on the final product, has been reviewed. [less ▲]

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See detailMicrocrystalline cellulose, a direct compression binder in a quality by design environment—A review
Thoorens, Grégory; Krier, Fabrice ULg; Leclercq, Bruno et al

in International Journal of Pharmaceutics (2014), 473(1-2), 64-72

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See detailTowards a real time release approach for manufacturing tablets using NIR spectroscopy
Pestieau, Aude ULg; Krier, Fabrice ULg; Thoorens, Grégory et al

Poster (2014, June)

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See detailTowards a real time release approach for manufacturing tablets using NIR spectroscopy
Pestieau, Aude ULg; Krier, Fabrice ULg; Thoorens, Grégory et al

in Journal of Pharmaceutical & Biomedical Analysis (2014), 98

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See detailDevice-based controlled local delivery of anastrozol into peritoneal cavity: in vitro and in vivo evaluation
Krier, Fabrice ULg; Riva, Raphaël ULg; Defrère, Sylvie et al

in Journal of Drug Delivery Science and Technology [=JDDST] (2014), 24(2), 198-204

Local treatment using drug loaded implants allows decreasing seric concentrations of the active ingredient with the purpose of limiting side effects and reaching perfect observance. Nowadays, some ... [more ▼]

Local treatment using drug loaded implants allows decreasing seric concentrations of the active ingredient with the purpose of limiting side effects and reaching perfect observance. Nowadays, some diseases are already treated with implants, but generally, by subcutaneous or intra vaginal implantation. In this work, a new implant device dedicated to the intra-peritoneal cavity was developed. For this purpose, a core-membrane polymer implant was selected. We propose an original method to determine the most appropriate membrane to control the release based on the use of Franz cells. The ability of the implant to release a constant quantity of an active ingredient will be assessed by testing implants in vitro. Finally, intra peritoneal cavity and subcutaneous in vivo implantation has been achieved in order to confirm the controlled and local release of the active ingredient. [less ▲]

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See detailPreformulation study of an itraconazole-based drug using hot-melt extrusion
Thiry, Justine ULg; Krier, Fabrice ULg; Pestieau, Aude ULg et al

Conference (2013)

Itraconazole (ITZ) is a synthetic broad-spectrum triazole active against fungal infections. According to the Biopharmaceutics Classification System (BCS), it belongs to the second class, which means it ... [more ▼]

Itraconazole (ITZ) is a synthetic broad-spectrum triazole active against fungal infections. According to the Biopharmaceutics Classification System (BCS), it belongs to the second class, which means it has a low aqueous solubility (± 1μg/mL) but good intestinal membrane permeability. The purpose of this project is to increase the solubility and therefore the bioavailability of ITZ. The chosen production method is Hot-Melt Extrusion (HME) because it presents many advantages such as: absence of organic solvents, low cost, fast production, small footprint and the ability to work continuously. In order to produce an ITZ-based drug by HME, several polymers used in HME were selected for a screening process. Many of them were dismissed regarding their high glass transition temperature (Tg), high melt viscosity, short Tg range and/or degradation temperature by using different techniques (Differential Scanning Calorimetry, Thermo Gravimetric Analysis, texture analyzer). Soluplus®/Itraconazole 25% extrudates were produced then the ITZ release was tested in-vitro. But several dissolution tests can be found in the Pharmacopeia and in the literature. So, four tests were selected: USP II non-sink (HCl 0.1M), USP II sink (HCl 0.1M+0.7% Sodium Dodecyl Sulfate), USP IV sink (HCl 0.1M+0.7% SDS) and biphasic with sink conditions in the organic phase (aqueous phase: HCl 0.1M; organic phase: octanol), in order to be able to choose the most discriminant one. Moreover, those tests were run in triplicate on a handmade Itraconazole capsule, on Sporanox® and on Soluplus®/Itraconazole 25% extrudates. The results show that using SDS can distort the test because some interaction may occur with the excipients and slow down/speed up the dissolution process. So, the two tests in sink conditions cannot be considered discriminant. As far as the two other tests are concerned, they both seem discriminant but more information can be found in the biphasic tests. Indeed, we can observe if the rate limiting state is the dissolution in water or the permeation to the organic phase. Thus, the dissolution test we chose to use is the biphasic dissolution test. Finally, the selected polymers were used in HME to produce extrudates with 25%-33% ITZ. The ITZ release was tested in-vitro to show which ones of the polymers is able to enhance the solubility of ITZ in water and the permeation to the octanol phase. [less ▲]

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See detailPAT tools for the control of co-extrusion implants manufacturing process
Krier, Fabrice ULg; Mantanus, Jérome; Sacre, Pierre-Yves ULg et al

in International Journal of Pharmaceutics (2013), 458

Hot melt extrusion is a novel pharmaceutical manufacturing process technique. In this study, we identified four Critical Quality Attributes (CQAs) of the implant manufacturing process by hot melt ... [more ▼]

Hot melt extrusion is a novel pharmaceutical manufacturing process technique. In this study, we identified four Critical Quality Attributes (CQAs) of the implant manufacturing process by hot melt extrusion: the implant diameter, the quantity of the Active Pharmaceutical Ingredient (API), the homogeneity distribution of API and the thickness of the membrane. We controlled the implant diameter and the quantity of API in-line with a laser measurement, NIR and Raman spectroscopy, respectively. These two different spectroscopic techniques provided comparable results. In fact, the RMSEC and RMSECV were very close in each PAT technique but NIR spectroscopy was easier to use and less sensitive to external changes. For the control of the homogeneity of API distribution and the thickness of the membrane, we used successfully Raman spectroscopy imaging. These PAT tools help reducing analysis time. [less ▲]

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