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See detailIs supercritical fluid chromatography hyphenated to massspectrometry suitable for the quality control of vitamin D3 oilyformulations?
Andri, Bertyl ULiege; Dispas, Amandine ULiege; Klinkenberg, Régis et al

in Journal of Chromatography. A (2017), 1515

Nowadays, many efforts are devoted to improve analytical methods regarding efficiency, analysis timeand greenness. In this context, Supercritical Fluid Chromatography (SFC) is often regarded as a ... [more ▼]

Nowadays, many efforts are devoted to improve analytical methods regarding efficiency, analysis timeand greenness. In this context, Supercritical Fluid Chromatography (SFC) is often regarded as a goodalternative over Normal Phase Liquid Chromatography (NPLC). Indeed, modern SFC separations arefast, efficient with suitable quantitative performances. Moreover, the hyphenation of SFC to mass spec-trometry (MS) provides additional gains in specificity and sensitivity. The present work aims at thedetermination of vitamin D3 by SFC-MS for routine Quality Control (QC) of medicines specifically. Basedon the chromatographic parameters previously defined in SFC-UV by Design of Experiments (DoE) andDesign Space methodology, the method was adapted to work under isopycnic conditions ensuring a base-line separation of the compounds. Afterwards, the response provided by the MS detector was optimizedby means of DoE methodology associated to desirability functions. Using these optimal MS parameters,quantitative performances of the SFC-MS method were challenged by means of total error approachmethod validation. The resulting accuracy profile demonstrated the full validity of the SFC-MS method. It was indeed possible to meet the specification established by the European Medicines Agency (EMA) (i.e. 95.0 − 105.0% of the API content) for a dosing range corresponding to at least 70.0-130.0% of theAPI content. These results highlight the possibility to use SFC-MS for the QC of medicine and obviouslysupport the switch to greener analytical methods. [less ▲]

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See detailEvaluation of different in vitro dissolution tests based on level A in vitro–in vivo correlations for fenofibrate self-emulsifying lipid-based formulations
Pestieau, Aude ULiege; Lebrun, Sonia; Cahay, Bernard et al

in European Journal of Pharmaceutics & Biopharmaceutics (2017), 112

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See detailOptimization and validation of a fast Supercritical Fluid Chromatography method for the quantitative determination of vitamin D3 and its related impurities.
Andri, Bertyl ULiege; Lebrun, Pierre ULiege; Dispas, Amandine ULiege et al

in Journal of Chromatography. A (2017)

In the uprising context of green analytical chemistry, Supercritical Fluid Chromatography (SFC) is often suggested as an alternative to Normal Phase Liquid Chromatography. Indeed, SFC provides fast ... [more ▼]

In the uprising context of green analytical chemistry, Supercritical Fluid Chromatography (SFC) is often suggested as an alternative to Normal Phase Liquid Chromatography. Indeed, SFC provides fast, efficient and green separations. In this report, the quantitative performances of SFC were challenged on a real-life case study: the Quality Control (QC) of vitamin D3. A rapid and green SFC method was optimized thanks to the Design of Experiments–Design Space (DoE–DS) methodology. It provided robust and high quality separation of the compounds within a 2 min timeframe, using a gradient of ethanol as co-solvent of the carbon dioxide. The analytical method was fully validated according to the total error approach, demon- strating the compliance of the method to the specifications of U.S. Pharmacopeia (USP: 97.0–103.0%) and European Pharmacopeia (EP: 97.0–102.0%) for an interval of [50–150%] of the target concentration. In order to allow quantification of impurities using vitamin D3 as an external standard in SFC-UV, correction factors were determined and verified during method validation. Thus, accurate quantification of impu- rities was demonstrated at the specified levels (0.1 and 1.0% of the main compound) for a 70.0–130.0% dosing range. This work demonstrates the validity of an SFC method for the QC of vitamin D3 raw material and its application to real samples. Therefore, it supports the switch to a greener and faster separative technique as an alternative to NPLC in the pharmaceutical industry. [less ▲]

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See detailSelection of a discriminant and biorelevant in vitro dissolution test for the development of fenofibrate self-emulsifying lipid-based formulations
Pestieau, Aude ULiege; Krier, Fabrice; Brouwers, Adeline et al

in European Journal of Pharmaceutical Sciences (2016)

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See detailIn vitro approach to study the synergistic effects of tobramycin and clarithromycin against Pseudomonas aeruginosa biofilms using prokaryotic or eukaryotic culture media
Thellin, Olivier ULiege; Zorzi, Willy ULiege; Jolois, Olivier et al

in International Journal of Antimicrobial Agents Corresponding (2015), 46

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See detailThorough characterization of a Self-Emulsifying Drug Delivery System with Raman hyperspectral imaging: A case study.
Sacre, Pierre-Yves ULiege; Netchacovitch, Lauranne ULiege; De Bleye, Charlotte ULiege et al

in International Journal of Pharmaceutics (2015), 484

Newly developed drugs often have poor bioavailability due to their poor water solubility (BCS class 2 drugs). It is therefore necessary to develop new strategies to enhance their solubility and their ... [more ▼]

Newly developed drugs often have poor bioavailability due to their poor water solubility (BCS class 2 drugs). It is therefore necessary to develop new strategies to enhance their solubility and their activity, among which, Self-Emulsifying Drug Delivery System (SEDDS). The efficacy of the drugs contained in these preparations is mainly affected by the solid state and the particle size of the active pharmaceutical ingredient (API). However, it is quite complex, long and expensive to characterize these parameters with classical techniques such as X-Ray powder diffraction, differential scanning calorimetry or hot stage microscopy. The present article presents, through a case study, the advantages of the Raman hyperspectral imaging in the characterization of such formulations. Indeed, Raman chemical imaging may fully characterize SEDDS with single equipment and operator in a non-destructive way allowing the follow-up of the formulation during stability studies. Raman imaging is therefore a tool of choice in the PAT framework since it increases the knowledge of the formulation and the process. A quantitative multivariate method using Raman hyperspectral imaging to assay the API in the lipid based formulation has been developed and fully validated following the “total error” approach. [less ▲]

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See detailEvaluation of SFC interest for the determination of cholecalciferol and its impurities in pharmaceuticals
Andri, Bertyl ULiege; Dispas, Amandine ULiege; Klinkenberg, Régis et al

Poster (2014, June 23)

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See detailApplication of hyperspectral Raman imaging to the analysis of a self-emulsifying drug delivery system (SEDDS).
Sacre, Pierre-Yves ULiege; De Bleye, Charlotte ULiege; Netchacovitch, Lauranne ULiege et al

Poster (2014, June)

Self-emulsifying drug delivery systems (SEDDS) are mixtures of drug and excipients that undergo emulsification when exposed to water. This pharmaceutical form is used to enhance the oral absorption of ... [more ▼]

Self-emulsifying drug delivery systems (SEDDS) are mixtures of drug and excipients that undergo emulsification when exposed to water. This pharmaceutical form is used to enhance the oral absorption of poorly water-soluble drugs. The API is finely dispersed in the excipients and forms a solid solution increasing its dissolution rate. Hyperspectral Raman imaging is a powerful tool that combines both spectral and spatial information. It returns qualitative and quantitative information useful during the development or the characterization of pharmaceutical preparations. The studied formulation consisted of a BCS 2 API (high permeability, low solubility) dispersed in excipients mainly composed of Lauroyl macrogol-32 glycerides (>50%). Two different preparations were analyzed: 100% of API dissolved and 70% of API dissolved with 30% of API powder added to the formulation. The two formulations have therefore exactly the same qualitative and quantitative composition but different spatial distribution and dispersion of the API mimicking a problem during the process. First a confocal Raman microscopic analysis was performed to evaluate the solid state of the API in the formulations. Then, an evaluation of the particle size was performed. These results are important since they can affect the bioavailability of the API and therefore its activity. Beside the microscopic scale analysis, a macroscopic imaging quantitative PLS model has been developed. The method has been validated within +/- 10% acceptance limits following the total error approach. This validated quantitative model enables reliable quantitative analysis at the pixel level of Raman images providing meaningful chemical images. [less ▲]

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See detailA new criterion to assess distributional homogeneity in hyperspectral images of solid pharmaceutical dosage forms
Sacre, Pierre-Yves ULiege; Lebrun, Pierre ULiege; Chavez, Pierre-François ULiege et al

in Analytica Chimica Acta (2014), 818

During galenic formulation development, homogeneity of distribution is a critical parameter to check since it may influence activity and safety of the drug. Raman hyperspectral imaging is a technique of ... [more ▼]

During galenic formulation development, homogeneity of distribution is a critical parameter to check since it may influence activity and safety of the drug. Raman hyperspectral imaging is a technique of choice for assessing the distributional homogeneity of compounds of interest. Indeed, the combination of both spectroscopic and spatial information provides a detailed knowledge of chemical composition and component distribution. Actually, most authors assess homogeneity using parameters of the histogram of intensities (e.g. mean, skewness and kurtosis). However, this approach does not take into account spatial information and loses the main advantage of imaging. To overcome this limitation, we propose a new criterion: Distributional Homogeneity Index (DHI). DHI has been tested on simulated maps and formulation development samples. The distribution maps of the samples were obtained without validated calibration model since different formulations were under investigation. The results obtained showed a linear relationship between content uniformity values and DHI values of distribution maps. Therefore, DHI methodology appears to be a suitable tool for the analysis of homogeneity of distribution maps even without calibration during formulation development. [less ▲]

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See detailHigh Throughput determination of Levonorgestrel in human plasma using a Sensitive LC-MS/MS method
Hubert, Cédric ULiege; Streel, Bruno; Sibenaler, Renilde et al

Poster (2011, June 19)

Detailed reference viewed: 265 (17 ULiège)