References of "Streel, Bruno"
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See detailEvaluation of SFC interest for the determination of cholecalciferol and its impurities un pharmaceuticals
Andri, Bertyl ULg; Dispas, Amandine ULg; 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 ULg; De Bleye, Charlotte ULg; Netchacovitch, Lauranne ULg 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 ULg; Lebrun, Pierre ULg; Chavez, Pierre-François ULg 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 ULg; Streel, Bruno; Sibenaler, Renilde et al

Poster (2011, June 19)

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See detailActive content determination of non-coated pharmaceutical pellets by near infrared spectroscopy: Method development, validation and reliability evaluation
Mantanus, Jérôme ULg; Ziemons, Eric ULg; Lebrun, Pierre ULg et al

in Talanta (2010), 80

A robust near infrared (NIR) method able to quantify the active content of pilot non-coated pharmaceutical pellets was developed. A protocol of calibration was followed, involving 2 operators, independent ... [more ▼]

A robust near infrared (NIR) method able to quantify the active content of pilot non-coated pharmaceutical pellets was developed. A protocol of calibration was followed, involving 2 operators, independent pilot batches of non-coated pharmaceutical pellets and two different NIR acquisition temperatures. Prediction models based on Partial Least Squares (PLS) regression were then carried out. Afterwards, the NIR method was fully validated for an active content ranging from 80 to 120% of the usual active content using new independent pilot batches to evaluate the adequacy of the method to its final purpose. Conventional criteria such as the R2, the Root Mean Square Error of Calibration (RMSEC), the Root Mean Square Error of Prediction (RMSEP) and the number of PLS factors enabled the selection of models with good predictive potential. However, such criteria sometimes fail to choose the most fitted for purpose model. Therefore, a novel approach based on accuracy profiles of the validation results was used, providing a visual representation of the actual and future performances of the models. Following this approach, the prediction model using signal pre-treatment Multiplicative Scatter Correction (MSC) was chosen as it showed the best ability to quantify accurately the active content over the 80–120% active content range. The reliability of the NIR method was tested with new pilot batches of non-coated pharmaceutical pellets containing 90 and 110% of the usual active content, with blends of validation batches and industrial batches. All those batches were also analyzed by the HPLC reference method and relative errors were calculated: the results showed low relative errors in full accordance with the results obtained during the validation of the method, indicating the reliability of the NIR method and its interchangeability with the HPLC reference method. [less ▲]

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See detailBuilding the quality into pellet manufacturing environment - feasibility study and validation of an in-line quantitative near infrared (NIR) method
Mantanus, Jérôme ULg; Ziemons, Eric ULg; Rozet, Eric ULg et al

in Talanta (2010), 83

The present study focuses on the implementation of an in-line quantitative near infrared (NIR) spectroscopic method for determining the active content of pharmaceutical pellets. The first aim was to non ... [more ▼]

The present study focuses on the implementation of an in-line quantitative near infrared (NIR) spectroscopic method for determining the active content of pharmaceutical pellets. The first aim was to non-invasively interface a dispersive NIR spectrometer with four realistic particle streams existing in the pellets manufacturing environment. Regardless of the particle stream characteristics investigated, NIR together with principal component analysis (PCA) was able to classify the samples according to their active content. Further, one of these particle stream interfaces was non-invasively investigated with a FT-NIR spectrometer. A predictive model based on Partial Least Squares (PLS) regression was able to determine the active content of pharmaceutical pellets. The NIR method was finally validated with an external validation set for an API concentration range from 80 to 120 % of the targeted active content. The prediction error of 0.9 % (root mean standard error of prediction, RMSEP) was low, indicating the accuracy of the NIR method. The accuracy profile on the validation results, an innovative approach based on tolerance intervals, demonstrated the actual and future performance of the in-line NIR method. Accordingly, the present approach paves the way for real-time release-based quality system. [less ▲]

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See detailProduction line real time near infrared (NIR) monitoring
Mantanus, Jérôme ULg; Ziemons, Eric ULg; Streel, Bruno et al

Conference (2009, September)

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See detailUsing tolerance intervals in pre-study validation of analytical methods to predict in-study results - The fit-for-future-purpose concept
Rozet, Eric ULg; Hubert, Cédric ULg; Ceccato, Attilio ULg et al

in Journal of Chromatography. A (2007), 1158(1-2), 126-137

It is recognized that the purpose of validation of analytical methods is to demonstrate that the method is suited for its intended purpose. Validation is not only required by regulatory authorities, but ... [more ▼]

It is recognized that the purpose of validation of analytical methods is to demonstrate that the method is suited for its intended purpose. Validation is not only required by regulatory authorities, but is also a decisive phase before the routine use of the method. For a quantitative analytical method the objective is to quantify the target analytes with a known and suitable accuracy. For that purpose, first, a decision about the validity of the method based on prediction is proposed: a method is declared proper for routine application if it is considered that most of the future results generated will be accurate enough. This can be achieved by using the "beta-expectation tolerance interval" (accuracy profile) as the decision tool to assess the validity of the analytical method. Moreover, the concept of "fit-for-purpose" is also proposed here to select the most relevant response function as calibration curve, i.e. choosing a response function based solely on the predicted results this model will allow to obtain. This paper reports four case studies where the results obtained with quality control samples in routine were compared to predictions made in the validation phase. Predictions made using the "beta-expectation tolerance interval" are shown to be accurate and trustful for decision making. It is therefore suggested that an adequate way to conciliate both the objectives of the analytical method in routine analysis and those of the validation step consists in taking the decision about the validity of the analytical method based on prediction of the future results using the most appropriate response function curve, i.e. the fit-for-future-purpose concept. [less ▲]

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See detailDevelopment and pre-validation of a high sensitive method for the determination of levonorgestrel in human plasma by SPE/LC/MS-MS
Hubert, Cédric ULg; streel, Bruno; Sibenaler, Renilde et al

Poster (2007, July)

Detailed reference viewed: 19 (4 ULg)