   Design space approach in the optimization of the spray-drying processLebrun, Pierre  ; Krier, Fabrice ; Mantanus, Jérôme et alin European Journal of Pharmaceutics & Biopharmaceutics (2012), 80(1), 226-234 From a quality by design perspective, the aim of the present study was to demonstrate the applicability of a Bayesian statistical methodology to identify the design space (DS) of a spray-drying process ... [more ▼] From a quality by design perspective, the aim of the present study was to demonstrate the applicability of a Bayesian statistical methodology to identify the design space (DS) of a spray-drying process. Following the ICH Q8 guideline, the DS is defined as the “multidimensional combination and interaction of input variables (e.g., materials attributes) and process parameters that have been demonstrated to provide assurance of quality”. Thus, a predictive risk-based approach was set up in order to account for the uncertainties and correlations found in the process and in the derived critical quality attributes such as the yield, the moisture content, the inhalable fraction of powder, the compressibility index and the Hausner ratio. This allowed quantifying the guarantees and the risks to observe whether the process shall run according to specifications. These specifications describe satisfactory quality outputs and were defined a priori given safety, efficiency and economical reasons. Within the identified DS, validation of the optimal condition was effectuated. The optimized process was shown to perform as expected, providing a product for which the quality is built in by the design and controlled set-up of the equipment, regarding identified critical process parameters: the inlet temperature, the feed rate and the spray flow rate. [less ▲] Detailed reference viewed: 166 (40 ULg) NIR monitoring of solid and liquid forms manufacturing – Development and validation of in-line quantitative methodsMantanus, Jérôme ; Ziemons, Eric ; et alPoster (2010, November 15) Detailed reference viewed: 127 (41 ULg) NIR as a PAT tool for solid and liquid forms manufacturing - Development and validation of in-line quantitative methodsMantanus, Jérôme ; Ziemons, Eric ; et alPoster (2010, May 05) Detailed reference viewed: 91 (22 ULg)Building the quality into pellet manufacturing environment - feasibility study and validation of an in-line quantitative near infrared (NIR) methodMantanus, Jérôme ; Ziemons, Eric ; Rozet, Eric et alin 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 ▲] Detailed reference viewed: 145 (50 ULg)Production line real time near infrared (NIR) monitoringMantanus, Jérôme ; Ziemons, Eric ; et alConference (2009, September) Detailed reference viewed: 51 (13 ULg)Quantitative in-line monitoring of pharmaceutical pellets active content using near infrared spectroscopyMantanus, Jérôme ; Ziemons, Eric ; et alPoster (2009, August) Detailed reference viewed: 50 (12 ULg)Interfacing near infrared (NIR) spectroscopy with production line - Role of sample movement and densityMantanus, Jérôme ; Ziemons, Eric ; et alPoster (2009, June) Detailed reference viewed: 43 (9 ULg) |
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