2014
DOI: 10.1016/j.jpba.2014.05.025
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Predicting final product properties of melt extruded solid dispersions from process parameters using Raman spectrometry

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Cited by 27 publications
(14 citation statements)
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“…In the context of ensuring final product quality in real time, the integration of this information into a model and data‐driven framework that aggregates all of the available measurements of raw and intermediate material properties, process parameters, and product attributes for the purpose of ensuring quality in real time is loosely referred to as real‐time release (RTR). Approaches to RTR have been extensively discussed in the literature and in regulatory guidances . However, progress has been slow, and thus, much work remains to be done; this makes this a fertile area for innovative research.…”
Section: Areas Of Technical Challengementioning
confidence: 99%
“…In the context of ensuring final product quality in real time, the integration of this information into a model and data‐driven framework that aggregates all of the available measurements of raw and intermediate material properties, process parameters, and product attributes for the purpose of ensuring quality in real time is loosely referred to as real‐time release (RTR). Approaches to RTR have been extensively discussed in the literature and in regulatory guidances . However, progress has been slow, and thus, much work remains to be done; this makes this a fertile area for innovative research.…”
Section: Areas Of Technical Challengementioning
confidence: 99%
“…21,22) These characteristics of EUD-E as a solid dispersion carrier are attributed to strong interactions between drugs and EUD-E, both in the solid dispersion and in the aqueous dispersion. To date, many studies examining interactions in solid dispersions have been performed mainly by thermal analysis (DSC, 23,24) micro thermal analysis, 25,26) and dynamic mechanical thermal analysis 27) ) and spectroscopic analyses (IR, 28,29) Raman, 30,31) and solid-state NMR 32,33) ). In a study by Chokshi et al, a single T g was observed in the DSC curves of solid dispersions with weight ratios of indomethacin/EUD-E of 3 : 7, 5 : 5, and 7 : 3, demonstrating high miscibility.…”
Section: Introductionmentioning
confidence: 99%
“…Furthermore, a PAT system can be particularly important and useful when tablets include ASDs since these metastable systems tend to crystallize during processing [42][43][44]. Raman and NIR spectroscopies can allow the detection of crystalline traces in the ASDs [45,46], thus these analytical methods can be of enormous significance for in-line process monitoring [47]. Our goal with this work was to achieve scaled-up production of spironolactone (SPIR) containing electrospun ASD after optimization of polymers matrices and drug loadings.…”
mentioning
confidence: 99%