Spectroscopic characterization of tablet properties in a continuous powder blending and tableting process

Nagy, Brigitta; Farkas, Attila; Magyar, Krisztina; Démuth, Balázs; Nagy, Zsombor Kristóf; Marosi, György

doi:10.1016/j.ejps.2018.07.025

Cited by 23 publications

(6 citation statements)

References 28 publications

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“…Although the chemical information delivered is less specific than NIR and Raman, UV-Vis holds high potential for early phase product development and monitoring manufacturing processes. However, only few studies have been published on the matter [18,19,20], quite often investigating dissolution processes in combination with vibrational spectroscopy [21,22,23,24,25].…”

Section: Introductionmentioning

confidence: 99%

In-Line UV-Vis Spectroscopy as a Fast-Working Process Analytical Technology (PAT) during Early Phase Product Development Using Hot Melt Extrusion (HME)

et al. 2018

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This paper displays the potential of an in-line PAT system for early phase product development during pharmaceutical continuous manufacturing following a Quality by Design (QbD) framework. Hot melt extrusion (HME) is used as continuous manufacturing process and UV–Vis spectroscopy as an in-line monitoring system. A sequential design of experiments (DoE) (screening, optimisation and verification) was used to gain process understanding for the manufacture of piroxicam (PRX)/Kollidon® VA64 amorphous solid dispersions. The influence of die temperature, screw speed, solid feed rate and PRX concentration on the critical quality attributes (CQAs) absorbance and lightness of color (L*) of the extrudates was investigated using multivariate tools. Statistical analysis results show interaction effects between concentration and temperature on absorbance and L* values. Solid feed rate has a significant effect on absorbance only and screw speed showed least impact on both responses for the screening design. The optimum HME process conditions were confirmed by 4 independent studies to be 20% w/w of PRX, temperature 140 °C, screw speed 200 rpm and feed rate 6 g/min. The in-line UV-Vis system was used to assess the solubility of PRX in Kollidon® VA64 by measuring absorbance and L* values from 230 to 700 nm. Oversaturation was observed for PRX concentrations higher than 20% w/w. Oversaturation can be readily identified as it causes scattering in the visible range. This is observed by a shift of the baseline in the visible part of the spectrum. Extrudate samples were analyzed for degradation using off-line High-Performance Liquid Chromatography (HPLC) standard methods. Results from off-line experiments using differential scanning calorimetry (DSC), and X-ray diffraction (XRD) are also presented.

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Section: Introductionmentioning

confidence: 99%

In-Line UV-Vis Spectroscopy as a Fast-Working Process Analytical Technology (PAT) during Early Phase Product Development Using Hot Melt Extrusion (HME)

et al. 2018

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“…3 Currently, several studies have reported the effect of compression forces, 13 formulation composition, 14 particle size 15 and lubrication time 16 on dissolution using NIR spectroscopy. In addition, thus far, NIR spectroscopy has also been used for monitoring different manufacturing processes such as blending, 17 tableting, 18 and coating. 19 Recently, Raman spectroscopy has emerged as an alternative to NIR spectroscopy in process measurements.…”

Section: Introductionmentioning

confidence: 99%

Dissolution profile prediction of sinomenine hydrochloride sustained release tablets, part II: a multisource data fusion approach

Wang

Zhang

et al. 2023

New J. Chem.

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“…12 Spectroscopic techniques, such as near-infrared (NIR) or Raman spectroscopy, provide a nondestructive and cost-effective means, and have been widely recognized as powerful PAT tools applied in the pharmaceutical industry. 13 More recently, NIR spectroscopy has emerged as one of the most popular measurement methods, which can monitor blend uniformity, 14 tablet strength, 15,16 drug dissolution, 17 powder density 18 and adulteration 19 and has attracted increasing attention. Ojala et al used the design of experiments (DoE) approach to study the effects of variables systematically and substituted a conventional sixsample dissolution analysis of Toremifene 80 mg immediate release tablets by non-invasive NIR scanning of the production batches.…”

Section: Introductionmentioning

confidence: 99%

Prediction of dissolution profiles of sinomenine hydrochloride sustained-release tablets part I: using near-infrared spectra as predictors

Wang

et al. 2023

New J. Chem.

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Spectroscopic characterization of tablet properties in a continuous powder blending and tableting process

Cited by 23 publications

References 28 publications

In-Line UV-Vis Spectroscopy as a Fast-Working Process Analytical Technology (PAT) during Early Phase Product Development Using Hot Melt Extrusion (HME)

In-Line UV-Vis Spectroscopy as a Fast-Working Process Analytical Technology (PAT) during Early Phase Product Development Using Hot Melt Extrusion (HME)

Dissolution profile prediction of sinomenine hydrochloride sustained release tablets, part II: a multisource data fusion approach

Prediction of dissolution profiles of sinomenine hydrochloride sustained-release tablets part I: using near-infrared spectra as predictors

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