Process Analytical Technology (PAT)

Lundsberg‐Nielsen, Line; Schlindwein, Walkiria; Berghaus, A

doi:10.1002/9781118895238.ch9

Cited by 6 publications

(6 citation statements)

References 21 publications

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“…The proposed QTPP is for an immediate release solid dosage form (tablet) with a dose of 20 mg of PRX for oral administration [10]. Batches of 250 g API/polymer mixture were blended for 10 min using a tubular mixer.…”

Section: Methodsmentioning

confidence: 99%

“…A preliminary risk assessment was carried out for the HME process using the Ishikawa diagram tool [10]. The die temperature, screw speed and solid feed rate were considered as potentially CPPs.…”

Section: Methodsmentioning

confidence: 99%

“…Schematic diagram showing the manufacturing process including the main unit operations from powders to final product, tablets [10]. The focus of this study is on the in-line UV-Vis monitoring of the hot melt extrusion (HME) process.…”

Section: Figurementioning

confidence: 99%

“…During pharmaceutical HME, API solubility, crystallinity, stability and content uniformity in the polymer mixture are examples of the potentially critical quality attributes (CQAs) that might need to be monitored and controlled [10]…”

Section: Introductionmentioning

confidence: 99%

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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: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Figurementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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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“…Dabei kommen neben thermischen und mechanischen Analysenmethoden auch optische Messtechniken zum Einsatz [14]. [25]. Daneben erfüllt eine auf Kennzahlen basierte digitale Prozessregelung eine Anforderung des Konzepts Industrie 4.0 [32,33].…”

Section: Introductionunclassified

Cleaning in Place Konzept zum Dauerbetrieb optischer Sonden in der Prozessanalytik der Polymerextrusion

Bäuerle¹

2018

Zeitschrift Kunststofftechnik

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Cleaning in place concept for continuous operation of optical probes in process analytics of polymer extrusion The continuous monitoring of quality parameters is an increasing requirement in polymer extrusion. Optical spectroscopy can fulfill this requirement as it detects other parameters besides color, such as chemical properties, turbidity or particle size. Here, optical probes are used for inline measurements in the extruder. During operation, material can accumulate on the probe windows (window fouling). This article presents a new cleaning in place concept that allows windows to be cleaned without interruption during production. Additionally, the calibration of the measurement system is possible. This prevents setup times and ensures a continuous inline measurement.

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