PAT for tableting: Inline monitoring of API and excipients via NIR spectroscopy

Wahl, Patrick; Fruhmann, Georg; Sacher, Stephan; Straka, Gerhard; Sowinski, S.; Khinast, Johannes G.

doi:10.1016/j.ejpb.2014.03.021

Cited by 95 publications

(44 citation statements)

References 40 publications

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“…Wahl et al [40] implemented an NIR probe directly above the paddle wheel, and they also detected segregation towards the end of the process. Järvinen et al [41] monitored not only the individual tablets on the tablet press but also the powder stream coming from a continuous mixer prior to tableting.…”

Section: Direct Compressionmentioning

confidence: 99%

Process Analytical Technology for continuous manufacturing of solid-dosage forms

Fonteyne

Vercruysse

Leersnyder

et al. 2015

TrAC Trends in Analytical Chemistry

144

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Currently, pharmaceutical production is making the switch from batch processing towards continuous processing. The quality of intermediate and end products produced by batch processes is assured by off-line testing. It is obvious that off-line tests in analytical laboratories cancel out the advantages of continuous processing, so the critical quality attributes of continuously produced pharmaceuticals need to be monitored in real time. In 2004, the US Food and Drug Administration launched the process analytical technology (PAT) concept to stimulate the pharmaceutical industry to change from off-line to real-time quality testing. This review explores the implementation of PAT tools within continuous pharmaceutical processes (i.e., blending, spray drying, roller compaction, twin-screw granulation and compression), focusing on both opportunities and challenges.

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Section: Direct Compressionmentioning

confidence: 99%

Process Analytical Technology for continuous manufacturing of solid-dosage forms

Fonteyne

Vercruysse

Leersnyder

et al. 2015

TrAC Trends in Analytical Chemistry

144

View full text Add to dashboard Cite

show abstract

“…For calibration, the active ingredient and two excipients concentrations were varied through eight experiments selected by means of a D-optimal design and two extra runs added to ensure equidistant steps in the content of each component. Spectral data were recorded in a dynamic acquisition mode, simulating real conditions [5].…”

Section: Calibration Strategy For Calibration In-line Monitoring Methodsmentioning

confidence: 99%

“…Scatter effects are common for all spectroscopic techniques and the phenomenon appears mostly because of the physical variabilities between samples or path-length variations. Two of those pre-processing concepts are standard normal variate (SNV) and multiplicative scatter correction (MSC) which also normalize the baseline shifts of different samples [4,5]. The second set of pre-processing methods has the capacity to reduce or remove the noise by smoothing and differentiating the spectral values.…”

Section: Handling Chemical Physical and Environmental Interferencesmentioning

confidence: 99%

“…The high-throughput analysis associated with vibrational spectroscopy favored its application to gain better process understanding, sustaining the pharmaceutical product development from a Quality by Design and Process Analytical Technology point of view [8], thus enhancing the opportunity to develop well-understood, well-controlled, and continuously optimized manufacturing processes and products [5]. The nondestructive nature of vibrational spectroscopic methods is of great importance in the quality evaluation of production batches, as they allow the testing of a high number of samples or the entire process, depending on the type of method.…”

Section: Introductionmentioning

confidence: 99%

“…Considering the pharmaceutical domain, these methods have been extensively applied to quantify active pharmaceutical ingredients, excipients, or physical properties either as offline method for intermediate/final product characterization [1] or as real-time-monitoring methods implemented within blending [2], granulation [3], extrusion [4], tableting [5], coating [6], or freeze-drying processes [7].…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Multivariate Calibration for the Development of Vibrational Spectroscopic Methods

Tomuță¹,

Porfire²,

Casian³

et al. 2018

Calibration and Validation of Analytical Methods - A Sampling of Current Approaches

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Vibrational spectroscopy, namely near infrared (NIR) and Raman spectroscopy, is based on the interaction between the electromagnetic radiation and matter. The technique is sensitive to chemical and physical properties and delivers a wide range of information about the analyzed sample, but in order to extract the information, multivariate calibration of the spectral data is required. The main goal of this work will be to present in detail the available multivariate calibration strategy for development of NIR and Raman spectroscopic methods, which was successfully applied in pharmaceutics.

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A flowsheet model for the development of a continuous process for pharmaceutical tablets: An industrial perspective

et al. 2017

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A dynamic model of a continuous direct compression process for pharmaceutical tablets is presented. The objective is to assess the impact of the variability from the feeder system on the concentration of drug in the powder in the feed frame of a tablet press. The model is based on principles of dispersed flow from the reaction engineering field. An estimability analysis was performed to understand the impact of the available measurements on the estimated parameters and suggest better ways to approach the parametrization. Predictions are successfully contrasted with experimental data. The model is used to produce residence time distributions at different process conditions and a graphical representation of the allowable range of disturbances in the feeders that can be mitigated by the process. The model was used in support of the method development for an online near infrared sensor. V C 2017 American Institute of Chemical Engineers AIChE J, 64: 511-525, 2018

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PAT for tableting: Inline monitoring of API and excipients via NIR spectroscopy

Cited by 95 publications

References 40 publications

Process Analytical Technology for continuous manufacturing of solid-dosage forms

Process Analytical Technology for continuous manufacturing of solid-dosage forms

Multivariate Calibration for the Development of Vibrational Spectroscopic Methods

A flowsheet model for the development of a continuous process for pharmaceutical tablets: An industrial perspective

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