Monitoring blend potency in a tablet press feed frame using near infrared spectroscopy

Ward, Howard W.; Blackwood, Daniel O.; Polizzi, Mark A.; Clarke, H. S.

doi:10.1016/j.jpba.2013.02.008

Cited by 76 publications

(23 citation statements)

References 10 publications

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“…In spite of the large volume of work from academics, publications on industrial applications of modeling technology to CM are rare and mostly focused on process analytical technology . Perspectives and commentary regarding cultural and structural changes in pharmaceutical development and manufacturing with the dawn of CM can be found and are potentially a useful source for the academic community as these communications are a collation of views and opinions across multiple corporations.…”

Section: Introductionmentioning

confidence: 99%

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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Section: Introductionmentioning

confidence: 99%

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

et al. 2017

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“…NIR measurements were also performed in the feed frame of a tablet press [42]. The derivative intensity of the API band was plotted versus time, and the influence of mass-flow rate, potency ingress and paddle-wheel speed on the method performance was studied.…”

Section: Direct Compressionmentioning

confidence: 99%

“…%API NIR In-line in the tablet press, measuring each individual tablet * Due to the large amount of data, only each 20th spectrum was taken into account [41] %API NIR Through a Plexi-glass observation window in the feed frame * NIR predictions were influenced by the paddle wheel rotational speed [42] …”

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confidence: 99%

Process Analytical Technology for continuous manufacturing of solid-dosage forms

Fonteyne

Vercruysse

Leersnyder

et al. 2015

TrAC Trends in Analytical Chemistry

142

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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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“…Ward et al reported the performance of a near‐infrared (NIR) probe installed in the feed‐frame of a Kilian T‐100 ( IMA, Koln, Germany ) tablet press, mainly seeking to determine the sensitivity of the instrument and the interference of physical factors. Their study found initial optimistic results correlating the signal reported by the NIR probe and the measured concentration of drug in the tablet.…”

Section: Introductionmentioning

confidence: 99%

Estimation of mass‐based composition in powder mixtures using Extended Iterative Optimization Technology (EIOT)

2018

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The Extended Iterative Optimization Technology (EIOT) method is proposed as an extension to Muteki's [I&ECR 2013;52 (35):12258-12268] Iterative Optimization Technology to address deviations from Beer-Lambert's law in powders. The new method estimates the apparent spectrum for the pure species, rather than using the measured spectrum and augments Beer-Lambert's law with a bilinear term to capture the signature and strength of the nonchemical interferences. The proposed method has exhibited acceptable performance in spite of using a lean data set to estimate its parameters. The method provides robust and coherent estimates within the physical boundaries of the system and exhibits robustness to instrument transfer. The lean effort needed to build the EIOT method positions it as an attractive option in early stages of pharmaceutical drug product development. Its robustness to distinguish chemical from nonchemical signals implies a potential to lower the total cost of ownership for an EIOT-based solution in manufacturing.

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Monitoring blend potency in a tablet press feed frame using near infrared spectroscopy

Cited by 76 publications

References 10 publications

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

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

Process Analytical Technology for continuous manufacturing of solid-dosage forms

Estimation of mass‐based composition in powder mixtures using Extended Iterative Optimization Technology (EIOT)

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