Analysis of powder phenomena inside a Fette 3090 feed frame using in-line NIR spectroscopy

Mateo-Ortiz, Daniel; Colon, Yleana Marie; Romañach, Rodolfo J.; Méndez, Rafael

doi:10.1016/j.jpba.2014.07.014

Cited by 67 publications

(30 citation statements)

References 26 publications

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“…In the analytics aspect, contributions are oriented toward the use of one or another in situ analytical technique to increase observability in the continuous line. Techniques such as the use of near infrared (NIR) spectrostcopy, and Raman spectroscopy have been investigated in their applications to CM, the reader is referred to the review by Fonteyne et al on the use of Process Analytical Technology (PAT) in CM. Monitoring and control of the CMDP is perhaps the most straightforward application for systems engineering tools in pharmaceutical manufacturing, as such there are decades of technology still to be brought to practice.…”

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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“…22 Such powder flow phenomena occurring inside the feed frame, e.g. density variations 23 and segregation, 21 have been explored with NIR spectroscopy. Despite challenges related to sample presentation, NIR spectroscopy has been useful in in-line concentration monitoring inside the feed frame.…”

Section: Nir Spectroscopy As a Pat Tool For Tablet Manufacturingmentioning

confidence: 99%

Concentration monitoring with near infrared chemical imaging in a tableting press

Dalvi

Fauteux‐Lefebvre

Guay

et al. 2018

J. Spectral Imaging

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Monitoring powder potency and homogeneity is important in achieving real-time release testing in a continuous tablet manufacturing operation. If quality related issues are encountered, monitoring powder potency inside a feed frame offers a last opportunity to intervene in the process before tablet compression. Feed frame monitoring methods based on near infrared (NIR) spectroscopy have been increasingly reported in recent years. New process analytical tools with the potential of being deployed alone or in combination with NIR spectroscopy for feed frame monitoring are now available commercially. The present study evaluated the potential of near infrared chemical imaging (NIR CI) for in-line monitoring of a prototype pharmaceutical composition containing ascorbic acid (AA), microcrystalline cellulose and dicalcium phosphate. NIR spectroscopy was the reference method. In-line calibration models based on partial least square regression were developed and validated with a range of AA concentrations. The ability of NIR spectroscopy and NIR CI to predict concentrations in test runs was ascertained both independently and in combination. NIR CI, with a single bandpass filter, predicted AA concentrations—present at commercially relevant concentrations—with acceptable accuracy. Comparative results showed that NIR CI has the potential for in-line monitoring of blend concentrations inside feed frames. In addition to the advantage of increased sample size, it also has the potential to detect segregation inside feed frames.

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“…Tablets are worldwide the most important solid drug dosage forms. Tablets are generally produced in rotary tablet presses, enabling continuous tablet production [1]. A key to successful continuous processing is the implementation of real-time release testing (RTRt) and real-time release (RTR).…”

Section: Introductionmentioning

confidence: 99%

“…A few studies were published in which the final blend circulating in the feed frame of the press was monitored by NIRS [1,3,13,14]. Monitoring blend potency in the feed frame enables the ability for feedback (e.g.…”

Section: Introductionmentioning

confidence: 99%

Development and validation of an in-line NIR spectroscopic method for continuous blend potency determination in the feed frame of a tablet press

Leersnyder

Peeters

Djalabi

et al. 2018

Journal of Pharmaceutical and Biomedical Analysis

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The UGent Institutional Repository is the electronic archiving and dissemination platform for all UGent research publications. Ghent University has implemented a mandate stipulating that all academic publications of UGent researchers should be deposited and archived in this repository. Except for items where current copyright restrictions apply, these papers are available in Open Access. This item is the archived peer-reviewed author-version of: Development and validation of an in-line NIR spectroscopic method for continuous blend potency determination in the feed frame of a tablet press

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Analysis of powder phenomena inside a Fette 3090 feed frame using in-line NIR spectroscopy

Cited by 67 publications

References 26 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

Concentration monitoring with near infrared chemical imaging in a tableting press

Development and validation of an in-line NIR spectroscopic method for continuous blend potency determination in the feed frame of a tablet press

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