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The Use of a Closed Feed Frame for the Development of Near-Infrared Spectroscopic Calibration Model to Determine Drug Concentration
23 Jul 2024 | Contributor(s):: Movilla-Meza, Nathaly A., Sierra-Vega, Nobel O., Alvarado-Hernández, Bárbara B., Méndez, Rafael, Romañach, Rodolfo J.
Purpose: This study evaluates the use of the closed feed frame as a material sparing approach to develop near-infrared (NIR) spectroscopic calibration models for monitoring blend uniformity. The effect of shear induced by recirculation on NIR spectra was also studied. Methods: Calibration models...
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Residence time distribution modelling and in line monitoring of drug concentration in a tablet press feed frame containing dead zones
09 Jun 2023 | Contributor(s):: Tanimura, Shinji, Singh, Ravendra Román-Ospino, Andrés D, Ierapetritou, Marianthi
The presence of a ‘significant dead zone’ in any continuous manufacturing equipment may affect the product quality and need to be investigated systematically. Dead zone will affect the residence time distribution (RTD) of continuous manufacturing and thus the mixing and product quality. Tablet...
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Monitoring blend potency in a tablet press feed frame using near infrared spectroscopy
09 Jun 2023 | Contributor(s):: Ward, Howard, Blackwood, Daniel, Polizzi, Mark, Clarke, Hugh
A near-infrared (NIR) probe was installed into the feed frame of a rotary tablet press to monitor API concentration as a function of time. A series of step change experimental trials were completed, where a placebo blend was initially charged into the feed frame, and an active blend was layered...
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In line monitoring of the powder flow behavior and drug content in a Fette 3090 feed frame at different operating conditions using Near Infrared spectroscopy
09 Jun 2023 | Contributor(s):: Sierra-Vega, Nobel, Sánchez-Paternina, Adriluz, Maldonado, Nadja, Cárdenas, Vanessa, Romañach, Rodolfo, Mendez, Rafael
Near infrared (NIR) spectroscopy was used to determine the drug concentration in 3% (w/w) acetaminophen blends within the complex flow regime of the tablet press feed frame just before tablet compaction. NIR spectra also provided valuable information on the powder flow behavior within the feed...
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Feed frame: The last processing step before the tablet compaction in pharmaceutical manufacturing
09 Jun 2023 | Contributor(s):: Sierra-Vega, Nobel, Romañach, Rodolfo J., Méndez, Rafael
The feed frame is a force-feeding device used in the die filling process. The die filling process is crucial within pharmaceutical manufacturing to guarantee the critical quality attributes of the tablets. In recent years, interest in this unit has increased because it can affect the properties...
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Evaluation of an in-line NIR spectroscopic method for the determination of the residence time in a tablet press
09 Jun 2023 | Contributor(s):: De Leersnyder, Fien, Vanhoorne, Valérie, Kumar, Ashish, Vervaet, Chris, De Beer, Thomas
In the current study, the ability to use in-line NIR inside the feed frame of a tablet press to monitor the residence time distribution inside the tablet press was investigated. Pulse-response experiments were performed. In-line measurements inside the feed frame were compared to measurements on...
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Development of near infrared spectroscopic calibration models for in-line determination of low drug concentration, bulk density, and relative specific void volume within a feed frame
09 Jun 2023 | Contributor(s):: Ortega-Zuñiga, Carlos, Pinzón-De la Rosa, Carlos, Román-Ospino, Andrés D., Serrano-Vargas, Alberto, Romañach, Rodolfo J., Mendez, Rafael
This study describes the development of a near infrared (NIR) calibration model for real time determination of drug concentration, powder density, and porosity or relative specific void volume (RSVV) of 3.00%w/w acetaminophen blends within a feed frame. The NIR calibration model was developed...
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Development of a tablet press feed frame lead lag determination model using in-line and off-line NIR measurements
09 Jun 2023 | Contributor(s):: Van;Hauwermeiren, D, Peeters, MPeeters, E, Cogoni, G, Yang, LA, De;Beer, T
For continuous pharmaceutical manufacturing of oral solid dosages, it is essential that product quality is measured inline. In this application, a continuous rotary tablet press is used. The goal is a model-based assessment of the quality of the blend in the feed frame to determine whether the...
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Development and validation of an in-line NIR spectroscopic method for continuous blend potency determination in the feed frame of a tablet press
09 Jun 2023 | Contributor(s):: De Leersnyder, Fien, Peeters, Elisabeth, Djalabi, Hasna, Vanhoorne, Valérie, Van Snick, Bernd, Hong, Ke, Hammond, Stephen, Liu, Angela, Ziemons, Eric, Vervaet, Chris, De Beer, Thomas
A calibration model for in-line API quantification based on near infrared (NIR) spectra collection during tableting in the tablet press feed frame was developed and validated. First, the measurement set-up was optimised and the effect of filling degree of the feed frame on the NIR spectra was...
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Detailed Analysis of the Online Near-Infrared Spectra of Pharmaceutical Blend in a Rotary Tablet Press Feed Frame
09 Jun 2023 | Contributor(s):: Šašić, Slobodan, Blackwood, Daniel, Liu, Angela, Ward, Howard W, Clarke, Hugh
The present study is an in-depth analysis of the online near-infrared (NIR) spectra acquired with a spectrometer mounted on the rotary tablet press feed frame. A 3.5% active pharmaceutical ingredient (API) formulation is analyzed. An attempt is made to determine the API univariately via the 2nd...
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Concentration monitoring with near infrared chemical imaging in a tableting press
09 Jun 2023 | Contributor(s):: Dalvi, Himmat, Fauteux-Lefebvre, Clémence, Guay, Jean-Maxime, Abatzoglou, Nicolas, Gosselin, Ryan
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...
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Assessment of blend uniformity in a continuous tablet manufacturing process
09 Jun 2023 | Contributor(s):: Sierra-Vega, Nobel, Román-Ospino, Andrés, Scicolone, James, Muzzio, Fernando, Romañach, Rodolfo, Mendez, Rafael
Blend uniformity was monitored throughout a continuous manufacturing (CM) process by near infrared (NIR) spectroscopic measurements of flowing blends and compared to the drug concentration in the tablets. The NIR spectra were obtained through the chute after the blender and within the feed frame,...
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Analysis of powder phenomena inside a Fette 3090 feed frame using in-line NIR spectroscopy
09 Jun 2023 | Contributor(s):: Mateo-Ortiz Daniel, Colon, Yleana, Romañach, Rodolfo, Mendez, Rafael
New analytical methods are needed to understand and optimize the processes by which tablets are produced. Fette 3090 tablet presses are commonly used in the pharmaceutical industry. A near-infrared (NIR) probe was installed into a Fette 3090 feed frame to understand and monitor the die filling...