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Blend uniformity monitoring in a continuous manufacturing mixing process for a low-dosage formulation using a stream sampler and near infrared spectroscopy
Peer-reviewed journal | 19 Jul 2024 | Contributor(s):: Rodolfo Romanach, Raúl S. Rangel-Gil, Juan M. Nasrala-Álvarez, Rafael Méndez
Continuous manufacturing has the potential to offer several benefits for the production of oral solid dosage forms, including reduced costs, low-scale equipment, and the application of process analytical technology (PAT) for real-time process control. This study focuses on the implementation of...
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Sam Henson
https://cmkc.usp.org/members/1182
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Visualization and understanding of the granulation liquid mixing and distribution during continuous twin screw granulation using NIR chemical imaging
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Vercruysse, Jurgen, Toiviainen, Maunu, Fonteyne, Margot, Helkimo, Niko, Ketolainen, Jarkko, Juuti, Mikko, Delaet, Urbain, Van Assche, Ivo, Remon, Jean Paul, Vervaet, Chris, De Beer, Thomas
Over the last decade, there has been increased interest in the application of twin screw granulation as a continuous wet granulation technique for pharmaceutical drug formulations. However, the mixing of granulation liquid and powder material during the short residence time inside the screw...
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Use of near-infrared spectroscopy to quantify drug content on a continuous blending process: Influence of mass flow and rotation speed variations
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Martínez, Lizbeth, Peinado, Antonio, Liesum, Lorenz, Betz, Gabriele
The aim of this study was to develop a quantitative Near-Infrared (NIR) method which monitors the homogeneity of a pharmaceutical formulation coming out of a continuous blender. For this purpose, a NIR diode array spectrometer with fast data acquisition was selected. Additionally, the dynamic...
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Sampling optimization for blend monitoring of a low dose formulation in a tablet press feed frame using spatially resolved near-infrared spectroscopy
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Román-Ospino, Andrés, Baranwal, Yukteshwar, Li, Jingzhe, Vargas, Jenny, Igne, Benoît, Bate, Simon, Brouckaert, Davinia, Chauchard, Fabien, Hausner, Douglas, Ramachandran, Rohit, Singh, Ravendra, Muzzio, Fernando
In-line measurements of low dose blends in the feed frame of a tablet press were performed for API concentration levels as low as 0.10% w/w. The proposed methodology utilizes the advanced sampling capabilities of a Spatially Resolved Near-Infrared (SR-NIR) probe to develop Partial Least-Squares...
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Residence time distribution modelling and in line monitoring of drug concentration in a tablet press feed frame containing dead zones
Peer-reviewed journal | 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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Real time monitoring of powder blend bulk density for coupled feed-forward/feed-back control of a continuous direct compaction tablet manufacturing process
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Singh, Ravendra, Román-Ospino, Andrés D. Romañach, Rodolfo J. Ierapetritou, Marianthi, Ramachandran, Rohit
The pharmaceutical industry is strictly regulated, where precise and accurate control of the end product quality is necessary to ensure the effectiveness of the drug products. For such control, the process and raw materials variability ideally need to be fed-forward in real time into an automatic...
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Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: De Beer, Thomas, Burggraeve, Anneleen, Fonteyne, Margot, Saerens, Lien, Remon, Jean Paul, Vervaet, Chris;
Within the Process Analytical Technology (PAT) framework, it is of utmost importance to obtain critical process and formulation information during pharmaceutical processing. Process analyzers are the essential PAT tools for real-time process monitoring and control as they supply the data from...
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Investigation of the variability of NIR in-line monitoring of roller compaction process by using Fast Fourier Transform (FFT) analysis
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Feng, Tao, Wang, Feng, Pinal, Rodolfo, Wassgren, Carl, Carvajal, M. Teresa
The purpose of this Research Article was to investigate the variability of the roller compaction process while monitoring in-line with near-infrared (NIR) spectroscopy. In this paper, a pragmatic method in determining this variability of in-line NIR monitoring roller compaction process was...
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Integrating sensors for monitoring blend content in a pharmaceutical continuous manufacturing plant
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Panikar, Savitha, Li, Jingzhe, Rane, Varsha, Gillam, Sean, Callegari, Gerardo, Kurtyka, Bogdan, Lee, Sau, Muzzio, Fernando
In a pharmaceutical manufacturing process, Critical Quality Attributes (CQAs) need to be monitored not only for the final product but also for intermediates. Blend uniformity of powders is one such attribute that needs to be measured to ensure the quality of the final product. Multiple in-line...
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Implementation of an advanced hybrid MPC–PID control system using PAT tools into a direct compaction continuous pharmaceutical tablet manufacturing pilot plan
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Singh, Ravendra, Sahay, Abhishek, Karry, Krizia, Muzzio, Fernando, Ierapetritou, Marianthi, Ramachandran, Rohit
It is desirable for a pharmaceutical final dosage form to be manufactured through a quality by design (QbD)-based approach rather than a quality by testing (QbT) approach. An automatic feedback control system coupled with PAT tools that is part of the QbD paradigm shift, has the potential to...
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Implementation of control system into continuous pharmaceutical manufacturing pilot plant (powder to tablet)
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Singh, Ravendra
Real-time process control is highly desired for efficient quality by design (QbD)-based pharmaceutical manufacturing. A control system ensures the predefined end-product quality, satisfies the high regulatory constraints, facilitates real-time release of the product, and optimizes the resources....
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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
Peer-reviewed journal | 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
Peer-reviewed journal | 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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Characterization of NIR interfaces for the feeding and in-line monitoring of a continuous granulation process
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Román-Ospino, Andrés D, Tamrakar, Ashutosh Igne, Benoît Dimaso, Elyse Towns Airiau, Christian Clancy, Donald J Pereira, Glinka Muzzio, Fernando J Singh, Ravendra, Ramachandran, Rohit
This work describes the characterization of three NIR interfaces intended to monitor a continuous granulation process. Two interfaces (i.e. a barrel interface and a rotating paddle interface) were evaluated to monitor the API concentration at the entrance of the granulator, and a third interface...
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Assessment and prediction of tablet properties using transmission and backscattering Raman spectroscopy and transmission NIR spectroscopy
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Peeters, Elisabeth, Tavares da Silva, Ana Filipa, Toiviainen, Maunu, Van Renterghem, Jeroen, Vercruysse, Jurgen, Juuti, Mikko, Lopes, Joao Almeida, De Beer, Thomas., Vervaet, Chris, Remon, Jean-Paul
This study investigated whether Raman and Near Infrared (NIR) spectroscopy could predict tablet properties. Granules were produced on a continuous line by varying granulation parameters. Tableting process parameters were adjusted to obtain uniform tablet weight and thickness. Spectra were...
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Application of Near-Infrared Spectroscopy in Real-Time Monitoring of Product Attributes of Ribbed Roller Compacted Flakes
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Samanta, Asim Kumar, Karande, Atul D., Ng, Ka Yun, Heng, Paul Wan Sia
This study assessed the utility of near-infrared (NIR) spectroscopy for the real-time monitoring of content uniformity and critical quality attributes (tensile strength, Young's modulus, and relative density) of ribbed roller compacted flakes made by axially corrugated or ribbed rolls. A...
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A systematic framework to monitor mulling processes using Near Infrared spectroscopy
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Wu, Suyang, Panikar, Savitha S Singh, Ravendra Zhang, Jun Glasser, Benjamin, Ramachandran, Rohit
The optimal design of sensor location and setup is essential to ensure the accuracy and precision of in-line process monitoring of water/moisture content. This manuscript presents a systematic framework of using Near Infrared (NIR) spectroscopy to monitor moisture content in an alumina mulling...
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A Review of Process Analytical Technology (PAT) in the U.S. Pharmaceutical Industry
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Munson, James, Stanfield, C. Freeman, Gujral, Bir
Process Analytical Technologies (PAT) are used to provide timely analysis of critical quality parameters with the end goal of improving final product quality as well as reducing manufacturing costs, thereby significantly benefiting the Pharmaceutical Industry. PAT involves mostly on-line or...
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A hybrid model for multipoint real time potency observation in continuous direct compression manufacturing operations
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Gallo-Molina, Juan Pablo, Cogoni, Giuseppe, Peeters, Elisabeth, Rao Ambati, Seshagiri, Nopens, Ingmar
The ongoing transition from batch to continuous manufacturing offers both challenges and opportunities in the field of oral solid dosage form production. In turn, Process Analytical Technology (PAT) offers a path towards the successful deployment of continuous tablet manufacturing in rotary...
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A hybrid NIR-soft sensor method for real time in-process control during continuous direct compression manufacturing operations
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Cogoni, Giuseppe, Husain, Anas, Alam, Md Anik, Liu, Yang Angela, Kamyar, Reza
Near Infrared (NIR) spectroscopy is commonly utilized for continuous manufacturing as Process Analytical Technology (PAT) tool. This paper focus on a continuous direct compression manufacturing process, in which an NIR PAT probe is integrated into the tablet press feed frame and into the tablet...