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The Use of a Closed Feed Frame for the Development of Near-Infrared Spectroscopic Calibration Model to Determine Drug Concentration
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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Blend uniformity monitoring in a continuous manufacturing mixing process for a low-dosage formulation using a stream sampler and near infrared spectroscopy
| 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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Real-Time Quantification of Low-Dose Cohesive Formulations within a Sampling Interface for Flowing Powders
| Contributor(s):: Sierra-Vega, Nobel. O., Romañach, Rodolfo J., Mendez, Rafael
This study investigates the performance of a sampling interface for monitoring cohesive, flowing powder formulations with Hausner's Ratio and Carr's Index higher than 1.5 and 35%, respectively. The sampler device was operated in combination with near-infrared (NIR) spectroscopy to quantify...
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Process analytical technology for continuous manufacturing tableting processing: A case study
| Contributor(s):: Pauli, Victoria, Pellegatti, Laurent, Nguyen Trung, Nhat Quang, Elbaz, Frantz, Ensslin, Simon, Kleinebudde, Peter, Roggo, Yves, Krumme, Markus
The use of Near Infrared Spectroscopy (NIRS) as a fast and non-destructive technique was employed for the control and monitoring of the tableting step during a continuous manufacturing process. Two NIRS methods were optimized in order to in-line control the blend uniformity in the tablet feed...
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Near-infrared spectroscopic applications in pharmaceutical particle technology
| Contributor(s):: Razuc, M, Grafia, AGallo, L, Ramirez-Rigo, MV, Romanach, RJ
Near-infrared spectroscopy (NIRS) is nowadays an established analytical technique in the pharmaceutical industry. The aim of this review is to present the progress of NIRS in providing useful information for pharmaceutical particle technology. NIR methods are now developed to characterize a wide...
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Modeling and simulation of continuous powder blending applied to a continuous direct compression process
| Contributor(s):: Galbraith, Shaun C., Liu, Huolong, Cha, Bumjoon, Park, Seo-Young, Huang, Zhuangrong, Yoon, Seongkyu
Continuous manufacturing techniques are increasingly being adopted in the pharmaceutical industry and powder blending is a key operation for solid-dosage tablets. A modeling methodology involving axial and radial tanks-in-series flowsheet models is developed to describe the residence time...
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In-line monitoring of low drug concentration of flowing powders in a new sampler device
| Contributor(s):: Sierra-Vega, Nobel O, Méndez, Rafael, Martínez-Cartagena, Pedro; Alvarado-Hernández, Bárbara B; Romañach, Rodolfo J.
A novel sampler device for flowing powders was tested to quantify drug concentrations as low as 0.76% w/w in pharmaceutical powder blends. The sampler device was developed based on the powder flow behavior within a tablet press feed frame, following the principles laid down in the Theory of...
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Development of an in-line Raman spectroscopic method for continuous API quantification during twin-screw wet granulation
| Contributor(s):: Harting Julia, Kleinebudde, Peter
Raman spectroscopy was evaluated as a process analytical technology (PAT) tool for continuous API quantification during twin-screw wet granulation. Therefore, a Raman probe was implemented in front of the granulator barrel. This setup enabled the collection of Raman spectra upon a constant...
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Continuous quantitative monitoring of powder mixing dynamics by near-infrared spectroscopy
| Contributor(s):: Koller, DM, Posch, A, Horl, G, Voura, C, Radl, S, Urbanetz, N, Fraser, SD, Tritthart, W, Reiter, F, Schlingmann, M, Khinast, JG
FT-NIR spectroscopy with a fiber optical reflection probe was applied as a process analytical technology tool for the continuous quantitative in-line monitoring of pharmaceutical powder mixing processes in a bladed mixer. Two powders, acetyl salicylic acid as an active pharmaceutical ingredient...
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Blend Segregation in Tablets Manufacturing and Its Effect on Drug Content Uniformity-A Review
| Contributor(s):: Jakubowska, E, Ciepluch, N
Content uniformity (CU) of the active pharmaceutical ingredient is a critical quality attribute of tablets as a dosage form, ensuring reproducible drug potency. Failure to meet the accepted uniformity in the final product may be caused either by suboptimal mixing and insufficient initial blend...