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The development and validation of a quality by design based process analytical tool for the inline quantification of Ramipril during hot-melt extrusion
Contributor(s):: Dadou, Suha, Senta-Loys, Zoe, Almajaan, Ammar, Li, Shu, Jones, David, Healy, Anne, Tian, Yiwei, Andrews, Gavin
Continuous processing is superseding conventional batch processing as a means of manufacturing within the pharmaceutical Research Article/industry. This paradigm shift has led to the implementation of Process Analytical Technology (PAT) as a semi-automatic, predictive tool offering real-time...
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Study of near Infrared Chemometric Models with Low Heterogeneity Films: The Role of Optical Sampling and Spectral Preprocessing on Partial Least Squares Errors
Contributor(s):: Ortega-Zuñiga, Carlos, Reyes-Maldonado, Kerimar, Méndez, Rafael, Romañach, Rodolfo J.
This study is focused on understanding absorption and scattering effects and their impact on the errors observed in near infrared calibration models developed using partial least squares regression able to predict the number of polypropylene film layers stacked together. The films provided a...
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Quality-by-Design III: Application of Near-Infrared Spectroscopy to Monitor Roller Compaction In-process and Product Quality Attributes of Immediate Release Tablets
Contributor(s):: Kona, Ravikanth, Fahmy, Raafat M., Claycamp, Gregg, Polli, James E., Martinez, Marilyn, Hoag, Stephen W.
The objective of this study is to use near-infrared spectroscopy (NIRS) coupled with multivariate chemometric models to monitor granule and tablet quality attributes in the formulation development and manufacturing of ciprofloxacin hydrochloride (CIP) immediate release tablets. Critical roller...
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Pharmaceutical manufacturing and the quality by design (QBD), process analytical technology (PAT) approach
Contributor(s):: Murphy, Trevor, O’ Mahony, Niall, Panduru, Krishna, Riordan, Daniel, Walsh, Joseph
This paper is the result of a literature review focusing on the application of process analytical technology (PAT) for the pharmaceutical industry in conjunction with the quality by design (QBD) framework. PAT and the QBD framework put forward by the FDA, offer a holistic approach to...
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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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Monitoring of the combined cooling and antisolvent crystallisation of mixtures of aminobenzoic acid isomers using ATR-UV/vis spectroscopy and FBRM
Contributor(s):: Saleemi, AN, Rielly, CD, Nagy, ZK
During the manufacturing of active pharmaceutical ingredients crystalline products in the purest forms are required. Quite often multiple components are present during crystallisation, which requires their continuous monitoring and finally separation. The current work demonstrates the application...
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Evaluation of Analytical and Sampling Errors in the Prediction of the Active Pharmaceutical Ingredient Concentration in Blends From a Continuous Manufacturing Process
Contributor(s):: Vargas, Jenny, Roman-Ospino, Andres, Sanchez, Eric, Romañach, Rodolfo
Purpos: A near-infrared (NIR) spectroscopic method was developed for real time analysis of the active pharmaceutical ingredient (API) in blends from a continuous manufacturing process. The sampling and analytical errors of these determinations were estimated through variographic analysis....
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Characterization of NIR interfaces for the feeding and in-line monitoring of a continuous granulation process
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 of Robustness for a Near-Infrared Concentration Model for Real-Time Release Testing in a Continuous Manufacturing Process
Contributor(s):: Colon, Yleana, Vargas, Jenny, Sánchez, Eric, Navarro, Gilfredo, Romañach, Rodolfo
This study describes the robustness test of a transmission near-infrared spectroscopic (NIRS) model for prediction of drug concentration in core tablets as part of real-time release testing (RTRt) efforts for a continuous manufacturing process. Seven calibration blend samples were prepared...
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Analytical Method Quality by Design for an On-Line Near-Infrared Method to Monitor Blend Potency and Uniformity
Contributor(s):: Corredor, Claudia, Bu, Xin, McCann, Ryan, Dougherty, Jeffrey, Stevens, Tim, Both, Douglas, Shah, Pankaj
In this work, an example of analytical method quality by design (AQbD) principles applied to an in-line NIR method to monitor blend potency and uniformity in the manufacturing of an oral solid dosage product is presented. An integrated process analytical technology (PAT) method was developed...