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Solid Dosage Form Analysis by near Infrared Spectroscopy: Comparison of Reflectance and Transmittance Measurements Including the Determination of Effective Sample Mass
Contributor(s):: Iyer, M., Morris, H. R., Drennen, J. K.
Investigations into the near infrared analysis of intact tablets allow comparison of the reflectance and transmittance methodologies. The studies involved estimation of the effective sample mass and the effect of sample inhomogeneities. An empirical method for determining effective sample mass...
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Process Analytical Technology for continuous manufacturing of solid-dosage forms
Contributor(s):: Fonteyne, Margot;, Vercrusysse, Jurgen, De Leersnyder, Fien, Van Snick, Bernd, Vervaet, Chris, Remon, Jean, De Beer, Thomas
Currently, pharmaceutical production is making the switch from batch processing towards continuous processing. The quality of intermediate and end products produced by batch processes is assured by off-line testing. It is obvious that off-line tests in analytical laboratories cancel out the...
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Monitoring the concentration of flowing pharmaceutical powders in a tableting feed frame
Contributor(s):: Gosselin, Ryan, Durão, Pedro, Abatzoglou, Nicolas, Guay, Jean-Maxime
The use of process analytical technology (PAT) tools is increasing steadily in the pharmaceutical industry. Such tools are now located throughout the process. When producing tablets, the tableting step itself may be the ideal moment to assess final product composition. Being the last unit...
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Monitoring blend potency in a tablet press feed frame using near infrared spectroscopy
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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Benchtop NIR method development for continuous manufacturing scale to enable efficient PAT application for solid oral dosage form
Contributor(s):: Alam, MA, Liu, YADolph, S, Pawliczek, M, Peeters, E, Palm, A
A Near Infrared (NIR) method was developed using a small benchtop feed frame system to quantify Saccharin potency in a powder blend during continuous manufacturing process. A 15-point Design of Experiments (DoE) was created based on the NIR spectral response and compositions of the formulation to...
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Application of the quantitative detection of a change in concentration of magnesium stearate in a feeder tube of tableting manufacture by real-time near-infrared spectroscopy
Contributor(s):: Sasakura, D., Nakayama, K., Chikuma, T.
Process analytical technology is important for the analysis and control of manufacturing processes. Near-infrared spectroscopy is widely used in various process analytical technologies for the analysis of the chemical components of solid dosage forms. Lubrication is an important process carried...
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An agile and robust in-line NIR potency deviation detection method for monitoring and control of a continuous direct compression process
Contributor(s):: Alam, Md Anik, Liu, Yang Angela
Near Infrared (NIR) method for blend potency estimation has been commonly used as an essential tool for process monitoring and control in continuous manufacturing of solid oral dosage forms. Robustness has been the main challenge for successful application of an NIR method, which often results in...
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A NIR-Based Study of Desorption Kinetics during Continuous Spin Freeze-Drying
Contributor(s):: Leys, Laurens, Nuytten, Gust, Lammens, Joris, Van Bockstal, Pieter-Jan, Corver, Jos, Vervaet, Chris, De Beer, Thomas
The pharmaceutical industry is progressing toward the development of more continuous manufacturing techniques. At the same time, the industry is striving toward more process understanding and improved process control, which requires the implementation of process analytical technology tools (PAT)....