-
A Perspective on Quality by Design: A Preclinical Opportunity
| Contributor(s):: Ajaz S. Hussain
-
Common CM Abbreviations - Input Needed
Forum › defaultsection › general
Hi all,
We are collecting commonly used abbreviations in PCM. This will serve as a useful reference for anyone reviewing PCM materials and studies. We’ve started a list but would like to...
https://cmkc.usp.org/forum/defaultsection/general/36
-
Using online mass spectrometry to predict the end point during drying of pharmaceutical products
| Contributor(s):: Dodda, Aditya G., Saranteas, Kostas, Henson, Michael A.
Drying of active pharmaceutical ingredients (APIs) is an energy-intensive process that is often a manufacturing bottleneck due to the relatively long processing times. A key objective is the ability to determine the drying end point, the time at which all solvent has been evaporated from the...
-
System-wide hybrid MPC–PID control of a continuous pharmaceutical tablet manufacturing process via direct compaction
| Contributor(s):: Singh, Ravendra, Ierapetritou, Marianthi, Ramachandran, Rohit
The next generation of QbD based pharmaceutical products will be manufactured through continuous processing. This will allow the integration of online/inline monitoring tools, coupled with an efficient advanced model-based feedback control systems, to achieve precise control of process variables,...
-
Real time monitoring of powder blend bulk density for coupled feed-forward/feed-back control of a continuous direct compaction tablet manufacturing process
| 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...
-
Monitoring ibuprofen–nicotinamide cocrystal formation during solvent free continuous cocrystallization (SFCC) using near infrared spectroscopy as a PAT tool
| Contributor(s):: Kelly, A.L., Gough, T., Dhumal, R.S., Halsey, S.A., Paradkar, A.
The purpose of this work was to explore NIR spectroscopy as a PAT tool to monitor the formation of ibuprofen and nicotinamide cocrystals during extrusion based solvent free continuous cocrystallization (SFCC). Drug and co-former were gravimetrically fed into a heated co-rotating twin screw...
-
Mechanistic modeling for systematic design and analysis of PAT systems
| Contributor(s):: Singh, Ravendra, Samad, Noor Asma Fazli Abdul Gernaey, Krist V Woodley, John M, Gani, Rafiqul
Not available
-
Mechanistic modelling of industrial-scale roller compactor ‘Freund TF-MINI model’
| Contributor(s):: Sajjia, Mustafa, Shirazian, Saeed Egan, David Iqbal, Javed, Albadarin, Ahmad, Southern, Mark, Walker, Gavin
A pharmaceutical roller compaction process was modelled using the Johanson powder mechanics model, which may be employed to achieve desired process performance. Mathematical modelling of the compaction of microcrystalline cellulose (PH102) was used to determine optimal process conditions for an...
-
Advances in Twin-Screw Granulation Processing
| Contributor(s):: Nandi, Uttom, Trivedi, Vivek, Ross, Steven A., Douroumis, Dennis
Twin-screw granulation (TSG) is a pharmaceutical process that has gained increased interest from the pharmaceutical industry for its potential for the development of oral dosage forms. The technology has evolved rapidly due to the flexibility of the equipment design, the selection of the process...
-
A Combined Feed-Forward/Feed-Back Control System for a QbD-Based Continuous Tablet Manufacturing Process
| Contributor(s):: Singh, Ravendra, Muzzio, Fernando J, Ierapetritou, Marianthi, Ramachandran, Rohit
Continuous pharmaceutical manufacturing together with PAT (Process Analytical Technology) provides a suitable platform for automatic control of the end product quality as desired by QbD (quality by design)-based efficient manufacturing. The precise control of the quality of the pharmaceutical...