-
Use of the channel fill level in defining a design space for twin screw wet granulation
Contributor(s):: Gorringe, L. J., Kee, G. S., Saleh, M. F., Fa, N. H., Elkes, R. G.
Twin screw wet granulation is a key process in the continuous manufacture of oral solid dosage forms. Previous Research Article has qualitatively suggested that the channel fill level influences the granules produced. In this paper a quantitative measure of the total volumetric fraction of the...
-
The impact of channel fill level on internal forces during continuous twin screw wet granulation
Contributor(s):: Torrecillas, Carlota Mendez, Gorringe, Lee J., Rajoub, Nazer, Robertson, John, Elkes, Richard G., Lamprou, Dimitrios A., Halbert, Gavin W
The forces experienced by the particles inside a twin screw granulator (TSG) are one of the most difficult parameters to measure quantitatively. However, it is possible to perform accurately this measurement through the use of dye containing calibrated microencapsulated sensors (LAMES) whose...
-
Tablet Quality-Prediction Model Using Quality Material Attributes: Toward Flexible Switching Between Batch and Continuous Granulation
Contributor(s):: Arai, H, Nagato, TKoide, T, Yonemochi, E, Yamamoto, H, Sugiyama, H
Purpose The purpose of the study was to develop a model to predict the critical quality attribute (CQA) of tablets during continuous and batch manufacturing using only critical material attributes (CMAs). Methods Experiments were performed using ethenzamide as the active pharmaceutical ingredient...
-
Switching from batch to continuous granulation: A case study of metoprolol succinate ER tablets
Contributor(s):: Kotamarthy, Lalith, Feng, Xin, Alayoubi, Alaadin, Bolla, Pradeep Kumar, Ramachandran, Rohit, Ashraf, Muhammad, O'Connor, Thomas, Zidan, Ahmed
Continuous manufacturing (CM) has been used to produce several immediate release drug products. No extended-release (ER) product manufactured employing CM technology has been approved yet. This study investigated the critical aspects of switching from the batch mode of high shear granulation to...
-
Part 3: Enhanced Approaches to the Development of the Control Strategy and its Implementation in the Manufacturing Process Description
Contributor(s):: Popkin, ME, Omer, BASeibert, KD, Luciani, CV, Srivastava, S, Hobson, L, Lepore, JV
A series of case histories from IQ consortium member companies will be presented to exemplify how the application of the ICH Q11 vision for enhanced Quality by Design (QbD) development of the active pharmaceutical ingredient (API) can lead to differentiated outcomes for elements such as the API...
-
Optimization of critical quality attributes in continuous twin-screw wet granulation via design space validated with pilot scale experimental data
Contributor(s):: Liu, Huolong, Galbraith, S. C., Ricart, Brendon, Stanton, Courtney, Smith-Goettler, Brandye, Verdi, Luke, O'Connor, Thomas, Lee, Sau, Yoon, Seongkyu
In this study, the influence of key process variables (screw speed, throughput and liquid to solid (L/S) ratio) of a continuous twin screw wet granulation (TSWG) was investigated using a central composite face-centered (CCF) experimental design method. Regression models were developed to predict...
-
Modeling the effects of material properties on tablet compaction: A building block for controlling both batch and continuous pharmaceutical manufacturing processes
Contributor(s):: Escotet-Espinoza, M Sebastian, Vadodaria, Shishir Singh, Ravendra Muzzio, Fernando J, Ierapetritou, Marianthi G
As the pharmaceutical industry modernizes its manufacturing practices and incorporates more efficient processing approaches, it is important to reevaluate which process design elements affect product quality and the means to study these systems. The purpose of this work is to provide insight on a...
-
Latent Variables-Based Process Modeling of a Continuous Hydrogenation Reaction in API Synthesis of Small Molecules
Contributor(s):: Shi, Zhenqi, Zaborenko, Nikolay, Reed, David
Continuous manufacturing can be benefited by the use of the Quality by Design (QbD) strategy for robust process development and by the use of Process Analytical Technology (PAT) for real-time process monitoring and control. A successful implementation of QbD and PAT for continuous processes...
-
Lubricant based determination of design space for continuously manufactured high dose paracetamol tablets
Contributor(s):: Taipale-Kovalainen, Krista, Karttunen, Anssi-Pekka, Ketolainen, Jarkko, Korhonen, Ossi
The objective of this study was to devise robust and stable continuous manufacturing process settings, by exploring the design space after an investigation of the lubrication-based parameters influencing the continuous direct compression tableting of high dose paracetamol tablets. Experimental...
-
Effects of process parameters on tablet critical quality attributes in continuous direct compression: a case study of integrating data-driven statistical models and mechanistic compaction models
Contributor(s):: Huang, Zhuangrong, Galbraith, Shaun C., Cha, Bumjoon, Liu, Huolong, Park, Seoyoung, Flamm, Matthew H., Metzger, Matt, Tantuccio, Anthony, Yoon, Seongkyu
Continuous manufacturing of oral-dosage drug products is increasing the need for rigorous process understanding both from a process design and control perspective. The purpose of this study is to develop a methodology that analyzes the effects of upstream process parameters on continuous tablet...
-
Control strategy definition for a drug product continuous wet granulation process: Industrial case study
Contributor(s):: Chavez, Pierre-François, Stauffer, Fanny, Eeckman, Frédéric, Bostijn, Nils, Didion, David, Schaefer, Cédric, Yang, Hong, El Aalamat, Yousef, Lories, Xavier, Warman, Martin, Mathieu, Benoit, Mantanus, Jérôme
This paper describes the specific control strategy of the commercial manufacturing process of an immediate release tablet formulation based on continuous twin-screw wet granulation. This control strategy has been defined by a multidisciplinary team using an enhanced approach, in alignment with...