-
Apr 16 2024
Continuous Manufacturing of Oral Solid Dosage Forms
"Continuous manufacturing holds the promise of improved efficiency, enhanced quality, greater operational flexibility and accelerated development. At Hovione we are proud to be at the...
https://cmkc.usp.org/events/details/48
-
Influence of refilling on dosing accuracy of loss-in-weight powder feeders in continuous manufacturing
| Contributor(s):: Jochen Thies, Peter Kleinebudde, Fabiola N. Santamaría Alvarez
Continuous manufacturing is a novel concept to produce high quality drug products. The manufacture of solid dosage forms starts with the feeding of materials, which is consider a critical step because it could have a high influence on the quality of the final product. Therefore, this unit...
-
MOOC I Blending - Flow and Mixing Regime
| Contributor(s):: RCPE
-
MOOC I Feeding - Refill Strategy
| Contributor(s):: RCPE
-
MOOC I Blending Basics
| Contributor(s):: RCPE
-
MOOC I Continuous Blender Types
| Contributor(s):: RCPE
-
MOOC I Feeding - Twin Screw Feeder
| Contributor(s):: RCPE
-
MOOC I Feeding - Disturbances
| Contributor(s):: RCPE
-
MOOC I Continuous Blend Analysis
| Contributor(s):: RCPE
-
Allan Clarke
Lead a project called Liquid Dispensing Technologies (LDT) in mid-2000's leading to a commercial-scale High-Potency-API continuous oral tablet manufacturing process. See chapter about...
https://cmkc.usp.org/members/1675
-
Pharmaceutical Continuous Manufacturing: A Guide to Control Strategies for Solid Oral Dose Drugs
| Contributor(s):: Atul Dubey
Advanced manufacturing technologies like pharmaceutical continuous manufacturing (PCM) can provide potential efficiencies for many medicines and their ingredients, thereby facilitating geographic diversity in manufacturing and supply chain resilience. One of the ways the U.S. Pharmacopeia (USP)...
-
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
-
Variographic analysis: A new methodology for quality assurance of pharmaceutical blending processes
| Contributor(s):: Sánchez-Paternina, Adriluz, Sierra-Vega, Nobel O., Cárdenas, Vanessa, Méndez, Rafael, Esbensen, Kim H., Romañach, Rodolfo J.
Analytical methods for real time monitoring of pharmaceutical blending processes are thoroughly validated but not the sampling methods. Variographic analysis was investigated as a method to determine the sampling and analytical errors when the drug concentration of pharmaceutical powder blends is...
-
Visualization and understanding of the granulation liquid mixing and distribution during continuous twin screw granulation using NIR chemical imaging
| Contributor(s):: Vercruysse, Jurgen, Toiviainen, Maunu, Fonteyne, Margot, Helkimo, Niko, Ketolainen, Jarkko, Juuti, Mikko, Delaet, Urbain, Van Assche, Ivo, Remon, Jean Paul, Vervaet, Chris, De Beer, Thomas
Over the last decade, there has been increased interest in the application of twin screw granulation as a continuous wet granulation technique for pharmaceutical drug formulations. However, the mixing of granulation liquid and powder material during the short residence time inside the screw...
-
Wet Granulation in a Twin-Screw Extruder: Implications of Screw Design
| Contributor(s):: Thompson, M. R., Sun, J.
Wet granulation in twin-screw extrusion machinery is an attractive technology for the continuous processing of pharmaceuticals. The performance of this machinery is integrally tied to its screw design yet little fundamental knowledge exists in this emerging field for granulation to intelligently...
-
WHAT are sampling errors-and WHAT can we do about them? Part 1
| Contributor(s):: Romañach, Rodolfo J., Joubert Castro, Aidalu, Esbensen, Kim H
The objective of this column is to provide easy-to-understand examples of sampling errors. Prompted by recent participationsand presentations at on-line conferences and meetings, we believe there is a need for a more fulfilling introduction andexemplification of the concept and real-world...
-
Use of a continuous twin screw granulation and drying system during formulation development and process optimization
| Contributor(s):: Vercruysse, J., Peeters, E., Fonteyne, M., Cappuyns, P., Delaet, U., Van Assche, I., De Beer, T., Remon, J. P., Vervaet, C.
Since small scale is key for successful introduction of continuous techniques in the pharmaceutical industry to allow its use during formulation development and process optimization, it is essential to determine whether the product quality is similar when small quantities of materials are...
-
Use of near-infrared spectroscopy to quantify drug content on a continuous blending process: Influence of mass flow and rotation speed variations
| Contributor(s):: Martínez, Lizbeth, Peinado, Antonio, Liesum, Lorenz, Betz, Gabriele
The aim of this study was to develop a quantitative Near-Infrared (NIR) method which monitors the homogeneity of a pharmaceutical formulation coming out of a continuous blender. For this purpose, a NIR diode array spectrometer with fast data acquisition was selected. Additionally, the dynamic...
-
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...
-
Using Residence Time Distributions (RTDs) to Address the Traceability of Raw Materials in Continuous Pharmaceutical Manufacturing
| Contributor(s):: Engisch, William, Muzzio, Fernando
Continuous processing in pharmaceutical manufacturing is a relatively new approach that has generated significant attention. While it has been used for decades in other industries, showing significant advantages, the pharmaceutical industry has been slow in its adoption of continuous processing,...
-
Validation of a continuous granulation process using a twin-screw extruder
| Contributor(s):: Van Melkebeke, B., Vervaet, C., Remon, J. P.
Using twin-screw granulation as particle size enlargement technique, the effect of modifying the screw configuration (number of mixing zones, configuration of kneading block) on granule quality, tablet properties and mixing efficiency was investigated. The amount of oversized agglomerates and...
-
TPLS as predictive platform for twin-screw wet granulation process and formulation development
| Contributor(s):: Ryckaert, A., Van Hauwermeiren, D., Dhondt, J., De Man, A., Funke, A., Djuric, D., Vervaet, C., Nopens, I., De Beer, T.
In recent years, the interest in continuous manufacturing techniques, such as twin-screw wet granulation, has increased. However, the understanding of the influence of the combination of raw material properties and process settings upon the granule quality attributes is still limited. In this...
-
Transfer from High-Shear Batch to Continuous Twin Screw Wet Granulation: A Case Study in Understanding the Relationship Between Process Parameters and Product Quality Attributes
| Contributor(s):: Beer, Paul, Wilson, David, Huang, Zhenyu, De Matas, Marcel
A twin screw to high-shear batch granulation technology switch was evaluated for a pharmaceutical development project. Differences in granule (particle size distribution and porosity) and tablet (dissolution) quality attributes were analysed for both continuous and batch technologies. Liquid to...
-
Twin Screw Continuous Wet Granulation
| Contributor(s):: Shah, Ankita V., Serajuddin, Abu T. M.
Granulation has become an integral part of the formulation of tablets. Wet granulation and roller compaction, which were developed over 50 years ago in the 1950s and 1960s, are still the most commonly used granulation methods in the pharmaceutical industry. However, these are batch processes and...
-
Twin screw granulation - review of current progress
| Contributor(s):: Thompson, M. R.
Twin screw granulation (TSG) is a new process of interest to the pharmaceutical community that can continuously wet granulate powders, doing so at lower liquid concentrations and with better product consistency than found by a high shear batch mixer. A considerable body of Research Article has...