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Five key factors to consider when selecting a granulation system for tablet manufacturing
| Contributor(s):: Fi Forrest
Granulation is a vital process in pharmaceutical dosage forms, transforming powders into granules. Michael Schupp from Gerteis - specialists in dry granulation systems for the pharmaceutical industry - discusses what you should be looking for when choosing your granulation method.
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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...
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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...
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The effect of screw configuration and formulation variables on liquid requirements and granule quality in a continuous twin screw wet granulation process
| Contributor(s):: Vandevivere, L., Van Wijmeersch, E., Hausler, O., De Beer, T., Vervaet, C., Vanhoorne, V.
The effect of two screw configurations with varying stagger angle was evaluated on the liquid amount required to produce good quality granules for a highly (mannitol-based) and a poorly (DCP-based) soluble formulation containing different binders. It is generally known that the use of a higher...
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System for Continuous Wet Granulation based on a High-shear Mixer
| Contributor(s):: Chao, Chi, Steffens, Klaus-Juergen
A new system for continuous wet granulation and drying, based on a modified high-shear-mixer is investigated using met-formine, paracetamole and ibuprofene as active ingredients. First experiments reveal the excellent shape and particle size distribution of the granules. Tabletting investigations...
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Process optimization for continuous extrusion wet granulation
| Contributor(s):: Tan, L, Carella, AJ, Ren, YK, Lo, JB
Three granulating binders in high drug-load acetaminophen blends were evaluated using high shear granulation and extrusion granulation. A polymethacrylate binder enhanced tablet tensile strength with rapid disintegration in simulated gastric fluid, whereas polyvinylpyrrolidone and hydroxypropyl...
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Predicting Pharmaceutical Particle Size Distributions Using Kernel Mean Embedding
| Contributor(s):: Van Hauwermeiren, Daan, Stock, Michiel, De Beer, Thomas, Nopens, Ingmar
In the pharmaceutical industry, the transition to continuous manufacturing of solid dosage forms is adopted by more and more companies. For these continuous processes, high-quality process models are needed. In pharmaceutical wet granulation, a unit operation in the ConsiGmaTM-25 continuous...
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In-line monitoring of granule moisture in fluidized-bed dryers using microwave resonance technology
| Contributor(s):: Buschmueller, Caroline, Wiedey, Wolfgang, Doescher, Claas, Dressler, Jochen, Breitkreutz, Joerg
This is the first report on in-line moisture measurement of pharmaceutical products by microwave resonance technology. In order to meet the FDA's PAT approach, a microwave resonance sensor appropriate for pharmaceutical use was developed and implemented into two different fluidized-bed dryers....
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Influence of binder attributes on binder effectiveness in a continuous twin screw wet granulation process via wet and dry binder addition
| Contributor(s):: Vandevivere, L., Denduyver, P., Portier, C., Hausler, O., De Beer, T., Vervaet, C., Vanhoorne, V.
The effect of a wide variety of binders on the quality of granules produced via continuous twin screw wet granulation was studied. Anhydrous dicalcium phosphate was used as poorly soluble filler and was granulated applying dry or wet addition of binders. Furthermore, dry and wet binder...
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Identifying Critical Binder Attributes to Facilitate Binder Selection for Efficient Formulation Development in a Continuous Twin Screw Wet Granulation Process
| Contributor(s):: Vandevivere, Lise, Vangampelaere, Maxine, Portier, Christoph, de Backere, Cedrine, Hausler, Olaf, De Beer, Thomas, Vervaet, Chris, Vanhoorne, Valerie
The suitability of pharmaceutical binders for continuous twin-screw wet granulation was investigated as the pharmaceutical industry is undergoing a switch from batch to continuous manufacturing. Binder selection for twin-screw wet granulation should rely on a scientific approach to enable...
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Foam granulation: new developments in pharmaceutical solid oral dosage forms using twin screw extrusion machinery
| Contributor(s):: Thompson, M. R., Weatherley, S., Pukadyil, R. N., Sheskey, P. J.
This paper investigates foam granulation in a twin screw extruder as a new continuous wet granulation technique for pharmaceutical powder drug formulations. Foamed aqueous binder has a reportedly lower soak-to-spread ratio than drop or spray liquid addition in batch granulation. This work...
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Exergetic sustainability assessment of batch versus continuous wet granulation based pharmaceutical tablet manufacturing: a cohesive analysis at three different levels
| Contributor(s):: De;Soete, W, Dewulf, JCappuyns, P, Van, der, Vorst, G, Heirman, B, Aelterman, W, Schoeters, K, Van;Langenhove, H
Identifying better performing Active Pharmaceutical Ingredient (API) synthesis routes with reference to green chemistry and green engineering principles was of the highest importance in the pharmaceutical industry during the past decade. However, very little attention was paid to other life cycle...
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Dynamic flowsheet model development and sensitivity analysis of a continuous pharmaceutical tablet manufacturing process using the wet granulation route
| Contributor(s):: Metta, Nirupaplava, Ghijs, Michael Schäfer, Elisabeth Kumar, Ashish Cappuyns, Philippe Van Assche, Ivo Singh, Ravendra Ramachandran, Rohit De Beer, Thomas, Ierapetritou, Marianthi
In view of growing interest and investment in continuous manufacturing, the development and utilization of mathematical model(s) of the manufacturing line is of prime importance. These models are essential for understanding the complex interplay between process-wide critical process parameters...
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Effect of formulation and process variables on lipid based sustained release tablets via continuous twin screw granulation: A comparative study
| Contributor(s):: Kallakunta, Venkata Raman, Tiwari, Roshan, Sarabu, Sandeep, Bandari, Suresh, Repka, Michael A.
The current study's aim is to prepare lipid based sustained release tablets via a twin-screw granulation technique and compare those dosage forms with conventional techniques, namely wet granulation and direct compression. The granules were successfully manufactured in a single-step, continuous...
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Development and Optimization of a Wet Granulation Process at Elevated Temperature for a Poorly Compactible Drug Using Twin Screw Extruder for Continuous Manufacturing
| Contributor(s):: Meena, Anuprabha K, Desai, Divyakant, Serajuddin,, Abu T. M.
The objective of this study was to enhance tabletability of a poorly compactible drug, acetaminophen, by wet granulation using twin screw extruder at high temperature. It was desired that there would be minimum amounts of excipients used and the granules obtained after extrusion would be dry and...
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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...
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Continuous twin screw granulation: Impact of binder addition method and surfactants on granulation of a high-dosed, poorly soluble API
| Contributor(s):: Portier, Christoph, Vigh, Tamas, Di Pretoro, Giustino, De Beer, Thomas, Vervaet, Chris, Vanhoorne, Valerie
Despite the recent commercialization of several drug products manufactured through continuous manufacturing techniques, knowledge on the formulation aspect of these techniques, such as twin screw wet granulation, is still rather limited. Previous Research Article identified lactose/MCC/HPMC as a...
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Continuous twin screw granulation: Impact of microcrystalline cellulose batch-to-batch variability during granulation and drying - A QbD approach
| Contributor(s):: Portier, Christoph, Vigh, Tamas, Di Pretoro, Giustino, Leys, Jan, Klingeleers, Didier, De Beer, Thomas, Vervaet, Chris, Vanhoorne, Valerie
Despite significant advances in the Research Article domain of continuous twin screw granulation, limited information is currently available on the impact of raw material properties, especially considering batch-to-batch variability. The importance of raw material variability and subsequent...
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Continuous twin screw granulation: Influence of process and formulation variables on granule quality attributes of model formulations
| Contributor(s):: Portier, Christoph, Pandelaere, Kenny, Delaet, Urbain, Vigh, Tamas, Kumar, Ashish, Di Pretoro, Giustino, De Beer, Thomas, Vervaet, Chris, Vanhoorne, Valerie
In recent years, continuous manufacturing techniques, such as twin screw wet granulation, have gained significant momentum. Due to the large diversity of the (model) formulations and equipment, it is often difficult to generalize conclusions about the importance of process settings. As only...
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Continuous twin screw granulation: Robustness of lactose/MCC-based formulations
| Contributor(s):: Portier, Christoph, De Vriendt, Charlotte, Vigh, Tamas, Di Pretoro, Giustino, De Beer, Thomas, Vervaet, Chris, Vanhoorne, Valerie
In recent years, significant progress has been made in the field of continuous twin screw granulation. However, only limited knowledge is currently available on the impact of active pharmaceutical ingredient (API) properties on granule quality and processability. In this study, the response...
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Continuous twin screw granulation: A complex interplay between formulation properties, process settings and screw design
| Contributor(s):: Portier, Christoph, Pandelaere, KDelaet, U, Vigh, T, Di, Pretoro, G, De, Beer, T, Vervaet, C, Vanhoorne, V
Due to the numerous advantages over batch manufacturing, continuous manufacturing techniques such as twin screw wet granulation are rapidly gaining importance in pharmaceutical production. Since a large knowledge gap on the importance of formulation variables exists, this study systematically...
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Continuous Twin Screw Granulation: A Review of Recent Progress and Opportunities in Formulation and Equipment Design
| Contributor(s):: Portier, Christoph, Vervaet, Chris, Vanhoorne, Valérie
Continuous twin screw wet granulation is one of the key continuous manufacturing technologies that have gained significant interest in the pharmaceutical industry as well as in academia over the last ten years. Given its considerable advantages compared to wet granulation techniques operated in...
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Comparison of a continuous ring layer wet granulation process with batch high shear and fluidized bed granulation processes
| Contributor(s):: Jarvinen, MA, Paavola, M, Poutiainen, S, Itkonen, P, Pasanen, V, Uljas, K, Leiviska, K, Juuti, M, Ketolainen, J, Jarvinen, K
The traditional batch wet granulation processes encounter several challenges, such as problems in the scale-up step, batch-to-batch variability together with the multivariate and difficult to control nature of the process. A continuous wet granulation technique could be a possible solution for...
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Conceptual framework for model-based analysis of residence time distribution in twin-screw granulation
| Contributor(s):: Kumar, Ashish, Vercruysse, Jurgen, Vanhoorne, Valerie, Toiviainen, Maunu, Panouillot, Pierre-Emmanuel, Juuti, Mikko, Vervaet, Chris, Remon, Jean Paul, Gernaey, Krist V., De Beer, Thomas, Nopens, Ingmar
Twin-screw granulation is a promising continuous alternative for traditional batchwise wet granulation processes. The twin-screw granulator (TSG) screws consist of transport and kneading element modules. Therefore, the granulation to a large extent is governed by the residence time distribution...
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Artificial neural network modelling of continuous wet granulation using a twin-screw extruder
| Contributor(s):: Shirazian, Saeed, Kuhs, Manuel, Darwish, Shaza, Croker, Denise., Walker, Gavin M
Computational modelling of twin-screw granulation was conducted by using an artificial neural network (ANN) approach. Various ANN configurations were considered with changing hidden layers, nodes and activation functions to determine the optimum model for the prediction of the process. The neural...