Article
Pharmacology & Pharmacy
S. Van de Steene, J. Van Renterghem, V. Vanhoorne, C. Vervaet, A. Kumar, T. De Beer
Summary: The aim of this study is to increase the understanding of the granulation mechanism in twin-screw melt granulation by investigating the influence of different screw configurations on granule formation and temperature. It is found that the direction of the kneading zone and the set barrel temperature are the most influential factors on the granule temperature, and granule formation mainly occurs in the zones with more kneading action.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2023)
Article
Pharmacology & Pharmacy
S. Van de Steene, J. Van Renterghem, V. Vanhoorne, C. Vervaet, A. Kumar, T. De Beer
Summary: This study evaluates the influence of process parameters for TSMG, mainly focusing on the effect of screw configuration combined with screw speed, throughput, and barrel temperature, to elucidate the melt granulation mechanisms. The results indicate that the screw configuration is the most influential factor, and different mechanisms are observed for different configurations and formulations.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2023)
Article
Pharmacology & Pharmacy
S. Van de Steene, J. Van Renterghem, V. Vanhoorne, C. Vervaet, A. Kumar, T. De Beer
Summary: In the pharmaceutical industry, the use of innovative continuous manufacturing technologies such as twin-screw melt granulation (TSMG) is increasing for challenging formulations. This study provides a better understanding of the granule formation during the TSMG process. The influence of screw configuration, process parameters, and formulation on granule properties and residence time distribution was investigated. It was found that different zones in the TSMG process have different effects on granulation, leading to variations in granule size, strength, porosity, and residence time.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2023)
Review
Pharmacology & Pharmacy
Seth P. Forster, Erin Dippold, Tiffany Chiang
Summary: This article discusses the advantages of pharmaceutical continuous melt granulation by twin-screw extrusion, different process options and excipients, binder selection methods, and the mechanism of granulation and its impact on granule properties. It also reviews the pharmaceutical applications of melt granulation, ranging from immediate release of soluble and insoluble APIs, taste-masking, to sustained release formulations, showcasing the versatility of twin-screw melt granulation in pharmaceutical industry.
Review
Pharmacology & Pharmacy
Christoph Portier, Chris Vervaet, Valerie Vanhoorne
Summary: Continuous twin screw wet granulation is a key manufacturing technology in the pharmaceutical industry and academia, with significant advantages over batch wet granulation techniques. However, most studies have focused on a single formulation, limiting the general validity of the results obtained. This review provides an overview of recent progress and highlights the importance of formulation and raw material properties in the field.
Article
Pharmacology & Pharmacy
Seth P. Forster, David B. Lebo
Summary: The study aimed to produce taste-masked ibuprofen granules using twin-screw melt granulation. Ibuprofen release was inversely related to granule size.
Article
Pharmacology & Pharmacy
L. Vandevivere, E. Van Wijmeersch, O. Hausler, T. De Beer, C. Vervaet, V. Vanhoorne
Summary: This study evaluated the impact of two different screw configurations on the liquid amount required for producing high-quality granules. The stagger angle of the screw elements played a significant role in determining the granule quality and size. Additionally, the type and solubility of binders also affected the liquid requirements for granulation.
JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY
(2022)
Article
Engineering, Chemical
Miu Matsushita, Shuji Ohsaki, Sanae Nara, Hideya Nakamura, Satoru Watano
Summary: This study investigated the effects of fill level in a twin-screw granulator on the properties of granules and tablets through experimental and simulation studies. It was found that a higher fill level increased granule strength and tablet hardness. Simulation results showed that the compression force on particles strongly depended on the fill level. Additionally, combining experimental and simulation results quantitatively revealed that a higher fill level increased interparticle adhesion, resulting in higher tablet hardness.
ADVANCED POWDER TECHNOLOGY
(2022)
Article
Pharmacology & Pharmacy
Lise Vandevivere, Maxine Vangampelaere, Christoph Portier, Cedrine de Backere, Olaf Hausler, Thomas De Beer, Chris Vervaet, Valerie Vanhoorne
Summary: The selection of pharmaceutical binders for twin-screw wet granulation should be based on a scientific approach to enable efficient formulation development. Binder effectiveness in the wet granulation process is influenced by binder attributes, which vary depending on the solubility of the formulation. Identifying critical binder attributes is essential for rational and efficient binder selection in both well soluble and poorly soluble formulations.
Review
Pharmacology & Pharmacy
Tongzhou Liu, Nada Kittikunakorn, Yi Zhang, Feng Zhang
Summary: Twin screw melt granulation is a new alternative method for granulation that offers several advantages over traditional methods, such as producing granules with more consistent and uniform quality and the flexibility to use thermoplastic binders with high melt viscosity.
JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY
(2021)
Article
Engineering, Chemical
Dinesh Nyavanandi, Venkata Raman Kallakunta, Sandeep Sarabu, Arun Butreddy, Sagar Narala, Suresh Bandari, Michael A. Repka
Summary: This research successfully developed stable lipid-based sustained release matrices of quetiapine fumarate (QTF) and demonstrated that granules prepared by TSMG method exhibited improved flow properties and tabletability, while the blends of DC method resulted in dose dumping issue.
ADVANCED POWDER TECHNOLOGY
(2021)
Article
Engineering, Chemical
Nana Kobina Gyan Sekyi, Adrian Kelly, Nejat Rahmanian
Summary: An experimental study using a design of experiments approach was conducted to investigate twin screw granulation (TSG). The effects of processing parameters such as speed, temperature, and binder content on granule strength and structure were analyzed. Seeded granule structures were found in all but one type of granulator, and longer residence times resulted in maximum seeded structures in a batch Cyclomix granulator. TSG showed higher granule crushing strengths compared to other continuous equipment, and the optimum condition for forming stronger granules with lower variation was around 65.4 degrees C. Overall, an equipment-specific design of experiments approach proved useful in understanding the relationship between process parameters, structure, and properties.
Article
Pharmacology & Pharmacy
A. Ryckaert, D. Van Hauwermeiren, J. Dhondt, A. De Man, A. Funke, D. Djuric, C. Vervaet, I. Nopens, T. De Beer
Summary: This study developed a TPLS model to better understand the link between raw material properties, formulation composition, and process settings with granule quality attributes. The predictive ability of the model was used to find suitable combinations for new APIs, reducing experimental efforts and consumption of expensive new APIs.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2021)
Article
Pharmacology & Pharmacy
Ivana Cotabarren, Thamer A. Omar, Fernando J. Muzzio
Summary: The study demonstrates the successful use of twin-screw binder-free melt granulation (BFMG) to produce granules containing 100% API, and establishes the design space for the end-product using a design of experiments (DoE) response surface methodology. The effects of process variables on granule properties and tablet attributes were thoroughly studied, with barrel temperature identified as the most significant variable for both drugs.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2021)
Article
Pharmacology & Pharmacy
A. Ryckaert, F. Stauffer, A. Funke, D. Djuric, V. Vanhoorne, C. Vervaet, T. De Beer
Summary: The study found that there was a correlation between granule size and torque increase only after the first kneading zone in twin-screw wet granulation. At other locations, changes in torque were associated with either granule breakage or growth.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2021)
Article
Chemistry, Multidisciplinary
Binlong Chen, Wenbing Dai, Dong Mei, Tongzhou Liua, Suxin Li, Bo He, Bing He, Lan Yuan, Hua Zhang, Xueqing Wang, Qiang Zhang
JOURNAL OF CONTROLLED RELEASE
(2016)
Article
Medicine, Research & Experimental
Fan Meng, Tongzhou Liu, Elizabeth Schneider, Shehab Alzobaidi, Marco Gil, Feng Zhang
MOLECULAR PHARMACEUTICS
(2017)
Article
Chemistry, Multidisciplinary
Kamil Wlodarski, Feng Zhang, Tongzhou Liu, Wieslaw Sawicki, Thomas Kipping
PHARMACEUTICAL RESEARCH
(2018)
Article
Pharmacology & Pharmacy
Tongzhou Liu, Shubhajit Paul, Brian T. Beeson, Johnny Alexander, Fengyuan Yang, Vivian Bi, Thomas Durig, Changquan Calvin Sun, Feng Zhang
Review
Pharmacology & Pharmacy
Tongzhou Liu, Nada Kittikunakorn, Yi Zhang, Feng Zhang
Summary: Twin screw melt granulation is a new alternative method for granulation that offers several advantages over traditional methods, such as producing granules with more consistent and uniform quality and the flexibility to use thermoplastic binders with high melt viscosity.
JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY
(2021)
Review
Chemistry, Medicinal
Yi Zhang, Tongzhou Liu, Shahab Kashani-Rahimi, Feng Zhang
Summary: Recent research has shown that twin screw wet granulation(TSWG) is gaining interest as a potential substitution for traditional batch granulation processes due to its continuous nature. Studies have revealed the impact of screw profiles and process conditions on the mixing performance and granule attributes in TSWG.
DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY
(2021)
Article
Pharmacology & Pharmacy
Nada Kittikunakorn, Shubhajit Paul, John J. Koleng, Tongzhou Liu, Rachel Cook, Fengyuan Yang, Vivian Bi, Thomas Durig, Changquan Calvin Sun, Aditya Kumar, Feng Zhang
Summary: By comparing the Leistritz Nano-16 and Micro-18 extruders, it was found that the Nano-16 extruder, with thinner kneading blocks, required increased axial compaction and barrel heating to achieve granulation, whereas the Micro-18 extruder could achieve efficient dispersive mixing and granulation with thicker kneading blocks. Higher specific mechanical energy led to more granulation, with critical processing parameters differing between the two extruders. Tabletability and degradant content correlated positively with degree of fill for the Nano-16 and with specific mechanical energy for the Micro-18 extruder.
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
(2021)
Article
Pharmacology & Pharmacy
Tongzhou Liu, Navpreet Kaur, Beibei Chen, Brian Phillips, Shao-Yu Chang, Fengyuan Yang, Vivian Bi, Thomas Durig, Feng Zhang
Summary: In this study, the twin-screw melt granulation process was used to investigate its impact on the chemical stability and physicochemical changes of a drug. The results showed that the degradation of the drug mainly occurred in the kneading section and the section post-kneading. The degradation in the kneading section was strongly correlated with the specific mechanical energy, while the degradation in the section post-kneading was correlated with the granule temperature. This knowledge can be applied to develop processing strategies for maintaining drug stability during and post-processing.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2022)
Review
Pharmacology & Pharmacy
Wenbing Dai, Xiaoyou Wang, Ge Song, Tongzhou Liu, Bing He, Hua Zhang, Xueqing Wang, Qiang Zhang
ADVANCED DRUG DELIVERY REVIEWS
(2017)
Article
Pharmacology & Pharmacy
Greta Camilla Magnano, Marika Quadri, Elisabetta Palazzo, Roberta Lotti, Francesca Loschi, Stefano Dall'Acqua, Michela Abrami, Francesca Larese Filon, Alessandra Marconi, Dritan Hasa
Summary: This study aimed to investigate the loading of sildenafil citrate in three commercial transdermal vehicles using 3D full-thickness skin equivalent and compare the results with permeability experiments using porcine skin. The results showed that the results obtained using the 3D skin equivalent were comparable to those obtained using porcine skin, suggesting that the 3D skin model can be a valid alternative for ex-vivo skin absorption experiments.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2024)
Article
Pharmacology & Pharmacy
James W. Mckeage, Andrew Z. H. Tan, Andrew J. Taberner
Summary: Needle-free jet injection is a promising alternative drug delivery technique that offers rapid, non-invasive, and large-volume injections. The study presents a prototype multi-orifice nozzle and a computational fluid dynamic model to demonstrate the feasibility and effectiveness of this technology.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2024)
