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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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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...
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The Use of Near-Infrared and Microwave Resonance Sensing to Monitor a Continuous Roller Compaction Process
| Contributor(s):: Austin, John, Gupta, Anshu, Mcdonnell, Ryan, Reklaitis, Gintaras V., Harris, Michael T
Roller compaction is commonly used in the pharmaceutical and nutraceutical industries to increase and narrow the size distribution of a particulate material, making it easier to process. Both the moisture content of the material and the density of the roller compacted ribbon affect the uniformity...
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The effect of lubrication on density distributions of roller compacted ribbons
| Contributor(s):: Miguelez-Moran, A. M, Seville, J. P. K.
Roller compaction is a continuous dry granulation process for producing free flowing granules in order to increase the bulk density and uniformity of pharmaceutical formulations. It is a complicated process due to the diversity of powder blends and processing parameters involved. The properties...
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Spray granulation for drug formulation
| Contributor(s):: Loh, Zhi Hui, Er, Dawn Z. L., Chan, Lai Wah, Liew, Celine V., Heng, Paul W. S.
Introduction: Granulation is a key unit process in the production of pharmaceutical solid dosage forms and involves the agglomeration of fine particles with the aid of a binding agent. Fluidized bed granulation, a classic example of spray granulation, is a technique of particle agglomeration...
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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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Nondestructive measurements of the compact strength and the particle-size distribution after milling of roller compacted powders by near-infrared spectroscopy
| Contributor(s):: Gupta, A, Peck, GE, Miller, RW, Morris, KR
Compact strength and the particle-size distribution of milled roller compacted compacts were correlated to the slope of the best-fit line through near-infrared spectra for samples prepared under different roll speeds and feed rates. The above correlations were found to hold for compacts prepared...
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Material Properties and Compressibility Using Heckel and Kawakita Equation with Commonly Used Pharmaceutical Excipients
| Contributor(s):: Choi, Du-Hyung, Kim, Nam-Ah Chu, Kyung-Rok Jung, Youn-Jung, Yoon, Jeong-Hyun, Jeong, Seong-Hoon
This study investigated basic material properties and compressibility of commonly used pharmaceutical excipients. Five classes of excipients are selected including starch, lactose, calcium phosphate, microcrystalline cellulose (MCC), and povidone. The compressibility was evaluated using...
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Integrated continuous manufacturing in pharmaceutical industry: current eolutionary steps toward revolutionary future
| Contributor(s):: Nada A Helal, Ola Elnoweam, Heba Abdullah Eassa, Ahmed M Amer, Mohamed Ashraf Eltokhy, Mohamed A Helal, Heba A Fayyaz, Mohamed Ismail Nonou
Continuous manufacturing (CM) has the potential to provide pharmaceutical products with better quality, improved yield and with reduced cost and time. Moreover, ease of scale-up, small manufacturing footprint and on-line/in-line monitoring and control of the process are other merits for CM....
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Continuous Twin Screw Wet Granulation and Drying - Control Strategy for Drug Product Manufacturing
| Contributor(s):: Dahlgren, Gabriella, Tajarobi, Pirjo, Simone, Eric, Ricart, Brendon, Melnick, Jason, Puri, Vibha, Stanton, Courtney, Bajwa, Gurjit
The use of continuous manufacturing has been increasing within the pharmaceutical industry over the last few years. Continuous direct compression has been the focus of publications on the topic to date. The use of wet granulation can improve segregation resistance, uniformity, enhance density,...
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Continuous twin screw extrusion for the wet granulation of lactose
| Contributor(s):: Keleb, EI, Vermeire, A, Vervaet, C, Remon, JP
The Suitability of continuous twin screw extrusion for the wet granulation of a-lactose monohydrate was studied and compared with conventional high shear granulation. The influence of process parameters (screw speed and total input rate) and formulation variables (water and polyvinylpyrrolidone...
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Continuous twin screw granulation and fluid bed drying: A mechanistic scaling approach focusing optimal tablet properties
| Contributor(s):: Menth, Judith, Maus, Martin, Wagner, Karl G.
This study provides the results of investigation on scaling approaches for three differently-sized continuous granulation lines, each consisting of a twin screw wet granulation process and a continuous fluid bed drying process. To check the initial scaling approach with regard to granule and...
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Continuous manufacturing: the future in pharmaceutical solid dosage form manufacturing
| Contributor(s):: Desai, Parind Mahendrakumar, Van Vaerenbergh, Griet, Holman, Jim, Liew, Celine Valeria, Heng, Paul Wan Sia
As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and...
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Continuous powder feeding for pharmaceutical solid dosage form manufacture: a short review
| Contributor(s):: Blackshields, Caroline A., Crean, Abina M.
Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products
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Closed-loop feedback control of a continuous pharmaceutical tablet manufacturing process via wet granulation
| Contributor(s):: Singh, Ravendra, Barrasso, Dana Chaudhury, Anwesha Sen, Maitraye Ierapetritou, Marianthi Ramachandran, Rohit
The wet granulation route of tablet manufacturing in a pharmaceutical manufacturing process is very common due to its numerous processing advantages such as enhanced powder flow and decreased segregation. However, this route is still operated in batch mode with little (if any) usage of an...
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Characterization of Amorphous Solid Dispersion of Pharmaceutical Compound with pH-Dependent Solubility Prepared by Continuous-Spray Granulator
| Contributor(s):: Tanaka, R, Hattori, YHorie, Y, Kamada, H, Nagato, T, Otsuka, M
A continuous-spray granulator (CTS-SGR) is a one-step granulation technology capable of using solutions or suspensions. The present Research Article objectives were, (1) to reduce the manufacturing operations for solid dosage formulations, (2) to make amorphous solid dispersion (ASD) granules...
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Assessment and prediction of tablet properties using transmission and backscattering Raman spectroscopy and transmission NIR spectroscopy
| Contributor(s):: Peeters, Elisabeth, Tavares da Silva, Ana Filipa, Toiviainen, Maunu, Van Renterghem, Jeroen, Vercruysse, Jurgen, Juuti, Mikko, Lopes, Joao Almeida, De Beer, Thomas., Vervaet, Chris, Remon, Jean-Paul
This study investigated whether Raman and Near Infrared (NIR) spectroscopy could predict tablet properties. Granules were produced on a continuous line by varying granulation parameters. Tableting process parameters were adjusted to obtain uniform tablet weight and thickness. Spectra were...
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Artificial Intelligence Tools for Scaling Up of High Shear Wet Granulation Process
| Contributor(s):: Landin, Mariana
The results presented in this article demonstrate the potential of artificial intelligence tools for predicting the endpoint of the granulation process in high-speed mixer granulators of different scales from 25L to 600L. The combination of neurofuzzy logic and gene expression programing...
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A systematic framework to monitor mulling processes using Near Infrared spectroscopy
| Contributor(s):: Wu, Suyang, Panikar, Savitha S Singh, Ravendra Zhang, Jun Glasser, Benjamin, Ramachandran, Rohit
The optimal design of sensor location and setup is essential to ensure the accuracy and precision of in-line process monitoring of water/moisture content. This manuscript presents a systematic framework of using Near Infrared (NIR) spectroscopy to monitor moisture content in an alumina mulling...