China
Africa
Explore chapters and articles related to this topic
Scale-Up Considerations in Granulation
Published in Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, 2021
Yinghe He, Lian X. Liu, James Litster, Defne Kayrak-Talay
Particle growth in a fluidized bed is closely related to the particle mixing and flow pattern in the bed. This dictates that the hydrodynamics of the scaled bed should be the same as the small unit, that is, hydrodynamic similarity. Basic fluidized-bed hydrodynamics are described in chapter 10.
Optimization of the coating process of minitablets in two different lab-scale fluid bed systems
Published in Drug Development and Industrial Pharmacy, 2020
Maja Szczepanska, Piotr Paduszynski, Hanna Kotlowska, Malgorzata Sznitowska
Fluidized bed coating is a widely used technology in the pharmaceutical industry. The principle of operation is relatively simple: first, the solid particles are fluidized by hot airflow through the bed, and then a solution or dispersion of a coating polymer is atomized and sprayed onto the cores in the fluidized bed. The coating proceeds by successive wetting of the fluidized solids with sprayed liquid followed by solidification of the polymer film through drying. Quality of applied layers of polymer to the core surfaces, operational efficiency, and stability of the process depend on the understanding of the mechanism of fluid bed coating. However, various process parameters that can influence quality of the product cause difficulties in understanding these mechanisms [9]. The scale-up of coating processes has been a challenge ever since the coating process started being used by the pharmaceutical industry. Despite the fact that statistical analysis is directly related to the tested product and process conditions, it allows us to investigate the process thoroughly. Further, it creates the opportunity to anticipate certain problems while scaling up and offers the possibility to minimize those [10].
Empirical prediction model based process optimization for droplet size and spraying angle during pharmaceutical fluidized bed granulation
Published in Pharmaceutical Development and Technology, 2020
Jia Zeng, Liangshan Ming, Jiamiao Wang, Ting Huang, Binbin Liu, Linglin Feng, Man Xue, Jianxing Chen, Ruo-fei Du, Yi Feng
Fluidized bed technology has been used widely in many industrial processes, e.g. in pharmaceuticals, food, agriculture, and chemical engineering, because of its advantages of simple production process, high automation, high efficiency of mass and heat transfer, and stable product quality (Liu et al. 2017). Fluidized bed granulation technology is an integrated system with a variety of functions, such as mixing, granulation, and drying (Liu et al. 2018), and has become one of the most significant granulation processes. Process development, process control, and process simulation of a fluidized bed, or improvement and optimization of the equipment, have aroused widespread research interest both academia and industry.
Enhancing tablet disintegration characteristics of a highly water-soluble high-drug-loading formulation by granulation process
Published in Pharmaceutical Development and Technology, 2018
Preetanshu Pandey, Christopher Levins, Steve Pafiakis, Brian Zacour, Dilbir S. Bindra, Jade Trinh, David Buckley, Shruti Gour, Shasad Sharif, Howard Stamato
One alternative to HSWG is wet granulation in a fluidized bed. In these processes, the powder bed is maintained in a fluidized state by a flow of air injected upward through a distributor plate at the base of the granulator12,13. The powder bed appears as a boiling liquid-like material and exhibits liquid-like properties. These includes flow properties, dynamic mixing, nearly isothermal conditions due to rapid mixing, and a resistance to rapid temperature changes due to efficient heat exchange, which makes a large magnitude of heat transport possible14. These properties are advantageous for a granulation process because the individual particles are well mixed and the distribution of the liquid binder is nearly homogeneous, which leads to uniform wetting and nucleation. The optimization of these systems is more complicated and requires careful design of experiments and care during scale-up15,16, but the properties of fluidized beds allow for the manufacture of a narrow distribution of granule particle size, granules with increased porosity, and strict control of powder moisture content. When granules collide, they break perpendicular to their longest axis with the greatest probability, which increases the probability of granules with a low aspect ratio. However, granules manufactured in a fluidized bed are generally more irregularly shaped and have increased surface roughness compared to granules from a high shear process12. Wet granulation in a fluidized bed provides the significant advantage that both granulation and drying can be accomplished in a single unit operation, reducing the time the drug product is exposed to high moisture conditions, and also reducing the cycle time and overhead costs associated with routine manufacturing.