Evaluating Scale-Up Rules of a High-Shear Wet Granulation Process

Tao, Jing; Pandey, Preetanshu; Bindra, Dilbir S.; Gao, Julia; Narang, Ajit S.

doi:10.1002/jps.24504

Cited by 24 publications

(6 citation statements)

References 22 publications

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“…This relative swept volume is a measure of the energy input efficiency of the impeller blade on the powder and related to densification work of the wet mass. Despite these granulator design differences, we have achieved comparable granule attributes by using a scaling index of 0.8, which is consistent with previously reported successful outcomes 15,24,25 .…”

Section: Comparison Of Granules From Diosna and Fielder Granulatorssupporting

confidence: 89%

An Integrated Approach for High-Shear Wet Granulation (HSWG) Processing of TPGS-Based Formulations: Demonstration of Process Robustness through Experimental Design Conditions

Sotthivirat

Ren

Wasylaschuk

et al. 2021

Journal of Pharmaceutical Sciences

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The goal of this study was to understand the impact of high-shear wet granulation (HSWG) processing conditions on product attributes for a tablet formulation containing the non-ionic surfactant TPGS. The use of TPGS in oral solid drug products has been reported to be challenging due to the low melting temperature of TPGS. In addition, literature on TPGS-based HSWG formulations, especially practical processing and scale-up knowledge, is limited. Presented here is an extension of this TPGS application in a tablet formulation, with a focus on the HSWG processing and scale-up across different granulators. To understand the processing space for this TPGS-based HSWG formulation, two consecutive studies were conducted with different objectives. First, an exploratory study was conducted to understand the impact of extreme processing conditions on product attributes. Subsequently, a factorial design of experiment (DoE) study assessed the separate contributions and interactions from HSWG processing variables. The outcome of both studies led to a successful process scale-up and product transfer from lab to commercial development using different granulators. The TPGS-based formulation was demonstrated to provide robust downstream processing (improved flowability and reduced segregation potential) within a wide HSWG operating space, while having a minimal impact on product performance across different granulators.

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Section: Comparison Of Granules From Diosna and Fielder Granulatorssupporting

confidence: 89%

An Integrated Approach for High-Shear Wet Granulation (HSWG) Processing of TPGS-Based Formulations: Demonstration of Process Robustness through Experimental Design Conditions

Sotthivirat

Ren

Wasylaschuk

et al. 2021

Journal of Pharmaceutical Sciences

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“…Only minor variations were observed between RC runs, and thus it can be concluded that feed rate and the intra-granular lubricant concentration did not exert any effect on the dissolution profile of tablets from the RC runs. Granule porosity has been found to correlate with the final blend compaction and tablet dissolution (Tao J, et al, 2015), which could explain the results. Furthermore, it can be concluded that the dissolved amount fulfilled the similarity requirements (EMA, 2010) in all runs.…”

Section: Dissolution Profilementioning

confidence: 76%

Converting a batch based high-shear granulation process to a continuous dry granulation process; a demonstration with ketoprofen tablets

Taipale-Kovalainen

Ketolainen

Korhonen

et al. 2020

European Journal of Pharmaceutical Sciences

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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“…These approaches can be grouped in three categories depending on the process parameter or rate process chosen as a mean to scale up: Based on Impeller power: Scale up using the impeller power as the granulation end point measurement, either determined through impeller workload inflection 7,8 or calculated from power number correlation 9 Based on Impeller speed: Scaling the impeller speed based on constant Froude number or constant tip speed or constant shear stress 10,11 Regime map approaches: Scale up using granule nucleation rate 12 or granule growth rate 13 …”

Section: Scale Up Approaches Based On Dimensionless Numbersmentioning

confidence: 99%

“…Hassanpour et al 15 was unsuccessful in using constant Froude number in scaling a granulation process between 1 and 50 L since the granule strengths across the scales were not comparable. On the other hand, Tao et al 10 produced granules with comparable compaction and dissolution behavior across different scales using a constant Froude number approach. Existence of such discrepancies in literature suggest that most of these rules are not universally applicable and no such structured guidance exist on how to choose a suitable one.…”

Section: Scale Up Approaches Based On Dimensionless Numbersmentioning

confidence: 99%

Development and implementation of a hybrid scale up model for a batch high shear wet granulation operation

Sen

García‐Muñoz

2021

AIChE Journal

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The high shear wet granulation (HSWG) operation consists of several rate processes influenced by the raw material properties, process operational parameters, and equipment design. Their combined effect determines the granule attributes. In literature, these rate processes have been modeled using different dimensionless numbers and their correlations. Each of these dimensionless numbers represent only certain rate processes. Since many of these rate processes occur at the same time, it is necessary to simultaneously model them to account for all the important degrees of freedom. Most of the HSWG scale up approaches in literature calculate scale up conditions based on a single rate process or operating parameter of interest that can lead to sub‐optimal process design. We present the development of a hybrid HSWG scale up model accounting simultaneously for all the rate processes. The approach was successfully implemented to scale up the HSWG operation across laboratory, pilot, and commercial scales.

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Evaluating Scale-Up Rules of a High-Shear Wet Granulation Process

Cited by 24 publications

References 22 publications

An Integrated Approach for High-Shear Wet Granulation (HSWG) Processing of TPGS-Based Formulations: Demonstration of Process Robustness through Experimental Design Conditions

An Integrated Approach for High-Shear Wet Granulation (HSWG) Processing of TPGS-Based Formulations: Demonstration of Process Robustness through Experimental Design Conditions

Converting a batch based high-shear granulation process to a continuous dry granulation process; a demonstration with ketoprofen tablets

Development and implementation of a hybrid scale up model for a batch high shear wet granulation operation

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