Process Modeling Techniques and Applications for Solid Oral Drug Products

Ende, Mary T. am; Bharadwaj, Rahul; García‐Muñoz, Salvador; Ketterhagen, William R.; Prpich, Andrew; Doshi, Pankaj

doi:10.1002/9780470882221.ch34

Cited by 3 publications

(2 citation statements)

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“…Adjustments or tuning in model parameters through 14 calibration are necessary to improve the ability of granulation models to replicate process measured condi- 15 tions and properly reflect the impact of any change in it ( Figure 3). This section of the review comprises the 16 currently reported developments in modelling practices and related measurement tools of the batch HSWG 17 in order to illustrate the degree to which this potential has been exploited thus far. This overview then 18 allows identifying potential gaps and developing a list of unexplored possibilities for facing the challenges 19 ( Table 1) inherent to the continuous form of HSWG.…”

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confidence: 99%

“…In the plastic and food industries where TSE has been used extensively, such studies 14 have been performed by having small windows in the side of a metal barrel or by using a transparent 15 barrel in combination with probes such as Laser Doppler Anemometers [127,128]. The other approach 16 consists of flow visualization in a barrel using radioactive particle tracking methods such as PEPT, or 17 imaging techniques such as PIV [129]. The obtained velocity profile in TSG has further been utilized to 18 construct RTD profiles [88] and study the effect of a change in viscosity of the granulation liquid [130].…”

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Model-based analysis of high shear wet granulation from batch to continuous processes in pharmaceutical production – A critical review

Kumar

Gernaey

Beer

et al. 2013

European Journal of Pharmaceutics and Biopharmaceutics

109

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The manufacturing of pharmaceutical dosage forms, which has traditionally been a batch-wise process, is now also transformed into a series of continuous operations. Some operations such as tabletting and milling are already performed in continuous mode, while the adaptation towards a complete continuous production line is still hampered by complex steps such as granulation and drying which are considered to be too inflexible to handle potential product change-overs. Granulation is necessary in order to achieve good flowability properties and better control of drug content uniformity. This paper reviews modelling and supporting measurement tools for the high shear wet granulation (HSWG) process, which is an important granulation technique due to the inherent benefits and the suitability of this unit operation for the desired switch to continuous mode. For gaining improved insight of the complete system, particle-level mechanisms are required to be better understood, and linked with an appropriate meso-or macro-scale model. A brief review has been provided to understand the mechanisms of the granulation process at micro or particle-level such as those involving wetting and nucleation, aggregation, breakage and consolidation. Further, population balance modelling (PBM) and the discrete element method (DEM), which are the current state-of-the-art methods for granulation modelling at micro-to meso-scale, are discussed. The DEM approach has a major role to play in future research as it bridges the gap between micro-and meso-scales. Furthermore, interesting developments in the measurement technologies are discussed with a focus towards inline measurements of the granulation process to obtain experimental data which are required for developing good models. Based on the current state of the developments, the review focuses on the twin screw granulator as a device for * Email address: ingmar.nopens@ugent.be, Tel.: +32 (0)9 264 61 96; fax: +32 (0) continuous HSWG and attempts to critically evaluate the current process. As a result, a set of open research questions are identified. These questions need to be answered in the future in order to fill the knowledge gap that currently exists both at micro-and macro-scale, and which is currently limiting the further development of the process to its full potential in pharmaceutical applications.

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confidence: 99%

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confidence: 99%

Model-based analysis of high shear wet granulation from batch to continuous processes in pharmaceutical production – A critical review

Kumar

Gernaey

Beer

et al. 2013

European Journal of Pharmaceutics and Biopharmaceutics

109

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Drug Product Process Modeling

Ende

Ketterhagen

Prpich

et al. 2019

Chemical Engineering in the Pharmaceutical Industry

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A quality by design approach to scale-up of high-shear wet granulation process

Pandey

Badawy

2015

Drug Development and Industrial Pharmacy

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High-shear wet granulation is a complex process that in turn makes scale-up a challenging task. Scale-up of high-shear wet granulation process has been studied extensively in the past with various different methodologies being proposed in the literature. This review article discusses existing scale-up principles and categorizes the various approaches into two main scale-up strategies - parameter-based and attribute-based. With the advent of quality by design (QbD) principle in drug product development process, an increased emphasis toward the latter approach may be needed to ensure product robustness. In practice, a combination of both scale-up strategies is often utilized. In a QbD paradigm, there is also a need for an increased fundamental and mechanistic understanding of the process. This can be achieved either by increased experimentation that comes at higher costs, or by using modeling techniques, that are also discussed as part of this review.

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Process Modeling Techniques and Applications for Solid Oral Drug Products

Cited by 3 publications

References 50 publications

Model-based analysis of high shear wet granulation from batch to continuous processes in pharmaceutical production – A critical review

Model-based analysis of high shear wet granulation from batch to continuous processes in pharmaceutical production – A critical review

Drug Product Process Modeling

A quality by design approach to scale-up of high-shear wet granulation process

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