Combination of a rotating tube sample divider and dynamic image analysis for continuous on-line determination of granule size distribution

Wilms, Annika; Knop, Klaus; Kleinebudde, Peter

doi:10.1016/j.ijpx.2019.100029

Cited by 7 publications

(6 citation statements)

References 20 publications

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“…Unlike NIR, which can be disturbed by water, Raman spectroscopy can clearly display the scattering of the API, because water does not have a strong Raman spectrum [121]. The techniques for measuring the real-time change in particle size in the granulation process include imaging technology and FBRM [41,122]. The particle size, particle size distribution or particle growth rate present evidence to determine the endpoint of wet granulation; thus, their QAs can be used for the wet granulation scale-up step.…”

Section: Scale-up Studies On Wet Granulation Using a Pat-based Modeling Methodsmentioning

confidence: 99%

Model-Based Scale-up Methodologies for Pharmaceutical Granulation

et al. 2020

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In the pharmaceutical industry, it is a major challenge to maintain consistent quality of drug products when the batch scale of a process is changed from a laboratory scale to a pilot or commercial scale. Generally, a pharmaceutical manufacturing process involves various unit operations, such as blending, granulation, milling, tableting and coating and the process parameters of a unit operation have significant effects on the quality of the drug product. Depending on the change in batch scale, various process parameters should be strategically controlled to ensure consistent quality attributes of a drug product. In particular, the granulation may be significantly influenced by scale variation as a result of changes in various process parameters and equipment geometry. In this study, model-based scale-up methodologies for pharmaceutical granulation are presented, along with data from various related reports. The first is an engineering-based modeling method that uses dimensionless numbers based on process similarity. The second is a process analytical technology-based modeling method that maintains the desired quality attributes through flexible adjustment of process parameters by monitoring the quality attributes of process products in real time. The third is a physics-based modeling method that involves a process simulation that understands and predicts drug quality through calculation of the behavior of the process using physics related to the process. The applications of these three scale-up methods are summarized according to granulation mechanisms, such as wet granulation and dry granulation. This review shows that these model-based scale-up methodologies provide a systematic process strategy that can ensure the quality of drug products in the pharmaceutical industry.

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Section: Scale-up Studies On Wet Granulation Using a Pat-based Modeling Methodsmentioning

confidence: 99%

Model-Based Scale-up Methodologies for Pharmaceutical Granulation

et al. 2020

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“…Unlike 2D devices, PartAn 3D measures the third dimension of the particle: thickness. Dynamic image analysis has found its application in granule research [15], in milling processes [16], [17], in particles analysis [18] or analysis of micro tablets [19]. The dried granules in the 0.4 -3 mm range characterized as product were analyzed to find their size and shape and the distribution curve width.…”

Section: Dynamic Image Analysismentioning

confidence: 99%

Dynamic Image Analysis to Determine Granule Size and Shape, for Selected High Shear Granulation Process Parameters

Macho

Matúš

Gabrišová

et al. 2019

Strojnícky Časopis - Journal of Mechanical Engineering

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The aim of this study was to investigate the usage of Dynamic Image Analysis for determination of size, shape and distribution of granules of microcrystalline cellulose, created by high shear granulation. A series of experiments was carried out to analyse the effect of process parameters on a created granule morphology. The amount of the granulation liquid and speed of the impeller have a significant effect on the median size granule value, the sphericity, the granule distribution width, but also on the granulation process yield.

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“…This results in difficulties to measure the full product flow as well as obtaining a representative sample to measure [20]. Therefore, limited research has been published on RCDG and in-line/on-line particle sizing [31][32][33].…”

Section: Introductionmentioning

confidence: 99%

Development and Evaluation of an In-line and On-line Monitoring System for Granule Size Distributions in Continuous Roll Compaction/Dry Granulation Based on Laser Diffraction

2020

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Purpose Roll compaction/dry granulation is established in manufacturing of solid oral dosage forms and, within the context of continuous manufacturing, it has sparked interest as material is fed, processed, and ejected continuously while also providing large possible throughputs. However, this amount of material has to be adequately controlled in real time to assure quality. Methods This research aimed at monitoring the critical quality attribute granule size distribution in continuous roll compaction/ dry granulation (QbCon®; L.B. Bohle, Ennigerloh, Germany) using in-line and on-line laser diffraction. The influence of varying process parameters and excipient formulations was studied and evaluated with the prospect of using this technique to develop control loops. For this purpose, residence time parameters were assessed. In-and on-line data was compared with off-line laser diffraction and dynamic image analysis data. Results The system successfully monitored the granule size distribution in a variety of process parameters and throughputs (up to 27.5 kg/h). It was sensitive to changes in process parameters and changes in material blends, which could pose a potential threat to the final drug products' quality. Average event propagation time from the compaction zone to the laser diffraction system of 17.7 s demonstrates the systems' fast reaction time. Conclusion Results highlight laser diffraction as a valuable method of in-and on-line size determination and allow for the development of a control strategy using this principle.

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Combination of a rotating tube sample divider and dynamic image analysis for continuous on-line determination of granule size distribution

Abstract: Graphical abstract

Cited by 7 publications

References 20 publications

Model-Based Scale-up Methodologies for Pharmaceutical Granulation

Model-Based Scale-up Methodologies for Pharmaceutical Granulation

Dynamic Image Analysis to Determine Granule Size and Shape, for Selected High Shear Granulation Process Parameters

Development and Evaluation of an In-line and On-line Monitoring System for Granule Size Distributions in Continuous Roll Compaction/Dry Granulation Based on Laser Diffraction

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