Scaling Wet Fine Grinding Processes of Organic Particles Using Stirred Media Mills

Flach, Frederik; Breitung‐Faes, Sandra; Kwade, Arno

doi:10.1002/cite.201600148

Cited by 10 publications

(8 citation statements)

References 28 publications

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“…The plotted process–product attribute relationship is well correlated within the investigated parameter ranges. This is an expected outcome for the mechanistic process model and in good agreement with the literature [ 40 , 48 , 49 ]. The relative standard deviation (RSD) of mean particle size at a constant mass specific energy is below 3.5% RSD for x PCS below 180 nm.…”

Section: Resultssupporting

confidence: 90%

“…Experimental approaches for the development of the material attributes, equipment and process parameters, and potential critical quality attributes (pCQAs) are reported in the literature [ 33 , 34 , 35 ]. Furthermore, different engineering approaches for the scale-up of the wet stirred media milling process from a laboratory/pilot to a commercial scale are available [ 10 , 40 , 49 , 50 ]. For this study, the established risk assessment; supporting experimental investigations for formulation, process, and product development at the laboratory/pilot scale; and the scale-up to commercial scale are not presented.…”

Section: Resultsmentioning

confidence: 99%

“…The stress-energy model developed by Kwade [ 36 , 37 , 38 , 39 , 40 ] is a mechanistic process model that is currently fully mature, well understood, and successfully applied for different applications in industry and academia, e.g., for mining [ 41 ], battery [ 42 , 43 , 44 ], pigment [ 45 , 46 ], ceramic [ 47 ], and pharmaceutical [ 10 , 48 , 49 ] applications. The stress-energy model describes the impact of equipment and process parameters on particle size for wet stirred media milling processes according to the following equation:

where E M is the mass specific energy, SE is the stress energy of the grinding media, and SN is the total stress number.…”

Section: Methodsmentioning

confidence: 99%

See 2 more Smart Citations

Design Space and Control Strategy for the Manufacturing of Wet Media Milled Drug Nanocrystal Suspensions by Adopting Mechanistic Process Modeling

Bitterlich,

Mihorko,

Juhnke

2024

Pharmaceutics

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Wet media milling is a fully industrialized technology for the manufacturing of drug nanocrystal suspensions. This work describes the development of an advanced control strategy and an associated design space for a manufacturing process at a commercial scale. Full-scale experiments and mechanistic process modeling have been used to establish a physically reasonable control strategy of factors relevant to the quality attributes of the nanocrystal suspension. The design space has been developed based on a mature mechanistic process model of the wet media milling procedure. It presents the process–product attribute relationship between a multidimensional range of measured process parameters and a range of the product-quality attribute mean particle sizes. The control strategy allows for simple, robust, and sound scientific process control as well as the operational flexibility of the suspension batch size. This is an industrial case study of control strategy and design-space definition with the crucial contribution of mechanistic process modeling for an intended commercial manufacturing process.

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Section: Resultssupporting

confidence: 90%

Section: Resultsmentioning

confidence: 99%

where E M is the mass specific energy, SE is the stress energy of the grinding media, and SN is the total stress number.…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Design Space and Control Strategy for the Manufacturing of Wet Media Milled Drug Nanocrystal Suspensions by Adopting Mechanistic Process Modeling

Bitterlich,

Mihorko,

Juhnke

2024

Pharmaceutics

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“…Using the latter, nanoparticles are generated by mechanical particle size reduction of coarse APIs. In this regard, wet media milling is the most frequently used top-down method for the production of nanosuspensions in the pharmaceutical industry [9] and has been intensively studied [10][11][12][13][14][15][16][17].…”

Section: Introductionmentioning

confidence: 99%

Influence of Formulation Parameters on Redispersibility of Naproxen Nanoparticles from Granules Produced in a Fluidized Bed Process

et al. 2020

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The particle size reduction of active pharmaceutical ingredients is an efficient method to overcome challenges associated with a poor aqueous solubility. With respect to stability and patient’s convenience, the corresponding nanosuspensions are often further processed to solid dosage forms. In this regard, the influence of several formulation parameters (i.e., type of carrier material, type and amount of additional polymeric drying excipient in the nanosuspension) on the redispersibility of naproxen nanoparticle-loaded granules produced in a fluidized bed process was investigated. The dissolution rate of the carrier material (i.e., sucrose, mannitol, or lactose) was identified as a relevant material property, with higher dissolution rates (sucrose > mannitol > lactose) resulting in better redispersibility of the products. Additionally, the redispersibility of the product granules was observed to improve with increasing amounts of polymeric drying excipient in the nanosuspension. The redispersibility was observed to qualitatively correlate with the degree of nanoparticle embedding on the surface of the corresponding granules. This embedding was assumed to be either caused by a partial dissolution and subsequent resolidification of the carrier surface dependent on the dissolution rate of the carrier material or by resolidification of the dissolved polymeric drying excipient upon drying. As the correlation between the redispersibility and the morphology of the corresponding granules was observed for all investigated formulation parameters, it may be assumed that the redispersibility of the nanoparticles is determined by their distance in the dried state.

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“…They can exist in many different sizes, and their specific energy consumption has been significantly reduced in recent years. Flach et al [19] presented that the reduction in the specific energy consumption of these mills is due to the small size of the grinding media and the high energy intensity. However, it is also essential to explore the relationships between different parameters, such as the ground material's density, the stirrer's speed, and the mill's major geometric dimensions.…”

Section: Introductionmentioning

confidence: 99%

Relation between Scale-Up and Life Cycle Assessment for Wet Grinding Process of Pumice

Mannheim

Kruszelnicka

2023

Energies

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This study examines the grinding process of pumice based on the dry and wet laboratory measurements, scale-up method, and life cycle assessment. This research’s main goal was to set up the relation between scale-up and life cycle assessment results for the wet grinding process with the help of mathematical equations. Within the first research works, basic grinding testing in a laboratory dry Bond mill was accomplished. This step allowed the description of the estimated particle size distribution, median particle size, specific grinding work, and grindability index number of pumice. The second step was the determination of power consumption and scale-up in a laboratory stirred media mill, and it involved the assessment of resources, primary energies, and environmental impacts of wet grinding using GaBi 8.0 software. According to the results, we obtain life cycle emission factors by introducing five coefficients for grinding in laboratory and industrial conditions. These constants depend on the external dimensions of the mill and can be expressed by a derived scale constant from the scale-up. Research results enable the industry to make a prognosis for industrial plants based on the integration between life cycle assessment and scale-up of the pilot grinding processes.

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Scaling Wet Fine Grinding Processes of Organic Particles Using Stirred Media Mills

Cited by 10 publications

References 28 publications

Design Space and Control Strategy for the Manufacturing of Wet Media Milled Drug Nanocrystal Suspensions by Adopting Mechanistic Process Modeling

Design Space and Control Strategy for the Manufacturing of Wet Media Milled Drug Nanocrystal Suspensions by Adopting Mechanistic Process Modeling

Influence of Formulation Parameters on Redispersibility of Naproxen Nanoparticles from Granules Produced in a Fluidized Bed Process

Relation between Scale-Up and Life Cycle Assessment for Wet Grinding Process of Pumice

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