Development of a Model-Based Quality-by-Control Framework for Crystallization Design

Eren, Ayşe; Szilágyi, Botond; Quon, Justin L.; Furuta, Masashi; Papageorgiou, Charles D.

doi:10.1016/b978-0-12-818634-3.50054-0

Cited by 7 publications

(6 citation statements)

References 5 publications

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“…However, these efforts can be minimized by adopting hybrid or systematic approaches that yield targeted experimental design with minimum numbers (e.g. for solubility [61] and for crystallization kinetics [62]).…”

Section: Discussionmentioning

confidence: 99%

Comprehensive sensitivity analysis and process risk assessment of large scale pharmaceutical crystallization processes

Öner

Stocks

Sin

2020

Computers & Chemical Engineering

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Section: Discussionmentioning

confidence: 99%

Comprehensive sensitivity analysis and process risk assessment of large scale pharmaceutical crystallization processes

Öner

Stocks

Sin

2020

Computers & Chemical Engineering

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“…Control of crystal size and distribution is critical in the pharmaceutical industries to ensure rigorous quality requirements in the manufacturing of APIs. 28 The manufacturing of APIs involves a variety of unit operations including crystallization followed by filtration, drying, and, in many cases, size reduction operations such as milling, which has a direct impact on downstream operations and end-use properties of the product. 29 The control of crystal size most importantly helps in regulating bioavailability and absorption of poorly soluble drugs in the gastrointestinal tract.…”

Section: Supersaturationmentioning

confidence: 99%

Control of Antisolvent Mass Transfer through Porous Membranes for the Crystallization of Organic Compounds

Chergaoui

Debecker

Leyssens

et al. 2023

Crystal Growth & Design

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Crystallization faces great challenges from the point of view of technology readiness, process economics, and energy consumption. Membranes are capable of controlling both energy and mass transfer, and they can lead to major improvements if integrated into antisolvent crystallization processes, for example, limiting unfavorable kinetics and thermodynamics that are responsible for undesired crystal size and shape. In this work, membrane-assisted antisolvent crystallization (MAAC) was used to crystallize the amino acid l-serine. Two commercial membranes made of polyvinylidene fluoride and polypropylene with water contact angles of 130° and 150°, respectively, allowed a controlled antisolvent crystallization. These membranes controlled the transmembrane mass transfer of antisolvent (ethanol) under different feed and antisolvent velocities at ambient conditions. In all cases, a narrow crystal size distribution of l-serine was obtained reflected in a coefficient of variation (CV) of 31–37%, compared with batch antisolvent crystallization or drop-by-drop crystallization where the CV was 63 and 54%, respectively. Thanks to the measurement of l-serine and ethanol concentration along the operating time, the mass transfer coefficient of MAAC was evaluated. Increasing the antisolvent or the crystallizing solution velocity showed that a too high value of one or the other could result in wetting or system blockage (inside the membrane contactor, module, or tubing). This study explains the transmembrane mass transfer in MAAC and the resulting crystal properties.

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“…7 There are various morphologies in which compounds have the potential to crystallize, one of the more frequent forms being needles. 8,9 There are a number of factors that can cause a compound to crystallize in this manner, 10,11 such as the choice of solvent, supersaturation, and the presence of impurities. 10 Needle-like crystals are an issue in the downstream processing of many active pharmaceutical ingredients (APIs) as they tend to block equipment, are problematic to filter, and have a low packing density.…”

Section: ■ Introductionmentioning

confidence: 99%

Morphological Control of Crystalline Savolitinib via the Volatile Deep Eutectic Solvent Technique

Symons,

Hall,

McCabe

et al. 2024

Crystal Growth & Design

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Savolitinib is a compound that can crystallize in an undesirable, high aspect ratio needle morphology. This morphology type may cause issues in downstream processing. This paper demonstrates a unique method to alter the crystal morphology of savolitinib to make it more processable, resulting in the active pharmaceutical ingredient (API) crystallizing out in considerably more processable stellates. The volatile deep eutectic solvent technique presents a simple and scalable method for changing the crystal morphology while maintaining the polymorph of the API in this case, confirmed via powder X-ray diffraction and differential scanning calorimetry analysis.

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Development of a Model-Based Quality-by-Control Framework for Crystallization Design

Cited by 7 publications

References 5 publications

Comprehensive sensitivity analysis and process risk assessment of large scale pharmaceutical crystallization processes

Comprehensive sensitivity analysis and process risk assessment of large scale pharmaceutical crystallization processes

Control of Antisolvent Mass Transfer through Porous Membranes for the Crystallization of Organic Compounds

Morphological Control of Crystalline Savolitinib via the Volatile Deep Eutectic Solvent Technique

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