2020
DOI: 10.1021/acs.oprd.9b00502
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Abstract: A material-sparing screening methodology has been developed for assessing the risk of particle size attrition of active pharmaceutical ingredients (APIs) during agitated drying using a single-ball mill process assisted by resonant acoustic mixing. This method requires only gram quantities of material and provides a critical particle fragility assessment that can be used to identify suitable agitation protocols that minimize attrition during at-scale manufacturing. The impact of initial particle size, as well a… Show more

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Cited by 3 publications
(2 citation statements)
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References 23 publications
(118 reference statements)
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“…This requirement can also be confirmed by comparing the results to published literature data. Attrition and agglomeration phenomena occur quite frequently during the drying processes [58,59] because there is no lubricant, which prevents direct particleparticle collision. Needles in particular tend to a simultaneous occurrence of abrasion and agglomeration, as already shown by Lekhal et al for similar particles (L-threonine) during agitated drying [39].…”
Section: Continuous Vacuum Screw Filter V2mentioning
confidence: 99%
“…This requirement can also be confirmed by comparing the results to published literature data. Attrition and agglomeration phenomena occur quite frequently during the drying processes [58,59] because there is no lubricant, which prevents direct particleparticle collision. Needles in particular tend to a simultaneous occurrence of abrasion and agglomeration, as already shown by Lekhal et al for similar particles (L-threonine) during agitated drying [39].…”
Section: Continuous Vacuum Screw Filter V2mentioning
confidence: 99%
“…Development of an optimal drying process in an AFBD requires an assessment of the influence of the drying kinetics and agitation intensity on the physical/chemical attributes and stability of the compound. Over the years, many different laboratory-scale agitated dryers [11][12][13][14] have been developed to investigate the agitated drying process, but most of them are in-house instruments, developed in academia and hence not readily accessible to the pharmaceutical industry. Custom laboratory setups that mimic heat and mass transfer characteristics and applied mechanical forces at large-scale operations require a substantial quantity of materials that are unavailable at the early process development stage.…”
Section: Introductionmentioning
confidence: 99%