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  • Title: Study of the capsule-filling dosator process via calibrated DEM simulations.
    Author: Madlmeir S, Loidolt P, Khinast JG.
    Journal: Int J Pharm; 2019 Aug 15; 567():118441. PubMed ID: 31212054.
    Abstract:
    Capsule filling is frequently accomplished via the dosator process. Controlling the main quality attributes, i.e., the fill weight and the fill weight variability, requires excellent process understanding. For the investigation of critical process parameters of low-dose capsule filling, DEM simulations were used. Two contact models (Hertz model and Luding model) were calibrated and validated to represent the lactose powder Lactohale 100. Both models gave good results, yet the Luding model resulted in better predictions. Since the dosator process is a volume-based approach, the dosator geometry is an important factor. We provide evidence that not only the volume, but also the proportions of the dosator affect the capsule fill weight. Slim nozzle chambers cause lower mass due to increased wall friction impact. The process is not volumetric, as a fill weight to volume correlation does not exist. Furthermore, the fill weight increases with higher powder beds and smaller gaps between the nozzle tip and the container bottom due to higher densification of the powder. Fill weight variations due to bed inhomogeneity were investigated by varying the bulk density of the initial powder bed.
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