Powder Flow Testing: Judicious Choice of Test Methods

Tay, Justin Yong Soon; Liew, Celine Valeria; Heng, Paul Wan Sia

doi:10.1208/s12249-016-0655-3

Cited by 43 publications

(14 citation statements)

References 35 publications

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“…The avalanche angle describes the angle at which the powder reaches the highest potential energy (the highest point) in the drum just before the loss of stability-visible as an avalanche [8]. The avalanche behavior of a powder sample can be used as a good predictor of powder flowability for powders that are not too cohesive [19]. The first avalanche angle is measured by image analysis at a low rotational speed, and the flowing angle is measured at a variable rotational speed.…”

Section: Powder Flowabilitymentioning

confidence: 99%

Capabilities and Limitations of Using Desktop 3-D Printers in the Laser Sintering Process

2020

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Almost one-third of the revenues of the Additive Manufacturing (AM) machines market is generated by desktop systems. A new category of such devices are Laser Sintering (LS) machines, in which we can find a few representatives of this group. A growing interest in the use of desktop AM solutions in research and industry is visible, and therefore an evaluation of its capabilities and limitations is desirable. The presented paper focuses on comparing desktop (Sintratec S1; Sinterit Lisa) and industrial (Formiga P110) LS systems. The properties of raw materials were characterized by Scanning Electron Microscopy (SEM) and Differential Scanning Calorimetry (DSC), as well as by determining the Particle Size Distribution (PSD) and static and dynamic flowability of powder. Laser Sintering commercial sets were characterized by their mechanical properties (tensile strength), surface quality (roughness), as well as by their accuracy and porosity (computed tomography). The conducted test showed significant differences, especially in the case of material properties and manufacturing repeatability. The found differences between desktop and industrial LS systems suggest that the use of a low-budget LS system, especially for the research and production of end-use parts, has to take into account its limitations.

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Section: Powder Flowabilitymentioning

confidence: 99%

Capabilities and Limitations of Using Desktop 3-D Printers in the Laser Sintering Process

2020

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“…For the particle size, the D10, D50 and D90 values of NPPs powders were relatively small compared to that of frequently used pharmaceutical excipients in the report [42,43]. Except for dextrin (Span value equal to 0.88), the Span values of NPPs were large, indicating that these materials had a wide Figure 2.…”

Section: Physical Properties Of Powder Materialsmentioning

confidence: 87%

Raw Material Variability and Its Impact on the Online Adaptive Control of Cohesive Powder Blend Homogeneity Using NIR Spectroscopy

Shi

Zhiqiang

et al. 2019

Processes

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It is significant to analyze the blend homogeneity of cohesive powders during pharmaceutical manufacturing in order to provide the exact content of the active pharmaceutical ingredient (API) for each individual dose unit. In this paper, an online monitoring platform using an MEMS near infrared (NIR) sensor was designed to control the bin blending process of cohesive powders. The state of blend homogeneity was detected by an adaptive algorithm, which was calibration free. The online control procedures and algorithm’s parameters were fine-tuned through six pilot experiments and were successfully transferred to the industrial production. The reliability of homogeneity detection results was validated by 16 commercial scale experiments using 16 kinds of natural product powders (NPPs), respectively. Furthermore, 19 physical quality attributes of all NPPs and the excipient were fully characterized. The blending end time was used to denote the degree of difficulty of blending. The empirical relationships between variability of NPPs and the blending end time were captured by latent variable modeling. The critical material attributes (CMAs) affecting the blending process were identified as the particle shape and flowability descriptors of cohesive powders. Under the framework of quality by design (QbD) and process analytical technology (PAT), the online NIR spectroscopy together with the powder characterization facilitated a deeper understanding of the mixing process.

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“…Our results show that isoniazid and amikacin can be precisely and accurately dosed with the Omnidose system in a vacuum pressure range from 200 to 600 mbar, as shown in Table 1 and Table 2 . Powder flowability decreases with decreasing particle size, with particles for pulmonary administration showing poor flow characteristics [ 17 ]. However, the poor flowability, expected from the two tested formulations, do not seem to result in unreliable dosing.…”

Section: Discussionmentioning

confidence: 99%

Automated Filling Equipment Allows Increase in the Maximum Dose to Be Filled in the Cyclops® High Dose Dry Powder Inhalation Device While Maintaining Dispersibility

et al. 2020

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In recent years there has been increasing interest in the pulmonary delivery of high dose dry powder drugs, such as antibiotics. Drugs in this class need to be dosed in doses far over 2.5 mg, and the use of excipients should therefore be minimized. To our knowledge, the effect of the automatic filling of high dose drug formulations on the maximum dose that can be filled in powder inhalers, and on the dispersion behavior of the powder, have not been described so far. In this study, we aimed to investigate these effects after filling with an Omnidose, a vacuum drum filler. Furthermore, the precision and accuracy of the filling process were investigated. Two formulations were used—an isoniazid formulation we reported previously and an amikacin formulation. Both formulations could be precisely and accurately dosed in a vacuum pressure range of 200 to 600 mbar. No change in dispersion was seen after automatic filling. Retention was decreased, with an optimum vacuum pressure range found from 400 to 600 mbar. The nominal dose for amikacin was 57 mg, which resulted in a fine particle dose of 47.26 ± 1.72 mg. The nominal dose for isoniazid could be increased to 150 mg, resulting in a fine particle dose of 107.35 ± 13.52 mg. These findings may contribute to the understanding of the upscaling of high dose dry powder inhalation products.

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Powder Flow Testing: Judicious Choice of Test Methods

Cited by 43 publications

References 35 publications

Capabilities and Limitations of Using Desktop 3-D Printers in the Laser Sintering Process

Capabilities and Limitations of Using Desktop 3-D Printers in the Laser Sintering Process

Raw Material Variability and Its Impact on the Online Adaptive Control of Cohesive Powder Blend Homogeneity Using NIR Spectroscopy

Automated Filling Equipment Allows Increase in the Maximum Dose to Be Filled in the Cyclops® High Dose Dry Powder Inhalation Device While Maintaining Dispersibility

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