Elucidation of the powder flow pattern in a twin-screw LIW-feeder for various refill regimes.
Continuous manufacturing
NIR spectroscopy
Residence time distribution
Twin-screw LIW-feeder
Journal
International journal of pharmaceutics
ISSN: 1873-3476
Titre abrégé: Int J Pharm
Pays: Netherlands
ID NLM: 7804127
Informations de publication
Date de publication:
25 Jan 2023
25 Jan 2023
Historique:
received:
08
08
2022
revised:
16
12
2022
accepted:
19
12
2022
pubmed:
24
12
2022
medline:
14
1
2023
entrez:
23
12
2022
Statut:
ppublish
Résumé
The importance of residence time distribution modeling is acknowledged as a tool for enabling material tracking and control within a continuous manufacturing line in order to safeguard both product quality and production efficiency. One of the first unit-operations into a continuous direct compression line (i.e. CDC-line) worthwhile doing extensive RTD-analysis upon are the LIW-feeders since they dose the ingredients in a controlled way following the label claim and hence can directly influence critical quality attributes like content uniformity. An NIR measurement method was developed determining the RTD of selected powders at specific feeder settings. Step-change experiments using sodium saccharin as a tracer were conducted. In order to gain and in depth understanding of the material flow, spatial samples throughout the hopper were taken at predefined timepoints during the step change experiments. This revealed the presence of a bypass trajectory along the edges of the agitator, while in the center of the agitator an inner mixing volume in which the tracer concentration lags behind seemed to be present. Finally, a model based on a plug flow and continuous stirred tank reactor was evaluated. The fitted model was not able to capture this complex flow behavior and shows the need for an extended compartmental model distinguishing between a bypass trajectory formed by the agitator and an inner mixing volume.
Identifiants
pubmed: 36563797
pii: S0378-5173(22)01089-4
doi: 10.1016/j.ijpharm.2022.122534
pii:
doi:
Substances chimiques
Powders
0
Pharmaceutical Vehicles
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
122534Informations de copyright
Copyright © 2022 Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.