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
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

122534

Informations 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.

Auteurs

L De Souter (L)

Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.

R Waeytens (R)

Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium; BIOMATH, Department of Mathematical Modelling, Statistics and Bioinformatics, Faculty of Bioscience Engineering, Ghent University, Coupure Links 653, B-9000 Ghent, Belgium.

D Van Hauwermeiren (D)

BIOMATH, Department of Mathematical Modelling, Statistics and Bioinformatics, Faculty of Bioscience Engineering, Ghent University, Coupure Links 653, B-9000 Ghent, Belgium.

W Grymonpré (W)

Fette Compacting Belgium, Schaliënoevedreef 1 b, B-2800 Mechelen, Belgium.

B Bekaert (B)

Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent university, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.

I Nopens (I)

BIOMATH, Department of Mathematical Modelling, Statistics and Bioinformatics, Faculty of Bioscience Engineering, Ghent University, Coupure Links 653, B-9000 Ghent, Belgium.

T De Beer (T)

Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium. Electronic address: Thomas.DeBeer@ugent.be.

Articles similaires

Animals Dietary Fiber Dextran Sulfate Mice Disease Models, Animal
Calcium Carbonate Sand Powders Construction Materials Materials Testing
Tissue Plasminogen Activator Retina Air Pressure Humans
Nanoparticles Needles Polylactic Acid-Polyglycolic Acid Copolymer Polyethylene Glycols Curcumin

Classifications MeSH