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Powder flow from an intermediate bulk container - Discharge predictions and experimental evaluation.
Wikström, Håkan; Remmelgas, Johan; Solin, Sara; Marucci, Mariagrazia; Sandler, Niklas; Boissier, Catherine; Tajarobi, Pirjo.
Afiliación
  • Wikström H; Oral Product Development, Pharmaceutical Technology & Development, Operations & IT, AstraZeneca Gothenburg, Sweden.
  • Remmelgas J; Oral Product Development, Pharmaceutical Technology & Development, Operations & IT, AstraZeneca Gothenburg, Sweden.
  • Solin S; Pharmaceutical Sciences Laboratory, Faculty of Science and Technology, Åbo Akademi University, Turku, Finland.
  • Marucci M; Oral Product Development, Pharmaceutical Technology & Development, Operations & IT, AstraZeneca Gothenburg, Sweden.
  • Sandler N; Pharmaceutical Sciences Laboratory, Faculty of Science and Technology, Åbo Akademi University, Turku, Finland.
  • Boissier C; Oral Product Development, Pharmaceutical Technology & Development, Operations & IT, AstraZeneca Gothenburg, Sweden.
  • Tajarobi P; Early Product Development and Manufacturing, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca Gothenburg, Sweden. Electronic address: Pirjo.Tajarobi@astrazeneca.com.
Int J Pharm ; 597: 120309, 2021 Mar 15.
Article en En | MEDLINE | ID: mdl-33540037
ABSTRACT
Powders are usually dispensed, blended, and transferred between different manufacturing steps in so-called Intermediate Bulk Containers (IBCs), and discharge from an IBC plays a critical role in the ability to manufacture high-quality tablets. To better understand IBC discharge, the flow behavior of selected excipients was comprehensively characterized using a number of techniques including the Hausner ratio/Carr's index, Erweka flow test, FlowPro flow test, shear test and wall friction test as well as FT4 powder rheometer experiments. Jenike's hopper design methodology was then used to predict the minimum non-arching outlet diameter and the mode of flow. Furthermore, the discharge rate from an IBC was predicted using a simple model that takes into account gravity and aerodynamic drag. The predictions were experimentally verified by measuring the discharge rate from a 20 L IBC using five commonly-used excipients. The small-scale Erweka flow test provided the best prediction of the full-scale IBC discharge experiment. Furthermore, a simple model that relied only on the particle size of the material and the diameter of the discharge opening was found to predict the IBC discharge rate remarkably well.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Alta del Paciente / Excipientes Tipo de estudio: Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Int J Pharm Año: 2021 Tipo del documento: Article País de afiliación: Suecia

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Alta del Paciente / Excipientes Tipo de estudio: Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Int J Pharm Año: 2021 Tipo del documento: Article País de afiliación: Suecia