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In-depth analysis of the long-term processability of materials during continuous feeding.
Bekaert, B; Van Snick, B; Pandelaere, K; Dhondt, J; Di Pretoro, G; De Beer, T; Vervaet, C; Vanhoorne, V.
Afiliación
  • Bekaert B; Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
  • Van Snick B; Oral Solid Dosage, Drug Product Development, Discovery Product Development and Supplies, Pharmaceutical Research and Development, Division of Janssen Pharmaceutica, Johnson & Johnson, Turnhoutseweg 30, B-2340 Beerse, Belgium.
  • Pandelaere K; Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
  • Dhondt J; Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
  • Di Pretoro G; Oral Solid Dosage, Drug Product Development, Discovery Product Development and Supplies, Pharmaceutical Research and Development, Division of Janssen Pharmaceutica, Johnson & Johnson, Turnhoutseweg 30, B-2340 Beerse, Belgium.
  • De Beer T; Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
  • Vervaet C; Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
  • Vanhoorne V; Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium. Electronic address: valerie.vanhoorne@ugent.be.
Int J Pharm ; 614: 121454, 2022 Feb 25.
Article en En | MEDLINE | ID: mdl-35026314
This study determined the feasibility of long-term continuous powder feeding and its effect on the overall process performance. Additionally, quantitative relationships were established between material properties, process settings and screw feeding responses during gravimetric feeding. Twelve divergent raw materials were processed over longer periods using a GEA Compact Feeder integrated in a continuous direct compression line (ConsiGma™ CDC-50). The resulting gravimetric feeding responses were combined with the material properties and process settings into an overall PLS model. The model elucidated the impact of the material descriptors for density; powder flow; particle size; compressibility; permeability and wall friction angle on the feeding process. Furthermore, long-term processing of the materials exhibited challenges related to the processability and refill consistency where a significant impact of the compressibility and cohesive/adhesive properties of the materials was observed. Overall, this approach provided insights into the feasibility of long-term continuous feeding which is not possible through 'short-term' feeding trials. Additionally, throughout this study, the need for material-specific adjustments of the feeding and refill equipment was highlighted.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tecnología Farmacéutica Idioma: En Revista: Int J Pharm Año: 2022 Tipo del documento: Article País de afiliación: Bélgica Pais de publicación: Países Bajos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tecnología Farmacéutica Idioma: En Revista: Int J Pharm Año: 2022 Tipo del documento: Article País de afiliación: Bélgica Pais de publicación: Países Bajos