Evaluation of fluid bed technology for the preparation of solid dispersions intended for immediate drug release systems

In the present thesis, it is demonstrated the potential of fluid bed top-spray technology as an alternative to spray drying for the production of amorphous solid dispersions (ASDs) intended for immediate drug release systems, i.e. tablets. Comparative analysis of ASDs physical properties, stability,...

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Detalles Bibliográficos
Autor: Fradera Gelabert, Sara
Tipo de recurso: tesis doctoral
Fecha de publicación:2024
País:España
Institución:Universidad de Santiago de Compostela (USC)
Repositorio:Minerva. Repositorio Institucional de la Universidad de Santiago de Compostela
Idioma:inglés
OAI Identifier:oai:minerva.usc.gal:10347/34496
Acceso en línea:http://hdl.handle.net/10347/34496
Access Level:acceso abierto
Palabra clave:320908 Preparación de medicamentos
320902 Composición de medicamentos
Descripción
Sumario:In the present thesis, it is demonstrated the potential of fluid bed top-spray technology as an alternative to spray drying for the production of amorphous solid dispersions (ASDs) intended for immediate drug release systems, i.e. tablets. Comparative analysis of ASDs physical properties, stability, and dissolution profiles obtained via both technologies were conducted. The effect of formulation variables, using fluid bed, was evaluated guided by a Quality by Design (QbD) approach. Finally, three ASD-based prototypes produced using fluid bed top-spray and different polymeric carriers (HPMCAS-MG and HPMCP HP-55) were developed followed by an in vivo pilot bioavailability study comparing their pharmacokinetic behaviour with a marketed spray dried formulation.