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Continuous twin screw granulation: Robustness of lactose/MCC-based formulations.
Portier, Christoph; De Vriendt, Charlotte; Vigh, Tamas; Di Pretoro, Giustino; De Beer, Thomas; Vervaet, Chris; Vanhoorne, Valérie.
Afiliación
  • Portier C; Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
  • De Vriendt C; Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
  • Vigh T; Pharmaceutical Research and Development, Division of Janssen Pharmaceutica, Johnson & Johnson, Turnhoutseweg 30, B-2340 Beerse, Belgium.
  • Di Pretoro G; 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 ; 588: 119756, 2020 Oct 15.
Article en En | MEDLINE | ID: mdl-32783981
In recent years, significant progress has been made in the field of continuous twin screw granulation. However, only limited knowledge is currently available on the impact of active pharmaceutical ingredient (API) properties on granule quality and processability. In this study, the response behavior of four formulations containing APIs (5-10% drug load) with diverse characteristics was compared to the behavior of the corresponding placebo formulation consisting of lactose, microcrystalline cellulose (MCC) and hydroxypropylmethylcellulose (HPMC). API selection was based on extensive material characterization, combining conventional testing with in silico descriptors. For each formulation, a design of experiments was set up, evaluating the impact of liquid to solid (L/S) ratio and screw speed. Response ranges, response behavior and processability of each of the four formulations proved very similar to the placebo formulation when an appropriate center point L/S ratio was chosen. Hence, this robust placebo formulation could prove useful by decreasing drug product development time and consequently providing patients with a faster access to innovative medicine. Additionally, APIs with similar properties exhibited highly comparable response behavior at similar L/S ratios, indicating the potential use of surrogate APIs in novel drug product development.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Celulosa / Lactosa Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Int J Pharm Año: 2020 Tipo del documento: Article País de afiliación: Bélgica Pais de publicación: Países Bajos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Celulosa / Lactosa Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Int J Pharm Año: 2020 Tipo del documento: Article País de afiliación: Bélgica Pais de publicación: Países Bajos