title: Evaluation of models for predicting spray mist diameter for scaling-up of the fluidized bed granulation process.
abstract: We evaluated models for predicting spray mist diameter suitable for scaling-up the fluidized bed granulation process. By precise selection of experimental conditions, we were able to identify a suitable prediction model that considers changes in binder solution, nozzle dimension, and spray conditions. We used hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC), or polyvinylpyrrolidone (PVP) binder solutions, which are commonly employed by the pharmaceutical industry. Nozzle dimension and spray conditions for oral dosing were carefully selected to reflect manufacturing and small (1/10) scale process conditions. We were able to demonstrate that the prediction model proposed by Mulhem optimally estimated spray mist diameter when each coefficient was modified. Moreover, we developed a simple scale-up rule to produce the same spray mist diameter at different process scales. We confirmed that the Rosin-Rammler distribution could be applied to this process, and that its distribution coefficient was 1.43-1.72 regardless of binder solution, spray condition, or nozzle dimension.
authors.affiliation: Department of Chemical Science and Engineering, Faculty of Engineering, Kobe University, 1–1 Rokkodai-cho,Nada, Kobe 657–8501, Japan. maya.fujiwara@astellas.com
authors.forename: Maya
authors.initials: M
authors.lastname: Fujiwara
authors.forename: Masafumi
authors.initials: M
authors.lastname: Dohi
authors.forename: Tomoko
authors.initials: T
authors.lastname: Otsuka
authors.forename: Kazunari
authors.initials: K
authors.lastname: Yamashita
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Sako
mesh_terms: D002482:Cellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D004339:Drug Compounding; D005079:Excipients / Q000737:chemistry*; D065347:Hypromellose Derivatives; D008747:Methylcellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D008956:Models, Chemical; D010316:Particle Size; D011205:Povidone / Q000737:chemistry*; D014867:Water / Q000737:chemistry
chemical_list: D005079:Excipients; D014867:Water; D065347:Hypromellose Derivatives; D002482:Cellulose; D008747:Methylcellulose; C008079:hydroxypropylcellulose; D011205:Povidone