title: Prediction of suitable amounts of water in fluidized bed granulation of pharmaceutical formulations using corresponding values of components.
abstract: This study describes application of a newly developed method to the fluidized bed granulation. The method is based on predicting suitable amounts of water to be added to multi-component formulations using the corresponding values of components prior to granulation trials. The range of appropriate amount of water for each component in a model formulation was estimated in our previous studies with a refractive near-infrared (NIR) moisture sensor. Using those values, we calculated the range of suitable amount of water to add for the model pharmaceutical formulation. In this study, we examined the relationship between the amount of water added to the model formulation and the NIR sensor output value. Then, we performed fluidized bed granulation of the model formulation at steady-state moisture content levels under monitoring with NIR sensor, within and beyond the suitable range of added water that was calculated from the corresponding range of each component. For the model formulation, we found that the predicted values for suitable amounts of added water well corresponded to those in the granulation trials, suggesting that this predictive method may be useful in estimating suitable amounts of water to be added to formulations before fluidized bed granulation trials.
authors.affiliation: Pharmaceutical Technology Laboratories, Taisho Pharmaceutical Co. Ltd., 403, Yoshino-cho 1-chome, Kita-ku, Saitama-shi, Saitama 331-9530, Japan. akio.miwa@po.rd.taisho.co.jp
authors.forename: Akio
authors.initials: A
authors.lastname: Miwa
authors.forename: Toshio
authors.initials: T
authors.lastname: Yajima
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ikuta
authors.forename: Kouji
authors.initials: K
authors.lastname: Makado
mesh_terms: D002626:Chemistry, Pharmaceutical; D004867:Equipment Design; D005079:Excipients / Q000737:chemistry*; D008956:Models, Chemical; D011208:Powders; D015203:Reproducibility of Results; D019265:Spectroscopy, Near-Infrared; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods*; D014867:Water / Q000737:chemistry*
chemical_list: D005079:Excipients; D011208:Powders; D013607:Tablets; D014867:Water