title: Possibility of monitoring granulation by analyzing the amount of hydroxypropylcellulose, a binder on the surface of granules, using ToF-SIMS.
abstract: The purpose of this study was to clarify the mechanism responsible for high-shear wet granulation using time-of-flight secondary ion mass spectrometry (ToF-SIMS), which can be used for surface chemical mapping. A total of 15 kinds of granules, including hydroxypropylcellulose (HPC) as a binder, were obtained in a model formulation using different granulation conditions, such as the amount of sprayed water and the granulation time. Surface chemical mapping of these granules was then performed using a ToF-SIMS analysis, which distinguishes each component by detecting the specific mass-to-charge ratio (m/z). As a result, we found that HPC got to appear on the surface of granule with proceeding wet granulation. By considering this result, we concluded that the distributions of HPC might be closely related to the progress of granule consolidation and growth in wet granulation. Therefore, the progress of granulation can likely be understood by measuring the content of HPC on the granule surface.
authors.affiliation: Pharmaceutics, Pharmaceutical Science Laboratories, Taisho Pharmaceutical Co. Ltd., 1-403 Yoshino-cho, Kita-ku, Saitama 331-9530, Japan. Electronic address: t-furudate@so.taisho.co.jp.
authors.forename: Takeaki
authors.initials: T
authors.lastname: Furudate
authors.affiliation: Pharmaceutics, Pharmaceutical Science Laboratories, Taisho Pharmaceutical Co. Ltd., 1-403 Yoshino-cho, Kita-ku, Saitama 331-9530, Japan.
authors.forename: Yuta
authors.initials: Y
authors.lastname: Kurasako
authors.affiliation: Pharmaceutics, Pharmaceutical Science Laboratories, Taisho Pharmaceutical Co. Ltd., 1-403 Yoshino-cho, Kita-ku, Saitama 331-9530, Japan.
authors.forename: Eriko
authors.initials: E
authors.lastname: Takata
authors.affiliation: Pharmaceutics, Pharmaceutical Science Laboratories, Taisho Pharmaceutical Co. Ltd., 1-403 Yoshino-cho, Kita-ku, Saitama 331-9530, Japan.
authors.forename: Taku
authors.initials: T
authors.lastname: Morishita
authors.affiliation: Pharmaceutics, Pharmaceutical Science Laboratories, Taisho Pharmaceutical Co. Ltd., 1-403 Yoshino-cho, Kita-ku, Saitama 331-9530, Japan.
authors.forename: Akio
authors.initials: A
authors.lastname: Miwa
authors.affiliation: Faculty of Pharmaceutical Sciences, Toho University, 2-2-1 Miyama, Funabashi, Chiba 274-8510, Japan.
authors.forename: Rei
authors.initials: R
authors.lastname: Suzuki
authors.affiliation: Faculty of Pharmaceutical Sciences, Toho University, 2-2-1 Miyama, Funabashi, Chiba 274-8510, Japan.
authors.forename: Katsuhide
authors.initials: K
authors.lastname: Terada
mesh_terms: D002482:Cellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004339:Drug Compounding / Q000379:methods; D005079:Excipients / Q000737:chemistry*; D018629:Spectrometry, Mass, Secondary Ion / Q000379:methods*; D013499:Surface Properties; D013678:Technology, Pharmaceutical / Q000379:methods; D014867:Water / Q000737:chemistry
chemical_list: D005079:Excipients; D014867:Water; D002482:Cellulose; C008079:hydroxypropylcellulose
keywords: Distribution; High-shear granulation; Hydroxypropylcellulose; Surface chemical mapping; ToF-SIMS