title: Quantitative Appearance Inspection for Film Coated Tablets.
abstract: The decision criteria for the physical appearance of pharmaceutical products are subjective and qualitative means of evaluation that are based entirely on human interpretation. In this study, we have developed a comprehensive method for the quantitative analysis of the physical appearance of film coated tablets. Three different kinds of film coated tablets with considerable differences in their physical appearances were manufactured as models, and their surface roughness, contact angle, color measurements and physicochemical properties were investigated as potential characteristics for the quantitative analysis of their physical appearance. All of these characteristics were useful for the quantitative evaluation of the physical appearances of the tablets, and could potentially be used to establish decision criteria to assess the quality of tablets. In particular, the analysis of the surface roughness and film coating properties of the tablets by terahertz spectroscopy allowed for an effective evaluation of the tablets' properties. These results indicated the possibility of inspecting the appearance of tablets during the film coating process.
authors.affiliation: Pharmaceutical Research & Technology Laboratories, Astellas Pharma Inc.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Yoshino
authors.forename: Kazunari
authors.initials: K
authors.lastname: Yamashita
authors.forename: Yasunori
authors.initials: Y
authors.lastname: Iwao
authors.forename: Shuji
authors.initials: S
authors.lastname: Noguchi
authors.forename: Shigeru
authors.initials: S
authors.lastname: Itai
mesh_terms: D002627:Chemistry, Physical; D013499:Surface Properties; D013608:Tablets, Enteric-Coated / Q000737:chemistry* / Q000592:standards*; D055068:Terahertz Spectroscopy
chemical_list: D013608:Tablets, Enteric-Coated