title: Rheological analysis and quantitative evaluation of wet kneaded wax matrix.
abstract: The properties of the wet kneaded wax matrix were evaluated using a compression tester, whereby a newly proposed sigma index for the plastic deformation was assessed in the pressure transmission diagram. The sigma index was indicative of a characteristic of the plastic yield point in the rheological behavior, and presented an initial and abrupt deformation of wet kneaded mass when the wet kneaded mass was subjected to the pressure. The value of sigma index was confirmed to decrease along with an increase in the plasticity of wet kneaded mass. The wet mass of wax matrix was prepared under various kneading time, and then extruded. The properties of the extruded granules such as pore volume, strength and dissolution were investigated. As a result, it was found that the sigma index decreased with an increase in kneading time. The granules with small value of sigma index showed few porosities, large strength and slow dissolution. It was demonstrated that the sigma index linked the characteristics of wet kneaded mass to the dissolution and the other granule properties. Existence of this link was revealed by sigma index evaluation relevant to the plasticity. The sigma index could be a decisive criterion to permit an in-process evaluation of the kneading progress quantitatively, and also useful for anticipating the dissolution of the final granules roughly.
authors.affiliation: Pharmaceutical R&D Group, Mitsubishi Pharma Corporation, Ibaraki, Japan. Abe.Hidaka@mg.m-pharma.co.jp
authors.forename: Hidaka
authors.initials: H
authors.lastname: Abe
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Suzuki
authors.forename: Ayako
authors.initials: A
authors.lastname: Ootsuki
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Ozaki
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Samemoto
authors.forename: Satoru
authors.initials: S
authors.lastname: Watano
mesh_terms: D019245:Compressive Strength; D004341:Drug Evaluation; D012212:Rheology / Q000379:methods; D014885:Waxes / Q000032:analysis* / Q000737:chemistry*
chemical_list: D014885:Waxes