title: Determination of useful ranges of mixing conditions for glycerin Fatty Acid ester by multiple regression analysis.
abstract: The interaction of the effects of the triglycerin full behenate (TR-FB) concentration and the mixing time on lubrication and tablet properties were analyzed under a two-factor central composite design, and compared with those of magnesium stearate (Mg-St). Various amounts of lubricant (0.07-3.0%) were added to granules and mixed for 1-30 min. A multiple linear regression analysis was performed to identify the effect of the mixing conditions on each physicochemical property. The mixing conditions did not significantly affect the lubrication properties of TR-FB. For tablet properties, tensile strength decreased and disintegration time increased when the lubricant concentration and the mixing time were increased for Mg-St. The direct interaction of the Mg-St concentration and the mixing time had a significant negative effect on the disintegration time. In contrast, any mixing conditions of TR-FB did not affect the tablet properties. In addition, the range of mixing conditions which satisfied the lubrication and tablet property criteria was broader for TR-FB than that for Mg-St, suggesting that TR-FB allows tablets with high quality attributes to be produced consistently. Therefore, TR-FB is a potential lubricant alternative to Mg-St.
authors.affiliation: Department of Pharmaceutical Engineering, School of Pharmaceutical Sciences, University of Shizuoka.
authors.forename: Takeaki
authors.initials: T
authors.lastname: Uchimoto
authors.forename: Yasunori
authors.initials: Y
authors.lastname: Iwao
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Hattori
authors.forename: Shuji
authors.initials: S
authors.lastname: Noguchi
authors.forename: Shigeru
authors.initials: S
authors.lastname: Itai
mesh_terms: D004339:Drug Compounding; D004952:Esters; D005227:Fatty Acids / Q000737:chemistry*; D008153:Lubrication; D012044:Regression Analysis; D013229:Stearic Acids / Q000737:chemistry; D013607:Tablets / Q000737:chemistry*; D013718:Tensile Strength
chemical_list: D004952:Esters; D005227:Fatty Acids; D013229:Stearic Acids; D013607:Tablets; C031183:stearic acid; C007547:behenic acid