Determination of Useful Ranges of Mixing Conditions for Glycerin Fatty Acid Ester by Multiple Regression Analysis

  • Uchimoto Takeaki
    Department of Pharmaceutical Engineering, School of Pharmaceutical Sciences, University of Shizuoka
  • Iwao Yasunori
    Department of Pharmaceutical Engineering, School of Pharmaceutical Sciences, University of Shizuoka
  • Hattori Hiroaki
    Department of Pharmaceutical Engineering, School of Pharmaceutical Sciences, University of Shizuoka
  • Noguchi Shuji
    Department of Pharmaceutical Engineering, School of Pharmaceutical Sciences, University of Shizuoka
  • Itai Shigeru
    Department of Pharmaceutical Engineering, School of Pharmaceutical Sciences, University of Shizuoka

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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.

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