Study on Adaptation of the Standard Formulation to the Direct Compression Method (1)—Comparison to Direct Compression Lactose and Wet Granulation Method—

DOI 4 Citations 35 References
  • Kato Hironobu
    Pharmacy Dept. Developmental Research Lab., Nippon Shinyaku Co., LTD.
  • Sunada Hisakazu
    Faculty of Pharmacy, Meijo University
  • Hasegawa Masaki
    Pharmaceutical Research Center, Industrial Research Division, Mie Pref. Science and Technology Promotion Center
  • Tanino Tadatsugu
    Settsu Plant, Shionogi & Co., LTD.
  • Ohkuma Moriyuki
    Drug Formulation Department Central Rcsearch Laboratories, Kaken Pharmaceutical Co., LTD.
  • Ueda Masumi
    Pharmaceutical Research & Technoligy Center Planning & Management Group, Dainippon Pharmaceutical Co., LTD.
  • Kato Yoshiteru
    Formulation Research Lab. Kawashima Research, Eisai Co., Ltd.

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  • 標準処方の直接打錠法への適応に関する検討(1)―直打用賦形剤並びに湿式造粒法との比較―

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<p>We defined the lactose/corn starch in a 7/3 mixture with 20 w/w% binder as the standard formulation for the dry compression method and investigated the adaptation of this formulation for the direct compression method. Powdered crystalline lactose monohydrate, which is generally used as an additive for solid dosage forms, and three kinds of direct compression lactose with differing physicochemical properties were used as lactose. Microcrystalline cellulose (PH-101) or low-substituted hydroxypropylcellulose (LH-21) were used as binder. Consequently, tablets that had sufficient hardness of 40 N or higher as well as disintegration ability within one minute were obtained using this formulation without using direct compression lactose. Moreover, these tablets had excellent characteristics compared with tablets obtained by the standard formulation for the wet granulation method. As for the binder, the hardness of tablets containing the microcrystalline cellulose was higher than that of the tablets containing the low-substitute hydroxypropylcellulose. However, the difference was not significant, and there were no differences in the disintegration time between those two tablets.</p>

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