Formulation Study for Lansoprazole Fast-disintegrating Tablet(3)Design of Rapidly Disintegrating Tablets

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  • Shimizu Toshihiro
    Pharmaceutical Development Laboratories, Pharmaceutical Production Division, Takeda Chemical Industries, Ltd.
  • Sugaya Masae
    Pharmaceutical Development Laboratories, Pharmaceutical Production Division, Takeda Chemical Industries, Ltd.
  • Nakano Yoshinori
    Pharmaceutical Development Laboratories, Pharmaceutical Production Division, Takeda Chemical Industries, Ltd.
  • Izutsu Daisuke
    Pharmaceutical Development Laboratories, Pharmaceutical Production Division, Takeda Chemical Industries, Ltd.
  • Mizukami Yoshio
    Pharmaceutical Development Laboratories, Pharmaceutical Production Division, Takeda Chemical Industries, Ltd.
  • Okochi Kazuhiro
    Pharmaceutical Development Laboratories, Pharmaceutical Production Division, Takeda Chemical Industries, Ltd.
  • Tabata Tetsuro
    Pharmaceutical Development Laboratories, Pharmaceutical Production Division, Takeda Chemical Industries, Ltd.
  • Hamaguchi Naoru
    Pharmaceutical Development Laboratories, Pharmaceutical Production Division, Takeda Chemical Industries, Ltd.
  • Igari Yasutaka
    Pharmaceutical Development Laboratories, Pharmaceutical Production Division, Takeda Chemical Industries, Ltd.

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タイトル別名
  • Formulation Study for Lansoprazole Fast-disintegrating Tablet. III. Design of Rapidly Disintegrating Tablets

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説明

Lansoprazole fast-disintegrating tablets (LFDT) are a patient-friendly formulation that rapidly disintegrates in the mouth. LFDT consist of enteric-coated microgranules (mean particle size, approximately 300 μm) and inactive granules. In the design of the inactive granules, mannitol was used as a basic excipient. Microcrystalline cellulose, low-substituted hydroxypropyl cellulose (L-HPC), and crospovidone were used as binders and disintegrants. A new grade of L-HPC (L-HPC-33), with a hydroxypropoxy group content of 5.0—6.9%, was developed and it has no rough texture due to a decrease in water absorption. It was clarified that L-HPC-33 could be useful as a binder and disintegrant in rapidly disintegrating tablets. LFDT contain enteric-coated microgranules in tablet form. The enteric-coated microgranule content in LFDT affect qualities such as tensile strength, disintegration time in the mouth, and dissolution behavior in the acid stage and in the buffer stage of LFDT. The 47.4% content of the enteric-coated microgranules was selected to give sufficient tensile strength (not less than 30 N/cm2), rapid disintegration time in the mouth (not more than 30 s), and dissolution behavior in the acid stage and buffer stage similar to current lansoprazole capsules. Compression force affected the tensile strength and the disintegration time in the mouth, but did not affect the dissolution behavior in the acid and buffer stages.

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