Preparation of Rapidly Disintegrating Tablet Using New Types of Microcrystalline Cellulose(PH-M Series)and Low Substituted-Hydroxypropylcellulose or Spherical Sugar Granules by Direct Compression Method

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概要

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• To decrease the sensation of roughness when a tablet, which is rapidly disintegrated by saliva(rapidly disintegrating tablet), is orally taken, we prepared rapidly disintegrating tablets using microcrystalline cellulose(Avicel PH-M series), a new type of pharmaceutical excipient that is spherical and has a very small particle size(particle size, 7-32 μm), instead of conventional microcrystalline cellulose(PH-102)used in the formulation of tablets containing acetaminophen or ascorbic acid as model drugs for tableting study. Tablets(200 mg)prepared using spherical microcrystalline cellulose, PH-M-06, with the smallest particle size(mean value, 7 μm)had sufficient crushing tolerance(approximately, 8 kg)and were very rapidly disintegrated(within 15 s)when the mixing ratio of PH-M-06 to low-substituted hydroxypropylcellulose(L-HPC) was 9:1. Sensory evaluation by volunteers showed that PH-M-06 was superior to PH-102 in terms of the feeling of roughness in the mouth. Consequently, it was found that particle size is an important factor for tablet preparation using microcrystalline cellulose. It is possible to prepare drugs such as acetaminophen and ascorbic acid(concentration of approximately 50%)in the tablet form using PH-M-06 in combination with L-HPC as a good disintegrant at a low compression force(1-6kN). To solve the problem of poor fluidity in the preparation of these tablets, we investigated the use of spherical sugar granules(Nonpareil^[○!R], NP-101(sucrose and starch, composition ratio of 7:3), NP-103(purified sucrose), NP-107(purified lactose)and NP-108(purified D-mannitol)). Rapidly disintegrating tablets can be prepared by the direct compression method when suitable excipients such as fine microcrystalline cellulose(PH-M-06)and spherical sugar granules(NP)are used.

• 公益社団法人日本薬学会の論文
• 2001-02-01

著者

• ISHIKAWA Tatsuya

  Department of Surgical Neurology, Research Institute for Brain and Blood Vessels-Akita

• Matsumoto M

  Osaka Medical Center For Cancer And Cardiovascular Diseases Osaka

• Matsumoto Misako

  Department Of Immunology Osaka Medical Center For Cancer And Cardiovascular Diseases

• Fujii Makiko

  Department of Pharmaceutics and Biopharmaceutics, Showa Pharmaceutical University

• Watanabe Yoshiteru

  Department of Pharmaceutics and Biopharmaceutics, Showa Pharmaceutical University

• Fujii Makiko

  Showa Pharmaceutical Univ.

• Fujii Makiko

  Department Of Chemistry Faculty Of Engineering Gifu University

• Matsumoto Mitsuo

  Department of Pharmaceutics, Showa Pharmaceutical University

• Fujii M

  Department Of Pharmaceutics And Biopharmaceutics Showa Pharmaceutical University

• Matsumoto Mitsuharu

  Takeda Chemical Industries Ltd. Pharmaceutical Research Division

• MUKAI Baku

  Department of Pharmaceutics and Biopharmaceutics, Showa Pharmaceutical University

• UTOGUCHI Naoki

  Department of Pharmaceutics and Biopharmaceutics, Showa Pharmaceutical University

• SHIRAISHI Shuji

  Department of Pharmaceutics and Biopharmaceutics, Showa Pharmaceutical University

• Ishikawa Tsutomu

  Dep. Of Medicinal Organic Chemistry Graduate School Of Pharmaceutical Sciences Chiba Univ.

• Ishikawa Tsutomu

  Graduate School Of Pharmaceutical Sciences Chiba University

• Fukuoka Masamichi

  Department Of Clinical Pharmacology And Toxicology Showa Pharmaceutical University

• Fukuoka Masamichi

  Division Of Medical Chemistry National Institute Of Hygienic Sciences

• Watanabe Yoshiteru

  Department Of Pharmaceutics And Biopharmaceutics Showa Pharmaceutical University

• Watanabe Y

  Showa Pharmaceutical Univ.

• Ishikawa T

  Graduate School Of Pharmaceutical Sciences Chiba University

• Mukai Baku

  Department Of Pharmaceutics And Biopharmaceutics Showa Pharmaceutical University

• Shirotake Shoichi

  Department Of Pharmaceutics And Biopharmaceutics Showa Pharmaceutical University

• Fujii M

  Showa Univ. Tokyo Jpn

• Matsumoto Mitsuo

  Department Of Pharmaceutics Showa Pharmaceutical University

• Ishikawa Tsutomu

  Graduate School Of Pharmaceutical Sciences Chiba Univ.

• Watanabe Yoshiteru

  Showa Pharmaceutical Univ.

• Ishikawa Tatsuya

  Department Of Neonatology And Pediatrics Nagoya City University Graduate School Of Medical Sciences

• Utoguchi Naoki

  Department Of Biopharmaceutics School Of Pharmaceutical Sciences Teikyo University

• Matsumoto Mitsuhiro

  First Department Of Internal Medicine Kumamoto University School Of Medicine

• Matsumoto Mitsuo

  Department Of Pharmaceutics And Biopharmaceutics Showa Pharmaceutical University

• Ishikawa Tatsuya

  Department Of Civil Engineering Nagoya University

• Ishikawa Tatsuya

  Department Of Applied Chemistry Faculty Of Science Science University Of Tokyo

• Shiraishi Shuji

  Department Of Information Systems Graduate School Of Engineering Science Kyushu University

• Shiraishi Shuji

  Department Of Pharmaceutics And Biopharmaceutics Showa Pharmaceutical University

• Matsumoto Mitsuo

  Department Of Ophthalmology Hirosaki University School Of Medicine

• Ishikawa Toshihisa

  Department of Biomolecular Engineering, Graduate School of Bioscience and Biotechnology, Tokyo Institute of Technology

• Ishikawa Toshihisa

  Graduate School of Pharmaceutical Sciences, Chiba University

• Matsumoto Mitsuo

  Department of Hydrocarbon Chemistry, Faculty of Engineering, Kyoto University

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