Application of Tumbling Melt Granulation (TMG) Method to Prepare Controlled-Release Fine Granules

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概要

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• The tumbling melt granulation (TMG) method was applied to prepare controlled-release fine granules of diltiazem hydrochloride (DH). The entire process, from the preparation of the cores by the adherence of DH to the sucrose crystal to the subsequent coating of the controlled-release layer, was performed without using any solvent. A mixture of meltable material, talc, and ethylcellulose was used for the controlled-release layer and controlled-release fine granules approximately 400μm in diameter were obtained with excellent producibility. The dissolution rate of DH from these fine granules was similar to that of a once-a-day dosage form obtained in the merket; further, the dependency of the dissolution profile on pH of the media was less. Thus, it was concluded that this TMG method was very useful for preparing not only controlled-release beads of granule size (usually 500 to 1400μm) but also fine granules.

• 公益社団法人日本薬学会の論文
• 1998-03-15

著者

• KOBAYASHI MASAO

  Pharmaceutics Division Department, Product & Technology Development Laboratory, Tanabe Seiyaku Co.,

• Kobayashi M

  Fujisawa Pharmaceutical Co. Ltd. :(peresent Address)fujisawa Research Insitute Of America Inc. North

• Osawa T

  Laboratory Of Food And Biodynamics Nagoya University Graduate School Of Bioagricultural Sciences

• Osawa T

  Pharmaceutical Research Laboratory Tanabe Seiyaku Co. Ltd.

• Osawa Takashi

  Pharmaceutics Research Laboratory Tanabe Seiyaku Co. Ltd.

• Kobayashi M

  Faculty Of Pharmaceutical Sciences Osaka University

• Kobayashi Masao

  Pharmaceutical Research Laboratory Tanabe Seiyaku Co. Ltd.

• Kobayashi M

  Graduate School Of Pharmaceutical Sciences Osaka University

• MAEJIMA Toru

  Pharmaceutics Research Laboratory, Tanabe Seiyaku Co., Ltd.

• 小林 資正

  Graduate School Of Pharmaceutical Sciences Osaka University

• Maejima T

  Pharmaceutical Research Laboratory Tanabe Seiyaku Co. Ltd.

• Maejima Toru

  Pharmaceutics Research Laboratory Tanabe Seiyaku Co. Ltd.

• Osawa Takashi

  Pharmaceutics Department Cmc Research Laboratory Tanabe Seiyaku Co Ltd

• KUBO Masashi

  Pharmaceutics Research Laboratory, Tanabe Seiyaku Co., Ltd.,

• NAKAJIMA Kingo

  Pharmaceutics Research Laboratory, Tanabe Seiyaku Co., Ltd.,

• Kawaguchi M

  Graduate School Of Pharmaceutical Sciences Osaka University

• Nakajima K

  Sankyo Co. Ltd. Tokyo Jpn

• Nakajima Kingo

  Pharmaceutical Research Laboratory, Tanabe Seiyaku Co., Ltd.,

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