Development of film coated orally disintegrating tablets “REMITCH<sup>®</sup> OD TABLETS 2.5µg

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  • Ohta Kotoe
    CMC Technical Dept., Manufacturing Division, Toray Industries, Inc.
  • Takaki Suguru
    CMC Technical Dept., Manufacturing Division, Toray Industries, Inc.
  • Minakami Satoshi
    CMC Technical Dept., Manufacturing Division, Toray Industries, Inc.
  • Fujisaki Yuki
    CMC Technical Dept., Manufacturing Division, Toray Industries, Inc.
  • Horiuchi Yasuhide
    CMC Technical Dept., Manufacturing Division, Toray Industries, Inc.

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Other Title
  • フィルムコーティング型口腔内崩壊錠 「レミッチ<sup>®</sup>OD錠2.5μg」の開発
  • DDS製品開発の最前線(39)フィルムコーティング型口腔内崩壊錠 「レミッチOD錠2.5μg」の開発
  • DDS セイヒン カイハツ ノ サイゼンセン(39)フィルムコーティングガタ コウコウ ナイ ホウカイジョウ 「 レミッチ ODジョウ 2.5mg 」 ノ カイハツ

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Description

The orally disintegrating tablets REMITCH® OD TABLETS 2.5µg composing Nalfurafine hydrochloride was launched. The composition rate of the active ingredient is extremely low and the Nalfurafine is unstable for temperature, humidity and light. To overcome these difficulties, the original film coating technology for OD tablets “RADIFIL®” was developed and applied to “REMITCH® OD TABLETS 2.5µg”. The key technology of RADIFIL® and the bioequivalence study between REMITCH® CAPSULES 2.5μg and REMITCH® OD TABLETS 2.5µg was summarized in this report.

Journal

  • Drug Delivery System

    Drug Delivery System 34 (5), 390-393, 2019-11-25

    THE JAPAN SOCIETY OF DRUG DELIVERY SYSTEM

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