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Formulation of novel functional dosage forms by spary congealing method.

Research Project

Project/Area Number 23590047
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Physical pharmacy
Research InstitutionUniversity of Shizuoka

Principal Investigator

ITAI Shigeru  静岡県立大学, 薬学部, 教授 (80453059)

Co-Investigator(Kenkyū-buntansha) IWAO Yasunori  静岡県立大学, 薬学部, 助教 (30433022)
Project Period (FY) 2011 – 2013
Project Status Completed (Fiscal Year 2013)
Budget Amount *help
¥4,940,000 (Direct Cost: ¥3,800,000、Indirect Cost: ¥1,140,000)
Fiscal Year 2013: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2012: ¥2,470,000 (Direct Cost: ¥1,900,000、Indirect Cost: ¥570,000)
Fiscal Year 2011: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
Keywords噴霧凝固造粒 / 放出制御 / 苦味マスキング / 大腸デリバリー / 微粒子設計 / 薬学 / 化学工学 / 材料加工・処理 / 設計工学 / 複合材料・物性
Research Abstract

By using spray congealing method, a taste masking technology with gastro-dissolvable polymer and low-melting-point material, a colon delivery system employing enteric polymer and low-melting-point material and a controlled release technology forming micropores dispersing sugars with various particle sizes were established. Furthermore, the optimization of formulation was carried out for each technology by applying multiple linear regression analysis. The spherical matrixes with optimum formula were manufactured by spray congealing method. As a result, each preparation exhibited intended release performance and both predictive and experimental data coincided with each other.

Report

(4 results)
  • 2013 Annual Research Report   Final Research Report ( PDF )
  • 2012 Research-status Report
  • 2011 Research-status Report
  • Research Products

    (53 results)

All 2014 2013 2012 2011

All Journal Article (15 results) (of which Peer Reviewed: 9 results) Presentation (33 results) (of which Invited: 3 results) Book (5 results)

  • [Journal Article] Investigation of internal structure of fine granules by microtomography using synchrotron X-ray radiation2013

    • Author(s)
      Noguchi, S., Kajihara, R., Iwao, Y., Fujinami, Y., Suzuki, Y., Terada, Y., Uesugi, K., Miura, K., Itai, S.
    • Journal Title

      Int. J. Pharm

      Volume: 445 Pages: 93-98

    • Related Report
      2013 Final Research Report
  • [Journal Article] Determination of useful ranges of mixing conditions for glycerin fatty acid ester by multiple regression analysis2013

    • Author(s)
      Uchimoto, T., Iwao, Y., Hattori, H., Noguchi, S., Itai, S.
    • Journal Title

      Chem. Pharm. Bull

      Volume: 61 (11) Pages: 1143-1148

    • NAID

      130003381780

    • Related Report
      2013 Final Research Report
  • [Journal Article] Investigation of internal structure of fine granules by microtomography using synchrotron X-ray radiation2013

    • Author(s)
      Noguchi, S., Kajihara, R., Iwao, Y., Fujinami, Y., Suzuki, Y., Terada, Y., Uesugi, K., Miura, K., Itai, S.,
    • Journal Title

      Int. J. Pharm.

      Volume: 445 Issue: 1-2 Pages: 93-98

    • DOI

      10.1016/j.ijpharm.2013.01.048

    • Related Report
      2013 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Determination of Useful Ranges of Mixing Conditions for Glycerin Fatty Acid Ester by Multiple Regression Analysis2013

    • Author(s)
      Uchimoto, T., Iwao, Y., Hattori, H., Noguchi, S., Itai, S.
    • Journal Title

      Chemical and Pharmaceutical Bulletin

      Volume: 61 Issue: 11 Pages: 1143-1148

    • DOI

      10.1248/cpb.c13-00472

    • NAID

      130003381780

    • ISSN
      0009-2363, 1347-5223
    • Related Report
      2013 Annual Research Report
    • Peer Reviewed
  • [Journal Article] A novel mathematical model considering change of diffusion coefficient for predicting dissolution behavior of acetaminophen from wax matrix dosage form2012

    • Author(s)
      Nitanai, Y., Agata, Y., Iwao, Y., Itai, S.
    • Journal Title

      Int. J. Pharm

      Volume: 428 Pages: 82-90

    • Related Report
      2013 Final Research Report
  • [Journal Article] Preparation and evaluation of granules with pH-dependent release by melt granulation2012

    • Author(s)
      Shiino, K., Iwao, Y., Fujinami, Y.,Itai, S.
    • Journal Title

      Int. J. Pharm

      Volume: 431 Pages: 70-77

    • Related Report
      2013 Final Research Report
  • [Journal Article] "Clarithromycin monohydrate: a synchrotron X-ray powder study,"2012

    • Author(s)
      Noguchi, S., Fujiki, S., Iwao, Y., Miura, K., Itai, S.
    • Journal Title

      Acta Crystallographica Section E

      Volume: 68 Pages: 667-668

    • Related Report
      2012 Research-status Report
    • Peer Reviewed
  • [Journal Article] " A novel mathematical model considering change of diffusion coefficient for predicting dissolution behavior of acetaminophen from wax matrix dosage form,"2012

    • Author(s)
      Nitanai, Y., Agata, Y., Iwao, Y., Itai, S.,
    • Journal Title

      International Journal of Pharmaceutics

      Volume: 428 Pages: 82-90

    • Related Report
      2012 Research-status Report
    • Peer Reviewed
  • [Journal Article] "Structure of clarithromycin form I determined by synchrotron X-ray powder diffraction,"2012

    • Author(s)
      Noguchi, S., Miura, K., Fujiki, S., Iwao, Y., Itai, S.,
    • Journal Title

      Acta Crystallographica Section C

      Volume: 68 Pages: 41-44

    • Related Report
      2012 Research-status Report
    • Peer Reviewed
  • [Journal Article] " Preparation and evaluation of granules with pH-dependent release by melt granulation,"2012

    • Author(s)
      Shiino, K., Iwao, Y., Fujinami, Y.,Itai, S.,
    • Journal Title

      International Journal of Pharmaceutics

      Volume: 431 Pages: 70-77

    • Related Report
      2012 Research-status Report
    • Peer Reviewed
  • [Journal Article] Application of principal component analysis enables to effectively find important physical variables for optimization of fluid bed granulator conditions2011

    • Author(s)
      Otsuka, T., Iwao, Y., Miyagishima, A., Itai, S.
    • Journal Title

      Int. J. Pharm

      Volume: 409 Pages: 81-88

    • Related Report
      2013 Final Research Report
  • [Journal Article] A theoretical approach to evaluate the release rate of acetaminophen from erosive wax matrix dosage forms2011

    • Author(s)
      Agata, Y., Iwao, Y., Shiino, K., Miyagishima, A., Itai, S.
    • Journal Title

      Int. J. Pharm

      Volume: 414 Pages: 63-68

    • Related Report
      2013 Final Research Report
  • [Journal Article] Application of principal component analysis enables to effectively find important physical variables for optimization of fluid bed granulator conditions2011

    • Author(s)
      Otsuka T, Iwao Y, Miyagishima A, Itai S.
    • Journal Title

      International Journal of Pharmaceutics

      Volume: 409 Pages: 81-88

    • URL

      http://www.ncbi.nlm.nih.gov/pubmed/21371547

    • Related Report
      2011 Research-status Report
    • Peer Reviewed
  • [Journal Article] A theoretical approach to evaluate the release rate of acetaminophen from erosive wax matrix dosage forms2011

    • Author(s)
      Agata Y, Iwao Y, Shiino K, Miyagishima A, Itai S.
    • Journal Title

      International Journal of Pharmaceutics

      Volume: 414 Pages: 63-68

    • URL

      http://www.ncbi.nlm.nih.gov/pubmed/21596120

    • Related Report
      2011 Research-status Report
    • Peer Reviewed
  • [Journal Article] Stabilization mechanism of clarithromycin tablets under gastric pH conditions2011

    • Author(s)
      Fujiki S, Iwao Y, Kobayashi M, Miyagishima A, Itai S.
    • Journal Title

      Chem Pharm Bull (Tokyo)

      Volume: 59 Pages: 553-558

    • NAID

      130000648868

    • URL

      http://www.ncbi.nlm.nih.gov/pubmed/21532191

    • Related Report
      2011 Research-status Report
    • Peer Reviewed
  • [Presentation] 潰瘍性大腸炎治療を目的とした、ワックスマトリックス製剤の設計と評価2014

    • Author(s)
      園部芙史、岩尾康範、野口修治、板井茂
    • Organizer
      日本薬学会第134年会講演要旨集
    • Place of Presentation
      熊本 (p.185)
    • Year and Date
      2014-03-30
    • Related Report
      2013 Final Research Report
  • [Presentation] 潰瘍性大腸炎治療を目的とした、ワックスマトリックス製剤の設計と評価2014

    • Author(s)
      園部芙史、岩尾康範、野口修治、板井茂
    • Organizer
      日本薬学会第134年会
    • Place of Presentation
      熊本
    • Related Report
      2013 Annual Research Report
  • [Presentation] 新規chitosan誘導体コーティング液を用いた薬物の大腸への特異的送達2013

    • Author(s)
      山田恭平、岩尾康範、野口修治、板井茂
    • Organizer
      第30回製剤と粒子設計シンポジウム講演要旨集
    • Place of Presentation
      岐阜 (p.158)
    • Year and Date
      2013-10-18
    • Related Report
      2013 Final Research Report
  • [Presentation] 新規キトサン誘導体/ラウレート塩の大腸デリバリーコーティング基剤としての応用2013

    • Author(s)
      山田恭平、岩尾康範、野口修治、板井茂
    • Organizer
      製剤機械技術学会第23回大会プログラム集
    • Place of Presentation
      東京 (p.221)
    • Year and Date
      2013-10-10
    • Related Report
      2013 Final Research Report
  • [Presentation] 放射光X線CT法を用いた薬物含有微小球形粒子の構造解析2013

    • Author(s)
      梶原隆介、野口修治、岩尾康範、鈴木芳生、寺田靖子、上杉健太朗、板井茂
    • Organizer
      製剤機械技術学会第23回大会プログラム集
    • Place of Presentation
      東京 (p.221)
    • Year and Date
      2013-10-10
    • Related Report
      2013 Final Research Report
  • [Presentation] Investigation of the Internal Structure of Tablets by Microtomography Using Synchrotron X-ray Radiation2013

    • Author(s)
      Ryusuke Kajihara, Shuji Noguchi, Yasunori Iwao, Yoshio Suzuki, Yasuko Terada, Kentaro Uesugi and Shigeru Itai
    • Organizer
      The 10th International Symposium on Agglomeration Proceedings,P-24
    • Place of Presentation
      Kobe, Japan
    • Year and Date
      2013-09-03
    • Related Report
      2013 Final Research Report
  • [Presentation] Preparation and Evaluation of Chitosan-Based Coating Dispersions as Colon-Specific Drug Delivery System2013

    • Author(s)
      Kyohei Yamada, Yasunori Iwao, Shuji Noguchi, and Shigeru Itai
    • Organizer
      The 10th International Symposium on Agglomeration Proceedings,P-9
    • Place of Presentation
      Kobe, Japan
    • Year and Date
      2013-09-03
    • Related Report
      2013 Final Research Report
  • [Presentation] 撹拌溶融造粒法を用いた低融点薬物含有粒子の調製と評価2013

    • Author(s)
      岩尾康範、藤浪友加里、野口修治、板井茂
    • Organizer
      日本薬剤学会第28年会プログラム集
    • Place of Presentation
      名古屋 (p.325)
    • Year and Date
      2013-05-25
    • Related Report
      2013 Final Research Report
  • [Presentation] 大腸デリバリーを目的とした新規chitosan誘導体コーティング液の調製と評価2013

    • Author(s)
      山田恭平、岩尾康範、野口修治、板井茂
    • Organizer
      日本薬剤学会第28年会プログラム集
    • Place of Presentation
      名古屋 (p.229)
    • Year and Date
      2013-05-23
    • Related Report
      2013 Final Research Report
  • [Presentation] 多孔質賦形剤と用いた撹拌溶融造粒による低融点薬物含有粒子の調製2013

    • Author(s)
      藤浪友加里、岩尾康範、野口修治、板井茂
    • Organizer
      日本薬学会第133年会プログラム集
    • Place of Presentation
      横浜 (p.172)
    • Year and Date
      2013-03-28
    • Related Report
      2013 Final Research Report
  • [Presentation] 賦形剤の粉砕処理と造粒条件が撹拌溶融造粒物の内部構造に及ぼす影響2013

    • Author(s)
      内本武亮、梶原隆介、岩尾康範、野口修治、寺田靖子、鈴木芳生、三浦圭子、板井茂
    • Organizer
      日本薬学会第133年会プログラム集
    • Place of Presentation
      横浜 (p.171)
    • Year and Date
      2013-03-28
    • Related Report
      2013 Final Research Report
  • [Presentation] 放射光X線CT法による薬物含有微小球形粒子の内部構造解析法の評価2013

    • Author(s)
      梶原隆介、野口修治、岩尾康範、鈴木芳生、寺田靖子、上杉健太朗、三浦圭子、板井茂
    • Organizer
      日本薬学会第133年会プログラム集
    • Place of Presentation
      横浜 (p.91)
    • Year and Date
      2013-03-28
    • Related Report
      2013 Final Research Report
  • [Presentation] 口腔内崩壊錠の製剤設計2013

    • Author(s)
      板井茂
    • Organizer
      富山県薬事研究所講演会
    • Place of Presentation
      富山
    • Related Report
      2013 Annual Research Report
    • Invited
  • [Presentation] 撹拌溶融造粒法を用いた低融点薬物含有粒子の調製と評価2013

    • Author(s)
      岩尾康範、藤浪友加里、野口修治、板井茂
    • Organizer
      日本薬剤学会第28年会
    • Place of Presentation
      名古屋
    • Related Report
      2013 Annual Research Report
  • [Presentation] Preparation and Evaluation of Chitosan-Based Coating Dispersions as Colon-Specific Drug Delivery System2013

    • Author(s)
      Kyohei Yamada, Yasunori Iwao, Shuji Noguchi, and Shigeru Itai
    • Organizer
      The 10th International Symposium on Agglomeration
    • Place of Presentation
      Kobe
    • Related Report
      2013 Annual Research Report
  • [Presentation] 放射光X線CT法を用いた薬物含有微小球形粒子の構造解析2013

    • Author(s)
      梶原隆介、野口修治、岩尾康範、鈴木芳生、寺田靖子、上杉健太朗、板井茂
    • Organizer
      製剤機械技術学会 第23回大会
    • Place of Presentation
      東京
    • Related Report
      2013 Annual Research Report
  • [Presentation] 新規キトサン誘導体/ラウレート塩の大腸デリバリーコーティング基剤としての応用2013

    • Author(s)
      山田恭平、岩尾康範、野口修治、板井茂
    • Organizer
      製剤機械技術学会 第23回大会
    • Place of Presentation
      東京
    • Related Report
      2013 Annual Research Report
  • [Presentation] 新規chitosan誘導体コーティング液を用いた薬物の大腸への特異的送達2013

    • Author(s)
      山田恭平、岩尾康範、野口修治、板井茂
    • Organizer
      第30回製剤と粒子設計シンポジウム
    • Place of Presentation
      岐阜
    • Related Report
      2013 Annual Research Report
  • [Presentation] "放射光X線CT法による薬物含有微小球形粒子の内部構造解析法の評価"2013

    • Author(s)
      梶原隆介、野口修治、岩尾康範、鈴木芳生、寺田靖子、上杉健太朗、三浦圭子、板井茂
    • Organizer
      日本薬学会第133年会
    • Place of Presentation
      横浜
    • Related Report
      2012 Research-status Report
  • [Presentation] "賦形剤の粉砕処理と造粒条件が撹拌溶融造粒物の内部構造に及ぼす影響"2013

    • Author(s)
      内本武亮、梶原隆介、岩尾康範、野口修治、寺田靖子、鈴木芳生、三浦圭子、板井茂
    • Organizer
      日本薬学会第133年会
    • Place of Presentation
      横浜
    • Related Report
      2012 Research-status Report
  • [Presentation] 加熱溶融造粒法を用いた新規製剤開発とその評価2012

    • Author(s)
      岩尾康範
    • Organizer
      創剤カンファレンス静岡
    • Place of Presentation
      静岡
    • Year and Date
      2012-12-14
    • Related Report
      2013 Final Research Report
    • Invited
  • [Presentation] 大腸への薬物送達を目的とした噴霧凝固造粒法による新規ワックスマトリックス製剤の設計と評価2012

    • Author(s)
      園部芙史、岩尾康範、野口修治、板井茂
    • Organizer
      第22回日本病院薬剤師会東海ブロック学術大会
    • Place of Presentation
      岐阜(平成24年度日本薬学会東海支部例会学術合同大会要旨集p.108)
    • Year and Date
      2012-11-18
    • Related Report
      2013 Final Research Report
  • [Presentation] 撹拌溶融造粒法の操作条件が造粒物の物性・内部構造に及ぼす影響―放射光X線CTによる非破壊的評価―2012

    • Author(s)
      内本武亮、梶原隆介、岩尾康範、野口修治、寺田靖子、鈴木芳生、三浦圭子、板井茂
    • Organizer
      第29回製剤と粒子設計シンポジウム要旨集
    • Place of Presentation
      愛知 (p.174-175)
    • Year and Date
      2012-10-26
    • Related Report
      2013 Final Research Report
  • [Presentation] 拡散理論を応用したワックスマトリックス製剤の物性評価に関する研究:経時的内部構造変化を反映した解析2012

    • Author(s)
      板井茂、似内雄太、阿形泰義、岩尾康範、野口修治
    • Organizer
      日本薬剤学会第27年会プログラム集
    • Place of Presentation
      神戸 (p.298)
    • Year and Date
      2012-05-24
    • Related Report
      2013 Final Research Report
  • [Presentation] "pH感受性ポリマーを用いた苦味マスキング製剤の設計と評価"2012

    • Author(s)
      清水裕介、古田翔士、岩尾康範、野口修治、板井茂
    • Organizer
      日本薬剤学会第27年会
    • Place of Presentation
      神戸
    • Related Report
      2012 Research-status Report
  • [Presentation] "拡散理論を応用したワックスマトリックス製剤の物性評価に関する研究:経時的内部構造変化を反映した解析"2012

    • Author(s)
      板井茂、似内雄太、阿形泰義、岩尾康範、野口修治
    • Organizer
      日本薬剤学会第27年会
    • Place of Presentation
      神戸
    • Related Report
      2012 Research-status Report
  • [Presentation] "撹拌溶融造粒法の操作条件が微小球形粒子の製造に及ぼす影響"2012

    • Author(s)
      内本武亮、岩尾康範、野口修治、板井茂
    • Organizer
      第58回日本薬学会東海支部総会・大会
    • Place of Presentation
      静岡
    • Related Report
      2012 Research-status Report
  • [Presentation] "Melt granulationによるコーティング用核粒子の設計と評価"2012

    • Author(s)
      青木肇、藤浪友加里、岩尾康範、野口修治、板井茂
    • Organizer
      第58回日本薬学会東海支部総会・大会
    • Place of Presentation
      静岡
    • Related Report
      2012 Research-status Report
  • [Presentation] "撹拌溶融造粒法の操作条件が造粒物の物性・内部構造に及ぼす影響―放射光X線CTによる非破壊的評価―"2012

    • Author(s)
      内本 武亮、梶原 隆介、岩尾 康範、野口 修治、寺田靖子、鈴木芳生、三浦圭子、板井 茂
    • Organizer
      第29回製剤と粒子設計シンポジウム
    • Place of Presentation
      愛知
    • Related Report
      2012 Research-status Report
  • [Presentation] "大腸への薬物送達を目的とした噴霧凝固造粒法による新規ワックスマトリックス製剤の設計と評価"2012

    • Author(s)
      園部 芙史、岩尾 康範、野口 修治、板井 茂
    • Organizer
      平成24年度日本薬学会東海支部例会学術合同大会
    • Place of Presentation
      岐阜
    • Related Report
      2012 Research-status Report
  • [Presentation] Taste masking by spray congealing technology2011

    • Author(s)
      Shigeru Itai
    • Organizer
      Asian Federation for Pharmaceutical Sciences 2011
    • Place of Presentation
      Kuala Lumpur, Malaysia
    • Year and Date
      2011-12-11
    • Related Report
      2013 Final Research Report
    • Invited
  • [Presentation] 炎症性腸疾患治療を目的とした新規ワックスマトリックス製剤の設計と評価2011

    • Author(s)
      石田武浩、岩尾康範、野口修治、板井茂
    • Organizer
      第21回日本病院薬剤師会東海ブロック学術大会・平成23年度日本薬学会東海支部例会
    • Place of Presentation
      愛知
    • Year and Date
      2011-11-23
    • Related Report
      2013 Final Research Report
  • [Presentation] Taste masking by spray congealing technology2011

    • Author(s)
      Shigeru Itai
    • Organizer
      Asian Federation for Pharmaceutical Sciences(招待講演)
    • Place of Presentation
      Kuala Lumpur, Malaysia
    • Related Report
      2011 Research-status Report
  • [Book] 製剤の種類と特性(経口投与する製剤&口腔内に適用する製剤)"図解製剤学2013

    • Author(s)
      板井茂
    • Publisher
      南山堂
    • Related Report
      2013 Final Research Report
  • [Book] 放射光X線コンピュータートモグラフィー法による薬物含有微粒子製剤の内部構造解析Pharm Tech Japan2013

    • Author(s)
      野口修治,岩尾康範,板井茂
    • Publisher
      じほう
    • Related Report
      2013 Final Research Report
  • [Book] 図解製剤学2013

    • Author(s)
      板井茂
    • Total Pages
      5
    • Publisher
      南山堂
    • Related Report
      2013 Annual Research Report
  • [Book] 医薬品製剤開発のための次世代微粒子コーティング技術2012

    • Author(s)
      板井茂
    • Publisher
      シーエムシー出版
    • Related Report
      2013 Final Research Report
  • [Book] 医薬品製剤開発のための次世代微粒子コーティング技術2012

    • Author(s)
      板井 茂
    • Total Pages
      260
    • Publisher
      シーエムシー出版
    • Related Report
      2012 Research-status Report

URL: 

Published: 2011-08-05   Modified: 2019-07-29  

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