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Insulin microneedle DDS

Research Project

Project/Area Number 18310095
Research Category

Grant-in-Aid for Scientific Research (B)

Allocation TypeSingle-year Grants
Section一般
Research Field Microdevices/Nanodevices
Research InstitutionKyoto Pharmaceutical University

Principal Investigator

TAKADA Kanji  Kyoto Pharmaceutical University, 薬学部, 教授 (30102106)

Co-Investigator(Kenkyū-buntansha) ITO Yukako  Kyoto Pharmaceutical University, Department of Pharmacokinetics, Post-doctoral research fellow (30278444)
Project Period (FY) 2006 – 2007
Project Status Completed (Fiscal Year 2007)
Budget Amount *help
¥17,160,000 (Direct Cost: ¥15,600,000、Indirect Cost: ¥1,560,000)
Fiscal Year 2007: ¥6,760,000 (Direct Cost: ¥5,200,000、Indirect Cost: ¥1,560,000)
Fiscal Year 2006: ¥10,400,000 (Direct Cost: ¥10,400,000)
KeywordsMicroneedles / insulin / percutaneous / DDS / absorption / bioavailability / skin / experimental animals / 安定性 / 含量 / 血糖降下作用 / 生理学的有効性 / 安全性 / 徐放性マイクロニードル
Research Abstract

Microneedles (MN) is a novel DDS for percutaneous delivery of peptide/proteins, vaccine and gene, DNA. Professor Takada innovated two types of MN, pen-type and patch type MN. MN is made of water-soluble polymer as the base, which contains drug as a supramolecular complex. After the administration of pen-type MN by inserting into the skin, base dissolves rapidly and releases drug that is absorbed into the systemic circulation. Proof-of-concept (POC) experiments were performed with insulin, EPO, IFN and growth hormone (GH), where high bioavailability, 70-99%, was obtained in mice, rats and dogs. For insulin, IFN and GH, the absorption rate is almost the same as subcutaneous injection preparation. EPO shows Tmax of 18 h, which suggests the absorption of EPO thorough lymphatic route. Safety study was performed with rats and dogs where evans blue (EB) was formulated into the MN in addition to insulin and EPO. After administration, ER was released from MN within 3 h. To prepare MN, supramolecular complex of drug is at first formed with thread-forming water-soluble polymer like dextran, chondroitin sulfate and albumin etc. Thereafter, MN is formed. The size of pen-type MN is about 2000μm length and 500μm in diameter. Also, patch type MN can be prepared. A machine to produce patch type MN was developed. With this machine, a patch having 16 MN on itself, 10cm^2 area, can be produced, where the length of MN is 500μm and the diameter of the bottom is 300 um. With the MN patch, insulin was formulated and pharmacodynamic study was performed. Hypoglycemic effect showed good dose-dependency in rats and was equivalent to insulin injection.

Report

(3 results)
  • 2007 Annual Research Report   Final Research Report Summary
  • 2006 Annual Research Report
  • Research Products

    (47 results)

All 2008 2007 2006

All Journal Article (24 results) (of which Peer Reviewed: 12 results) Presentation (16 results) Book (6 results) Patent(Industrial Property Rights) (1 results)

  • [Journal Article] Evaluation of self-dissolving needles containing low molecular weight heparin(LMWH)in rats2008

    • Author(s)
      Y.Ito, A.Murakami, T.Maeda, N.Sugioka and K.Takada
    • Journal Title

      Int.J.Pharmaceut. 349

      Pages: 124-129

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2007 Final Research Report Summary
    • Peer Reviewed
  • [Journal Article] Antihyperglycemic effect of insulin from self-dissolving micropiles in dogs2008

    • Author(s)
      Y.Ito, Y.Ohashi, A.Saeki, N.Sugioka and K.Takada
    • Journal Title

      Chem.Pharm.Bull. 56

      Pages: 243-246

    • NAID

      110006622622

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2007 Final Research Report Summary
    • Peer Reviewed
  • [Journal Article] Evaluation of self-dissolving needles containing low molecular weight heparin(LMWH) in rats.2008

    • Author(s)
      Y. Ito, A. Murakami, T. Maeda, N. Sugioka, K. Takada
    • Journal Title

      Int. J. Pharmaceut. 349

      Pages: 124-129

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Journal Article] Antihyperglycemic effect of insulin from self-dissolving micropiles in dogs.2008

    • Author(s)
      Y. Ito, Y. Ohashi, A. Saeki, N. Sugioka, K. Takada
    • Journal Title

      Chem. Pharm. Bull. 56

      Pages: 243-246

    • NAID

      110006622622

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Journal Article] Percutaneous absorption of interferon-α by self-dissolving micropiles2008

    • Author(s)
      Y.Ito, A.Saeki, K.Shiroyama, N.Sugioka and K.Takada
    • Journal Title

      J.Drug Target 16

      Pages: 243-249

    • Related Report
      2007 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Evaluation of self-dissolving needles containing low molecular weight heparin (LMWH) in rats2008

    • Author(s)
      Y.Ito, A.Murakami, T.Maeda, N.Sugioka and K.Takada
    • Journal Title

      Int.J.Pharmaceut 349

      Pages: 124-129

    • Related Report
      2007 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Antihyperglycemic effect of insulin from self-dissolving micropiles in dogs2008

    • Author(s)
      Y.Ito, Y.Ohashi, A.Saeki, N.Sugioka and K.Takada
    • Journal Title

      Chem.Pharm.Bull 56

      Pages: 243-246

    • NAID

      110006622622

    • Related Report
      2007 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Pharmacokinetic and pharmacodynamic studies following percutaneous absorption of erythropoietin micropiles to rats2007

    • Author(s)
      Y.Ito, K.Shiroyama, J.Yoshimitsu, Y.Ohashi, N.Sugioka and K.Takada
    • Journal Title

      J.Control.Rel. 121

      Pages: 176-180

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2007 Final Research Report Summary
    • Peer Reviewed
  • [Journal Article] Sustained-release self-dissolving micropiles for percutaneous absorption of insulin in mice2007

    • Author(s)
      Y.Ito, E.Hagiwara, A.Saeki, N.Sugioka and K.Takada
    • Journal Title

      J.Drug Target. 15

      Pages: 323-356

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2007 Final Research Report Summary
    • Peer Reviewed
  • [Journal Article] Pharmacokinetic and pharmacodynamic studies following percutaneous absorption of erythropoietin micropiles to rats.2007

    • Author(s)
      Y. Ito, K. Shiroyama, J. Yoshimitsu, Y. Ohashi, N. Sugioka, K. Takada
    • Journal Title

      J. Control. Rel. 121

      Pages: 176-180

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Journal Article] Sustained-release self-dissolving micropiles for percutaneous absorption of insulin in mice.2007

    • Author(s)
      Y. Ito, E. Hagiwara, A. Saeki, N. Sugioka, K. Takada
    • Journal Title

      J. Drug Target. 15

      Pages: 323-356

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Journal Article] Handbook of Pharmaceutical Biotechnology Chapter 6.3. Pharmacokinetics2007

    • Author(s)
      Nobuhito Shibata, Yukako Ito, Kanji Takada
    • Journal Title

      Wiley-Interscience. ed by Shayne Cox Gad

      Pages: 757-814

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Journal Article] Pharmacokinetic and pharmacodynamic studies following percutaneous absorption of erythropoietin micropiles to rats2007

    • Author(s)
      Y.Ito, K.Shiroyama, J.Yoshimitsu, YOhashi, N.Sugioka and K.Takada
    • Journal Title

      J.Control.Rel. 121

      Pages: 176-180

    • Related Report
      2007 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Sustained-release self-dissolving micropiles for percutaneous absorption of insulin in mice2007

    • Author(s)
      Y.Ito, E.Hagiwara, A.Saeki, N.Sugioka and K.Takada
    • Journal Title

      J.Drug Target 15

      Pages: 323-356

    • Related Report
      2007 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Self-dissolving microneedles fir the percutaneous absorption of EPO in mice2006

    • Author(s)
      Y.Ito, J.I.Yoshimitsu, K.Shiroyama, N.Sugioka and K.Takada
    • Journal Title

      J.Drug Target. 14

      Pages: 255-262

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2007 Final Research Report Summary
    • Peer Reviewed
  • [Journal Article] Feasibility of microneedles for percutaneous absorption of insulin2006

    • Author(s)
      Y.Ito, E.Hagiwara, A.Saeki, N.Sugioka and K.Takada
    • Journal Title

      Europ.J.Pharmaceut.Sci. 29

      Pages: 82-88

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2007 Final Research Report Summary
    • Peer Reviewed
  • [Journal Article] Kanji Takada,"Oral delivery of haematopoietic factors:Progress with gastrointestinal mucoadhesive patches,microdevices and other microfabrication technologies"2006

    • Author(s)
      K.Takada
    • Journal Title

      Am.J.Drug Deliv. 4

      Pages: 65-77

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2007 Final Research Report Summary
    • Peer Reviewed
  • [Journal Article] Self-dissolving microneedles for the percutaneous absorption of EPO in mice.2006

    • Author(s)
      Y. Ito, J. I. Yoshimitsu, K. Shiroyama, N. Sugioka, K. Takada
    • Journal Title

      J. Drug Target. 14

      Pages: 255-262

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Journal Article] Feasibility of microneedles for percutaneous absorption of insulin.2006

    • Author(s)
      Y. Ito, E. Hagiwara, A. Saeki, N. Sugioka, K. Takada
    • Journal Title

      Europ. J. Pharmaceut. Sci. 29

      Pages: 82-88

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Journal Article] Oral delivery of haematopoietic factors : Progress with gastrointestinal mucoadhesive patches, microdevices and other microfabrication technologies2006

    • Author(s)
      Kanji Takada
    • Journal Title

      Am. J. Drug Deliv 4(2)

      Pages: 65-77

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Journal Article] Nanotechnologies for the Life Sciences. Volume 10. Nanomaterials for medical diagnosis and therapy: Chapter 6: Nanoporous and nanosize materials for drug delivery systems2006

    • Author(s)
      Yoshinobu Fukumori, Kanji Takada, Hirofumi Takeuchi
    • Journal Title

      Wiley-Vch. ed. By C. Kumar

      Pages: 255-309

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Journal Article] Feasibility of microneedles for percutaneous absorption of insulin.2006

    • Author(s)
      Ito Y, Hagiwara E, Saeki A, Sugioka N, Takada K.
    • Journal Title

      European J. Pharmaceutical Sciences 29(1)

      Pages: 82-88

    • Related Report
      2006 Annual Research Report
  • [Journal Article] Self-dissolving microneedles for the percutaneous absorption of EPO in mice.2006

    • Author(s)
      Ito Y, Yoshimitsu J, Shiroyama K, Sugioka N, Takada K.
    • Journal Title

      J. Drug Targeting 14(5)

      Pages: 255-261

    • Related Report
      2006 Annual Research Report
  • [Journal Article] Oral delivery of haematopoietic factors : Progress with gastrointestinal mucoadhesive patches, microdevices and other microfabrication technologies2006

    • Author(s)
      Kanji Takada
    • Journal Title

      American J. Drug Delivery 4(2)

      Pages: 65-77

    • Related Report
      2006 Annual Research Report
  • [Presentation] 日曜なんとか学:溶けて消えゆく極微の注射2008

    • Author(s)
      高田 寛治
    • Organizer
      朝日新聞
    • Place of Presentation
      全国紙、日曜版、第一面
    • Year and Date
      2008-03-16
    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Presentation] インスリン微小ミサイルカプセルの有用性の検討2008

    • Author(s)
      山崎 赳尚、城山 圭司、福島 恵造、杉岡 信幸、高田 寛治
    • Organizer
      第128回日本薬学会
    • Place of Presentation
      横浜
    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2007 Annual Research Report 2007 Final Research Report Summary
  • [Presentation] 自己溶解性マイクロニードル(MN)からの高分子薬のバイオアベイラビリティ(BA)に及ぼす分子量(MW)の影響2008

    • Author(s)
      伊勢 彩香、杉岡 信幸、高田 寛治
    • Organizer
      第128回日本薬学会
    • Place of Presentation
      横浜
    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2007 Annual Research Report 2007 Final Research Report Summary
  • [Presentation] インスリン微小ミサイルカプセルの有用性の検討2008

    • Author(s)
      山崎赴尚、城山圭司、福島恵造、杉岡信幸、高田寛治、
    • Organizer
      第128回日本薬学会Ann. Meeting Pharm. Soc. Jap.
    • Place of Presentation
      横浜Yokohama
    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Presentation] 自己溶解性マイクロニードル(MN) からの高分子薬のバイオアベイラビリティ(BA) に及ぼす分子量(MW) の影響2008

    • Author(s)
      伊勢彩香、杉岡信幸、高田寛治、
    • Organizer
      第128回日本薬学会Ann. Meeting Pham. Soc. Jap.
    • Place of Presentation
      横浜Yokohama
    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Presentation] 自己溶解性インスリン・マイクロニードル(MN)のPK/PD解析およびグルコース負荷試験(OGTT)よる薬効評価2007

    • Author(s)
      中根 遥、大橋 良徳、石畑 雅大、落井 裕也、山崎 赳尚、伊藤 由佳子、杉岡 信幸、高田 寛治
    • Organizer
      第23回日本DDS学会
    • Place of Presentation
      熊本
    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2007 Annual Research Report 2007 Final Research Report Summary
  • [Presentation] 自己溶解性インスリン・マイクロニードル(MN) のPK/PD解析およびグルコース負荷試験(OGTT) よる薬効評価2007

    • Author(s)
      中根遥、大橋良徳、石畑雅大、落井裕也、山崎赴尚、伊藤由佳子、杉岡信幸、高田寛治、
    • Organizer
      第23回日本DDS学会Ann. Meeting Jap. Soc. Drug Deliv. Sys.
    • Place of Presentation
      熊本Kumamoto
    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Presentation] インスリン微小ミサイルカプセル2006

    • Author(s)
      高田 寛治
    • Organizer
      多田しげおの気分爽快〜朝からPON〜8時13分〜20分
    • Place of Presentation
      名古屋
    • Year and Date
      2006-08-23
    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Presentation] Percutaneous delivery of erythropoietin(EPO)and low molecular weight heparin(LMWH)by self-dissolving microneedle(SDMIN)2006

    • Author(s)
      K.Takada, Y.Ito, N.Sugioka, A.Murakami, A.Saeki and J.Yoshimitu
    • Organizer
      2006 AAPS National Biotechnology Conference
    • Place of Presentation
      Boston,USA
    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Presentation] Self-dissolving microneedle(SDMIN)for percutaneous delivery of insulin(INS)2006

    • Author(s)
      K.Takada, Y.Ito, N.Sugioka, E.Hagiwara and Y.Ohashi
    • Organizer
      2006 AAPS National Biotechnology Conference
    • Place of Presentation
      Boston,USA
    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Presentation] 低分子ヘパリン(LMWH)マイクロニードル(MN)製剤の設計と評価2006

    • Author(s)
      村上 愛子、前田 友大、長谷川 みのり、芝池 知徳、伊勢 彩香、伊藤 由佳子、杉岡 信幸、高田 寛治
    • Organizer
      第22回日本DDS学会
    • Place of Presentation
      東京
    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Presentation] エリスロポエチン・マイクロニードルDDSの設計と薬効評価2006

    • Author(s)
      城山 圭司、伊藤 由佳子、杉岡 信幸、高田 寛治
    • Organizer
      第27回日本臨床薬理学会年会
    • Place of Presentation
      東京
    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Presentation] Percutaneous delivery of erythropoietin(EPO) and low molecular weight heparin(LMWH) by self-dissolving microneedle(SDMIN).2006

    • Author(s)
      Kanji Takada, Yukako Ito, Nobuyuki Sugioka, Aiko Murakami, Atsushi Saeki, Junichiro Yoshimitu
    • Organizer
      2006 AAPS National Biotechnology Conference
    • Place of Presentation
      Boston, USA
    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Presentation] Self-dissolving microneedle(SDMIN) for percutaneous delivery of insulin(INS).2006

    • Author(s)
      Kanji Takada, Yukako Ito, Nobuyuki Sugioka, Eiji Hagiwara, Yoshinori Ohashi
    • Organizer
      2006 AAPS National Biotechnology ConferenCe
    • Place of Presentation
      Boston, USA
    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Presentation] 低分子ヘパリン(LMWH) マイクロニードル(MN) 製剤の設計と評価2006

    • Author(s)
      村上愛子、前田友大、長谷川みのり、芝池知徳、伊勢彩香、伊藤由佳子、杉岡信幸、高田寛治、
    • Organizer
      第22回日本DDS学会Ann. Meeting Jap. Soc. Drug Deliv. Sys.
    • Place of Presentation
      東京Tokyo
    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Presentation] エリスロポエチン・マイクロニードルDDSの設計と薬効評価.2006

    • Author(s)
      城山圭司、伊藤由佳子、杉岡信幸、高田寛治、
    • Organizer
      第27回日本臨床薬理学会年会Ann. Meeting Jap. Soc. Clin. Pharmacol. Ther.
    • Place of Presentation
      東京Tokyo
    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Book] 日曜なんと学:溶けて消えゆく極微の注射朝日新聞、2008年3月16日 日曜版、第一面2008

    • Author(s)
      高田寛治
    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Book] Handbook of Pharmaceutical Biotechnology, Chapter 6.3."Pharma cokinetics"ed by Shayne Cox Gad.2007

    • Author(s)
      Nobuhito Shibata, Yukako Ito and Kanji Takada
    • Publisher
      Wiley-Interscience
    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Book] Handbook of Pharmaceutical Biotechnology, Chapter 6.3."Pharmacokinetics"ed by Shayne Cox Gad2007

    • Author(s)
      Nobuhito Shibata, Yukako Ito and Kanji Takada
    • Publisher
      Wiley-Interscience
    • Related Report
      2007 Annual Research Report
  • [Book] Nanotechnologies for the Life Sciences.Volume 10.Nanomaterials for medical diagnosis and therapy:Chapter 6:Nanoporous and nanosize materials for drug delivery systems", ed.By C.Kumar.2006

    • Author(s)
      Yoshinobu Fukumori, Kanji Takada and Hirofumi Takeuchi
    • Publisher
      Wiley-Vch
    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Book] 多田しげおの気分爽快〜朝から PON〜8時13分〜20分(名古屋)2006

    • Author(s)
      高田寛治
    • Publisher
      インスリン微小ミサイルカプセル
    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2007 Final Research Report Summary
  • [Book] Nanotechnologies for the Life Sciences. Volume 10. Nanomaterials for medical diagnosis and therapy : Chapter 6 : Nanoporous and nanosize materials fro drug delivery systems2006

    • Author(s)
      Yoshinobu Fukumori, Kanji Takada, Hirofumi Takeuchi
    • Publisher
      Wiley-Vch
    • Related Report
      2006 Annual Research Report
  • [Patent(Industrial Property Rights)] 数百ミクロンの円錐状突起物を有する貼付剤の製造法2007

    • Inventor(s)
      高田 寛治
    • Industrial Property Rights Holder
      (株)バイオセレンタック
    • Industrial Property Number
      2007-150574
    • Filing Date
      2007-06-06
    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2007 Annual Research Report 2007 Final Research Report Summary

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Published: 2006-04-01   Modified: 2016-04-21  

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