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Formulation design of pharmaceutical emulsions based on magnetic resonance imaging and quality-by-design approach

Research Project

Project/Area Number 25460045
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Physical pharmacy
Research InstitutionUniversity of Toyama (2015)
Hoshi University (2013-2014)

Principal Investigator

Onuki Yoshinori  富山大学, 大学院 医学薬学研究部(薬学), 客員教授 (10350224)

Project Period (FY) 2013-04-01 – 2016-03-31
Project Status Completed (Fiscal Year 2015)
Budget Amount *help
¥4,940,000 (Direct Cost: ¥3,800,000、Indirect Cost: ¥1,140,000)
Fiscal Year 2015: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2014: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2013: ¥2,470,000 (Direct Cost: ¥1,900,000、Indirect Cost: ¥570,000)
KeywordsMRI / クリーム剤 / 製剤安定性 / QbD / エマルション製剤 / 自己組織化マップ / 水分子運動性
Outline of Final Research Achievements

Physical stability is an important quality attribute of pharmaceutical emulsions. In general, the physical stability is affected by various factors in a complicated manner. Since the quality-by-design concept was issued, the importance of understanding the relationships between formulation variables and responses has been expanding in the development of pharmaceuticals. The purpose of this study is to gain a comprehensive understanding of the physical stability of pharmaceutical emulsions. The key technology used to evaluate the state of water was magnetic resonance imaging (MRI). From the findings, formulation variables had a significant impact on the state of water in the model formulations. Furthermore, it was clarified that the state of water played an important role in the stability of the model emulsions. In conclusion, we succeeded in gaining a comprehensive understanding of the physical stability of the model emulsions and establishing conditions to prepare stable emulsions.

Report

(4 results)
  • 2015 Annual Research Report   Final Research Report ( PDF )
  • 2014 Research-status Report
  • 2013 Research-status Report
  • Research Products

    (39 results)

All 2016 2015 2014 2013

All Journal Article (10 results) (of which Peer Reviewed: 10 results,  Acknowledgement Compliant: 7 results) Presentation (29 results) (of which Invited: 3 results)

  • [Journal Article] Magnetic Resonance Imaging of the Phase Separation in Mixed Preparations of Moisturizing Cream and Steroid Ointment after Centrifugation2015

    • Author(s)
      Onuki, Y., Funatani, C., Yokawa, T., Yamamoto, Y., Fukami, T., Koide, T., Obata, Y., Takayama, K.
    • Journal Title

      Chemical and Pharmaceutical Bulletin

      Volume: 63 Issue: 5 Pages: 377-383

    • DOI

      10.1248/cpb.c15-00088

    • NAID

      130005067239

    • ISSN
      0009-2363, 1347-5223
    • Related Report
      2015 Annual Research Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] Magnetic Resonance Imaging Study on the Physical Stability of Menthol and Diphenhydramine Cream for the Treatment of Chronic Kidney Disease-Associated Pruritus2015

    • Author(s)
      Onuki, Y., Machida, Y., Yokawa, T., Seike, C., Sakurai, S., Takayama, K.
    • Journal Title

      Chemical and Pharmaceutical Bulletin

      Volume: 63 Issue: 6 Pages: 457-462

    • DOI

      10.1248/cpb.c15-00192

    • NAID

      130005072096

    • ISSN
      0009-2363, 1347-5223
    • Related Report
      2015 Annual Research Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] Self-organizing Map Analysis for Understanding Comprehensive Relationships between Formulation Variables, State of Water, and the Physical Stability of Pharmaceutical Emulsions2015

    • Author(s)
      Onuki, Y., Hasegawa, N., Horita, A., Ueno, N., Kida, C., Hayashi, Y., Obata, Y., Takayama, K.
    • Journal Title

      Chemical and Pharmaceutical Bulletin

      Volume: 63 Issue: 11 Pages: 901-906

    • DOI

      10.1248/cpb.c15-00516

    • NAID

      130005105720

    • ISSN
      0009-2363, 1347-5223
    • Related Report
      2015 Annual Research Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] MRI as a promising tool for evaluation of the stability of cosmetic emulsions2015

    • Author(s)
      Onuki, Y., Kida, C., Funatani, C., Hayashi, Y., Takayama, K.
    • Journal Title

      J Cosmet Sci

      Volume: 37 Issue: 3 Pages: 272-278

    • DOI

      10.1111/ics.12290

    • Related Report
      2015 Annual Research Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] Contribution of Glucose to Crystallization of Phenytoin in Injectable Dosage Form by Dilution with Infusion Fluids2014

    • Author(s)
      Onuki, Y., Hasegawa, N., Ikegami-Kawai, M., Suematsu, T., Sakurai, S., Shirozu, S., Tsubuki, M., Obata, Y., Takayama, K.
    • Journal Title

      Chemical and Pharmaceutical Bulletin

      Volume: 62 Issue: 10 Pages: 989-993

    • DOI

      10.1248/cpb.c14-00353

    • NAID

      130004693777

    • ISSN
      0009-2363, 1347-5223
    • Related Report
      2014 Research-status Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] Study of the contribution of the state of water to the gel properties of a photocrosslinked polyacrylic acid hydrogel using magnetic resonance imaging2014

    • Author(s)
      Onuki, Y., Hasegawa, N., Kida, C., Obata, Y., Takayama, K.
    • Journal Title

      J. Pharm. Sci.

      Volume: 103 Issue: 11 Pages: 3532-3541

    • DOI

      10.1002/jps.24140

    • Related Report
      2014 Research-status Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] Effect of Process Variables on the Drucker–Prager Cap Model and Residual Stress Distribution of Tablets Estimated by the Finite Element Method2014

    • Author(s)
      Hayashi, Y., Otoguro, S., Miura, T., Onuki, Y., Obata, Y., Takayama, K.
    • Journal Title

      Chemical and Pharmaceutical Bulletin

      Volume: 62 Issue: 11 Pages: 1062-1072

    • DOI

      10.1248/cpb.c14-00190

    • NAID

      130004677397

    • ISSN
      0009-2363, 1347-5223
    • Related Report
      2014 Research-status Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] Comparative pharmaceutical evaluation of brand and generic clobetasone butyrate ointments2014

    • Author(s)
      Yamamoto Y, Fukami T, Koide T, Onuki Y, Suzuki T, Metori K, Katori N, Hiyama Y, Tomono K.
    • Journal Title

      Int J Pharm

      Volume: 463 Issue: 1 Pages: 62-67

    • DOI

      10.1016/j.ijpharm.2013.12.054

    • Related Report
      2013 Research-status Report
    • Peer Reviewed
  • [Journal Article] Comparative study of novel ultradeformable liposomes: menthosomes, transfersomes and liposomes for enhancing skin permeation of meloxicam2014

    • Author(s)
      Duangjit S, Obata Y, Sano H, Onuki Y, Opanasopit P, Ngawhirunpat T, Miyoshi T, Kato S, Takayama K.
    • Journal Title

      Biol Pharm Bull

      Volume: 37 Pages: 239-247

    • Related Report
      2013 Research-status Report
    • Peer Reviewed
  • [Journal Article] Prediction of tablet characteristics from residual stress distribution estimated by the finite element method2013

    • Author(s)
      Y. Hayashi, T. Miura, T. Shimada, Y. Onuki, Y. Obata, K. Takayama
    • Journal Title

      J. Pharm. Sci

      Volume: 102 Issue: 10 Pages: 2678-2686

    • DOI

      10.1002/jps.23675

    • Related Report
      2013 Research-status Report
    • Peer Reviewed
  • [Presentation] 透析掻痒症に適用されるメントール・ジフェンヒドラミン含有クリームの製剤安 定性改善2016

    • Author(s)
      横川雅光, 大貫義則, 町田昌明, 清家千江子, 内海俊一, 小幡誉子, 櫻井正太郎, 髙山幸三
    • Organizer
      日本薬学会 第136年会
    • Place of Presentation
      神奈川
    • Year and Date
      2016-03-26
    • Related Report
      2015 Annual Research Report
  • [Presentation] 近赤外分光法を用いたヘパリン類似物質含有保湿剤とステロイド軟膏からなる混 合物の安定性に関する研究2016

    • Author(s)
      山本佳久, 久米谷萌水, 大貫義則, 鈴木豊史, 小出達夫, 深水啓朗
    • Organizer
      日本薬学会 第136年会
    • Place of Presentation
      神奈川
    • Year and Date
      2016-03-26
    • Related Report
      2015 Annual Research Report
  • [Presentation] MRI を用いた皮膚外用剤の混合製剤の製剤安定性に関する定量的比較2016

    • Author(s)
      鮒谷千明, 大貫義則, 山本佳久, 深水啓朗, 小出達夫, 内海俊一, 小幡誉子, 髙山幸三
    • Organizer
      日本薬学会 第136年会
    • Place of Presentation
      神奈川
    • Year and Date
      2016-03-26
    • Related Report
      2015 Annual Research Report
  • [Presentation] W/O型保湿クリーム製剤と副腎皮質ステロイド外用剤からなる混合物の保存安定性に関する研究2015

    • Author(s)
      山本佳久, 久米谷萌水, 大貫義則, 深水啓朗, 小出達夫, 鈴木豊史, 伴野和夫
    • Organizer
      第25回日本医療薬学会年会
    • Place of Presentation
      神奈川
    • Year and Date
      2015-11-21
    • Related Report
      2015 Annual Research Report
  • [Presentation] MRIを利用したエマルション化粧品の乳化状態の評価2015

    • Author(s)
      黄田千尋,大貫義則,小幡誉子,髙山幸三
    • Organizer
      第40回日本香粧品学会
    • Place of Presentation
      東京
    • Year and Date
      2015-06-18
    • Related Report
      2015 Annual Research Report
  • [Presentation] Quality by Designを指向した製剤化研究2015

    • Author(s)
      大貫義則
    • Organizer
      フォーラム富山「創薬」 第41回研究会
    • Place of Presentation
      富山
    • Year and Date
      2015-05-29
    • Related Report
      2015 Annual Research Report
    • Invited
  • [Presentation] MRIを利用した製剤物性評価:院内製剤メントール・ジフェンヒドラミン含有クリームの製剤安定性2015

    • Author(s)
      林祥弘、黄田千尋、鮒谷千明、町田昌明、髙山幸三、大貫義則
    • Organizer
      フォーラム富山「創薬」 第41回研究会
    • Place of Presentation
      富山
    • Year and Date
      2015-05-29
    • Related Report
      2015 Annual Research Report
  • [Presentation] MRI を利用した製剤物性評価:エマルション製剤の製剤安定性における増粘剤の影響2015

    • Author(s)
      黄田 千尋, 大貫 義則, 小幡 誉子, 髙山 幸三
    • Organizer
      日本薬学会 第135年会
    • Place of Presentation
      兵庫
    • Year and Date
      2015-03-25 – 2015-03-28
    • Related Report
      2014 Research-status Report
  • [Presentation] MRI を利用したステロイド軟膏と保湿クリームの混合製剤の製剤安定性評価2015

    • Author(s)
      鮒谷 千明, 大貫 義則, 山本 佳久, 深水 啓朗, 小出 達夫, 余川 隆, 小幡 誉子, 髙山 幸三
    • Organizer
      日本薬学会 第135年会
    • Place of Presentation
      兵庫
    • Year and Date
      2015-03-25 – 2015-03-28
    • Related Report
      2014 Research-status Report
  • [Presentation] エマルション製剤の製剤安定性に対する薬物塩の影響2015

    • Author(s)
      長谷川 直毅, 大貫 義則, 堀田 敬紘, 中室 奈緒美, 小幡 誉子, 髙山 幸三
    • Organizer
      日本薬学会 第135年会
    • Place of Presentation
      兵庫
    • Year and Date
      2015-03-25 – 2015-03-28
    • Related Report
      2014 Research-status Report
  • [Presentation] MRI を用いたメントール・ジフェンヒドラミン含有クリームの製剤安定性評価2015

    • Author(s)
      町田 昌明, 大貫 義則, 遠藤 佳奈, 清家 千江子, 小幡 誉子, 櫻井 正太郎, 高山 幸三
    • Organizer
      日本薬学会 第135年会
    • Place of Presentation
      兵庫
    • Year and Date
      2015-03-25 – 2015-03-28
    • Related Report
      2014 Research-status Report
  • [Presentation] スティッキング現象に影響を及ぼす各種杵表面の物理化学的特性評価2014

    • Author(s)
      上原直人, 湯汲省吾, 島田泰拓, 國次真輔, 大貫義則, 小幡誉子, 髙山幸三
    • Organizer
      第20回創剤フォーラム若手研究会
    • Place of Presentation
      東京
    • Year and Date
      2014-11-29
    • Related Report
      2014 Research-status Report
  • [Presentation] 向精神薬含有経皮吸収型製剤開発および角層微細構造解析2014

    • Author(s)
      赤木千夏, 小幡誉子, 大貫義則, 髙山幸三
    • Organizer
      第20回創剤フォーラム若手研究会
    • Place of Presentation
      東京
    • Year and Date
      2014-11-29
    • Related Report
      2014 Research-status Report
  • [Presentation] MRIを利用したクリーム剤の製剤安定性評価2014

    • Author(s)
      大貫義則, 長谷川直毅, 黄田千尋, 鮒谷千明, 小幡誉子, 髙山幸三
    • Organizer
      第24回日本医療薬学会年会
    • Place of Presentation
      愛知
    • Year and Date
      2014-09-27 – 2014-09-28
    • Related Report
      2014 Research-status Report
  • [Presentation] アセトアミノフェン坐剤における加熱融解によって生じる主薬偏析の要因に関する研究2014

    • Author(s)
      山本佳久, 足立真希, 大貫義則, 深水啓朗, 小出達夫, 香取典子, 鈴木豊史, 伴野和夫
    • Organizer
      第24回日本医療薬学会年会
    • Place of Presentation
      愛知
    • Year and Date
      2014-09-27 – 2014-09-28
    • Related Report
      2014 Research-status Report
  • [Presentation] 向精神薬含有経皮吸収型製剤開発における最適処方の探索と薬理評価2014

    • Author(s)
      赤木千夏, 小幡誉子, 大貫義則, 山本章午, 池上めぐみ, 池田弘子, 亀井淳三, 髙山幸三
    • Organizer
      第24回日本医療薬学会年会
    • Place of Presentation
      愛知
    • Year and Date
      2014-09-27 – 2014-09-28
    • Related Report
      2014 Research-status Report
  • [Presentation] 半固形製剤の物性評価におけるMRIの有用性2014

    • Author(s)
      大貫義則
    • Organizer
      医療薬学フォーラム2014
    • Place of Presentation
      東京
    • Year and Date
      2014-06-28 – 2014-06-29
    • Related Report
      2014 Research-status Report
    • Invited
  • [Presentation] アトピー性皮膚炎角層細胞間脂質モデルの微細構造解析2014

    • Author(s)
      小幡誉子, 佐野 啓, 太田 昇, 森脇太郎, 八木直人, 石田賢哉, 内田良一, 大貫義則, 髙山幸三
    • Organizer
      第39回日本香粧品学会
    • Place of Presentation
      東京
    • Year and Date
      2014-06-05 – 2014-06-06
    • Related Report
      2014 Research-status Report
  • [Presentation] MRIおよび統計学的手法に基づいたエマルション製剤の設計2014

    • Author(s)
      長谷川直毅,大貫義則,堀田敬紘,中室奈緒美,小幡誉子,髙山幸三
    • Organizer
      日本薬剤学会第29年会
    • Place of Presentation
      埼玉
    • Year and Date
      2014-05-20 – 2014-05-22
    • Related Report
      2014 Research-status Report 2013 Research-status Report
  • [Presentation] 外用剤基剤用ヒドロゲルにおける水分子運動性と物性との因果関係2014

    • Author(s)
      大貫義則、長谷川直毅、黄田千尋、小幡誉子、髙山幸三
    • Organizer
      日本薬剤学会第29年会
    • Place of Presentation
      埼玉
    • Year and Date
      2014-05-20 – 2014-05-22
    • Related Report
      2014 Research-status Report 2013 Research-status Report
  • [Presentation] Involvement of water molecular mobility in the properties of photocrosslinked polyacrylic acid hydrogel for use in dermatological patch adhesive2014

    • Author(s)
      Onuki, Y., Hasegawa, N., Kida, C., Obata, Y., Takayama, K.
    • Organizer
      5th FIP Pharmaceutical Sciences World Congress (PSWC2014)
    • Place of Presentation
      オーストラリア
    • Year and Date
      2014-04-13 – 2014-04-16
    • Related Report
      2014 Research-status Report
  • [Presentation] MRIを利用したヒドロゲル中の水分子運動性評価およびゲル物性への寄与2014

    • Author(s)
      大貫義則,長谷川直毅,黄田千尋,小幡誉子,高山幸三
    • Organizer
      日本薬学会 第134年会
    • Place of Presentation
      熊本
    • Related Report
      2013 Research-status Report
  • [Presentation] MRIを利用した薬物塩含有エマルション製剤の製剤安定性評価2013

    • Author(s)
      長谷川 直毅,大貫 義則,堀田 敬紘,小幡 誉子,高山 幸三
    • Organizer
      製剤機械技術学会第23回大会
    • Place of Presentation
      東京
    • Related Report
      2013 Research-status Report
  • [Presentation] テラヘルツイメージングによる錠剤内密度分布の評価2013

    • Author(s)
      林祥弘,高桑真樹,入澤昭好,今村元規,小幡誉子,大貫義則,高山幸三
    • 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 Research-status Report
  • [Presentation] 外用剤基剤用ヒドロゲル中の水分子運動性評価及びゲル物性への寄与2013

    • Author(s)
      大貫義則,長谷川直樹,黄田千尋,小幡誉子,高山幸三
    • Organizer
      日本薬学会第57回関東支部大会
    • Place of Presentation
      東京
    • Related Report
      2013 Research-status Report
  • [Presentation] MRIを用いた製剤のイメージング2013

    • Author(s)
      大貫義則
    • Organizer
      第19回創剤フォーラム若手研究会
    • Place of Presentation
      千葉
    • Related Report
      2013 Research-status Report
    • Invited
  • [Presentation] エマルション製剤の製剤安定における薬物塩の影響2013

    • Author(s)
      長谷川直樹,黄田千尋,大貫義則,堀田敬紘,小幡誉子,高山幸三
    • Organizer
      第19回創剤フォーラム若手研究会
    • Place of Presentation
      千葉
    • Related Report
      2013 Research-status Report
  • [Presentation] A novel MRI method for monitoring creaming behavior of emulsion-based formulations2013

    • Author(s)
      Y. Onuki, A. Horita, Y. Okuno, Y. Obata, K. Takayama
    • Organizer
      3rd Conference on Innovation in Drug Delivery: Advances in Local Drug Delivery
    • Place of Presentation
      Pisa, Italy
    • Related Report
      2013 Research-status Report
  • [Presentation] Prediction of tablet characteristics from residual stress distribution estimated by the finite element method2013

    • Author(s)
      Y. Hayashi, T. Miura, T. Shimada, Y. Onuki, Y. Obata, K. Takayama
    • Organizer
      3rd Conference on Innovation in Drug Delivery: Advances in Local Drug Delivery
    • Place of Presentation
      Pisa, Italy
    • Related Report
      2013 Research-status Report

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Published: 2014-07-25   Modified: 2019-07-29  

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