| Project/Area Number |
01400005
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| Research Category |
Grant-in-Aid for General Scientific Research (A)
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| Allocation Type | Single-year Grants |
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| Research Field |
広領域
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| Research Institution | Gifu Pharmaceutical University |
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Principal Investigator |
KAWASHIMA Yoshiaki Gifu Pharmaceutical University, Professor, 薬学部, 教授 (30082978)
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| Co-Investigator(Kenkyū-buntansha) |
NIWA Toshiyuki Gifu Pharmaceutical University, Assistant Professor, 薬学部, 助手 (30198543)
HINO Tomoaki Gifu Pharmaceutical University, Assistant Professor, 薬学部, 助手 (90208778)
TAKEUCHI Hirofumi Gifu Pharmaceutical University, Associate Professor, 薬学部, 助教授 (50171616)
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| Project Period (FY) |
1989 – 1991
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| Project Status |
Completed (Fiscal Year 1991)
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| Budget Amount *help |
¥21,200,000 (Direct Cost: ¥21,200,000)
Fiscal Year 1991: ¥2,000,000 (Direct Cost: ¥2,000,000)
Fiscal Year 1990: ¥3,000,000 (Direct Cost: ¥3,000,000)
Fiscal Year 1989: ¥16,200,000 (Direct Cost: ¥16,200,000)
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| Keywords | controlled release system / floating system / microballoon / emulsion-solvent-diffusion method / drug release rate / residence time in stomach / spherical crystallization / particle design / エマルションー溶媒ー拡散法 / 微小中空浮遊型デバイス / 血中濃度 / X線ラジオグラフィ- / 製剤設計 / コントロ-ルリリ-ス / 浮遊性 / 晶析 / ラジオグラフィ- / 造粒 / 微小中空粒子 / 空隙率 / 比重 / せん断付着力 / 流動性 |
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| Research Abstract |
A novel controlled drug release floating system with micro-hollow spheres of polymer, termed microballoons, was developed for pharmaceutical, chemical and pesticide by the "emulsion -solvent-diffusion" method. In this system, the drug, eg. ibuprofen or tranilast, was entrapped in the outer polymer (acrylic resin) shell of the device. The device was characterized with small particle size, 100-500) Am, and low specific gravity, -0.8. Those properties resulted in forming a multiple unit floating system, which released slowly the drug in acidic medium. In alkaline solution, the drug release rate increased due to the increase in the dissolution property of polymer. The crystalline form of the drug and the drug release profiles from microballoon were controlled by changing the ratio of polymer to drug in the device. An in vivo X-ray radiographical study with barium sulfate contained in the shell of device proved that the microballoons orally adwinistered to humans were dispersed in the upper part of stomach. This finding suggested a prolonged residence time of the device in the stomach.
The emulsion-solvent-diffusion method can apply further to design the particulate properties of drug crystals for direct tabletting by transforming them into the spherically agglomerated crystals.
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