Analysis of the state of water in semisolid formulations using MRIand its contribution to the formulation stability
| Project/Area Number |
23790057
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| Research Category |
Grant-in-Aid for Young Scientists (B)
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| Allocation Type | Multi-year Fund |
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| Research Field |
Physical pharmacy
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| Research Institution | Hoshi University |
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Principal Investigator |
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| Project Period (FY) |
2011 – 2013
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| Project Status |
Completed (Fiscal Year 2013)
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| Budget Amount *help |
¥2,340,000 (Direct Cost: ¥1,800,000、Indirect Cost: ¥540,000)
Fiscal Year 2012: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2011: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
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| Keywords | MRI / 製剤安定性 / エマルション製剤 / クリーム剤 / ADC マップ / 相分離 / 非破壊的モニタリング / ADCマップ / 非侵襲的モニタリング / 油水分散系 / 相分離挙動 |
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| Research Abstract |
A nondestructive method for monitoring creaming of emulsion-based formulations is in great demand because it allows us to understand fully their instability mechanisms. This study was aimed at demonstrating the usefulness of magnetic resonance (MR) techniques, including magnetic resonance imaging (MRI) and MR spectroscopy, for evaluating the physicochemical stability of emulsion-based formulations. Emulsions that are applicable as the base of practical skin creams were used as test samples. The creaming oil droplet layer and aqueous phase were clearly distinguished by quantitative MRI by measuring T1 and the apparent diffusion coefficient. Components in a selected volume in the emulsions could be analyzed using MR spectroscopy. Then, model emulsions having different hydrophilic-lipophilic balance (HLB) values were tested, and the optimal HLB value for a stable dispersion was determined. In addition, the MRI examination enables the detection of creaming occurring in a polyethylene tube, which is commonly used for commercial products, without losing any image quality. These findings strongly indicate that MR techniques are powerful tools to evaluate the physicochemical stability of emulsion-based formulations. This study will make a great contribution to the development and quality control of emulsion-based formulations.
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Report
(3 results)
Research Products
(34 results)
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[Journal Article] A Novel approach to establishing the design space for oral formulation manufacturing process2013
Author(s)
Norioka, T., Hayashi, Y., Onuki, Y., Andou, H., Tsunashima, D., Yamashita, K., Takayama, K.
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Journal Title
Chem. Pharm. Bull
Volume: 61
Pages: 39-49
Related Report
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[Journal Article] Nondestructive monitoring of creaming of oil-in-water emulsion-based formulations using magnetic resonance imaging2013
Author(s)
Onuki, Y., Horita, A., Kuribayashi, H., Okuno, Y., Obata, Y., Takayama, K.
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Journal Title
Drug Dev. Ind. Pharm.
Volume: (in press)
Related Report
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[Journal Article] Latent structure analysis of the process variables and pharmaceutical responses of an orally disintegrating tablet2012
Author(s)
Hayashi, Y., Oshima, E., Maeda, J., Onuki, Y., Obata, Y., Takayama, K.
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Journal Title
Chem. Pharm Bull
Volume: 60
Pages: 1419-1425
Related Report
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[Journal Article] Contribution of the physicochemical properties of active pharmaceutical ingredients to tablet properties identified by ensemble artificial neural networks and Kohonen's self-organizing maps2012
Author(s)
Onuki, Y., Kawai, S., Arai, H., Maeda, J., Takagaki, K., Takayama, K.
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Journal Title
J. Pharm. Sci.
Volume: in press
Related Report
Peer Reviewed
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