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| 固形分散体製剤× | f1/f2 類似度因子(Dissolution f1/f2 Similarity Factor)× | |
|---|---|---|
| 分野 | 薬理学 | 薬理学 |
| 系統 | Process / pipeline | Process / pipeline |
| 提唱年≠ | 1971 | 1996 |
| 提唱者≠ | William Chiou and Solomon Riegelman | James Moore and Hector Flanner |
| 種類≠ | solubility enhancement | similarity testing |
| 原典≠ | Chiou, W. L., Riegelman, S. (1971). Pharmaceutical applications of solid dispersions. Journal of Pharmaceutical Sciences, 60(9), 1281-1302. link ↗ | Moore, J. W., & Flanner, H. H. (1996). Mathematical comparison of dissolution profiles. Pharmaceutical Technology, 20(6), 64-74. link ↗ |
| 別名 | solid solution, amorphous dispersion, polymer-based formulation | f1, f2, similarity factor |
| 関連 | 3 | 3 |
| 概要≠ | Solid dispersion is a formulation technique where a poorly soluble drug is molecularly dispersed in a hydrophilic polymer matrix, improving aqueous solubility and bioavailability. Introduced by Chiou and Riegelman in 1971, solid dispersions remain a key strategy for overcoming solubility-limited absorption. | The f1 and f2 factors are dimensionless statistical measures developed by Moore and Flanner to quantify the similarity between two dissolution profiles. Adopted by regulatory agencies (FDA, EMA) as the gold standard for comparing dissolution curves, these factors enable rapid assessment of whether formulation changes significantly impact drug release. |
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