Investigation of Physicochemical Drug Properties to Prepare Fine Globular Granules Composed of Only Drug Substance in Fluidized Bed Rotor Granulation
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- Mise Ryohei
- Department of Pharmaceutical Engineering, School of Pharmaceutical Sciences, University of Shizuoka
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- Iwao Yasunori
- Department of Pharmaceutical Engineering, School of Pharmaceutical Sciences, University of Shizuoka
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- Kimura Shin-ichiro
- Pharmaceutical Research & Development, Kissei Pharmaceutical Co., Ltd.
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- Osugi Yukiko
- Department of Pharmaceutical Engineering, School of Pharmaceutical Sciences, University of Shizuoka
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- Noguchi Shuji
- Department of Pharmaceutical Engineering, School of Pharmaceutical Sciences, University of Shizuoka
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- Itai Shigeru
- Department of Pharmaceutical Engineering, School of Pharmaceutical Sciences, University of Shizuoka
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The effect of some drug properties (wettability and particle size distribution) on granule properties (mean particle size, particle size distribution, sphericity, and granule strength) were investigated in a high (>97%) drug-loading formulation using fluidized bed rotor granulation. Three drugs: acetaminophen (APAP); ibuprofen (IBU); and ethenzamide (ETZ) were used as model drugs based on their differences in wettability and particle size distribution. Granules with mean particle sizes of 100–200 µm and a narrow particle size distribution (PSD) could be prepared regardless of the drug used. IBU and ETZ granules showed a higher sphericity than APAP granules, while APAP and ETZ granules exhibited higher granule strength than IBU. The relationship between drug and granule properties suggested that the wettability and the PSD of the drugs were critical parameters affecting sphericity and granule strength, respectively. Furthermore, the dissolution profiles of granules prepared with poorly water-soluble drugs (IBU and ETZ) showed a rapid release (80% release in 20 min) because of the improved wettability with granulation. The present study demonstrated for the first time that fluidized bed rotor granulation can prepare high drug-loaded (>97%) globular granules with a mean particle size of less than 200 µm and the relationship between physicochemical drug properties and the properties of the granules obtained could be readily determined, indicating the potential for further application of this methodology to various drugs.
収録刊行物
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- CHEMICAL & PHARMACEUTICAL BULLETIN
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CHEMICAL & PHARMACEUTICAL BULLETIN 63 (12), 1070-1075, 2015
公益社団法人 日本薬学会
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詳細情報 詳細情報について
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- CRID
- 1390001204178705536
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- NII論文ID
- 130005112212
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- NII書誌ID
- AA00602100
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- ISSN
- 13475223
- 00092363
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- NDL書誌ID
- 026950145
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- PubMed
- 26633029
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- 本文言語コード
- en
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- データソース種別
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- JaLC
- NDL
- Crossref
- PubMed
- CiNii Articles
- KAKEN
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- 抄録ライセンスフラグ
- 使用不可