Particle Design of Three-Component System for Sustained Release Using a 4-Fluid Nozzle Spray-Drying Technique
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概要
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We prepared composite particles of acetaminophen (Act) with chitosan (Cht) and hydroxypropylmethylcellulose phthalate (HPMCP) as a carrier using a newly developed 4-fluid nozzle spray-dryer. Cht dissolves in acid solutions and forms a gel, but it is insoluble in alkaline solutions. On the other hand, HPMCP is insoluble in acid solutions, but it dissolves in alkaline solutions. Therefore, we tested a preparation of controlled release composite particles using the characteristics of these carriers. Act and Cht mixtures in prescribed ratios were dissolved in an acid solution. Composite particles of Act and HPMCP in prescribed ratios were dissolved in alkaline solutions. We evaluated the composite particles of the three components (Act, Cht, and HPMCP) by preparing solid dispersions using a 4-fluid nozzle spray-dryer. Observation of particle morphology by scanning electron microscopy (SEM) revealed that the particles from the spray-drying process had atomized to several microns and had all become spherical. We investigated the physical properties of the composite particles by powder X-ray diffraction, differential scanning calorimetry, and dissolution rate analysis to clarify the effects of crystallinity on the dissolution rate. Powder X-ray diffraction peaks and the heat of fusion of Act in the spray-dried samples decreased in proportion to the carrier content, indicating that the drug was amorphous. These results indicate that the Act-Cht-HPMCP system formed a solid dispersion. Furthermore, we investigated the interaction between the drug and the carrier using FT-IR analysis. FT-IR spectroscopy of the Act solid dispersions suggested that the Act carbonyl and Cht amino groups formed a hydrogen bond. On the other hand, interaction by hydrogen bond was observed between the carbonyl group of HPMCP with the amino group of Act. In the three-component Act-Cht-HPMCP system, the 4-fluid nozzle spray-dried preparation with a mixing ratio of 1:2.5:2.5 obtained sustained release preparation in all pH test solutions.
- 公益社団法人日本薬学会の論文
- 2006-11-01
著者
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岡本 博
神戸学院大学薬学部 生命薬学部門 循環器薬理学研究室
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壇上 和美
名城大学薬学部製剤学研究室
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檀上 和美
Faculty of Pharmacy, Meijo University
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Danjo K
名城大学 薬学部
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Danjo Kazumi
Faculty Of Pharmacy Meijo University
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壇上 和美
名城大学薬学部製剤学教室
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OKAMOTO Hirokazu
Faculty of Pharmaceutical Sciences, Kyoto University
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Danjo K
Fac. Of Pharmacy Meijo Univ.
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Okamoto H
Faculty Of Pharmacy Meijo University
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CHEN Richer
Mintai Chemical Co., Ltd.
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TAKAHASHI Hirokazu
Faculty of Pharmacy, Meijo University
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Chen Richer
Mintai Chemical Co. Ltd.
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Takahashi Hirokazu
Faculty Of Pharmacy Meijo University
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Okamoto Hirokazu
Fac. Of Pharmacy Meijo Univ.
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