Studies on Uniformity of the Active Ingredients in Acetaminophen Suppositories Re-solidified after Melting under High Temperature Conditions
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- Yamamoto Yoshihisa
- Faculty of Pharmaceutical Sciences, Teikyo Heisei University
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- Fukami Toshiro
- Department of Molecular Pharmaceutics, Meiji Pharmaceutical University
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- Koide Tatsuo
- Division of Drugs, National Institute of Health Sciences
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- Onuki Yoshinori
- Department of Pharmaceutics, Hoshi University
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- Suzuki Toyofumi
- Laboratory of Pharmaceutics, School of Pharmacy, Nihon University
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- Katori Noriko
- Division of Drugs, National Institute of Health Sciences
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- Tomono Kazuo
- Laboratory of Pharmaceutics, School of Pharmacy, Nihon University
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抄録
The target of the present pharmaceutical study was the antipyretic analgesic, acetaminophen; its suppository form is usually split when used in pediatric patients. We focused on the active ingredient uniformity in these products, which were re-solidified after melting under high temperature condition. When sections of the cut surfaces of the seven acetaminophen suppository products (SUP-A–G) commercially available in Japan were visualized by polarized microscopy, acetaminophen crystals that were dispersed in the base were identified. The results of the quantitative determination of agent concentration for each cut portion (mg/g) suggested uniform dispersion of these crystals in the base of each product. The agent concentration in each portion of the suppositories that was re-solidified after melting at high temperatures was measured. Segregation of the active ingredient was observed in four products at a temperature of 40°C for 1 h, while active ingredient uniformity was maintained in the other three products (SUP-C, SUP-F and SUP-G). The latter three products also showed high viscosity at 40°C. At 50°C for 4 h, only the uniformity of the active ingredient in SUP-C was maintained. These results suggest that the uniformity of the active ingredient is lost in some acetaminophen suppositories that were re-solidified after melting under high temperature conditions. The degree of loss varies depending on the product.
収録刊行物
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- CHEMICAL & PHARMACEUTICAL BULLETIN
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CHEMICAL & PHARMACEUTICAL BULLETIN 63 (4), 263-272, 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
- 1390001204176875520
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- NII論文ID
- 130005061432
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- NII書誌ID
- AA00602100
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- ISSN
- 13475223
- 00092363
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- NDL書誌ID
- 026283568
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- PubMed
- 25739525
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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
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- 抄録ライセンスフラグ
- 使用不可