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A Study on Pharmacokinetics of Acetylsalicylic Acid Mini-Tablets in Healthy Adult Males-Comparison with the Powder Formulation.
Hida, Noriko; Yamazaki, Taigi; Fujita, Yoshiaki; Noda, Hidehiro; Sambe, Takehiko; Ryu, Kakei; Mizukami, Takuya; Takenoshita, Sachiko; Uchida, Naoki; Nakamura, Akihiro; Harada, Tsutomu.
Afiliación
  • Hida N; Division of Clinical Research and Development, Department of Clinical Pharmacy, School of Pharmacy, Showa University, Tokyo 142-8555, Japan.
  • Yamazaki T; Clinical Research Institute for Clinical Pharmacology and Therapeutics, Showa University, Tokyo 157-8577, Japan.
  • Fujita Y; Division of Clinical Research and Development, Department of Clinical Pharmacy, School of Pharmacy, Showa University, Tokyo 142-8555, Japan.
  • Noda H; Clinical Research Institute for Clinical Pharmacology and Therapeutics, Showa University, Tokyo 157-8577, Japan.
  • Sambe T; Division of Pharmaceutics, Department of Pharmacology, Toxicology and Therapeutics, School of Pharmacy, Showa University, Tokyo 142-8555, Japan.
  • Ryu K; Pharmacy, Showa University Fujigaoka Hospital, Yokohama 227-8501, Japan.
  • Mizukami T; Clinical Research Institute for Clinical Pharmacology and Therapeutics, Showa University, Tokyo 157-8577, Japan.
  • Takenoshita S; Division of Clinical Pharmacology, Department of Pharmacology, School of Medicine, Showa University, Tokyo 142-8555, Japan.
  • Uchida N; Clinical Research Institute for Clinical Pharmacology and Therapeutics, Showa University, Tokyo 157-8577, Japan.
  • Nakamura A; Clinical Research Institute for Clinical Pharmacology and Therapeutics, Showa University, Tokyo 157-8577, Japan.
  • Harada T; Division of Clinical Pharmacology, Department of Pharmacology, School of Medicine, Showa University, Tokyo 142-8555, Japan.
Pharmaceutics ; 15(8)2023 Aug 03.
Article en En | MEDLINE | ID: mdl-37631293
Children with Kawasaki disease are prescribed acetylsalicylic acid powder as an antipyretic analgesic and antiplatelet agent; however, some of it remains in the mouth, leading to a bitter or sour taste. To address this issue, an in-hospital mini-tablet formulation of acetylsalicylic acid was developed. In order to use the mini-tablets safely and effectively, dissolution tests alone are not sufficient. Therefore, an open-label crossover study on six healthy participants was conducted to evaluate comparative pharmacokinetic parameters. The pharmacokinetic parameters of salicylic acid were Cmax: 4.80 ± 0.79 mg/L (powder; P), 5.03 ± 0.97 mg/L (mini-tablet; MT), AUC0-12: 18.0 ± 3.03 mg-h/L (P), 18.9 ± 4.59 mg-h/L (MT), those of acetylsalicylic acid Cmax: 0.50 ± 0.20 mg/L (P), 0.41 ± 0.24 mg/L (MT), AUC0-12: 0.71 ± 0.27 mg-h/L (P), 0.61 ± 0.36 mg-h/L (MT), with no significant differences between the mini-tablet and powder formulations. Although pharmacokinetic results obtained from adults cannot be directly applied to children, the results of this study are important for predicting pharmacokinetics. Furthermore, a formulation that can improve medication adherence in children who have difficulty taking acetylsalicylic acid powder, thus contributing to pediatric drug therapy.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Pharmaceutics Año: 2023 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Suiza

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Pharmaceutics Año: 2023 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Suiza