Comparative acceptability of mini-tablets, fine granules, and liquid formulations in young children: An exploratory randomized crossover study

Miyazaki, Kazuki; Hida, Noriko; Kamiya, Taro; Yamazaki, Tomoo; Murayama, Nobuhiro; Kuroiwa, Miyu; Kurata, Nori; Ishikawa, Yoichi; Yamashita, Shinji; Nakamura, Hidefumi; Nakamura, Akihiro; Harada, Tsutomu

doi:10.1016/j.jddst.2022.103154

Cited by 6 publications

(1 citation statement)

References 15 publications

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“…In Japan, powder and fine granules are popular pediatric dosage forms [ 2 ]; however, their taste and roughness present difficulties [ 7 ]. Mini-tablets can circumvent problems associated with syrups, powders, and fine granules, making them easy to develop globally; however, studies on the dosing and acceptability of mini-tablets in pediatric patients have only been conducted using a placebo [ 8 , 9 ].…”

Section: Introductionmentioning

confidence: 99%

A Study on Pharmacokinetics of Acetylsalicylic Acid Mini-Tablets in Healthy Adult Males—Comparison with the Powder Formulation

et al. 2023

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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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