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

Noriko Hida1,2, Taigi Yamazaki1,2, Yoshiaki Fujita3

  • 1Division of Clinical Research and Development, Department of Clinical Pharmacy, School of Pharmacy, Showa University, Tokyo 142-8555, Japan.

Pharmaceutics
|August 26, 2023
PubMed

Insights

A new mini-tablet formulation of acetylsalicylic acid (aspirin) offers a better-tasting alternative for children with Kawasaki disease. Pharmacokinetic studies in adults show no significant differences in absorption between the mini-tablet and powder forms, aiding pediatric drug therapy.

Area of Science:

  • Pediatric Pharmacology
  • Drug Formulation
  • Pharmacokinetics

Background:

  • Children with Kawasaki disease often receive acetylsalicylic acid (aspirin) powder.
  • The powder's bitter taste can lead to poor medication adherence.
  • A new mini-tablet formulation aims to improve palatability and compliance.

Purpose of the Study:

  • To compare the pharmacokinetic parameters of a novel acetylsalicylic acid mini-tablet formulation against the standard powder form.
  • To assess the safety and efficacy of the mini-tablet formulation in a clinical setting.

Main Methods:

  • An open-label, crossover study was conducted with six healthy adult participants.
  • Participants received both acetylsalicylic acid powder and mini-tablet formulations.
  • Blood samples were analyzed to determine pharmacokinetic parameters like Cmax and AUC0-12.

Main Results:

  • No statistically significant differences were observed in the pharmacokinetic parameters (Cmax, AUC0-12) for salicylic acid and acetylsalicylic acid between the powder and mini-tablet formulations.
  • Adult pharmacokinetic data provides a basis for predicting pediatric responses.

Conclusions:

  • The acetylsalicylic acid mini-tablet formulation demonstrates comparable pharmacokinetic profiles to the powder form in adults.
  • This formulation has the potential to improve medication adherence in pediatric patients with Kawasaki disease.
  • The study contributes to advancing pediatric drug therapy by offering a more palatable option.

Keywords:
Kawasaki diseaseacetylsalicylic acidbioequivalence studyhospital formulationmini-tabletpersonalized medicinepowder

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