Ibuprofen lysine salt complexed with β-cyclodextrin oral suspension: an innovative pediatric formulation with

Giorgio Ciprandi1, Raffaele Badolato2, Susanna Esposito3

  • 1Allergy Clinic, Casa di Cura Villa Montallegro, Genoa, Italy - gio.cip@libero.it.

Minerva Pediatrics
|June 18, 2025
PubMed

Insights

Ibuprofen lysine salt complexed with β-cyclodextrin (ILS-β-CD) offers rapid and prolonged pain and fever relief in children. This formulation enhances absorption and tolerability, making it a beneficial option for pediatric acute conditions.

Area of Science:

  • Pediatric Pharmacology
  • Drug Delivery Systems
  • Pain Management

Background:

  • Fever and acute pain are common in children, necessitating effective and rapid relief.
  • Standard ibuprofen formulations have poor solubility, leading to delayed absorption and action onset.
  • Salification with lysine and complexation with β-cyclodextrin (β-CD) improve ibuprofen's solubility, absorption, and pharmacokinetic profile.

Purpose of the Study:

  • To review and discuss the pharmacological profile of ibuprofen lysine salt complexed with β-cyclodextrin (ILS-β-CD).
  • To evaluate the suitability of ILS-β-CD for managing fever and pain in pediatric patients.

Main Methods:

  • Pharmacological profile review of ILS-β-CD.
  • Analysis of clinical studies investigating the product's efficacy and safety.

Main Results:

  • ILS-β-CD demonstrates rapid absorption, leading to high and prolonged plasma concentrations.
  • The safety profile of ILS-β-CD is comparable to other NSAIDs.
  • Two clinical studies support the efficacy of this formulation.

Conclusions:

  • ILS-β-CD is a promising option for managing acute fever and pain in children and adolescents.
  • The formulation provides rapid onset of action and sustained therapeutic concentrations.
  • Optimal tolerability and a favorable safety profile are key benefits.
Abstract

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