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Study on Acute Toxicity of Amiodarone New Complexes With Cyclodextrin.

Cristina Mihaela Ghiciuc1, Maytham Razaq Shleghm2, Cornelia Vasile3

  • 1Department of Pharmacology, Faculty of Medicine, "Grigore T. Popa" University of Medicine and Pharmacy, Iasi, Romania.

Frontiers in Pharmacology
|April 26, 2021
PubMed
Summary

New amiodarone formulations using 2-hydroxypropyl-β-cyclodextrin (AMD/HP-β-CD) complexes show reduced toxicity. Kollidon® and chitosan matrices enhance safety, increasing the lethal dose by 1.5 times compared to pure amiodarone.

Keywords:
acute toxicityamiodaronecyclodextrin complexlaboratory animalsnew complexes

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Area of Science:

  • Pharmacology
  • Drug Delivery
  • Toxicology

Background:

  • Amiodarone's low solubility limits bioavailability and increases toxicity.
  • Cyclodextrin complexation improves amiodarone dissolution, solubility, and drug release control.

Purpose of the Study:

  • To characterize the acute toxicity of a novel amiodarone 2-hydroxypropyl-β-cyclodextrin complex (AMD/HP-β-CD).
  • To evaluate two matrix formulations (Kollidon® and chitosan-based) for amiodarone delivery.

Main Methods:

  • Intraperitoneal administration of amiodarone, AMD/HP-β-CD, and matrix formulations in laboratory animals.
  • Acute toxicity assessment, including determination of LD50 values and histopathological analysis.

Main Results:

  • Amiodarone and AMD/HP-β-CD showed equitoxicity (LD50 ≈ 289-298 mg/kg) with similar histopathological changes.
  • Matrix formulations (Fc and F10) exhibited higher LD50 values (347.5 mg/kg and 455.6 mg/kg, respectively).
  • The Kollidon® and chitosan matrix significantly increased the LD50 of the amiodarone complex by 1.5 times compared to pure amiodarone.

Conclusions:

  • Kollidon® and chitosan matrices modify amiodarone solubility and control its release, enhancing safety.
  • The developed matrix formulations offer a safer route for amiodarone administration.
  • AMD/HP-β-CD complexation within a KOL and CHT matrix presents a promising approach to mitigate amiodarone toxicity.