PM101: intravenous amiodarone formulation changes can improve medication safety

Area of Science:

• Cardiology
• Pharmaceutical Sciences

Background:

• Intravenous amiodarone (A-IV) manages cardiac arrhythmias but its current formulation has adverse events and incompatibilities due to polysorbate 80 and benzyl alcohol.
• A new FDA-approved formulation, PM101, utilizes cyclodextrin for amiodarone solubilization, aiming to overcome these limitations.

Purpose of the Study:

• To review the clinical and pharmaceutical development of intravenous amiodarone formulations.
• To highlight the issues with current A-IV and the advantages of the novel PM101 formulation.

Main Methods:

• Literature search of medical and pharmaceutical databases from 1948 to present.
• Focused on intravenous amiodarone, PM101, and formulation components.

Main Results:

• Current A-IV administration presents challenges including hypotension and incompatibility with infusion materials, impacting drug safety.
• PM101 is designed to mitigate these specific issues associated with traditional A-IV.

Conclusions:

• PM101 represents a significant advancement in intravenous amiodarone therapy.
• The new formulation demonstrates stability with common infusion materials and eliminates co-solvent related toxicities.