PM101: intravenous amiodarone formulation changes can improve medication safety.
BACKGROUND
Intravenous amiodarone (A-IV) is used to manage ventricular and atrial arrhythmias. The current formulation uses polysorbate 80 and benzyl alcohol to maintain amiodarone in solution, and these co-solvents are linked with clinically-important adverse events and pharmaceutical incompatibilities. PM101 is a recently FDA-approved intravenous formulation of amiodarone that uses a cyclodextrin to solubilize amiodarone.


METHODS
This review describes the clinical and pharmaceutical development of formulations of amiodarone for intravenous administration. The medical and pharmaceutical literature was searched for papers discussing A-IV, PM101 and their formulation components. Relevant literature was identified starting from 1948 to the present.


RESULTS
The reader will learn about the important medical and pharmaceutical issues complicating A-IV administration, including an understanding of related hypotension and compatibility with commonly used infusion materials and how these issues may impact drug safety. PM101 has been developed to address several of these important issues.


CONCLUSIONS
PM101 is a new formulation of A-IV that is stable in commonly used infusion materials and avoids co-solvent related toxicities.
Souney
Paul F
PF
Prism Pharmaceuticals, Inc., 1016 West Ninth Avenue, Suite 130, King of Prussia, PA 19406, USA. psouney@prismpharma.com
Cooper
Warren D
WD
Cushing
Daniel J
DJ
D000638:Amiodarone / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry*; D000818:Animals; D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry; D001145:Arrhythmias, Cardiac / Q000188:drug therapy / Q000378:metabolism; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D006801:Humans; D007275:Injections, Intravenous
D000889:Anti-Arrhythmia Agents; D000638:Amiodarone