Prism Pharmaceuticals, Inc., 1016 West Ninth Avenue, Suite 130, King of Prussia, PA 19406, USA.
Expert Opin Drug Saf. 2010 Mar;9(2):319-33. doi: 10.1517/14740331003586811.
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.
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.
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.
PM101 is a new formulation of A-IV that is stable in commonly used infusion materials and avoids co-solvent related toxicities.
静脉注射胺碘酮（A-IV）用于治疗室性和房性心律失常。目前的配方使用聚山梨醇酯 80 和苯甲醇来维持胺碘酮的溶液状态，这些共溶剂与临床上重要的不良事件和药物不相容性有关。PM101 是最近获得 FDA 批准的静脉注射用胺碘酮制剂，它使用环糊精来增溶胺碘酮。
本综述描述了用于静脉给药的胺碘酮制剂的临床和药物开发。医学和药物文献中搜索了讨论 A-IV、PM101 及其制剂成分的论文。从 1948 年至今，确定了相关文献。
读者将了解到 A-IV 给药复杂的重要医学和药物问题，包括了解相关低血压和与常用输液材料的相容性，以及这些问题如何影响药物安全性。PM101 的开发旨在解决其中的一些重要问题。
PM101 是一种新的 A-IV 制剂，在常用的输液材料中稳定，避免了共溶剂相关的毒性。
