Perflubron emulsion (Oxygent(tm)): a temporary intravenous oxygen carrier.

Abstract

Perfluorocarbon (PFC) emulsions, first developed almost 40 years ago, possess physical properties that make them ideal temporary intravenous oxygen carriers for a variety of clinical indications where tissues may be at risk of hypoxia. The first commercial development of an injectable PFC emulsion occurred over 25 years ago when the Green Cross Corporation (Osaka, Japan) produced Fluosol, a 20% w/v PFC emulsion emulsified primarily with Pluronic F-68, a synthetic poloxamer. In 1989, Fluosol became the only synthetic oxygen carrier approved by the FDA for use as an adjunct to high-risk coronary balloon angioplasty. Some limitations of this first generation product, however, included the need for frozen storage of the stem emulsion, the need to thaw and subsequently mix with annex solutions prior to use, and short product stability (8 hours) after reconstitution. Over the past 10 years, Alliance Pharmaceutical Corp. (San Diego) has been developing Oxygent, an improved second-generation PFC emulsion based on perflubron (perfluorooctyl bromide; C8F17Br). This concentrated 60% w/v perflubron-based formulation is emulsified with lecithin as the only surfactant, has a median particle diameter of ∼ 0.17 μm, and can be stored for ∼ 2 years with standard refrigeration. Perflubron emulsion is presently in late-stage clinical testing as a temporary intravenous oxygen carrier in surgical patients, and is being developed in conjunction with Baxter Healthcare Corporation.