Benefits of olidocanol endovenous microfoam (Varithena®) compared with physician compounded foams

OBJECTIVETo compare foam bubble size and bubble size distribution, stability, and degradation rate (DR) of commercially available polidocanol endovenous microfoam (Varithena®) and physician compounded foams (PCFs) using a number of laboratory tests.METHODSFoam properties of polidocanol endovenous microfoam and PCFs were measured and compared using a glass plate method and a Sympatec QICPIC image analysis method to measure bubble size and bubble size distribution, Turbiscan™ LAB for foam half time and drainage, and a novel biomimetic vein model to measure foam stability. PCFs composed of polidocanol and room air (RA), CO2, or mixtures of oxygen and carbon dioxide (O2:CO2) were generated by different methods.RESULTSPolidocanol endovenous microfoam was found to have a narrow bubble size distribution with no large (>500 ?m) bubbles. PCFs made with the Tessari method had broader bubble size distribution and large bubbles, which have an impact on foam stability. Polidocanol endovenous microfoam had a lower degradation rate (DR) than any PCFs, including foams made using RA (p<0.035). The same result was obtained at different liquid to gas ratios (1:4 and 1:7) for PCFs. In all tests performed, CO2 foams were the least stable and different O2:CO2 mixtures had intermediate performance. In the biomimetic vein model, polidocanol endovenous microfoam had the slowest DR, and longest calculated dwell time, which represents the length of time the foam is in contact with the vein, almost twice that of PCFs using RA and eight times better than PCFs prepared using equivalent gas mixes.CONCLUSIONBubble size, bubble size distribution, and stability of various sclerosing foam formulations show that polidocanol endovenous microfoam results in better overall performance compared with PCFs. Polidocanol endovenous microfoam offers better stability and cohesive properties in a biomimetic vein model compared to PCFs. Polidocanol endovenous microfoam, which is indicated in the United States for treatment of great saphenous vein system incompetence, provides clinicians with a consistent product with enhanced handling properties