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

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

METHODS
Foam 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.

RESULTS
Polidocanol 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.

CONCLUSION
Bubble 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.
foam drainage times, foam half time, physician-compounded foams, bubble size, bubble size distribution, varicose veins, polidocanol endovenous microfoam, sclerotherapy, biomimetic analysis method, polidocanol injectable foam
283-295
Carugo, Dario
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Ankrett, Dyan N.
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Zhao, Xuefeng
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Zhang, Xunli
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Hill, Martyn
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O'Byrne, Vincent
f9a573d5-6e2d-4d67-9478-dcfc161d79e6
Hoad, James
75fe0241-ea30-4329-b063-7af160bf8ab8
Arif, Mehreen
59febc35-91a3-45d5-86e9-a497e3482c95
Wright, D.I.
48e338e7-f5f6-458c-beb6-a7a2297aa3ad
Lewis, Andrew L.
f604ae82-4d54-4f04-ac8f-e7bc6f1f832c
Carugo, Dario
0a4be6cd-e309-4ed8-a620-20256ce01179
Ankrett, Dyan N.
22d8eb6d-70db-4b47-9587-c4d048cd34b7
Zhao, Xuefeng
5b7a35ab-f71e-4625-80e2-676c4a15533a
Zhang, Xunli
d7cf1181-3276-4da1-9150-e212b333abb1
Hill, Martyn
0cda65c8-a70f-476f-b126-d2c4460a253e
O'Byrne, Vincent
f9a573d5-6e2d-4d67-9478-dcfc161d79e6
Hoad, James
75fe0241-ea30-4329-b063-7af160bf8ab8
Arif, Mehreen
59febc35-91a3-45d5-86e9-a497e3482c95
Wright, D.I.
48e338e7-f5f6-458c-beb6-a7a2297aa3ad
Lewis, Andrew L.
f604ae82-4d54-4f04-ac8f-e7bc6f1f832c

Carugo, Dario, Ankrett, Dyan N., Zhao, Xuefeng, Zhang, Xunli, Hill, Martyn, O'Byrne, Vincent, Hoad, James, Arif, Mehreen, Wright, D.I. and Lewis, Andrew L. (2016) Benefits of olidocanol endovenous microfoam (Varithena®) compared with physician compounded foams. Phlebology, 31 (4), 283-295. (doi:10.1177/0268355515589063).

Record type: Article

Abstract

OBJECTIVE
To 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.

METHODS
Foam 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.

RESULTS
Polidocanol 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.

CONCLUSION
Bubble 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.

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More information

Accepted/In Press date: 1 May 2015
e-pub ahead of print date: 1 June 2015
Published date: 1 May 2016
Keywords: foam drainage times, foam half time, physician-compounded foams, bubble size, bubble size distribution, varicose veins, polidocanol endovenous microfoam, sclerotherapy, biomimetic analysis method, polidocanol injectable foam
Organisations: Bioengineering Group, Institute for Life Sciences, Mechatronics

Identifiers

Local EPrints ID: 377335
URI: http://eprints.soton.ac.uk/id/eprint/377335
PURE UUID: 4ffe1e3e-0003-40c5-af98-f2bcb9523ea6
ORCID for Xunli Zhang: ORCID iD orcid.org/0000-0002-4375-1571
ORCID for Martyn Hill: ORCID iD orcid.org/0000-0001-6448-9448

Catalogue record

Date deposited: 19 Jun 2015 16:03
Last modified: 17 Dec 2019 02:02

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Contributors

Author: Dario Carugo
Author: Dyan N. Ankrett
Author: Xuefeng Zhao
Author: Xunli Zhang ORCID iD
Author: Martyn Hill ORCID iD
Author: Vincent O'Byrne
Author: James Hoad
Author: Mehreen Arif
Author: D.I. Wright
Author: Andrew L. Lewis

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