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Physicochemical Characteristics of Sonazoid™, A New Contrast Agent for Ultrasound Imaging

Authors
Journal
Ultrasound in Medicine & Biology
0301-5629
Publisher
Elsevier
Publication Date
Volume
34
Issue
5
Identifiers
DOI: 10.1016/j.ultrasmedbio.2007.11.006
Keywords
  • Ultrasound
  • Contrast Agents
  • Microspheres
  • Physicochemical Properties
  • Acoustic Properties
  • Perfluorobutane
  • Phosphatidyl Serine
Disciplines
  • Chemistry
  • Medicine
  • Musicology
  • Physics

Abstract

Abstract The objective of the current work is to describe the physicochemical characteristics of Sonazoid™, a new ultrasound contrast agent for detection and characterisation of focal liver lesions. It has been demonstrated that Sonazoid™ powder for injection consists of microspheres of perfluorobutane (PFB) stabilised by a monomolecular membrane of hydrogenated egg phosphatidyl serine, embedded in an amorphous sucrose structure. Upon reconstitution with sterile water, stabilised microspheres of PFB are released in a predefined amount and size into a low viscosity, isotonic sucrose solution with a neutral pH. Sonazoid™ reconstituted product contains approximately 8 μl microspheres/ml with volume median diameter of approximately 2.6 μm. The product contains approximately 1.2 billion microspheres/ml of which less than 0.1% are larger than 7 μm. The acoustic properties of Sonazoid™ such as attenuation efficacy, fundamental and second harmonic backscatter efficacy are all well correlated to the microsphere volume concentration. The stability of Sonazoid™ after reconstitution is good, with no significant changes in physicochemical properties 2 h after reconstitution. Pressure stress is well tolerated by both concentrated and diluted Sonazoid™ with no permanent effects of pressures up to 300 mm Hg. The level and consistency of the investigated physicochemical properties demonstrate that Sonazoid™ should be well suited as a contrast agent for medical imaging with ultrasound. (E-mail: [email protected])

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