Preclinical acute toxicology study of surfactant-stabilized ultrasound contrast agents in adult rats

International Journal of Toxicology

Volumn 29, Issue 1, 2010, Pages 32-39

  Forsberg, Flemming ^a   Liu, Ji Bin ^a   Patel, Mihir ^b   Liu, Liping ^a   Lin, G ^a   Solis, Carl ^b   Fox, Traci B ^c   Wheatley, Margaret A ^b  

^a THOMAS JEFFERSON UNIVERSITY   (United States)

^b DREXEL UNIVERSITY   (United States)

^c THOMAS JEFFERSON UNIVERSITY   (United States)

Author keywords

Contrast agent; Preclinical safety assessment; Surfactant stabilized gas filled microbubbles; Ultrasound imaging

Indexed keywords

ECHO CONTRAST MEDIUM; ST44; ST68; SURFACTANT; UNCLASSIFIED DRUG; CONTRAST MEDIUM; HEXOSE; POLYSORBATE;

ACUTE TOXICITY; ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; CELL INFILTRATION; CONTROLLED STUDY; DOSE RESPONSE; FEMALE; HISTOPATHOLOGY; MALE; NONHUMAN; RAT; TOXICITY TESTING; ANIMAL; BODY WEIGHT; DRUG EFFECT; ECHOGRAPHY; LONGEVITY; MICROBUBBLE; SPRAGUE DAWLEY RAT;

ANIMALIA; RATTUS;

ACUTE TOXICITY TESTS; ANIMALS; BODY WEIGHT; CONTRAST MEDIA; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HEXOSES; LONGEVITY; MALE; MICROBUBBLES; POLYSORBATES; RATS; RATS, SPRAGUE-DAWLEY; SURFACE-ACTIVE AGENTS; ULTRASONOGRAPHY;

EID: 77949885676     PISSN: 10915818     EISSN: 1092874X     Source Type: Journal    
DOI: 10.1177/1091581809354342     Document Type: Article

References (41)

1. Goldberg BB, Raichlen JS, Forsberg F. Ultrasound Contrast Agents: Basic Principles and Clinical Practice. 2nd ed. London: Martin Dunitz Ltd; 2001.
2. Dolan MS, Gala SS, Dodla S, et al. Safety and efficacy of commercially available ultrasound contrast agents for rest and stress echocardiography a multicenter experience. J Am Coll Cardiol. 2009;53:32-38.
3. Main ML, Goldman JH, Grayburn PA. Ultrasound contrast agents: balancing safety versus efficacy. Expert Opin Drug Saf. 2009;8:49-56.
4. Shaikh K, Chang SM, Peterson L, et al. Safety of contrast administration for endocardial enhancement during stress echocardiography compared with noncontrast stress. Am J Cardiol. 2008;102:1444-1450.
5. Wei K, Mulvagh SL, Carson L, et al. The safety of Definity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses. J Am Soc Echocardiogr. 2008;21:1202-1206.
6. FDA Alert (10/12/2007, updated 7/17/2008). Information for healthcare professionals: micro-bubble contrast agents (marketed as Definity (perflutren lipid microsphere) injectable suspension and Optison (perflutren protein-type a microspheres for injection). http://www.fda.gov/CDER/drug/InfoSheets/HCP/ microbubbleHCP.htm. Accessed May 5, 2009.
7. Basude R, Duckworth JW, Wheatley MA. Influence of environmental conditions on a surfactant-stabilized contrast agent: ST68. Ultrasound Med Biol. 2000;26:621-628. (Pubitemid 30336664)
8. Wang W, Moser CC, Wheatley MA. Langmuir trough study of surfactant mixtures used in the production of a new ultrasound contrast agent consisting of stabilized microbubbles. J Phys Chem. 1996;100:13815-13821. (Pubitemid 126814716)
9. Wheatley MA, Shen P, Goldberg BB, Singhal S. Surfactant-stabilized microbubble mixtures, process for preparation and methods of using same. US patent 5,352,436. October 4, 1994.
10. Wheatley MA. Composition of contrast microbubbles: basic chemistry of encapsulated and surfactant coated bubbles. In: Ultrasound Contrast Agents: Basic Principles and Clinical Practice. 2nd ed. Goldberg BB, Raichlen JS, Forsberg F, eds. London: Martin Dunitz; 2001.
11. Wheatley MA, Forsberg F, Dube N, Patel M, Oeffinger BE. Surfactant-stabilized contrast agent on the nano-scale for diagnostic ultrasound imaging. Ultrasound Med Biol. 2006;32: 83-93. (Pubitemid 41814864)
12. Forsberg F, Basude R, Liu JB, et al. Effect of filling gasses on the backscatter from contrast bubbles: theory and in vivo measurements. Ultrasound Med Biol. 1999;25:1203-1211. (Pubitemid 29465794)
13. Forsberg F, Wu Y, Makin IRS, Wang W, Wheatley MA. Quantitative acoustic characterization of a new surfactant based ultrasound contrast agent. Ultrasound Med Biol. 1997;23:1201-1208. (Pubitemid 27452781)
14. Basude R, Wheatley MA. Generation of ultra-harmonics in surfactant-based ultrasound contrast agents- use and advantages. Ultrasonics. 2001;39:437-444. (Pubitemid 33092771)
15. Ambudkar SV, Dey S, Hrycyna CA, Ramachandra M, Pastan I, Gottesman MM. Biochemical, cellular, and pharmacological aspects of the multidrug transporter. Ann Rev Pharmacol Toxicol. 1999;39:361-398. (Pubitemid 29222564)
16. Ferrara KW. Driving delivery vehicles with ultrasound. Adv Drug Del Rev. 2008;60:1097-1102.
17. Hugger ED, Audus KL, Borchardt RT. Effects of poly(ethylene)-glycol on efflux transporter activity in Caco-2 cell monolayers. J Pharm Sci. 2001;91:1980-1990.
18. Nerurkar MM, Burton PS, Borchardt RT. The use of surfactants to enhance the permeability of peptides through Caco-2 cells by inhibition of an apically polarized efflux system. Pharm Res. 1996;13:528-534.
19. Nerurkar MM, Ho PS, Burton TJ, Vidmar RT. Mechanistic roles of neutral surfactants on concurrent polarized and passive membrane transport of a model peptide in Caco-2 cells. J Pharm Sci. 1997;86:813-821.
20. Institute of Laboratory Animal Resources (ILAR). Guide for the Care and Use of Laboratory Animals. Washington, DC: National Academy Press; 1996.
21. Forsberg F, Liu JB, Burns PN, Merton DA, Goldberg BB. Artifacts in ultrasonic contrast agent studies. J Ultrasound Med. 1994;13:357-365. (Pubitemid 24372044)
22. Cleves MA, Gould WW, Gutierrez RG. An Introduction to Survival Analysis Using Stata. College Station, Tex: Stata Press; 2002.
23. Oser BL, Oser M. Nutritional studies on rats on diets containing high levels of partial ester emulsifiers, II: reproduction and lactation. J Nutr. 1956;60:489-505.
24. Lanigan RS, Yamarik TA; Cosmetic Ingredient Review Expert Panel. Final report on the safety assessment of sorbitan stearate, sorbitan laurate, sorbitan sesquioleate, sorbitan oleate, sorbitan tristearate, sorbitan palmitate, and sorbitan trioleate. Int J Toxicol. 1985;4:65-121.
25. Gong J, Huo M, Zhou J, et al. Synthesis, characterization, drug-loading capacity and safety of novel octyl modified serum albumin micelles. Int J Pharm. 2009;376:161-168.
26. Iijima H, Moriyasu F, Miyahara T, Yanagisawa K. Ultrasound contrast agent, Levovist microbubbles are phagocytosed by Kupffer cells: in vitro and in vivo studies. Hepatol Res. 2006;35:235-237.
27. Watanabe R, Matsumura M, Munemasa T, Fujimaki M, Suematsu M. Mechanism of hepatic parenchyma-specific contrast of microbubble-based contrast agent for ultrasonography: microscopic studies in rat liver. Invest Radiol. 2007;42:643-651. (Pubitemid 47262933)
28. Yanagisawa K, Moriyasu F, Miyahara T, Yuki M, Iijima H. Phagocytosis of ultrasound contrast agent microbubbles by Kupffer cells. Ultrasound Med Biol. 2007;33:318-325. (Pubitemid 46240604)
29. Goldberg BB, Merton DA, Liu JB, Murphy G, Forsberg F. Contrast-enhanced sonographic imaging of lymphatic channels and sentinel lymph nodes. J Ultrasound Med. 2005; 24: 953-965. (Pubitemid 40885182)
30. Kono Y, Steinbach GC, Peterson T, Schmid-Schönbein GW, Mattrey RF. Mechanism of parenchymal enhancement of the liver with a microbubble-based US contrast medium: an intravital microscopy study in rats. Radiology. 2002;224:253-257. (Pubitemid 34680403)
31. Kindberg GM, Tolleshaug H, Roos N, Skotland T. Hepatic clearance of Sonazoid perfluorobutane microbubbles by Kupffer cells does not reduce the ability of liver to phagocytose or degrade albumin microspheres. Cell Tissue Res. 2003;312:49-54. (Pubitemid 36578845)
32. Killam AL, Mehlhaff PM, Zavorskas PA, et al. Tissue distribution of 125I-labeled Albumin in rats, and whole blood and exhaled elimination kinetics of octafluoropropane in anesthetized canines, following intravenous administration of Optison (FS069). Int J Toxicol. 1999;18:49-63.
33. Straub JA, Chickering DE, Hartman TG, Gloff CA, Bernstein H. AI-700 pharmacokinetics, tissue distribution and exhaled elimination kinetics in rats. Int J Pharm. 2007;328:35-41. (Pubitemid 44827560)
34. Toft KG, Hustvedt SO, Hals PA, et al. Disposition of perfluorobutane in rats after intravenous injection of Sonazoid. Ultrasound Med Biol. 2006;32:107-114.
35. Walday P, Tolleshaug H, Gjøen T, et al. Biodistributions of air-filled albumin microspheres in rats and pigs. Biochem J. 1994;299:437-443. (Pubitemid 24114137)
36. Correas JM, Meuter AR, Singlas E, Kessler DR, Worah D, Quay SC. Human pharmacokinetics of a perfluorocarbon ultrasound contrast agent evaluated with gas chromatography. Ultrasound Med Biol. 2001;27:565-570. (Pubitemid 32479147)
37. Landmark KE, Johansen PW, Johnson JA, Johansen B, Uran S, Skotland T. Pharmacokinetics of perfluorobutane following intravenous bolus injection and continuous infusion of sonazoid in healthy volunteers and in patients with reduced pulmonary diffusing capacity. Ultrasound Med Biol. 2008;34:494-501. (Pubitemid 351625456)
38. Greener Y, Killam AL, Cornell ST, Osheroff MR, Wolford ST. Nonclinical safety assessment of intravenous Optison®: a perfluoropropane (PFP)-filled albumin microspheres contrast agent for ultrasonography. Int J Toxicol. 1998;17:631-662. (Pubitemid 28487351)
39. Miller DL, Averkiou MA, Brayman AA, et al. Bioeffects considerations for diagnostic ultrasound contrast agents. J Ultrasound Med. 2008;27:611-632.
40. Bland JM, Altman DG. Multiple significance tests: the Bonferroni method. Br Med J. 1995;310:170.
41. Perneger TV. What's wrong with Bonferroni adjustments. Br Med J. 1998;316:1236-1238.