Currently, there are two commercially available microbubble preparations that are FDA-approved for clinical use in the United States; viz. Definity (Bristol Myers Squibb) and Optison (General Electric). Both are filled with octafluoropentane gas, and both preparations have an average, microbubble diameter of about 3.5 mm. Both products are quite non-homogeneous with respect to the size distribution of their constituent microbubbles, with each preparation containing microbubbles with diameters that range from 1.0 mm to 6 mm. Among other physical characteristics, the acoustic properties of microbubbles vary as a function of their diameter, hence, the Definity and Optison microbubbles behave non-uniformly with respect to an insonating ultrasonic field.
This discovery involves new methods for:
1) Producing microbubbles with narrow and defined size distributions
2) Varying the serum albumin/dextrose shell to increase or decrease shell strength and elasticity
3) Store the microbubbles for protracted periods and for shipment
4) Chemically couple peptides, antibodies, drugs, magnetic nanoparticles, and other molecules to the microbubbles to help target microbubbles to desired in vivo locations and/or to deliver therapeutic molecules to specific tissues or diseased sites
University researchers are able to manufacture microbubble preparations with very homogeneous diameters and with distinct shell thickness and strength. This provides the unique capability to produce microbubbles that have defined acoustic properties to meet the demands for a wide range of clinical and research applications, e.g. sonoporation, thrombolysis, drug delivery, etc. Such flexibility does not exist for the current, commercially available microbubble preparations. The protocols presented in this disclosure provide microbubble preparations that have distinct advantages over existing preparations.
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07-46 (D & E) Borrelli