Echocardiography is the prime imaging modality for the diagnosis of cardiovascular diseases but remained sub-optimal due to poor endocardial delineation. The introduction of a contrast medium helps in overcoming these limitations. Poly Glycerol Sebacate (PGS) is approved by FDA and has been extensively employed in tissue engineering but never in the field of acoustics or drug delivery due to its insolubility. Due to its excellent viscoelastic properties, we used its pre-polymer which is soluble in organic solvents as shell material for nanobubble contrast agent. We fabricated Pre-PGS- perfluoropentane nanobubbles via solvent displacement method and checked it's in vitro, in vivo enhancement, and safety profile. For in vivo analysis, we have performed experiments on 20 male Wistar rats and 2 dogs. Biochemical assays of both rats and dogs included complete blood profiles, liver function tests, and renal function tests. For rat vitals, monitoring and histopathological analysis were also performed. Non-phase converted nanobubbles showed the size of 210.3±60.99 nm while phase converted nanobubbles showed the size of 1076±288.1 nm and a small peak at 5359±341.6 nm. Nanobubbles showed excellent contrast enhancement, better than Sonovue® for in vitro and in vivo imaging. Nanobubbles showed a duration of enhancement of up to 14 minutes. Pre-PGS nanobubbles also showed liver and kidney enhancement which makes them suitable for abdominal imaging too. All biochemical assays remained within the normal range during the study period. The histopathological analysis didn’t show any signs of drug-induced toxicity. Pre-PGS-PFP nanobubbles hold great potential to be used for echocardiography and abdominal imaging in both human and veterinary applications.

In vivo safety evaluation and contrast enhancement of novel elastomer-based phase convertible nanobubbles as echocardiographic contrast agents

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