Silicone-based enteric CT contrast material

Abstract

The present invention provides a silicon-based polymer contrast media for use in CT imaging. In an exemplary embodiment, the invention provides an enteric contrast medium formulation. An exemplary formulation comprises, (a) an enteric contrast medium comprising silicon-based polymer oil emulsified in water. Exemplary silicon-based polymer oil has a viscosity between about 50 eSt and 100,000 eSt. In various embodiments, the silicon-based polymer oil is emulsified with a vehicle or dispersing medium compatible with enteric administration of the formulation to a subject in need of such administration. In an exemplary embodiment, the contrast material is incorporated into a pharmaceutically acceptable vehicle in which the material is emulsified in the presence of a surfactant. In an exemplary embodiment, the silicon-based polymer comprises 30% or more of the weight of the contrast material formulation.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims, under 35 USC 119(e), the benefit of U.S. Provisional Application No. 61 / 866,806 filed Aug. 16, 2013, which is incorporated herein by reference in its entirety for all purposes.BACKGROUND OF THE INVENTION[0002]Computed tomography (CT) currently outperforms all other diagnostic tests for the evaluation of many common clinical scenarios, including urgent trauma triage, the evaluation of abdominal pain, and the evaluation for inflammatory or ischemic bowel. The development of contrast material for CT imaging revolutionized medical imaging, particularly in the abdomen and pelvis where visceral organs show intertwined anatomy. Despite the proven value of contrast materials for CT, no substantially improved clinical agent has been introduced in the past 20 years. All commercial CT contrast materials are based on iodine (intravascular or enteric) or barium (enteric only).[0003]A fundamental limitation of current clinical ...

AI Technical Summary

Benefits of technology

This invention provides safe and effective formulations containing silicone-polymer based compounds as enteric CT (or DECT) contrast materials suitable for human use. This contrast material can be used for both "positive" and "negative" enteric contrast with CT without the pitfalls of either type. The "positive" enteric contrast has benefits of superior identification of enteric leaks, detection of extralumenal collections, evaluation of intestinal transit time, identification of bowel wall thickening, evaluation of bowel mural hyper- or hypo-enhancement, non- interference with three-dimensional reformations of CT angiograms, and lower radiation dose. The "negative" enteric contrast has benefits of superior evaluation of bowel mural hyper- or hypoenhancement, non-interference with three-dimensional reformations of CT angiograms, and lower radiation dose. The use of low atomic number atom containing agents has many benefits over use of higher atomic number agents. The formulations and method of this invention also provide the advantage of reducing radiation dose, reducing the need for repeat CT scans.

Problems solved by technology

Pitfalls of “positive” enteric contrast include: toxicity of iodinated or barium contrast material (see below), or when concurrent intravascular contrast material is given, obscuration of critically important findings for bowel mural ischemia or bowel inflammation, obscuration of abdomenopelvic vasculature, prevention of 3D reformation for CT angiography, ambiguity as to the origin of extravasated contrast material, and obscuration of active intraluminal gastrointestinal bleeding.

Pitfalls of “negative” enteric contrast include reduced ability to detect bowel leakage or extralumenal fluid collections, abscesses, or hematomas.

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