The cardiovascular safety of Pheroid® in the conscious rat

Abstract

The Pheroid® technology is a patented colloidal drug delivery system comprised of a dispersed oil phase of omega 3 and omega 6 fatty acids emulsified in N2O saturated water. Pheroid® has pharmaceutical applicability for the enhancement of therapeutic efficacy due to better drug exposure, reduced cytotoxicity and faster onset of action. The purpose of this paper was to evaluate the possible cardiovascular effects of the Pheroid® drug delivery system in the conscious rat. Six male rats instrumented with telemetry transmitters were used in a three-way crossover design. The effects of single intravenous administrations of Pheroid® and oral administration of Pheroid® and pro-Pheroid® on cardiovascular parameters were measured. These parameters included arterial blood pressure, heart rate and the ECG. As positive controls, a single intraperitoneal dose of clonidine (0.03 mg/kg) and an oral dose of theophylline (30 mg/kg) were also tested. No significant effects of Pheroid® on cardiovascular parameters were observed at any time following oral or intravenous administration. The expected effects of clonidine (decreased heart rate) and theophylline (increased heart rate) could be demonstrating confirming the sensitivity of the experimental model to detect changes in the cardiovascular parameters measured. We have demonstrated that Pheroid® has no effects on cardiovascular function following both oral and intravenous administration. These data showing cardiovascular safety are supportive for the use of Pheroid® for various pharmacological applications