The advancement sought in this research conducted by Diteba was to develop and validate a specific, sensitive and reliable assay method that was capable of:
- Exhibiting linear pharmacokinetics, i.e., proportional to dose administrated from approximately 10 pg/mL to 5 000 pg/mL;
- Assessing clinical studies conducted for a population of patients with inoperable chronic pulmonary hypertension (which are usually dosed 45-125 ng/kg/min); and
- Proving that the synthetic prostacyclin analogue plasma concentrations remain linearly proportional to doses up to 125 ng/kg/min.
This compound is a long-acting analogue of prostacycline and it is administered in low doses (1.25-15 ng/kg/min) by continuous intravenous infusion to patients with pulmonary hypertension. The drug improves survival and the hemodynamics in these patients. However, the treatment is limited by a very short half-life (1-2 minutes) and chemical instability requiring continuous intravenous infusion and refrigeration during administration. Some research has been published with regards to biotransformation and pharmacokinetics for Beraprost, a synthetic analog of prostacyclin.