Table 2

Properties of the study composition, a water/oil (w/o) emulsion of lipiodol (LIP) drug delivery system, containing idarubicin (IDA) as the active drug

Study drug delivery system
Active pharmaceutical ingredientIDA (molecular mass 497.5; Log P1=1.69)
Vehiclewater/oil (w/o) LIP emulsion. LIP consists of linoleic acid (50%–70%), oleic acid (~15%), palmitic acid (~10%), stearic acid (~5%).
Type of formulationEmulsion, preferably w/o with higher LIP volume than aqueous IDA volume
BiodegradableYes, but LIP can be accumulated in tumour tissue for up to 3 months. LIP does not interact with transporters or enzymes important for doxorubicin (another anthracycline).
Loading mechanismEmulsification of aqueous IDA solution in LIP
Common drug loadVariable
Maximum dose (per treatment)15 mg
Release mechanismDiffusion and partitioning lipid/aqueous
Release rateDependent on type of w/o emulsion
Technique used for administrationVia image-guided insertion of catheter into hepatic artery via femoral artery
Site of administrationWhole-liver, lobar, segmental or subsegmental
Embolisation after administrationPartial and temporary
In vivo distributionDependent on tumour size and tumour vasculature