CLINICAL PHARMACOKINETICS AND DELIVERY OF BOVINE SUPEROXIDE-DISMUTASE

Experimentally, superoxide dismutase (SOD) protects against cytotoxolo gical and histotoxological effects of superoxide anions, which play a fundamental role where inflammatory processes are involved. Currently, only bovine copper containing SOD (Cu-SOD) is available for clinical application in the treatment of patients with various arthritic diseas es. The intramuscular route is the principal route to administer usual dosages of bovine Cu-SOD 4 to 32mg, 2 or 3 times weekly, A single dos e corresponds to an optimal dose ranging from 30 to 200 mu g/kg, deter mined from an established dose-response curve. After intramuscular inj ection of bovine Cu-SOD 8, 16 and 32mg the peak plasma concentration o ccurs 4 to 8 hours postdose and is 0.05, 0.16 and 0.39 mg/L, respectiv ely. Clinically this metallo-protein is particularly effective for the treatment of inflammation and toxicity resulting from ionising irradi ations, ischaemia and tumours. The major advantages of liposomally enc apsulated bovine Cu-SOD are its improved pharmacokinetic characteristi cs, leading to a longer plasma half-life and a slower release of free bovine Cu-SOD. In humans, bovine Cu-SOD (foe or liposomal), although a foreign protein, is well tolerated and produces no acute or delayed t oxic effects.