Absence of gastrointestinal absorption or urinary excretion of aluminium from an allantoinate complex contained in two antacid formulations in patients with normal renal function.

ABSTRACT

We studied the plasma and urinary excretion levels of aluminum (Al) on day 0, 10 and 30 in 79 patients with gastrointestinal symptoms and normal renal function who were receiving a complex based on Al allantoinates [C4H5N4 O3 Al (OH)2] and [C4H5N4 O3 Cl Al2 (OH)4]. We evaluated the extent of Al absorption after repeated administration of this complex in two antacid formulations, Ulfon Lyoc in lyophilised tablet form (group 1; n = 40) and Ulfon suspension (group 2; n = 39). The total Al load for each antacid and patient was 512 mg daily for a total of 15360 mg during the 30-day treatment. No significant rise in plasma Al concentration was noted with either formulation between day 0 and 10, day 0 and 30 or day 10 and 30, nor was there any significant increase in urinary excretion levels. Al absorption was not increased and no toxic effects were noted, indicating that such formulations are suitable for long-term therapy in patients with gastrointestinal symptoms.