Aluminium release of pharmaceutical glass containers: Determination by GFAAS in the extract solutions and study of the inner surfaces by XPS and SIMS

Abstract

It is well-known that aluminium accumulation in the body is responsible for severe neurological diseases to which patients receiving haemodialysis are particularly exposed. This problem, which could arise for any kind of solutions for hypodermoclysis, seems to be overcome if the aluminium content of the injectable preparations is less than 10 µg/l. In the present paper the aluminium release has been determined for different glass containers for pharmaceutical use after autoclave treatment with distilled water for 60 min at 121 °C. The determinations have been carried out by Graphite Furnace Atomic Absorption Spectrometry in the extracts: The best result was obtained for the glass of type II whose release was lower than 2 μg/l for any capacity. An explanation of the aluminium release mechanism from these glasses is attempted an the basis of XPS and SIMS data obtained for the inner surface of the containers. The sulphur treatment depletes the surface almost completely of calcium and sodium ions, thus forming a highly durable SiO2-rich layer. After autoclaving the pH value of the solution remains in the range of neutral values and the dissolution process is limited to about 5 nm. No preferential extraction of aluminium has been detected in the bloom.