title: Silicate release from glass for pharmaceutical preparations.
abstract: Glass is made of polymeric silica and other minor components, which are necessary for turning the silica into a material more easily moldable and resistant to temperature changes. Glass containers for pharmaceutical usage are classified according to their resistance to a chemical attack, a test carried out in the presence of water and heat. The test is designed to show the released alkalinity, a variable dependent on the amount of sodium oxide, one of the minor components added to the glass mass. In this work, the release of silica from glass by action of constituents from pharmaceutical formulations was investigated. The study included products used in large volumes and usually stored in glass containers. Solutions of amino acids, electrolytes, glucose, oligoelements and others such as heparin and sodium bicarbonate were individually stored in glass containers and heated at 121 degrees C for 30min, as in the water attack test. The test was also carried out only with water, where the pH varied from 2 to 12. The released silicate was measured either by photometry or atomic absorption spectrometry, depending on the nature of the sample. The results showed that silicate is released during the heating cycle even if the contact is with pure water only. The pH exerts a considerable influence on the release, being that the higher the pH, the higher the silica dissolved. An elevated pH, however, is not the only factor responsible for silica dissolution. While in the solutions of NaCl, KCl, Mg Cl2 and ZnSO4 and in most of the amino acids, the concentration of silicate was as high as in pure water (0.1-1.0mg Si/L). In the solutions of sodium acetate, bicarbonate and gluconate, its concentration was much higher, over 30mg Si/L. These results were confirmed by the analysis of commercial products, where in solutions of amino acids the level of silicate ranged from 0.14 to 0.19mg Si/L. On the other hand, calcium gluconate, sodium bicarbonate and potassium phosphate presented silicate levels from 1 to 4mg/L. Although silica is not considered a toxic substance for humans, it is necessary to be aware of its presence in solutions for parenteral nutrition due to the direct introduction into the bloodstream and the large volume usually administrated, even to pre-term infants.
authors.affiliation: Departamento de Química, Universidade Federal de Santa Maria, 97105-900 Santa Maria, RS, Brazil. ndenise@quimica.ufsm.br
authors.forename: Denise
authors.initials: D
authors.lastname: Bohrer
authors.forename: Fabiana
authors.initials: F
authors.lastname: Bortoluzzi
authors.forename: Paulo Cícero
authors.initials: PC
authors.lastname: Nascimento
authors.forename: Leandro Machado
authors.initials: LM
authors.lastname: Carvalho
authors.forename: Adrian Gustavo
authors.initials: AG
authors.lastname: Ramirez
mesh_terms: D002626:Chemistry, Pharmaceutical; D004340:Drug Contamination; D004349:Drug Packaging; D004573:Electrolytes; D005526:Food, Formulated; D005898:Glass / Q000737:chemistry*; D006358:Hot Temperature; D006863:Hydrogen-Ion Concentration; D007202:Indicators and Reagents; D010288:Parenteral Nutrition; D019999:Pharmaceutical Solutions; D010969:Plastics; D017640:Silicates / Q000737:chemistry*; D013054:Spectrophotometry, Atomic
chemical_list: D004573:Electrolytes; D007202:Indicators and Reagents; D019999:Pharmaceutical Solutions; D010969:Plastics; D017640:Silicates