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Glass-Based Devices to Generate Drops and Emulsions

Glass-Based Devices to Generate Drops and Emulsions

Published on: April 5, 2022

Silicate release from glass for pharmaceutical preparations.

Denise Bohrer¹, Fabiana Bortoluzzi, Paulo Cícero Nascimento

¹Departamento de Química, Universidade Federal de Santa Maria, 97105-900 Santa Maria, RS, Brazil. ndenise@quimica.ufsm.br

International Journal of Pharmaceutics

|February 15, 2008

Summary

Silica leaches from pharmaceutical glass containers, especially at higher pH levels. Certain pharmaceutical ingredients significantly increase silica release, raising concerns for parenteral nutrition solutions.

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Area of Science:

Materials Science
Pharmaceutical Chemistry
Analytical Chemistry

Background:

Glass containers are essential for pharmaceutical storage.
Pharmaceutical glass quality is assessed by chemical attack resistance, measuring alkalinity.
Minor glass components like sodium oxide influence chemical resistance.

Purpose of the Study:

Investigate silica release from glass containers by pharmaceutical formulations.
Evaluate the impact of various pharmaceutical constituents and pH on silica dissolution.
Assess silicate levels in commercial pharmaceutical products.

Main Methods:

Simulated water attack test with pharmaceutical solutions (amino acids, electrolytes, glucose, heparin, bicarbonate) at 121°C for 30min.
Tested pH range from 2 to 12 using pure water.
Measured released silicate using photometry and atomic absorption spectrometry.

Main Results:

Silicate release occurs even with pure water, increasing significantly with higher pH.
Certain compounds like sodium acetate, bicarbonate, and gluconate dramatically elevate silica release (>30mg Si/L).
Commercial products showed varied silicate levels, with some parenteral nutrition components yielding higher concentrations (1-4mg/L).

Conclusions:

Silica dissolution from glass is influenced by pH and specific pharmaceutical ingredients.
Elevated silicate levels in parenteral nutrition solutions warrant attention due to direct intravenous administration.
Further research may be needed to optimize glass-drug compatibility for sensitive applications.