Accelerated extractable studies of borosilicate glass containers.

Area of Science:

• Materials Science
• Analytical Chemistry
• Pharmaceutical Packaging

Background:

• Borosilicate glass is a common material for pharmaceutical containers.
• Understanding glass-container interactions with aqueous solutions is crucial for drug stability and safety.
• Existing protocols, like the PDA Task Force method, provide a baseline for extractables testing.

Purpose of the Study:

• To develop and validate an accelerated extractables procedure for borosilicate glass containers.
• To evaluate the influence of different aqueous extraction media (pH variations) on extractables.
• To assess extractables from various borosilicate glass types (tubing, molded, ampoules) from different suppliers.

Main Methods:

• An accelerated extraction procedure was employed, adapted from a PDA Task Force protocol.
• Extraction solutions included unbuffered water across a pH range (4-10.4) and buffered solutions (pH 8, 10).
• Analysis focused on key elements (Si, Na, K, Al, Ba, Ca, Mg, Fe, Zn), pH changes, and total extractables.

Main Results:

• The study analyzed extractables from multiple borosilicate glass types and suppliers.
• Variations in elemental leachables and pH were observed depending on the extraction medium's pH.
• Data on Si, Na, K, Al, Ba, Ca, Mg, Fe, and Zn were collected for different glass formulations.

Conclusions:

• The developed accelerated procedure effectively assesses extractables from borosilicate glass.
• The pH of the extraction medium significantly impacts the type and quantity of leached substances.
• Results provide valuable data for understanding borosilicate glass-container interactions in pharmaceutical applications.