Method of preventing lamellar silica formation in glass container
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United States of America
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Mar 18, 2025
Grant Date -
Oct 17, 2024
app pub date -
Apr 23, 2024
filing date -
Apr 23, 2024
priority date (Note) -
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Abstract
Methods of screening a glass container for storing a pharmaceutical formulation for susceptibility to lamellar silica formation includes filling the container with a buffer for the pharmaceutical formulation, storing the container with the buffer and optically analyzing the buffer after storage for one or more particles in the buffer. The one or more particles can be analyzed to determine a morphology and chemical composition and the interior surface of the container, once emptied, can be analyzed for delamination type deformation. The presence of particles in the buffer having a chemical comprising silicon, oxygen, and carbon and the absence of delamination type deformation is indicative of susceptibility to lamellar silica formation.
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