SMALL GLASS BOTTLE HAVING LOWER MIGRATION LOAD

A glass vial including a boron-containing multicomponent glass includes constituents and is partially filled with a pharmaceutical ingredient formulation having a pH in a range from 5 to 9. The glass vial has a total volume of <4.5 mL, a filling level of the glass vial with the formulation is not...

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Bibliographic Details
Main Authors HLADIK, Bernhard, BUSCKE, Florence, ROTHHAAR, Uwe, FROST, Robert
Format Patent
LanguageEnglish
French
German
Published 16.08.2023
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Summary:A glass vial including a boron-containing multicomponent glass includes constituents and is partially filled with a pharmaceutical ingredient formulation having a pH in a range from 5 to 9. The glass vial has a total volume of <4.5 mL, a filling level of the glass vial with the formulation is not more than 0.25, and an inner wall of the glass vial has chemical resistance to leaching-out of at least one of the constituents of the multicomponent glass. A ratio of a concentration of a leached-out constituent at a fill volume of 0.5 mL and a concentration of the leached-out constituent at a fill volume of 2 mL is not more than 3 and a ratio between a concentration of the leached-out constituent at a fill volume of 1 mL and the concentration of the leached-out constituent at a fill volume of 2 mL is not more than 2.
Bibliography:Application Number: EP20190704769