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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Main Authors | , , , |
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Format | Patent |
Language | English French German |
Published |
16.08.2023
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Subjects | |
Online Access | Get full text |
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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. |
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Bibliography: | Application Number: EP20190704769 |