Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients
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United States of America Patent
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Jul 11, 2017
Grant Date -
Nov 20, 2014
app pub date -
Apr 23, 2014
filing date -
Apr 24, 2013
priority date (Note) -
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Abstract
The present invention is based, at least in part, on the identification of a pharmaceutical container formed, at least in part, of a glass composition which exhibits a reduced propensity to delaminate, i.e., a reduced propensity to shed glass particulates. As a result, the presently claimed containers are particularly suited for storage of pharmaceutical compositions and, specifically, a pharmaceutical solution comprising a pharmaceutically active ingredient, for example, GAMMAGARD LIQUID (an immune globulin infusion (human)); ADVATE (Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method, (rAHF)); BAX 111 (vonicog alfa, or [618-threonine,709-aspartic acid] von Willebrand factor Homo sapiens (1381A>T,1472H>D variant)); or an adeno-associated viral vector containing a liver-specific human factor IX expression cassette, e.g., sscAAV2/8-LP1-hFIXco.
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