Sustained release drug delivery systems with reduced impurities and related methods
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United States of America Patent
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Oct 3, 2023
Grant Date -
Sep 1, 2022
app pub date -
Jan 21, 2022
filing date -
Jan 13, 2020
priority date (Note) -
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Abstract
The present disclosure relates to sustained release drug delivery systems. In some cases, a composition comprises an active pharmaceutical agent; at least one of sucrose acetate isobutyrate and a polyorthoester; an organic solvent; and 2,6-dimethylaniline, wherein the 2,6-dimethylaniline is present at a level less than 500 ppm. In some cases, a composition comprises N-oxide of active pharmaceutical agent at a level less than 1 wt %, based on weight of the composition. In some case, a composition comprises metal present at a level less than 5 ppm. Dosage forms and methods are also provided.
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