Investigation of the Influence of Copovidone Properties and Hot-Melt Extrusion Process on Level of Impurities, In Vitro Release, and Stability of an Amorphous Solid Dispersion Product
Isha Saraf,
Ognen Jakasanovski,
Tijana Stanić
et al.
Abstract:Hot-melt extrusion (HME) is a widely used method for
creating amorphous
solid dispersions (ASDs) of poorly soluble drug substances, where
the drug is molecularly dispersed in a solid polymer matrix. This
study examines the impact of three different copovidone excipients,
their reactive impurity levels, HME barrel temperature, and the distribution
of colloidal silicon dioxide (SiO2) on impurity levels,
stability, and drug release of ASDs and their tablets. Initial peroxide
levels were higher in Kollidon VA 64 (… Show more
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