Biosurfactant Stabilized Nanosuspension of KRAS inhibitor - Sotorasib (AMG-510): Systematic optimization using Quality by Design Approach - Pharma Excipients
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Biosurfactant Stabilized Nanosuspension of KRAS inhibitor - Sotorasib (AMG-510): Systematic optimization using Quality by Design Approach - Pharma Excipients
Abstract This research study aimed to develop and evaluate a novel freeze-dried nanocrystals formulation of sotorasib (AMG-510) using Quality by Design (QbD) approach to enhance solubility, dissolution, and oral bioavailability. A QbD framework use for identification, optimization and validation of critical process and formulation parameters, significantly influcing key quality attributes of nanosuspension. A stable sotorasib nanocrystal formula…
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