Torben96
$CING
Results: High-resolution dissolution profiling demonstrated consistent and reproducible trimodal release behavior across all compression DOE batches. All formulations met predefined dissolution specifications at each time point, including 40 min (NLT 26%), 2:30 h (25-45%), 5:30 h (65-95%), and 8:30 h (NLT 90%). Observed average release ranged from approximately 33-38% at early time points, 35-39% at intermediate time points, 71-86% at mid-phase, and 100-109% at late phase across batches (n=6-12). Inter-batch variability remained low with narrow dissolution ranges across the design space. Compression force showed minimal impact on early-phase release but contributed to modest variation in late-phase (third pulse) release behavior, indicating a controlled process sensitivity within the EBL-driven release architecture.
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