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Novel Co-processed Excipient for Directly Compressed Controlled Release Formulations

Published 14 January 2015 | By MEGGLE

A novel excipient comprising 50% lactose monohydrate and 50% hypromellose K4M was prepared via co-processing, integrating the parent materials into a monoparticulate structure offering superior functional performance and simplified processing compared to simple physical admixtures of the same composition. Powder flow, tablet compaction, and wettability showed enhanced performance as a result of excipient co-processing. API dissolution studies with slight compositional modifications and simplified manufacturing method demonstrated flexibility in tablet performance without altering the API release profile.

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Novel Co-processed Excipient for Directly Compressed Controlled Release Formulations