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Oral Delivery (Focus Group – OrD)

Cellulose Acetate coatings to convert IR (immediate release) tablet to USP compliant ER (extended release) tablet

Raj Arunagiri – Manager, Eastman; Chhanda Kapadia – Director, IMCD India Pvt Ltd; Pramod Kolsure – Scientist, IMCD India Pvt Ltd; Nishant Nirale – Scientist, IMCD India Pvt Ltd; Matt Stephens – Manager, Eastman; Walter Thompson – Manager, Eastman
Introduction:

Metoprolol succinate was selected as a model, highly water‑soluble API1 to enable conversion of an IR to ER tablet using semi-permeable cellulose acetate (CA) coatings without strong osmogens. The study evaluates key coating variables—including ratios of CA398‑10 NF: CA320S NF, plasticizer type and level, bed temperature, curing conditions and size of orifice—to optimize dissolution performance. It also examines feasibility of CPOP (controlled porosity osmotic pump) tablets without an orifice to achieve desired dissolution profile. The developed ER tablets show robust coating performance and excellent multi‑media dissolution suited for critical CVS and CNS therapies.

Learning Objectives:

  • • New approach to convert IR tablets into ER tablets through a simple coating process
  • • Key coating composition and process variables to consider for coating of tablets
  • • CA coatings can be tailored to achieve controlled dissolution profiles with or without a laser drilled orifice