Appraisal of Surelease Clear E-7–19040, an Ethylcellulose Aqueous Dispersion, as a Release Modifier for the Hydrophilic Core

Abstract

Purpose

This study evaluated the efficacy of ethylcellulose aqueous dispersion type B (surelease clear E-7–19040) in modifying the drug release from the hydrophilic cores. Because of its ideal physicochemical and biological properties for the controlled-release formulation, Pindolol was selected as the model drug.

Methods

The final modified-release drug product comprises the immediate-release loading dose and the controlled-release maintenance dose. The tablet formulation was designed to have a seal-coated hydrophilic core with 75% of the drug, followed by a controlled-release polymer coating, immediate-release drug coating with 25% of the drug, followed by a color film coating.

Results

The controlled-release polymer coating was the critical step to achieving the desired product characteristics. During the coating of aqueous polymer dispersions, the adjustment of the controlled-release polymer to the pore former ratio, the control of the manufacturing process parameters, and the curing conditions are vital to developing a robust and stable end product. The final drug product achieved a targeted drug release profile in the selected dissolution method without a dose-dumping effect in the presence of alcohol and was unaffected by the accelerated stability study condition.

Conclusion

The ethylcellulose aqueous dispersion type B is very effective in modulating the release of hydrophilic drug core for achieving a desired drug release profile as per the drug product’s quality target product profile and the material of choice for the organic solvent-free, eco-friendly, controlled-release polymer coating system.