Assessment of Material and Process Related Attributes for a Desired Drug Release from Extended Release Film Coated Beads – A Design of Experimental Approach

Abstract

Aims: Extended Release (ER) film coated bead products are an effective way to achieve extended drug release. The ER film typically comprises both insoluble and soluble polymers and the drug release is influenced by both material and process attributes. The current study is aimed to evaluate the influence of material attribute (polymer viscosity) and process attribute (spray rate) on the drug release from ER beads.

Methodology: A full-factorial design was used to study the influence of HPC polymer viscosity and ER solution spray rate on drug release from ER beads. Based on the data obtained from the experiments, a mathematical equation and response surface plots were generated to predict the drug release from ER coated beads.

Results:The data demonstrated, the variability in drug release is observed with changes in the HPC viscosity and ER solution spray rate and the drug release is predominantly influenced by spray rate compared to viscosity. The polymer phase separation during the film formation process due to solubility differences of polymers creates either a bi-continuous or dis-continuous network within polymer films is hypothesized to the causative factor for observed differences in the drug release.

Conclusion:The results demonstrated the potential of the Design of Experiments in selecting the optimal material and process attributes for a desired drug release from ER beads.