Formulation and Evaluation of Immediate-Release Multiparticulate Pellets of Fenofibrate by Wurster Fluidized-Bed Coating for Dissolution Enhancement

Abstract

This study focused on the development and evaluation of immediate-release multiparticulate
pellets of fenofibrate using Wurster-based fluidized-bed coating to enhance the dissolution
and oral performance of this poorly water-soluble BCS Class II drug. Fenofibrate exhibits
dissolution-rate-limited absorption; therefore, pelletization was employed to improve surface
area, wettability, and drug dispersion. Pre-formulation studies confirmed poor solubility and
sub-optimal flow characteristics, supporting the need for dissolution-enhancing strategies.
FT-IR analysis indicated the absence of drug–excipient incompatibilities. Immediate-release
pellet formulations (F1–F4) were prepared via solution/suspension layering onto MCC cores,
and process parameters were optimized to achieve uniform coating and reproducible pellet
characteristics. All formulations demonstrated acceptable micromeritic behavior, uniform
drug content, satisfactory mechanical strength, and good flow properties. Among these,
formulation F2 exhibited superior performance, with improved flow, low friability, optimal
hardness, enhanced wettability, and rapid drug release. Dissolution studies revealed fast and
complete release within 30 minutes, with F2 showing the highest dissolution rate. Accelerated
stability studies confirmed the robustness of the optimized formulation with no significant
changes in drug content or dissolution profile. The findings establish fluidized-bed
pelletization as an effective and industrially viable strategy for enhancing the dissolution
characteristics and potential therapeutic performance of fenofibrate and similar poorly soluble
BCS Class II drugs.