DEVELOPMENT OF FENOFIBRIC ACID DELAYED RELEASE PELLETS: OPTIMIZATION OF PROCESS VARIABLES IN FLUID BED PROCESS

The objective of the present study was to optimize the process of Fenofibric acid delayed release (DR) pellets. Wurster (Bottom spray fluid bed coating) process was employed to develop the Fenofibric acid DR pellets. This study assesses the impact of various process variables on drug layering by using statistical interpretation such as ANOVA. A face centered central composite design (CCD) was employed to study the effect of independent variables (product temperature, atomization air pressure, fluidization air volume and spray rate) on dependent variables (Fines, agglomerates, coating efficiency and assay). Fabricated pellets were characterized for various physico-chemical parameters and stability studies. Optimization was done by fitting experimental results to the software program (Design expert). The design space for process parameters and its influence on %fines, % agglomerates, coating efficiency and assay was developed. From the obtained results, 40°C ± 3°C as product temperature, 0.8 -1.2 kg/cm2 as atomization air pressure, 50 -65 cfm as fluidization air volume and 2-6 g/min as spray rate were selected as the operating ranges for robust coating process, desired yield and quality of the product. The drug release from the optimized formulation followed first order kinetics and controlled by non fickian transport. There is no significant change observed during stability. It was concluded that the face centered central composite design facilitated the process optimization of Fenofibric acid DR pellets. The Fenofibric acid DR pellets were successfully developed by employing bottom spray fluid bed coating (Wurster) technique. Key-Words: Fenofibric acid, Pellets, Fluid bed process, Process parameters, CCD.