Abstract :
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.
Keyword :
Fenofibric acid, Pellets, Fluid bed process, Process parameters, CCD.