Abstract

DEVELOPMENT OF FENOFIBRIC ACID DRUG LOADED PELLETS BY EXTRUSION SPHERONIZATION: A STATISTICAL DESIGN FOR OPTIMIZATION OF PROCESS VARIABLES

Bala Vishnu Priya Mukkala*, Gopala Krishna Murthy Talasila and Prameela Rani Avula

Abstract

The objective of the present investigation was to develop a drug loaded pellets of Fenofibric acid employing Extrusion spheronization process. This study evaluates the impact of certain process variables of extrusion spheronization technique in the feasability of producing Fenofibric acid drug loaded pellets. Impact of various process variables were assessed by using statistical interpretation such as ANOVA. A 33 (three factor, three level) face centered central composite design was employed to study the effect of independent variables on dependent variables. The selected process variables such as % Fluid uptake, Spheronizer speed and Spheronization time were studied, as well as their influences on the properties of Bulk density, % fines and % retains were determined. Optimization was done by fitting experimental data to the software program (Design Expert). The design space for process variables and its influence on responses was developed. Low fluid uptake, Higher spheronization speed and time leads to fines generation as well as high fluid uptake, low spheronization speed and time results in agglomerates. Water content and spheronizer speed interaction influence the sphere density. Fabricated pellets were characterized for various physico-chemical parameters. The optimized formulation showed desired drug release profile. The information acquired in this study recommends that the extrusion spheronization process can be effectively intended to develop drug loaded pellets of Fenofibric acid.

Keywords: Fenofibric acid, Pellets, Extrusion, Spheronization, CCD.