Multi-particulate Drug Delivery Systems of Fenofibric Acid: Optimization of Formulation Using Statistical Experimental Design
Bala Vishnu Priya Mukkala1*, Murthy T.E.G.K2, Prameela Rani Avula3
1Formulation research and development, RA Chem Pharma Ltd, Hyderabad-500076, Telangana, India
2Department of pharmaceutics, Bapatla College of Pharmacy, Bapatla, Guntur-522101, Andhra Pradesh, India
3Department of pharmaceutics, Acharya Nagajuna University, Guntur-522510, Andhra Pradesh, India
Received: 02-Nov-2017 , Accepted: 01-Feb-2018
Keywords: Fenofibric acid, Pellets, Modified drug delivery systems, Central composite design
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Multi-particulate Drug Delivery Systems of Fenofibric Acid: Optimization of Formulation Using Statistical Experimental Design. UKJPB. 2017;6(1):16-24.
The objective of the present research work was to develop a multi-particulate modified release system of Fenofibric acid using Wurster (Bottom spray fluid bed coating) process. Impact of various formulation variables was 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 (concentration of ER Polymer, plasticizer and pore former), on dependent variables (drug release at 2.5th h & 6th h). Optimization of the formulation variables was done by fitting experimental data to the software program (Design Expert). The design space for formulation variables was developed. Fabricated pellets were characterized for various physico-chemical parameters. In vitro release data of the optimized formulation was fitted into various kinetic equations. The optimized formulation showed a desired drug release at both 2.5th h and 6th h as 17.5 ± 2.28% & 87.1 ± 0.75% respectively. The drug release from the capsules followed first order kinetics and controlled by non fickian transport. The information acquired in this study recommends that the multi-particulates of Fenofibric acid can be effectively intended to give a delayed release of Fenofibric acid and thus enhanced bioavailability.