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Abstract

FORMULATION AND EVALUATION OF SELF NANOEMULSIFYING DRUG DELIVERY SYSTEM CONTAINING POORLY WATER SOLUBLE ANTILIPIDEMIC DRUGS

Milan D. Limbani* and Dr. L. D. Patel

ABSTRACT

The present work was aimed for the formulation development of stable SNEDDS of Fenofibrate and Atorvastatin Calcium using concentration of oil and surfactant/cosurfactant on the basis of preliminary trials. The 32 factorial design was employed using concentration of Capmul MCM oil and Cremophor RH 40: Transcutol-P (3:1) as independent variables. The Globule size (GS), Polydispersity index (PDI), Zeta potential (ZP) and drug release at 15 minutes for Fenofibrate and Atorvastatin calcium were selected as dependent variables. The optimized batch was selected on the basis of arbitary criteria using Design Expert software employing overlay plot with desirability approach. The SNEDDS formulations were evaluated for their physico-chemical parameters such as globule size, zeta potential, polydispersity index, drug release profile and physico-chemical stability. The composition of optimized formulation consisted of Capmul MCM Oil as oil (0.471ml), Cremophor RH 40 as surfactant (1.206ml) and Transcutol-P as cosurfactant (0.402ml), containing 10mg of Atorvastatin and 45mg of Fenofibrate showing drug release for liquid SNEDDS formulation (>95%), droplet size (78.3nm), Zeta potential (-23.13), and infinite dilution capability. In-vitro drug release of the optimized batch was highly significant (p<0.05) as compared to marketed conventional capsule (Fenostat) of Fenofibrate and Atorvastatin Calcium.

Keywords: Capmul MCM oil, non-ionic surfactant/co-surfactant, Nanoemulsion, SNEDDS.


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