FORMULATION AND EVALUATION OF PRONIOSOMAL GEL BASED TRANSDERMAL DELIVERY OF ATORVASTATIN CALCIUM BY BOX BEHNKEN DESIGN
Objective: The aim of this study was to investigate the combined influence of 3 independent variables in the preparation of Atorvastatin proniosomes by Coacervation phase separation method.
Methods: On the basis of the preliminary trials a 3-factor, 3-level Boxâ€“Behnken design was employed to study the effect of Cholesterol, soya lecithin and Span 60 independent variable on dependent variables (particle size and % entrapment efficiency). TEM analysis of optimized formulation has demonstrated the presence of individual Proniosomes in spherical shape.
Results: Atorvastatin optimized proniosomal formulation F2 shown better particle size and % entrapment efficiency and also the drug release was 99.72% within 24h in slow and controlled manner when compared with control. Kinetic analysis of drug release profiles showed that the drug release was followed by zero-order manner with Korsmeyer-Peppas model, which implies super case II release kinetics. The particle size and Zeta potential of the optimized atorvastatin proniosomal gel was found to be 65.72 and -10.5 respectively. Optimized batch of Proniosomes was used for the preparation of Atorvastatin-based proniosomal hydrogel by incorporating hydrated Proniosomes to Carbopol matrix to enhance the stability and viscosity of the system.
Conclusion: The enhanced skin permeation for prolonged period of time, may lead to improved efficacy and better patient compliance. This study suggests that proniosomal gel containing atorvastatin could perform therapeutically better effects than the conventional formulations.
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