FORMULATION AND EVALUATION OF LIPOSOMES OF FENOFIBRATE PREPARED BY THIN FILM HYDRATION TECHNIQUE

The objectives of the present study were to use design of experiments (DOE) for formulation and optimization liposomal formulations and study the impact of process variables on quality attributes of the complex liposomal formulation system. Several factors may have contributed to the slow pace of commercialization of liposome drug products during the last decade: 1) the difficulties associated with identifying the formulation and process design critical quality attributes of these complex systems and 2) Higher manufacturing cost due to low preparation reproducibility and low entrapment of therapeutic active agents. Thus, a central composite design (CCD) was used for the optimization of the liposomal formulation. In the present study, the hydration volume, hydration time, sonication time and drug: lecithin ratio were chosen as input variables for the liposomal preparation and whereas; like particle size, peak shape, polydispersity Index, drug loading, entrapment efficiency and redispersion behavior were investigated as quality attributes. Additionally, contour plots and response surface plots were also utilized to understand the fundamental relationships between input variables and quality attributes. In-vitro dissolution utilizing United States Pharmacopeia (USP) apparatus II showed enhanced dissolution for the entire drug: lecithin ratios in the comparison to the equivalent amount of fenofibrate. The input variables showed significant effect on the quality attributes of the liposomal formulation as studied by the contour plots and surface response plots. This study will provide further understanding of the impact of process variables on the quality of the liposomal formulation.