PRODUCT DEVELOPMENT, CHARACTERIZATION AND SPECTROPHOTOMETRIC EVALUATION OF CETILISTAT SELFMICROEMULSIFYING DRUG DELIVERY SYSTEM

BCS-Class-IV drugs such as Cetilistat have challenges like developing a product with desirable oral bioavailability and method estimation by routine analysis. In present, self-microemulsion drug delivery system was formulated to develop drug in more soluble and resolve the analytical estimation issues and check the feasibility of UV Spectrophotometric method. Solubility of Cetilistat was determined in various oils, surfactants, and co-surfactants. Pseudo ternary phase diagrams were constructed to identify the microemulsion region. From pseudo-ternary diagram, different Smix ratios were selected to identify optimum formulation. The formulation was evaluated for identification test, droplet size, zeta potential, and drug content. The optimum formulation was 12.5% of oil (IPM), 50% of Surfactant and co-surfactant (Milcoside-200 and Acconon MC8). This formulation was converted to solid SMEDDS using adsorbent like Aerosil. The method estimation of prepared liquid formulation was done by UV Spectrophotometric method. The method was found simple, accurate, precise and effective in the routine analysis without any interference of excipients used in SMEDDS formulation.