Development of lipid nanocarriers with the approach of increasing the solubility of a drug molecule belong to biopharmaceutical classification system class II

Self-emulsifiable systems, which are among the lipid-structured drug delivery systems, are of particular interest in the development of oral dosage forms of active substances in low water solubility. Among these systems classified according to the ingredients in their composition, Type IV formulations are prepared using surfactants and/or co-surfactants without adding an oil. In this study, it was aimed to develop the Type IV lipid carrier system of Tadalafil, which is a Class II molecule according to the Biopharmaceutical Classification System (BCS) as a model active substance, and to soldification of the optimized Type IV formulations using by different porous carriers. Labrasol, Kolliphor PS 20, Kolliphor PS 60, Kolliphor PS 80, Kolliphor CS 12, Kolliphor CS 20, Kolliphor HS 15, Kolliphor EL, Kolliphor ELP, Kollisolv PEG 400, Gelucire 44/14 or Gelucire 48/16 were used as surfactant for preparing Type IV formulations of Tadalafil. Transcutol HP was used as co-surfactant. The stability of formulations prepared with components in different proportions was monitored by taking into account their droplet size and polydispersity index (PDI) values. It was determined that the formulations prepared with Kolliphor PS 80, Kolliphor HS 15 and Kolliphor EL with Transcutol HP (2: 1) were physically stable with droplet size (<50 nm) and PDI values (<0.2). New solid delivery systems were prepared with selected formulations and porous carriers (Florite R, Neusilin US2, Neusilin UFL2, Syloid XDP 3050 and Syloid XDP 3150). The dissolution rate performance of Tadalafil of soldified Type IV formulations was analyzed in comparison with its reference tablet product. In this thesis; it has been concluded that the solidified Type IV lipid formulations of Tadalafil increases the dissolution rate of Tadalafil and, that a new solid lipid carrier system has a potential to provide rapid absorption compared to the conventional oral tablet dosage form of Tadalafil.