Cancer is the second largest disease globally, although conventional chemotherapy has been successful to some extent, the main drawbacks of chemotherapy are its poor bioavailability, high-dose requirements, adverse side effects and low therapeutic indices etc. Most of anticancer drugs discovered in the last two decades belong to biopharmaceutical classification system-I, where solubility is the major drawback for the drugs and it decreases the systemic availability of the drug. Hence, it is prepared as lipid-based drug delivery systems with an aim to enhance its dissolution rate. The objective of the research is to develop Self emulsifying drug delivery systems (SEDDS) of Ibrutinib (IBR). IBR is an anticancer drug, which binds irreversibly to Bruton’s tyrosine kinase (BTK) receptor to the cysteine residue and inhibits BTK active site. Screening of excipients was done by determining the saturation solubility studies and Capryol 90 was selected as an oil phase, kolliphor EL as surfactant and transcutol HP as co-surfactant due to their higher solubilization effect. The best composition of oil, surfactant and co-surfactant was obtained by aqueous titration method and further optimized by design of experiments (DOE) by using Central composite model (CCD). In-vivo bioavailability studies were conducted for the pure drug suspension, L-SNEDDS (Liquid-self-nano emulsifying drug delivery systems) and S-SNEDDS (Solid-self-nano emulsifying drug delivery systems) and pharmacokinetics parameters were estimated. The lymphatic uptake of SNEDDS is studied. The in-vivo oral bioavailability studies of optimized SNEDDS formulation showed 3.57 folds higher than the pure drug Ibrutinib. The I-L-SNEDDS and I-S-SNEDDS were passed Level-A with correlation coefficient of 0.934.

Key Words: Ibrutinib, Self-emulsifying drug delivery systems, capryol 90, kolliphor EL, Transcutol HP, Cancer etc.