Title:Role of Biorelevant Media in the Estimation of in vitro Lipolysis and Food Impact on Self-emulsifying Drug Delivery Systems
VOLUME: 15
Author(s):Ravinder Verma and Deepak Kaushik*
Affiliation:Department of Pharmaceutical Sciences, M.D. University, Rohtak, Department of Pharmaceutical Sciences, M.D. University, Rohtak
Keywords:Biorelevant media, SEDDS, SMEDDS, FeSSIF V-2, in vitro lipolysis, bioavailability.
Abstract:Self-emulsifying drug delivery systems (SEDDS) includes self-micro emulsifying drug delivery system
(SMEDDS) and self-nano emulsifying drug delivery system (SNEDDS) whose major benefits is reduction of inter/intra
subject variability and food effect which may alter the pharmacological response of the drug. Oral intake of these
formulations triggers the digestion process because of pancreatic lipase which emulsify/digest the lipidic ingredients of the
formulation resulting into precipitation of the drug. As a tool to foresee in vivo medicament precipitation, in vitro lipolysis
models are established. Biorelevant media play an important role to study the effect of in vitro lipolysis and food impact
on the bioavailability of SEDDS formulations. It is vital to generate composition of fluids for both fed and fasting
conditions of gastric, small intestine and colon to investigate the impact of in vitro lipolysis and food effect on the release
behavior of drug from SEDDS. Fed/Fasted state simulated gastric fluid (Fe/FaSSGF), Fed/Fasted state simulated gastric
fluid (Fe/FaSSIF) (Phosphate buffers) are first generation while Fa/FeSSIF-V2 (maleate) are second generation
biorelevant media utilized for these studies. FaSSIF-V3 belongs to third generation which differs from other generations
in the composition and source of bile salts. With updates in physiological data, it is vital to incorporate changes in the
dissolution media to make it more biorelevant. This review paper mainly laid emphasis on the compositions of biorelevant
media of gastric and small intestine for both fed and fasting conditions. In addition to these, applications of biorelevant to
investigate effect of in vitro lipolysis and food on SEDDS are discussed with some recent research reports.
