The Faculty of Pharmacy discussed the doctoral dissertation, “Preparation, in vitro, and ex vivo evaluation of fenofibrate as a self-emulsifying drug delivery system with the assistance of a mathematical model” by Hayder Jaafar Sadeq and his supervisor, Professor Dr. Moafaq Mohammed Gareeb, in the Pharmaceutics Department. The aim of this study is to enhance the water solubility of fenofibrate, and to study the effect of dosage form digestion by pancreatic lipase enzyme, and how the digestion can reflect drug absorption, also studying the possibility of applying of the hydrophilic-lipophilic-difference (HLD) theory as a tool in the preparation of the final dosage form. Hansen’s solubility parameters (HSP) theory was used to predict the solubility of the drug in different natural oils (soybean, lemon oil, black seed oil, cardamom, and garlic oil). The calculation of HSP theory was done with the aid of HSPiP 5th edition software. The results showed that there was a good correlation between the predicted solubility of fenofibrate in natural oils from HSP theory and those calculated practically, indicating that HSP is a good tool for the proper selection of oils in the formulation. The results showed that a simple and validated UV-spectroscopic approach was used to detect the amount of drug in various natural oils as well as in SEDDS formulas by the addition of sodium lauryl sulphate (SLS) to the samples for reading by a UV-spectrophotometer. The results also showed that extensive lipid digestion was proved in the study, with a significant amount of drug precipitated when in-vitro lipolysis was performed. But when orlistat was used to oppose the digestion effect of lipase enzyme on the dosage form, no precipitation was detected. The result showed that HLD theory is an effective tool in the formulation of self-emulsifying drug delivery systems with fewer experiments. The construction of the time vs concentration profile of the drug in the in vivo study of the best formula showed complete absorption of the drug when administrated orally in rats. The result showed an enhancement in the solubility of the drug in water and that the HLD theory is a good tool for microemulsion production.
