Self-emulsifying properties of Moringa oleifera seed oil and Camelus homolipid (camel fat) for the delivery of 5- fluorouracil (5-fu) in the management of breast cancer

Background and Aim: To formulate a self-emulsifying drug delivery system (SEDDS) based on Moringa seed oil (MSO) and its admixture with a homo-lipid from camel hump fat, Camelus dromedarius (CDH) for the delivery of 5-Fluorouracil for the management of breast cancer.Method: MSO and CDH were extracted and characterised using standard methods, and utilized in the formulation of SEDDS (coded SDA1 to SDA4) loaded with 5-fluorouracil (5-FU). The properties of these were investigated with reference to isotropic test, droplet size determination, polydispersity index (PDI), zeta potential (ZP), emulsification time, absolute drug content, and percentage mortality against MCF-7 cell line. Granule formulations prepared through wet granulation technique were subjected to Carr’s and Hausner’s ratios analysis, encapsulated using hard gelatin shells, and subjected to relevant Pharmacopoeia quality control tests.Results: MSO and CDH yielded 41 and 43% v/w, respectively with their oleic acid contents being MSO (72.5%) and CDH (39.2%). The saponification, crude fat, protein, carbohydrate, and ash values showed no significant differences from previously reported values. All formulations of 5-FU-loaded SEDDS were stable with no sign of precipitation or colour changes, gave mean emulsification times ≤ 40 minutes, and all droplet sizes were within the nano range (199 to 222.1 nm). The formulations were stable and polydisperse, as indicated by their PDI (< 0.5) and ZP (-40 mV) values. PDI, ZP and the IC50 were ranked as: SDA1≤ SDA4 ≤ SDA2 ≤ SDA3. Granules' flow parameters (p ≤ 0.05) are ranked: SDA1≤ SDA4 ≤ SDA2 ≤ SDA3, except for the flow rate of granules having a reverse ranking: SDA1≥SDA4 ≥ SDA2 ≥ SDA3. All formulations of 5-FU-loaded SEDDS capsules complied with United States Pharmacopeia requirements. SDA2 and SDA3 failed content uniformity test, which may be a direct consequence of the 5-FU SEDDS composition and the batch processing variables.Conclusion: The Moringa seed oil and C. dromedarius homolipid were successively utilised in the formulation of SEDDS. Only SDA1 and SDA4 performances were pharmacopoeial compliant, and require further in vivo investigation and optimisation.