Formulasi, Karakterisasi Self-Emulsifying Drug Delivery System Ibuprofen dan Uji Pengurangan Efek Iritasi terhadap Lambung pada Tikus

Abstract

Background: Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID). One disadvantage of NSAIDs is their potential to trigger gastric ulcers. To mitigate the local irritating effects of NSAIDs, a self-emulsifying drug delivery system (SEDDS) of ibuprofen was formulated. Objectives: To formulate, characterize, determine the reduction of gastric irritation and anti-inflammatory effects of ibuprofen SEDDS in rats. Methods: The solubility of ibuprofen was visually tested in various oils (corn oil, canola oil, soybean oil, coconut oil, olive oil, isopropyl myristate, oleic acid). Then, SEDDS was formulated with various oils, and the formula with the best oil was further formulated with varying surfactant concentration (20%, 30%, 40%). Then, characterization including organoleptics, density, pH, particle size, zeta potential, ibuprofen concentration in SEDDS, dissolution tests, and stability testing was done. Furthermore, anti-inflammatory effects were tested using the paw edema method and gastric irritation effects were evaluated macroscopically and microscopically using rats, grouped into three groups of six rats each. Results: The results showed that oleic acid produced the best SEDDS formula compared to other oils. The SEDDS formulation using oleic acid with a higher surfactant concentration (40%) resulted in a smaller particle size at 104.19 nm and a faster dissolution rate with a cumulative percentage reaching 88.41% after 60 minutes. In the anti-inflammatory effect test, ibuprofen SEDDS produced a better effect but not significant compared to ibuprofen suspension. However, the gastric irritation effect test showed that ibuprofen SEDDS was proven to reduce the gastric irritation effect significantly compared to ibuprofen suspension. Conclusion: Based on the results of the study, it can be concluded that ibuprofen can be formulated in SEDDS dosage form and ibuprofen SEDDS can reduce the gastric irritation effect.