Abstract

Background: In the Biopharmaceutical Classification System (BCS), ibuprofen (IBU) belongs to Class II (poorly soluble, well-absorbed), which limits its therapeutic effectiveness due to low bioavailability. Currently, self-microemulsifying drug delivery systems (SMEDDS) are used to stabilize drug compounds and enhance solubility and absorption of poorly soluble and poorly absorbable drugs. Therefore, the objective of this study was to develop and characterize a SMEDDS formulation containing IBU for oral administration. Materials and methods: The study utilized IBU (from China), various oils (such as oleic acid, Peceol, etc.), surfactants (such as Acrysol EL-135, Acrysol K-140, etc.), and co-surfactants (such as propylene glycol, Lauroglycol 90). The study investigated and selected the appropriate excipients and their ratios to optimize the formulation, and evaluated various aspects such as appearance, emulsification capacity, droplet size, size distribution, and drug content. Results: The results showed that the IBU-containing SMEDDS consisted of IBU 8.7%, Capryol 8.7%, Acrysol EL-135 66.08%, and propylene glycol 16.52%, with a droplet size of 16.33 ± 0.124 nm and a PDI of 0.185 ± 0.003. It is capable of rapid self-emulsification within 30 seconds of gentle stirring with distilled water (with a volume ratio of 1:500, v/v) to form a clear microemulsion. Conclusion: In conclusion, this study successfully developed a SMEDDS formulation containing IBU, which shows promise for the development of an oral dosage form.