PREPARATION AND CHARACTERIZATION OF KETOPROFEN MENTHOSOME GEL AS A TOPICAL DELIVERY NANOCARRIER: EX VIVO ASSESSMENT

Objective: This study aimed to enhance the transdermal permeation of ketoprofen (KTP) by formulating a menthosomal gel as a vesicular nanocarrier. Methods: KTP-loaded menthosomes were produced using the ethanol injection-probe sonication method. A mixed-level factorial design was employed to statistically investigate the effects of menthol (X1), Span60® (X2), and soybean lecithin (SL) (X3) as independent variables at different actual levels on the dependent responses, including particle size (PS), polydispersity index (PDI), and entrapment efficiency (%EE). These independent variables generated fifteen experimental runs. Fourier Transform Infrared Spectroscopy (FTIR) analysis confirmed the compatibility between KTP and the excipients. The surface morphology of the menthosome was examined using Field Emission Scanning Electron Microscopy (FESEM). The selected formula was incorporated into a Carbopol 934 gel. Viscosity, pH, drug content (DC), and ex vivo permeation were used to characterize the KTP menthosomal gel. Results: Among the formulations, K11 showed a PS of 218.4 ± 12 nm, a PDI of 0.14 ± 0.04, a zeta potential (ZP) of −35 ± 2 mV, indicating high stability of the formulation, an EE% of 89.3 ± 1.3%, and a percentage of release of 95.7 ± 0.9% within 6 hours. The FESEM images demonstrated that the KTP-loaded menthosomes exhibited a spherical morphology with a uniform distribution. KTP-excipient compatibility was confirmed by FTIR analysis. The best formula was incorporated into a gel based on Carbopol 934, which demonstrated a pH of 6 ± 0.2, meeting the benchmark pH for skin application, and a DC of 98.7 ± 0.8%, which is crucial for ensuring therapeutic efficacy, and an ex vivo permeation rate of 81.2 ± 3.1% over 14 h. Conclusion: The findings suggest that KTP-loaded menthosomes could be a promising carrier for the transdermal delivery of the hydrophobic drug; by facilitating deeper penetration and sustained delivery, these improvements can be attributed to the synergistic action of menthol with lipid-based nanocarriers. This lipoidal vesicular system effectively enhances therapeutic performance.