Ex vivo permeation of agomelatine from DLP 3D-printed ethanol gel-coated pyramid microneedle systems

Raw data from ex vivo permeation test (IVPT) of agomelatine (AGM) from microneedle systems.

Microneedle system specifications:

• 3D printing method: DLP
• microneedle shape: pyramid
• coating-gel type: ethanol gel

Drug permeation studies:

The permeation of agomelatine (AGM) was evaluated using Franz Diffusion Cells (Teledyne Hanson 376 Research, USA) with full-thickness human skin as the diffusion membrane. The skin was thawed in PBS at room temperature, mounted on the diffusion cells, and conditioned for 30 min. After this time the microneedle system was placed onto the chamber opening (1 cm²) with full-thickness human skin as the diffusion membrane. The study lasted for 7 days and sodium azide 0.02% w/v was added to the acceptor fluid as an antimicrobial agent. At specific time points, 0.3 mL samples were taken and analyzed using High-Performance Liquid Chromatography (HPLC). The amount of the acceptor medium taken for the analysis was immediately replaced with the fresh portion of the fluid. Six replications were performed for each formulation. After the study, the epidermis and dermis from each skin sample were separated manually using scissors and forceps and inserted in tubes with 3 mm zirconium beads (Benchmark Scientific Inc., Sayreville, NJ, USA). Next, 1 mL of water and ethanol solution (50:50 v/v) was added to each tube, and the samples were homogenized for 9 min using a BeadBug Microtube Homogenizer (Benchmark Scientific Inc., USA). Then, the samples were centrifuged for 5 min at 10,000 rpm, and the supernatant was analyzed using HPLC to examine the amount of the drug in the tissue.

Quantification of AGM:

The amount of AGM permeated was analyzed using High-Performance Liquid Chromatography (HPLC) (Shimadzu Nexera-I LC-2040C, Japan) with LabSolution Lite software.

Chromatographic Conditions:

• Column: Reversed-phase C18 (HyperClone BDS C18, 5 µm, 4.6 × 250 mm, Phenomenex, Torrance, CA, USA)
• Column Temperature: 30.0 ± 0.2°C
• Mobile Phase: Acetonitrile and 0.05 M potassium dihydrogen phosphate solution (pH = 2.9, adjusted with 85% orthophosphoric acid) in a 35:65 ratio
• Mode: Isocratic
• Flow Rate: 1.0 mL/min
• Detection Wavelength: 230 nm

The set contains data in LCD/ LCB format, created using the LabSolutions software (HPLC, Nexera LC 2040C). Data file (.lcd) contains all analysis results and acquisition information from the following files. Data in .txt format can be read without the need for LabSolutions software.