Ex vivo permeation of agomelatine from DLP 3D-printed cone microneedle systems containing a 3% AGM-drug resin mixture

Raw data from ex vivo permeation test (IVPT) of agomelatine (AGM) from microneedle systems.Microneedle system specifications:3D printing method: DLPmicroneedle shape: conecoating-gel type: - (no coating) 3% AGM mix within resin (served as printing material)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°CMobile Phase: Acetonitrile and 0.05 M potassium dihydrogen phosphate solution (pH = 2.9, adjusted with 85% orthophosphoric acid) in a 35:65 ratioMode: IsocraticFlow Rate: 1.0 mL/minDetection Wavelength: 230 nmThe 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.

阿戈美拉汀（agomelatine，AGM）经微针系统的离体皮肤渗透试验（ex vivo permeation test，IVPT）原始数据。

微针系统规格：
3D打印方法：数字光处理（DLP）
微针形状：圆锥形
涂层凝胶类型：-（无涂层），树脂中混合3% AGM（作为打印材料）

药物渗透研究：
采用Franz扩散池（Franz Diffusion Cells，Teledyne Hanson 376 Research，美国）评估阿戈美拉汀（AGM）的渗透情况，以全层人体皮肤作为扩散膜。皮肤在PBS中室温解冻，安装于扩散池上并平衡30分钟。随后，将微针系统置于腔室开口处（面积1 cm²），扩散膜为全层人体皮肤。研究持续7天，接受液中添加0.02% w/v的叠氮化钠作为抗菌剂。在特定时间点取样0.3 mL，采用高效液相色谱（High-Performance Liquid Chromatography，HPLC）分析。取样的接受介质体积立即用新鲜接受液补充。每种制剂重复6次。研究结束后，用剪刀和镊子手动分离各皮肤样本的表皮和真皮，放入含3 mm锆珠的试管中（Benchmark Scientific Inc.，美国新泽西州赛勒维尔）。随后向各试管中加入1 mL水-乙醇溶液（50:50 v/v），使用BeadBug微量管匀浆器（Benchmark Scientific Inc.，美国）匀浆9分钟。然后以10,000 rpm离心5分钟，取上清液用HPLC分析组织中的药物含量。

AGM的定量分析：
采用高效液相色谱（High-Performance Liquid Chromatography，HPLC）（Shimadzu Nexera-I LC-2040C，日本）结合LabSolution Lite软件分析AGM的渗透量。

色谱条件：
色谱柱：反相C18柱（HyperClone BDS C18，5 µm，4.6 × 250 mm，Phenomenex，美国加利福尼亚州托兰斯）
柱温：30.0 ± 0.2°C
流动相：乙腈与0.05 M磷酸二氢钾溶液（pH=2.9，用85%磷酸调节）按35:65比例混合
模式：等度洗脱
流速：1.0 mL/min
检测波长：230 nm

本数据集包含LabSolutions软件（HPLC，Nexera LC 2040C）生成的LCD/LCB格式数据。.lcd格式文件包含以下文件的所有分析结果及采集信息。.txt格式数据无需LabSolutions软件即可读取。