(T0930-06-34) 3D DLP Printed Cannabinoid Microneedles Patch and Its Pharmacokinetic Evaluation in Sprague Dawley Rats

Purpose: Because of high lipophilicity, cannabinoids tend to retain more in the lipophilic epidermal region (stratum corneum) compared to hydrophilic dermal region which results in limited or no transdermal permeation. The purpose of the present study was to enhance the CBD transdermal permeation using 3D DLP printed microneedle drug delivery system.

Methods: CBD MN patch (100 MNs on each patch) was fabricated and optimized using 3D DLP printing technology using CBD (8% w/v), polyethylene LAP (0.49% w/v), distilled water (20% w/v) and poly (ethylene glycol) dimethacrylate 550 (PEGDAMA 550) (up to 100% w/v). CBD MNs were characterized for their morphology, mechanical strength, in vitro release testing (IVRT), in vitro permeation testing (IVPT) and in vivo pharmacokinetic profile. LC-MS method was developed for the detection of CBD in plasma samples.

Results: Microscopic images showed that sharp CBD MNs with aspect ratio of ~3 and radius of curvature~15 micron were successfully printed using optimized settings (25 m slice thickness, 125 intensity and 5 sec exposure time) of the 3D printer. Mechanical strength studies using texture analyzer showed no significant deformation in morphology of CBD MNs even after applying 0.5N/needle force. IVRT study showed significant drug release ( >50%) in 8 hours. IVPT study showed significant (p < 0.001) permeation of CBD in the receiving media as compared to CBD gel formulation (control). In vivo pharmacokinetic study showed significant (p < 0.001) increase in CBD concentration in plasma as compared to CBD gel formulation (control) in 24 hors study.

Conclusion: This is the first study of printing dissolvable CBD MN patch with biocompatible resin formulation. Overall, CBD transdermal permeation was significantly enhanced using 3D printed microneedle drug delivery system.