Dissolving microneedle patches for transdermal delivery of paroxetine: in-vitro, ex-vivo studies and its PBPK modeling

BACKGROUND: Paroxetine HCl (PRX-HCl), an antidepressant, has poor water solubility and low oral bioavailability with 50% being metabolized in the liver. The oral formulations have multiple side effects. The present work aimed to develop dissolving microneedle patches (MNPs) of PRX-HCl to resolve low bioavailability and side effect issues while achieving enhanced transdermal delivery. MATERIALS AND METHODS: PBPK modeling, and stability. RESULTS: and AUC compared to PAXIL CR 12.5 mg oral, and showed higher stability in the room and refrigerator conditions. CONCLUSION: The prepared MNPs were stable and can deliver PRX-HCl sufficiently across skin barrier with enhanced bioavailability compared to oral administration at similar doses and thus be a better alternative to already available delivery systems for PRX-HCl.