Dissolving microneedle-based intradermal delivery of interferon-α-2b

Area of Science:

• Pharmaceutical Sciences
• Biotechnology
• Drug Delivery Systems

Background:

• Dermal and transdermal delivery of protein drugs is challenging but offers significant potential for non-invasive treatments.
• Protein pharmaceuticals require innovative delivery methods to overcome barriers to systemic administration.

Purpose of the Study:

• To develop and evaluate dissolving microneedles (MNs) for the transdermal delivery of interferon-α-2b (IFN).
• To assess the in vitro release, in vivo pharmacokinetics, immunogenicity, and stability of IFN-loaded MNs.

Main Methods:

• Interferon-α-2b (IFN) was encapsulated into dissolving MNs at varying doses.
• In vitro release studies and percutaneous administration in rats were conducted.
• Serum IFN levels, Cmax, Tmax, AUC, immunogenicity, and skin integrity were analyzed.

Main Results:

• IFN MNs demonstrated efficient in vitro release (49.2%) and achieved therapeutic serum levels in rats after percutaneous administration.
• Peak serum IFN levels (Cmax) and time to reach maximum concentration (Tmax) were 11.58 ng/ml and 40 min for high-dose MNs.
• AUC for MNs was comparable to intramuscular injection, with no significant immunogenicity or skin damage observed.

Conclusions:

• Dissolving IFN MNs represent a viable and stable alternative to intramuscular injection for transdermal protein drug delivery.
• This technology holds significant potential for non-invasive treatment of diseases requiring protein-based therapeutics.