QbD-guided development of hydrogel-forming microneedles with reservoir for enfuvirtide delivery
Tuesday, July 15, 2025
11:49 AM – 12:00 PM EDT
Introduction: To address the 98% incidence of injection site reactions from 90 mg twice-daily subcutaneous injections of enfuvirtide, novel chemically crosslinked hydrogel-forming microneedles (MNs) were introduced as a minimally invasive, painless transdermal delivery method. Using quality by design (QbD) and design of experiment, this study identified critical material attributes (CMAs) and process parameters (CPPs) linked to microneedle quality attributes, ensuring a robust, systematic formulation process targeting an optimal product profile.
Learning Objectives:
At the completion of this activity, participants will know
Understand how to identify critical factors and their impact on hydrogel-forming MNs.
Explore the application of QbD principles to target MN profiles for peptide transdermal delivery.
Recognise the feasibility of this systematic strategy across broader pharmaceutical contexts.
