Quality by Design-Guided Development of Hydrogel-Forming Microneedles for Transdermal Delivery of Enfuvirtide.

ABSTRACT: Enfuvirtide, the inaugural biomimetic fusion inhibitor of HIV-1, has exhibited remarkable antiviral efficacy when administered in conjunction with an optimized antiretroviral regimen. Nonetheless, the high incidence (98%) of injection site reactions associated with twice-daily subcutaneous administration severely compromises patient adherence and long-term therapeutic outcomes. This study proposes hydrogel-forming microneedles (MNs) as a minimally invasive and painless modality for the transdermal delivery of this therapeutic peptide. Leveraging a rigorous Quality by Design (QbD) framework, this investigation systematically delineated the critical material attributes (CMAs) and critical process parameters (CPPs) of the hydrogel formulation, mapping their influence on the critical quality a

SUBMITTER: Li H 

PROVIDER: S-EPMC12067383 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature