Self-Nanoformulating Poly(2-oxazoline) and Poly(2-oxazine) Copolymers Based Amorphous Solid Dispersions as Microneedle Patch: A Formulation Study

24 May 2024, Version 1
This content is a preprint and has not undergone peer review at the time of posting.

Abstract

Here, we introduce a pioneering approach in the domain of transdermal drug delivery systems (TDDS) by using microneedles (MNs) fabricated from amorphous solid dispersion comprising only a model drug and an amphiphilic block copolymer to form a drug nanoformulation upon MN dissolution. This approach presents the most minimalistic approach to maximize drug loading in MN, reaching 40 wt.%. Using scanning electron microscopy, we carefully examined the morphology of MNs across a spectrum of drug loading ratios, revealing a remarkable consistency in structure and integrity. Mechanical testing confirms the MNs' proficiency in effective skin penetration. Furthermore, a comparative study on the formation of polymeric micelles underscores the innovative concept of a “nano-in-micro drug delivery system”, offering an approach to drug release. The results demonstrate that MNs manufactured from an amorphous solid dispersion of drug and amphiphilic block copolymer with ultra-high loading, enhancing the availability and release dynamics of hydrophobic drugs, positioning them as a potent tool for enhancing TDDS. This study sets a new benchmark in the utilization of polymer-drug nanoformulations for transdermal applications and underscores the exceptional capacity for high drug loading and the creation of adaptable drug delivery mechanisms for the studied amphiphilic block copolymer.

Keywords

microneedles
poly(2-oxazoline)
poly(2-oxazine)
transdermal drug delivery
amorphous solid dispersion

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