Development and Characterization of Zein/Eudragit Composite Nanoparticles for Insulin Intranasal Delivery

Area of Science:

• Nanotechnology
• Pharmaceutical Sciences
• Biomaterials

Background:

• Diabetes mellitus (DM) necessitates effective insulin delivery, with parenteral routes facing challenges like patient discomfort and adherence issues.
• Intranasal administration offers a potential alternative due to the nasal cavity's unique physiological characteristics, despite existing absorption barriers.

Purpose of the Study:

• To develop and characterize Zein-Eudragit nanoparticles (ZEU/INS NPS) for intranasal insulin delivery.
• To optimize nanoparticle formulation and assess its physicochemical properties, stability, and in vitro performance.

Main Methods:

• Zein-Eudragit nanoparticles loaded with insulin were prepared using a liquid-liquid dispersion method and optimized via a 2^4 factorial design.
• Characterization included particle size, PDI, zeta potential, FTIR, DSC, TG, morphology, in vitro insulin release, and mucoadhesion studies.

Main Results:

• Optimized ZEU/INS NPS showed particle size <200 nm, PDI <0.3, zeta potential ~+30 mV, and 42% encapsulation efficiency.
• Nanoparticles demonstrated good thermal stability, maintained physical stability for 60 days under refrigeration, and exhibited sustained in vitro insulin release (~60% over 24h).
• In vitro mucoadhesion assays indicated enhanced nasal residence time.

Conclusions:

• Zein-Eudragit nanoparticles possess favorable physicochemical properties for intranasal insulin delivery.
• These nanoparticles represent a promising noninvasive strategy for managing diabetes mellitus, potentially improving patient compliance and treatment efficacy.