Injectable Devices for Delivery of Liquid or Solid Protein Formulations

Area of Science:

• Biomaterials Science
• Drug Delivery Systems
• Ophthalmology

Background:

• Sustained delivery of protein therapeutics is a significant challenge across various anatomical sites.
• Miniaturized devices offer a promising solution for minimally invasive administration of protein formulations.
• Developing formulation-independent manufacturing techniques is key for broad applicability.

Purpose of the Study:

• To develop and characterize miniaturized tubular devices for sustained protein therapeutic release.
• To evaluate the loading capacity, release kinetics, and in vivo safety of these devices.

Main Methods:

• Fabrication of fine-scale (down to 30 μm wall thickness) tubular devices using a dip-casting process.
• Development of techniques for loading solid or liquid protein formulations into devices compatible with 22-gauge needles.
• In vitro release studies of a model protein, demonstrating sustained release over 400 days.
• In vivo intravitreal injection in a rabbit model to assess ocular safety and tolerability.

Main Results:

• Reliable production of tubular devices with controlled wall thickness and cylindrical form-factor.
• Successful loading of protein formulations into devices suitable for miniaturized applications (∼300 μm diameter).
• Sustained release of a model protein exceeding 400 days from solid-loaded devices.
• Demonstrated ocular safety in a rabbit model following intravitreal injection, with no significant inflammation.

Conclusions:

• The developed dip-casting technique enables fabrication of miniaturized devices for sustained protein delivery.
• These devices can effectively load protein formulations and provide long-term release.
• The technology shows promise for minimally invasive therapeutic applications, particularly in ophthalmology, with acceptable ocular safety.