Nanodelivery systems for long-term controlled release of pharmaceuticals

This invention describes a nanodelivery system for controlled drug release using biocompatible materials. It features implantable or injectable devices with precise aperture control for zero-order kinetics, ensuring consistent therapeutic delivery over extended periods of time.

Background

Implantable drug delivery systems offer significant advantages over traditional administration routes, such as oral or sublingual, due to their ability to provide localized drug delivery with predictable and uniform bioavailability, bypassing the digestive tract. This approach enhances efficacy and compliance, particularly in elderly patients and those undergoing treatment for drug addiction, while minimizing systemic side effects.

However, the precision required in fabricating these devices poses substantial challenges, particularly in high-volume production. Variations in geometric configurations can lead to inconsistent release rates, deviating from the intended zero-order kinetics to first or second-order kinetics, which can result in unpredictable plasma drug profiles and reduced therapeutic benefits.

Current fabrication techniques, like laser drilling, struggle with maintaining dimensional control and are costly, especially for creating apertures smaller than 10 microns. Furthermore, ensuring biocompatibility of the materials used in these devices is critical, as the host response can compromise their functionality and durability. Traditional approaches, such as biocompatible coatings or the use of benign processing technologies, are often insufficient or economically unfeasible, especially when dealing with compliant polymers and irregularly shaped substrates.

The integration of semiconductor and nanotechnology advancements has expanded design possibilities, yet challenges remain in pattern registry and maintaining precision across varying surface heights. Existing solutions often involve complex assembly processes that shift the burden from patterning to packaging, complicating production and increasing costs.

Technology description

The technology described is a nanodelivery system for the controlled release of active pharmaceutical ingredients over extended periods. It employs implantable or injectable devices that achieve zero-order release kinetics, ensuring a constant release rate of drugs.

The fabrication process involves creating non-planar enclosures from biocompatible materials, which are then coupled to a substrate. Apertures are precisely formed in these enclosures, using advanced maskless fabrication techniques like focused ion beam or electron beam lithography. This allows for meticulous control over the size and distribution of apertures, which is crucial for regulating the drug release rate. The system is designed to be biocompatible, reducing adverse reactions, and is scalable for high-volume production, addressing challenges in maintaining dimensional control.

This technology is differentiated by its ability to maintain a steady, controlled release of drugs, which is a significant advancement over traditional methods that often result in variable release rates. The use of maskless fabrication techniques allows for precise aperture creation without the need for a rigid substrate, overcoming common issues related to pattern registration and surface topography.

Additionally, the biocompatibility of the materials used minimizes the risk of adverse tissue reactions, making it safer for long-term implantation. The scalability of the production process also makes it economically viable for widespread use, offering a reliable solution for chronic disease management and other therapeutic applications requiring consistent drug delivery.