Gastric-Resident Devices for Gram-level Drug Delivery

Applications

This technology is a gastric-resident device for administering drugs over the course of weeks to months. The technology is relevant to the pharmaceutical, healthcare, and medical devices industries, as it serves to maximize drug adherence. 

Problem Addressed

Patients’ adherence rates to oral therapies taken over an indefinite amount of time are poor, especially for asymptomatic diseases in which the therapy has no noticeable immediate effect. Other factors contributing to poor adherence rates include cost, side effects, accessibility, and the inconvenience of dosing regimens. Current options to increase adherence include the MicroChip device, which requires surgical implantation and is only useful for very potent therapeutics delivered in microgram or smaller quantities. Alternatively, there are orally delivered systems for extended release, but they can only hold at most 1.6 grams of the drug. This technology holds up to 10 grams of active pharmaceutical ingredient, allowing for long-term delivery of a broad range of drugs. 

Technology

This biocompatible device, which has been tested in porcine models, is composed of elastomeric tubing and a retention frame made of materials such as elastomer wire and shape-memory alloy elastic wire. The technology could be implemented in a variety of shapes like a J-hook, sphere, series of circles, or toroid-inspired shape. Regardless of final form, the device is capable of being stretched out straight (to a fully elongated length of at least 28.66 cm) in order to be administered transesophageally. The drug can be delivered using a series of cylindrical pills composed of the drug and a nonerodable matrix like vinylpolysiloxane. Each pill contains a 0.5 mm hole, such that many pills can be strung together on a superelastic wire. The pills may include a coating such as Eudragit NM 30D to prevent a burst release of the drug, as well as excipients like polyethylene glycol to control the rate of drug release. The technology also includes a specialized retrieval device, which utilizes a sensor and magnet to locate and extract the device from the body transesophageally.

Advantages

  • Maximizes drug adherence in the face of factors such as cost, accessibility, and convenience

  • Holds up to 10 grams of active pharmaceutical ingredient, allowing delivery of a broad range of drugs

  • Can treat infectious diseases like tuberculosis, and holds potential for other indications like pain management, depression, schizophrenia, and alcohol dependency

  • Specialized retrieval device that operates without the need for imaging

  • Potential for veterinary use

Intellectual Property

IP Type: Published US Patent Application

IP Title: Resident articles for gram-level dosing

IP Number: US 2019-0366064A1

 

IP Type: Published US Patent Application

IP Title: Drug delivery articles for gram-level dosing

IP Number: US 2019-0365645A1

 

IP Type: Published US Patent Application

IP Title: Retrieval systems and related methods

IP Number: US 2019-0365418A1