I-Corps: Translation potential of a monthly oral drug delivery platform

This I-Corps project is based on the development of a once-monthly oral capsule designed to replace daily pills and injections. Many patients stop taking prescribed medications because daily pills are easy to miss, while long-acting alternatives require injections that patients often find painful, inconvenient, or stigmatizing. This technology, once swallowed, self-assembles into a structure that resides safely in the stomach for over a month, releasing the ideal dose of medication before breaking apart and passing naturally, removing the need for daily dosing or needles. In addition, it may be used across multiple chronic disease indications. This may help patients stay on treatment, reduce hospitalization and healthcare costs while expanding access for people who avoid injections or daily medications. This I-Corps project utilizes experiential learning coupled with first-hand investigation of the industry ecosystem to assess the translation potential of a once-monthly, gastric-resident oral drug delivery platform. Current conventional oral formulations are limited by rapid gastrointestinal transit, or long-acting injectables, which require trained administration, cold-chain storage, and clinic visits. This technology is an engineered capsule that self-assembles into a structure whose geometry resists passage through the pylorus, conferring gastric residence exceeding one month while permitting food passage. The platform combines oral dosing with month-long pharmacokinetic coverage through engineered biocompatible polymers, structural linkers, and geometric design enabling high drug loading and reversible disassembly. The capsule releases a small-molecule drug payload at a controlled, tunable rate before undergoing programmed disassembly into fragments that safely transit and clear the gastrointestinal tract. Previous research demonstrated sustained, controlled release exceeding one month across multiple distinct drug payloads, supporting feasibility across multiple therapeutic classes. This technology may allow patients to replace daily dosing or injections with a single monthly, needle-free, room temperature-stable oral dose, which may improve adherence and continuity of care. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.