Delivery of macromolecule therapeutics via jetting in the gastrointestinal tract

Abstract

Biologics are a class of therapeutic substances composed of large and complex "macromolecules." Examples include vaccines, insulin, monoclonal antibodies, and allergens. However, a practical limitation of these molecules is that they are easily degraded by digestive processes and, as a result, are not generally considered effective for oral dosing. Therefore, these life-saving drugs are typically delivered via intravenous, intramuscular or subcutaneous injection. Oral administration, however, yields some of the highest patient adoption and adherence rates, and is often critical in determining a drug's efficacy. Herein lies the goal of this research: to make it possible to successfully deliver a broad set of biologics by mouth. To that end, needleless delivery, or jetting, has been identified as a promising approach. This work describes mechanistic modeling of jets, an empirical evaluation of jet interaction with gastrointestinal tissues, a millimeter-scale jetting device capable of autonomous drug delivery, and in-vivo studies in which the tested devices elicit substantial drops in blood glucose levels via the delivery of insulin across the gastric mucosa.