Preparations of coagulation factors for release into the tissue of the intestinal tract by means of an ingestible drug delivery device

Abstract

The embodiments provide devices, preparations, and methods for delivering therapeutic agents (TAs), such as clotting factors (CFs, e.g., Factor VIII), into the gastrointestinal tract. Many embodiments provide an ingestible device, e.g., a capsule, for delivering the TAs to the intestinal wall (IW). The embodiments also provide TA preparations configured to be contained within the capsule, migrate from the capsule into the IW and / or surrounding tissue (ST), and degrade to release the TA into the bloodstream and produce a therapeutic effect (e.g., enhanced clotting). The preparation can be operationally coupled to delivery methods with a first configuration in which the preparation is contained within the capsule and a second configuration in which the preparation migrates from the capsule into the IW or ST (e.g., the peritoneal cavity).These realizations are particularly useful for the administration of FC for the treatment of coagulation disorders (e.g., hemophilia) where such FC are poorly absorbed and / or degraded in the gastrointestinal tract.

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