Residence structures and related methods

Abstract

Residence structures, systems, and related methods are generally provided. Certain embodiments comprise administering (e.g., orally) a residence structure to a subject (e.g., a patient) such that the residence structure is retained at a location internal to the subject for a particular amount of time (e.g., at least about 24 hours) before being released. The residence structure may be, in some cases, a gastric residence structure. In some embodiments, the structures and systems described herein comprise one or more materials configured for high levels of active substances (e.g., a therapeutic agent) loading, high active substance and/or structure stability in acidic environments, mechanical flexibility and strength in an internal orifice (e.g., gastric cavity), easy passage through the GI tract until delivery to at a desired internal orifice (e.g., gastric cavity), and/or rapid dissolution/degradation in a physiological environment (e.g., intestinal environment) and/or in response to a chemical stimulant (e.g., ingestion of a solution that induces rapid dissolution/degradation). In certain embodiments, the structure has a modular design, combining a material configured for controlled release of therapeutic, diagnostic, and/or enhancement agents with a structural material necessary for gastric residence but configured for controlled and/or tunable degradation/dissolution to determine the time at which retention shape integrity is lost and the structure passes out of the gastric cavity. For example, in certain embodiments, the residence structure comprises a first elastic component, a second component configured to release an active substance (e.g., a therapeutic agent), and, optionally, a linker. In some such embodiments, the linker may be configured to degrade such that the residence structure breaks apart and is released from the location internally of the subject after a predetermined amount of time.

Description

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AI Technical Summary

Benefits of technology

The patent text describes how exposure to certain substances can cause the dissociation of enteric elastomer linkers, which can help to break down the structure of the retention structure and allow it to pass through the internal orifice. This can have technical effects on the performance of the retention structure.

Problems solved by technology

The technical problem addressed in this patent text is the low adherence rates of patients to self-administration protocols for therapeutics and diagnostics, particularly for chronic asymptomatic conditions where the therapy has no immediate tangible benefit. The challenge of low adherence rates is greatest in primary and secondary prevention applications where the therapy has no immediate tangible benefit. The current state-of-the-art approaches to improving adherence rates include educational interventions, telephone-based counseling, health information technology solutions, interactive pharmacy tools, and changing models of payment for care. However, these approaches have only achieved modest improvements. The challenge of delivering therapeutic agents with high potency is that oral delivery systems have a short transit time through the gastrointestinal tract, making it difficult to achieve extended release beyond 24 hours via the oral route. The patent text proposes a solution to this problem by prolonging the transit time of an orally-administered therapeutic and addressing the challenges of gastric residence for drug delivery.

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