Abstract: The invention provides gastric residence systems with configurations and geometrical dimensions that allow for improved shelf life during prolonged storage, and optimal residence properties when the systems are deployed in the stomach of a patient.

Abstract: Gastric residence systems and methods of delivering a drug to an individual using a gastric residence system are described herein. The gastric residence system may include a time-dependent and/or enteric, or dual time-dependent and enteric polymeric linker. In some embodiments, the time-dependent polymeric linker includes PLGA, and optionally PLA or a carrier polymer. The enteric polymeric linker includes an enteric polymeric, and optionally a carrier polymer such as PCL or TPU. The time-dependent polymeric linker may degrade in the stomach of the individual according to a degradation (or flexural modulus loss) profile described herein, and the enteric polymeric linker may degrade in the intestine of the individual another degradation profile described herein (or flexural modulus loss).

Abstract: The invention provides gastric residence systems for administration of adamantane-class drugs or pharmaceutically acceptable salts thereof, such as memantine or pharmaceutically acceptable salts thereof, and methods for making and using such systems. The systems provide extended release of drug, reducing the frequency with which the drug must be administered to the patient. The gastric residence systems, or components of gastric residence system such as segments or elongate members of gastric residence systems, can have release rate-modulating films, which provide good control over release of adamantane-class drugs or pharmaceutically acceptable salts thereof present in the gastric residence system. Some embodiments of the films can provide resistance against burst release of adamantane-class drugs or pharmaceutically acceptable salts thereof upon exposure to alcohol.

Abstract: Gastric residence systems comprising therapeutic agent formulations for sustained gastric release of therapeutic agents are disclosed, as well as methods for using such systems. The systems are characterized by use of a dispersant in the formulations, which improves the burst release characteristics and long-term release rate characteristics of the systems. Milling of therapeutic agent can also be performed to prepare agent particles of desired size.

Abstract: Provided are gastric residence systems comprising: a core; a plurality of arms connected to the core at a proximal end through a plurality of linker components, one linker component of the plurality of linker components corresponding to each arm of the plurality of arms, and the plurality of arms extending radially from the proximal end, and a filament circumferentially connecting each arm of the plurality of arms.

Abstract: Gastric residence systems for administration of agents, such as drugs, are disclosed. Features which enhance gastric retention during the desired residence time and which allow for more precise control over residence time are disclosed, including circumferential filaments connecting the arms of a stellate gastric residence system; flexible arms for a gastric residence system; improved time-dependent and enteric disintegrating matrices (linkers); and release rate-modulating polymer coatings which are resistant to change in release rate properties during heat-assisted assembly or thermal cycling. Combinations of these features are also disclosed.

Abstract: Provided are gastric residence dosage forms comprising flexible arms that can help prevent premature passage of the gastric residence system through the pylorus of a patient. In particular, described herein are gastric residence systems comprising one or more arms extending radially, the one or more arms comprising a first segment comprising a first polymer composition and a second segment comprising a second polymer composition, wherein the first segment has a stiffness of greater than a stiffness of the second segment, as measured using a 3-point bending test per ASTM D790. The second segments of the arms of the gastric residence systems help prevent premature passage of the gastric residence system through the pylorus of a patient.

Abstract: Provided are enrobed gastric residence dosage forms comprising: a gastric residence system in a folded configuration; and a coating enrobing the gastric residence system in the folded configuration, wherein the enrobed gastric residence dosage form is configured to release the gastric residence system in the folded configuration in a stomach of a patient, allowing the gastric residence system to assume an open configuration. The coating comprises water, a plasticizer, a gelling agent, and/or a polymer.

Abstract: Provided are stomach simulating devices and methods for simulating a stomach. Stomach simulating devices can comprise a bag-shaped conduit, a mechanical constrictor, and a valve. The conduit can have a body portion, a first diameter at an inlet portion, and a second diameter at an outlet portion, wherein the first diameter at the inlet portion is greater than the second diameter at the outlet portion, the body portion is located between the inlet portion and the outlet portion, and at least a portion of the conduit is curved in a direction from the inlet portion the outlet portion. The mechanical constrictor can he configured to constrict at least a portion of the body portion of the conduit. The valve can be configured to at least partially close a portion of the conduit closer to the outlet portion than the inlet portion of the conduit.

Abstract: Described herein are systems for the enteric delivery of therapeutic agents, and methods of administering a therapeutic agent to a patient by orally administering an enteric delivery system. The enteric deliver system includes one or more carrier members comprising a carrier polymer and a therapeutic agent, and the system is configurable in a compacted configuration and an expanded configuration, and is sized to maintain contact with the intestinal wall of the small intestine by applying an outwardly directed pressure to the intestinal wall and transport at least a portion of the therapeutic agent across the enteric mucosa of the small intestine.

Abstract: The invention provides gastric residence systems, or components of gastric residence system such as segments or elongate members of gastric residence systems, with release rate-modulating films and methods for making and using such systems. The release rate-modulating films provide good control over release of agents (such as therapeutic, diagnostic, or nutritional agents) present in the gastric residence system. The films also permit higher drug loading in the gastric residence systems and components of gastric residence systems while maintaining good control over release of agents. Some embodiments of the films can provide resistance against burst release of agent upon exposure to alcohol.

Abstract: The invention provides gastric residence systems with configurations and geometrical dimensions that allow for improved shelf life during prolonged storage, and optimal residence properties when the systems are deployed in the stomach of a patient.

Abstract: The invention provides gastric residence systems with specifically tailored architectures and methods for making such systems. The components of the gastric residence systems can be manufactured by three-dimensional printing or by co-extrusion. The ability to construct precise architectures for the systems provides excellent control over drug release, in vivo stability, and residence time of the systems.

Abstract: The invention provides gastric residence systems for administration of adamantane-class drugs or pharmaceutically acceptable salts thereof, such as memantine or pharmaceutically acceptable salts thereof, and methods for making and using such systems. The systems provide extended release of drug, reducing the frequency with which the drug must be administered to the patient. The gastric residence systems, or components of gastric residence system such as segments or elongate members of gastric residence systems, can have release rate-modulating films, which provide good control over release of adamantane-class drugs or pharmaceutically acceptable salts thereof present in the gastric residence system. Some embodiments of the films can provide resistance against burst release of adamantane-class drugs or pharmaceutically acceptable salts thereof upon exposure to alcohol.

Abstract: Gastric residence systems comprising therapeutic agent formulations for sustained gastric release of therapeutic agents are disclosed, as well as methods for using such systems. The systems are characterized by use of a dispersant in the formulations, which improves the burst release characteristics and long-term release rate characteristics of the systems. Milling of therapeutic agent can also be performed to prepare agent particles of desired size.