Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade to release the drug into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

The invention provides a method of inducing satiety in a subject comprising a step of orally administering a composition comprising an effective amount of a first agent capable of inducing satiety and of a second agent capable of augmenting the satiety-inducing effect of the first agent. Also disclosed are compositions for carrying out the method, and a body weight management system comprising such compositions in combination with a device configured for the collection, storage and/or display of information relating to a subject's response to a predefined therapeutic regimen of orally administering the composition.

The invention features compositions, methods, and kits containing (i) one or more cysteamine precursor compounds convertible to cysteamine in vivo, and (ii) optionally agents to enhance that conversion, formulated to produce a spectrum of pharmacokinetic profiles of cysteamine that can be tailored to individual patients and diseases. The invention also features varying modes of administration of the therapeutic substances in the treatment of cystinosis and other cysteamine sensitive disorders. In particular, formulations combining active ingredient(s) with pharmaceutical excipients that permit sustained cysteamine plasma concentrations are featured.

The present invention relates to a cysteine releasing pharmaceutical preparation(s) for novel use in preventing and/or treating alcohol flushing and alcohol induced hypersensitivity reactions. Additionally, the invention relates to a method for eliminating histamine releasing effect of locally formed acetaldehyde in the digestive tract.

Self-righting articles, such as self-righting capsules for administration to a subject, are generally provided. In some embodiments, the self-righting article may be configured such that the article may orient itself relative to a surface (e.g., a surface of a tissue of a subject). The self-righting articles described herein may comprise one or more tissue engaging surfaces configured to engage (e.g., interface with, inject into, anchor) with a surface (e.g., a surface of a tissue of a subject). In some embodiments, the self-righting article may have a particular shape and/or distribution of density (or mass) which, for example, enables the self-righting behavior of the article. In some embodiments, the self-righting article may comprise a tissue interfacing component and/or a pharmaceutical agent (e.g., for delivery of the active pharmaceutical agent to a location internal of the subject). In some cases, upon contact of the tissue with the tissue engaging surface of the article, the self-righting article may be configured to release one or more tissue interfacing components. In some cases, the tissue interfacing component is associated with a self-actuating component. For example, the self-righting article may comprise a self-actuating component configured, upon exposure to a fluid, to release the tissue interfacing component from the self-righting article. In some cases, the tissue interfacing component may comprise and/or be associated with the pharmaceutical agent (e.g., for delivery to a location internal to a subject).

The present disclosure is in the field of gastroretentive dosage forms. A gastroretentive dosage form for extended retention in a stomach is provided.

Triggerable hydrogel compositions and related methods are generally disclosed. In some embodiments, the compositions and related methods may be used for medical-related or other applications. For example, the compositions and methods described herein may be useful, for example, in biomedical applications such as articles for (e.g., gastric) retention. In some embodiments, methods for deploying and/or removing an article comprising the composition, such as an article for gastric retention, are provided. The article and/or composition may be removed internally from a subject by, for example, introducing at least one reagent (e.g., one reagent, two reagents) such that at least a portion of the composition disassociates. In certain embodiments, the composition comprises a polymer network comprising two or more interpenetrating polymers. In some cases, a first polymer comprises a first cross-link moiety configured to dissociate upon interaction with a reagent. For example, the composition may be administered to a subject such that it is retained at a location internal (e.g., gastric) to the subject. In some embodiments, a reagent may be administered to the subject (e.g., the subject drinks the reagent) such that the reagent interacts with the composition and at least a first cross-link moiety disassociates. In some embodiments, upon disassociation of one or more cross-link moieties of the polymer network, the composition is no longer retained at the location internal to the subject (e.g., dissociates such that it exits the subject). In some cases, the polymer network is configured (e.g., upon administration of the composition to a subject) such that the composition is retained at the location internal to the subject for greater than or equal to 24 hours.

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.

The present disclosure provides floating gastroretentive compositions comprising a multilayer core comprising 1) a pull layer containing liothyronine or a pharmaceutically acceptable salt thereof, an acid, and a gas-generating agent; and 2) a push layer. Each of the pull layer and the push layer comprises a swellable water-soluble hydrophilic polymer. The composition further comprises a permeable elastic membrane covering at least a portion of the multilayer core and containing at least one orifice in fluid communication with the pull layer. The permeable elastic membrane comprises a copolymer of ethyl acrylate, methyl methacrylate, and trimethylammonioethyl methacrylate chloride. The composition provides sustained release of liothyronine or a pharmaceutically acceptable salt thereof.

Provided herein are methods for treating, preventing or alleviating the symptoms of and inflammation associated with inflammatory diseases and conditions of the gastrointestinal tract, for example, those involving the esophagus. Also provided herein are pharmaceutical compositions useful for the methods of the present invention.