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.

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.

Extended release pyridostigmine dosage forms, suitable for maintaining stable plasma concentrations with reduced or minimized initial burst release/dose dumping of pyridostigmine, are provided. The dosage forms include matrix tablets, gastroretentive tablets, and pellets, the latter being suitable for dosing in capsules, tablets, and sachets, as well as for sprinkling on foodstuffs. The disclosure also provides methods for improving patient compliance by administering once-a-day extended release pyridostigmine bromide dosage forms that provide a superior controlled drug release.

The present invention discloses a microcapsule powder stable in gastric acid, a method for preparing the same and use thereof. The microcapsule powder comprises a core material and a capsule material coated outside the core material, wherein the capsule material has a melting point of greater than 42° C., and the capsule material does not decompose or dissolve under the action of protease and gastric acid, but decomposes under the action of intestinal digestive enzymes. The core material is coated with the capsule material in the microcapsule powder, thus achieving high-efficiency coating of the core material by a single component. The microcapsule powder achieves conventional intragastric stability as well as favorable stability in an open environment at room temperature, thus solving the problem that the conventional embedding solution may only achieve intragastric stability, but the stability in an open environment at room temperature is low.

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. The self-righting articles described herein may comprise one or more tissue engaging surfaces configured to engage with a surface. 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.

The present disclosure is in the field of gastric resident systems. A device for extended retention in a stomach is provided. The device includes: first, second, and third arms, the second and third arms being connected to respective ends of the first arm. The device is configured to transform between a compressed configuration and an expanded configuration. The device further includes a biasing member configured to bias the device into the expanded configuration whereby the second and third arms are configured to mechanically engage each other to retain the system in the expanded configuration.

Extended release pyridostigmine dosage forms, suitable for maintaining stable plasma concentrations with reduced or minimized initial burst release/dose dumping of pyridostigmine, are provided. The dosage forms include matrix tablets, gastroretentive tablets, and pellets, the latter being suitable for dosing in capsules, tablets, and sachets, as well as for sprinkling on foodstuffs. The disclosure also provides methods for improving patient compliance by administering once-a-day extended release pyridostigmine bromide dosage forms that provide a superior controlled drug release.

Provided herein are gastroretentive dosage forms (GRDFs) for extended retention in a human stomach, comprising a body comprising at least two arms, the body configured to transform between a collapsed configuration for ingestion, an expanded configuration for retention within the stomach and a disassembled configuration wherein after a predetermined time period has elapsed, the GRDF disassembles into at least two parts such that each of the disassembled parts of the GRDF is sized for exiting the stomach; and, an erodible insert comprising a therapeutic agent, a diagnostic agent, an electronical device, or a combination thereof.

A composition that is self-foaming in an acid medium, and includes: at least one hydrophilic polymer, at least one compound capable of crosslinking the hydrophilic polymer by forming ionic bonds, at least one foaming agent, and at least one foam stabilizer agent; and to the use thereof as a drug, particularly for preventing and/or treating obesity.

The present disclosure provides a gastroretentive drug delivery device having an expandable structure. The drug delivery device includes: a capsule body having a space formed therein; an arm mounted at one end of the capsule body, the arm comprising a first hinge part, a second hinge part, a third hinge part and an elastic support part which enable unfolding and folding, wherein the first hinge part engages the elastic support part, the second hinge part engages a wing of the arm and is connected rotatably to the first hinge part, the third hinge part is positioned at one end of the wing and is connected rotatably to the second hinge part, a sustained-release supporter is positioned to face the third hinge part, an immediate-release formulation is positioned to face the elastic support part, and a sustained-release formulation is positioned between the sustained-release supporter and the immediate-release formulation; an elastic body acting to move the elastic support part in a direction toward the one end of the capsule body within the capsule body; and a capsule cap configured to engage the other end of the capsule body.