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

Provided herein are oral dosage forms comprising a) a core tablet comprising (i) a drug layer comprising apremilast and hypromellose acetate succinate (HPMCAS) in an amorphous solid dispersion; and (ii) a swellable layer comprising one or more swellable polymers; and b) a coating layer disposed on the core tablet, wherein the oral dosage form surface comprises at least one drug release orifice. The disclosed oral dosage forms provide once-a-day dosing of apremilast and are suitable for treating diseases or disorders ameliorated by inhibiting phosphodiesterase subtype IV (PDE4).

Methods of manufacturing tissue interfacing components, such as solid needles comprising one or more therapeutic agents, are disclosed. In some embodiments, a method for manufacturing a tissue interfacing component comprises compressing a granular therapeutic agent within a mold cavity of a mold to form a solid tissue interfacing component. The mold cavity may define an elongated shape extending along a longitudinal axis from an opening of the mold cavity to a distal end of the mold cavity, and the granular therapeutic agent may be compressed by moving a mold punch along the longitudinal axis towards the distal end. After compressing the granular therapeutic agent to form the solid tissue interfacing component, the tissue interfacing component may be removed from the mold and subsequently inserted into tissue to deliver the therapeutic agent to a subject.

A method for designing and manufacturing a long release capsule for extended delivery of a drug to a patient in an ingestible capsule. The method includes determining a drug volume to be delivered and a drug delivery rate. A buoyancy element is selected based on the drug volume. A release port is selected based on the drug delivery rate and the properties of the drug. The design elements are used to produce a capsule design for an ingestible capsule. The design of the capsule is used to generate manufacturing instructions and produce the capsule.

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.

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.

Provided herein are gastric residence systems, or components of gastric residence system such as arms (elongate members) or segments of gastric residence systems, with release rate-modulating films. The release rate-modulating films provide good control over release of agents (such as therapeutic, diagnostic, or nutritional agents) from the gastric residence systems. The release rate-modulating films disclosed herein resist changes to their release properties during heat-assisted assembly of the gastric residence systems.

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.

The present disclosure provides a gastroretentive drug delivery device having an expandable structure. The drug delivery device includes: a capsule body; an arm moving part movable within the capsule body; an elastic body positioned between one end of the capsule body and the arm moving part and acting to move the arm moving part toward the other end of the capsule body; an arm support part movable within the capsule body; a capsule cap configured to engage the other end of the capsule body; a rail formed within the capsule body; and an arm configured to be unfolded by longitudinal movement of the arm moving part and move along the rail. A disintegrable immediate-release formulation is positioned between the arm moving part and the arm support part. A disintegrable sustained-release formulation is positioned between the arm support part and the capsule cap.

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).