A gastroretentive, sustained-release dosage form including 5-hydroxytryptophan (5-HTP) as an active ingredient and low-dose carbidopa is described. For example, the dosage form can be provided as a bilayer tablet comprising a swelling layer and a modified release layer, where the 5-HTP and carbidopa are both included in the modified release layer. The dosage form provides for essentially parallel release of the 5-HTP and the carbidopa with, for instance, release of 80% of the 5-HTP and carbidopa at about 5 hours to about 12 hours.

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 pivotally 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.

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.

Drug delivery articles, resident articles, and retrieval systems e.g., for gram-level dosing, are generally provided. In some embodiments, the articles are configured for transesophageal administration, transesophageal retrieval, and/or gastric retention to/in a subject. In certain embodiments, the article includes dimensions configured for transesophageal administration with a gastric resident system. In some cases, the article may be configured to control drug release e.g., with zero-order drug kinetics with no potential for burst release for weeks to months. In some embodiments, the articles described herein comprise biocompatible materials and/or are safe for gastric retention. In certain embodiments, the article includes dimensions configured for transesophageal retrieval. In some cases, the articles described herein may comprise relatively large doses of drug (e.g., greater than or equal to 1 gram).

The present invention relates to a gastroretentive extended release suspension composition, wherein the composition is characterized by having no substantial change in the in-vitro dissolution release profile upon storage for at least seven days. The invention also relates to processes for the preparation of said gastroretentive extended release suspension compositions.

Embodiments provide devices, preparations and methods for delivering therapeutic agents (TAs) such as clotting factors (CFs, e.g., Factor 8) within the GI tract. Many embodiments provide a swallowable device e.g., a capsule for delivering TAs into the intestinal wall (IW). Embodiments also provide TA preparations configured to be contained within the capsule, advanced from the capsule into the IW and/or surrounding tissue (ST) and degrade to release the TA into the bloodstream to produce a therapeutic effect (e.g., improved clotting). 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 IW or ST (e.g., the peritoneal cavity). Embodiments are particularly useful for delivery of CFs for treatment of clotting disorders (e.g., hemophilia) where such CFs are poorly absorbed and/or degraded within the GI tract.

Many drug therapies could be greatly improved by dosage forms that reside in the stomach for prolonged time and release the drug slowly. In this specification, therefore, a gastroretentive structured dosage form is disclosed. The dosage form comprises a solid core having at least a fluid-absorptive first excipient. The dosage form further comprises a semi-permeable surface layer substantially encapsulating said solid core. The surface layer comprises at least a mechanically strengthening second excipient. Upon ingestion, the surface layer-supported solid core expands with physiological fluid absorption and remains in the stomach for prolonged time.

The present disclosure provides osmotic, floating gastroretentive compositions comprising a multilayer core comprising a pull layer containing liothyronine or a pharmaceutically acceptable salt thereof, an acid, a gas-generating agent, a first osmogen, and at least one water-soluble hydrophilic polymer; and a push layer comprising a polyethylene oxide polymer with an average molecular weight of at least 900,000 Da, and a second osmogen. 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 composition provides sustained release, while maintaining plasma concentration of from 0.5 ng/ml to 3 ng/ml, of liothyronine or a pharmaceutically acceptable salt, for at least 6 hours.

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. 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. 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 may comprise and/or be associated with the pharmaceutical agent.

The present invention to unit dosage forms which are capable of floating on gastric fluid and delivering the therapeutic agent over an extended period of time. Particularly the invention relates to Droxidopa sustained release gastroretentive dosage form for release of drug over period of 12 hrs. The gastroretentive dosage form of Droxidopa of the present invention comprises drug, polymer (Hydroxy propyl methyl cellulose K200M) as rate controlling polymer and the formulation maintains buoyancy on the gastric fluid for a period of 12 hrs, thus providing better patient compliance by providing reducing dosing frequency.