Disclosed is a therapeutic patch for the gastrointestinal tract including a mucoadhesive material along with magnetic nanoparticles and a drug to be delivered to a living body, which are supported on the mucoadhesive material. A method of manufacturing the therapeutic patch for the gastrointestinal tract is also provided and includes preparing a mucoadhesive polymer, preparing a catechol precursor, mixing the mucoadhesive polymer and the catechol precursor, freeze-drying a mixture in the mixing step, mixing a powder resulting from the freeze-drying step with magnetic nanoparticles and a drug, and subjecting the resultant mixture to molding using a mold and then freeze-drying.

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 relates to floating drug delivery systems (FDDS) that provide solutions to the particular problems often encountered with floating drug delivery systems described in the art. On such generally recognized problem is the vulnerability of the systems, especially damage to the gas-filled compartment making it accessible to water so as to impair its buoyancy, ultimately resulting in insufficient gastric residence time. The invention, in an aspect, provides a self-repairing FDDS that maintains its floating capacity after damaging. The floating drug delivery systems of the invention, furthermore, allow for incorporation of high loads of active ingredients. The floating drug delivery systems can be designed in such a way that release of active ingredient from the system occurs entirely independent from the pH of the fluid surrounding the system. Furthermore, the procedure of manufacturing the floating drug delivery system of the invention is simple and straightforward, and therefore economically attractive.

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.

The invention provides oral vaccine formulations which deliver an antigen in the vicinity of the distal ileum and the area of the ileal Brake and/or the appendix. These vaccines are useful in the treatment and/or prevention of variety of disorders, including viral and bacterial infections and cancers. Related methods of treatment which use the oral vaccine formulations of the invention are also provided.

An oral gastro-retentive delivery device is provided which unfolds rapidly upon contact with gastric juice. The device is configured in a collapsed configuration for oral intake and unfolding for gastric retention for a predetermined period of time and eventually reducing in size for passage through the rest of the GI track.

The present document describes extended release gastro retentive dosage form comprising a carboxylated polysaccharide and cinnamaldehyde conjugate formed via an acetal, hemiacetal or cyclic hemiacetal formed between an aldehyde group of the cinnamaldehyde and a hydroxyl group of the carboxylated polysaccharide. The document also describes extended release gastro retentive dosage form comprising an artesunate emulsion having a pH value of from about 7.5 to 7.9 and comprising an artesunate or pharmaceutically acceptable salts thereof, and stereoisomers thereof stabilized with an emulsifying agent. The document also describes the use of the dosage forms for treatment of H. Pylori infection.

Methods and formulations of reducing one or more symptoms of gastroesophageal reflux disease (GERD) in a human patient with symptomatic GERD not completely responsive to proton pump inhibitors (PPIs). The patient is administered a therapeutically effective amount of an enteric coated gastro-retentive oral dosage form in the form of a tablet of a bile acid sequestrant dispersed in a polymeric matrix consisting essentially of poly(alkylene)oxide and one or more filler or compressing agent such that the patient experiences a clinically meaningful reduction in one or more symptoms of GERD.

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).

This application relates to pharmaceutical compositions, comprising solabegron that are useful for the treatment of lower urinary tract symptoms such as, for example, overactive bladder and prostate disorders. Additionally, this application relates to methods for treating lower urinary tract symptoms utilizing the pharmaceutical compositions, comprising solabegron. In some embodiments, the pharmaceutical compositions, comprising solabegron comprise a dual release drug delivery system.