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 are ingestible polymeric formulations and oral dosage forms for the reduction of gastric volume in the treatment of overweight and obese patients. The formulation includes an acid-sensitive, gelatin coating over a dehydrated hydrophilic polymer. When ingested, the acid-sensitive coating is quickly dissolved by gastric secretions and the hydrophilic polymer is exposed to the aqueous environment of the gastric milieu. The polymer absorbs water and expands to the point that will not allow the polymer to pass beyond the pyloric valve, and the expanded polymer is therefore trapped in the stomach.

A sustained release composition for oral administration comprises a physiologically active ingredient mixed with a methylcellulose, wherein the methylcellulose has anhydroglucose units joined by 1-4 linkages and wherein hydroxy groups of anhydroglucose units are substituted with methyl groups such that the s23/s26 is more than 0.27, and wherein the concentration of methylcellulose is from 0.1 to 10% by dry weight of the active ingredient.

Disclosed is a pregabalin sustained-release preparation, wherein the sustained-release tablet contains a pharmaceutically active ingredient containing pregabalin or a salt or hydrate thereof, a gel framework material containing alginic acid, and a swellable material containing polyoxyethylene.

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.

This disclosure features methods and compositions for treating diseases of the gastrointestinal tract with a TLR agonist.

A sustained release composition for oral administration comprises a physiologically active ingredient mixed with a methylcellulose, wherein

the methylcellulose has anhydroglucose units joined by 1-4 linkages and wherein hydroxy groups of anhydroglucose units are substituted with methyl groups such that the s23/s26 is 0.27 or less,
the composition further comprising a liquid diluent in a weight ratio of liquid diluent to active ingredient in the range of 0:1 to 0.85:1.

Self-regulating, osmotic, floating gastroretentive compositions that provide extended release, delayed release, and/or delayed extended release of active pharmaceutical agents, as well as, optionally, immediate release of the same or a different active pharmaceutical agent, are provided here. The gastroretentive compositions of the disclosure comprise a swellable, extended release, multilayer core comprising a push layer and a pull layer; a water-insoluble permeable elastic membrane surrounding the multilayer core; and an orifice (e.g., a laser-drilled orifice, a manually drilled orifice) on the pull-layer side of the dosage form. The gastric retention of the composition is controlled by rapid floating of the composition and expansion of the membrane. The rapid swelling of the composition to a size greater than the size of the pyloric sphincter is due to the presence of an osmogen, adequate membrane permeability that provides for fast generation of CO.sub.2 from a gas-generating agent(s), and adequate membrane elasticity that provides for rapid expansion of the membrane. The hydrated core, especially the polyethylene oxide in the push layer, and the permeable elastic membrane with an orifice (1) provide extended release of the active pharmaceutical agent, and (2) maintain the dosage form at a size suitable for gastric retention. The self-regulating composition collapses, or breaks into pieces, after releasing at least about 80% of the drug from the composition.

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, an expandable, multi-excipient dosage form for prolonged release is disclosed. The dosage form generally comprises a three-dimensional structural framework of solid elements. The elements comprise at least a drug, at least a physiological fluid-absorptive excipient, and at least a strength-enhancing excipient. Upon ingestion, the three-dimensional structural framework expands in at least one dimension and forms an expanded semi-solid mass that can be retained in the stomach and release drug over prolonged time.

A delivery system is described that includes a controlled release device that includes a crosslinked poly(glycerol sebacate) (PGS) or other glycerol ester and a controlled release compound, the controlled release device being provided in a contracted state and being expandable to a three-dimensional expanded state in a target location. The delivery systems provides an expandible, flexible biodegradable elastomer loaded with an active ingredient to allow for extended release for different dosage forms for either human or animal health products in vivo, delivered through the gastrointestinal tract.