An orally disintegrating dosage form of a proton pump inhibitor, methods for its production and use thereof are provided. The dosage form includes a plurality of pellets containing a proton pump inhibitor admixed with a disintegrant to afford rapid disintegration in the oral cavity after administration.

The present disclosure is directed to methods of treating neurological disorders in a patient such as Parkinson's disease, drug-induced extrapyramidal reactions, and/or levodopa-induced dyskinesia comprising administering to the patient once daily in the morning a pharmaceutical composition comprising about 50 mg to about 400 mg of extended-release amantadine or a pharmaceutically acceptable salt thereof.

A pharmaceutical formulation comprising an erosion matrix comprising one or more fumaric acid esters as well as one or more rate-controlling agents, wherein erosion of said erosion matrix permits controlled release of said fumaric acid ester(s).

The present disclosure provides chewable tablets comprising (i) a compressed core including a bioactive molecule; (ii) a protective layer over said compressed core, and (iii) one or more soft-coating layers over said protective layer, each soft coating layer comprises gum base powder; wherein the protective layer comprises water-insoluble cellulose based polymers, preferably ethyl cellulose based polymer.

The present invention relates to a delayed-release pharmaceutical composition comprising an active ingredient prednisone and one or more pharmaceutical excipient(s). The invention further relates to a process for preparation of said pharmaceutical composition for oral administration, particularly a tablet, comprising prednisone with one or more pharmaceutically acceptable excipient(s), wherein the tablet is formulated using a coating technique which has a significant impact on drug release.

Sustained release pharmaceutical dosage forms include a core containing at least one swellable, water soluble, pH independent polymer and a first water insoluble, pH independent polymer, and a permeable membrane coat containing a swellable, water soluble, pH independent polymer and a second water insoluble, pH independent polymer. The sustained release pharmaceutical dosage forms are free of osmagens and/or diluents and demonstrate similar release characteristics as compared to known sustained release formulations that contain osmagens and/or diluents. Additionally, the release profile for the sustained release pharmaceutical dosage forms is resistant to dose dumping in the presence of alcohol.

Described herein are cholix-IL-10 fusion proteins, and methods of use thereof, which can be characterized by a distinct response in an individual when administered. This distinct response can comprise changes in levels of one or more markers in the individual and/or co-localization of IL-10 in the Lamina propria of the individual. Further described herein, in some embodiments, are oral formulations of the cholix-IL-10 fusion proteins. Described herein are methods for the purification of an IL-10 delivery construct, including methods for refolding and enrichment, which can result in maintenance of a high percentage of the IL-10 delivery constructs in the biologically active dimer form. Described herein are oral formulations configured for site-specific release of a therapeutic protein in the small intestines or colon. In some cases, the therapeutic protein is in the form of a dimer, such as an IL-10 delivery construct capable of crossing the gut epithelium.

Described are immediate release oral dosage forms that contain abuse-deterrent features. In particular, the disclosed dosage forms provide deterrence of abuse by ingestion of multiple individual doses. In addition, the disclosed dosage forms provide protection from overdose in the event of accidental or intentional ingestion of multiple individual doses.

The present invention provides for a formulation comprising an active alkaline phosphatase (AP)-based agent and an enteric agent, wherein the formulation is suitable for releasing a substantial amount of the active AP-based agent in the intestines.

The present disclosure provides pharmaceutical compositions comprising cytidine analogs for oral administration, wherein the compositions release the cytidine analog substantially in the stomach. Also provided are methods of treating diseases and disorders using the oral formulations provided herein.