Provided herein are fixed-dose combination formulations of a pharmaceutically effective amount of eflornithine together with a pharmaceutically effective amount of sulindac. Also provided are methods of use and of methods of manufacture of these formulations.

An orally administered solid dosage form drug for treating cancers, tumors or cell proliferative disorders contains a compound of the following structural formula I or II.

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In exemplary embodiments, the disclosure provides a Colesevelam Colon Specific Drug Delivery System for use in treatment of, for example, cholestasis and/or cholestatic pruritus.

The present disclosure provides a modified-release pharmaceutical composition comprising 4-[(7-methoxy-2,3-dihydro-1,4-benzothiazepin-4(5H)yl)methyl]benzoic acid hemifumarate, and a pharmaceutically-acceptable excipient. The present disclosure methods of treating conditions associated with RyRs, including, for example, cardiac disorder or disease, a musculoskeletal disorder or disease, cancer associated muscle weakness, malignant hyperthermia, and diabetes.

A method of treating diabetes Type 2 by delivery of butyric acid, bile acid, long-chain fatty acid, or glutamine to the colon by bypassing the upper digestive tract, with the composition combined either by the same or different route of administration with a DPP-IV inhibitor such as vildagliptin.

The present invention relates to pharmaceutical compositions comprising fixed dose combinations of a DPP-4 inhibitor drug and a partner drug, processes for the preparation thereof, and their use to treat certain diseases.

The present invention is related to the discovery of new oral dosage formulations and combination therapies for 1-(((2S,3S,4S)-3-ethyl-4-fluoro-5-oxopyrrolidin-2-yl)methoxy)-7-methoxyisoquinoline-6-carboxamide, or a pharmaceutically acceptable salt thereof, for treating conditions ameliorated by inhibition of IRAK4.

The present disclosure relates to a stable, reproducible and bioequivalent apixaban compositions, wherein the composition comprising apixaban having a D.sub.90 particle size of more than 100 microns, preferably between 300 and 1000 microns, and more preferably between 350 and 800 microns, and further comprising one or more pharmaceutically acceptable excipients. The present disclosure further provides a process for preparation of a pharmaceutical composition comprising apixaban by wet granulation.

The present invention relates to a composition/formulation for reducing uremic toxins, particularly protein bound uremic toxins in chronic kidney disease (CKD). More particularly, the pharmaceutical composition/formulation comprises a synergistic combination of Inulin and Betaine or their pharmaceutically acceptable salts for reducing protein bound uremic toxins. The present application also provides various compositions/formulations and process of preparing the same.

The invention provides ingestible particles comprising a water-swellable or water-soluble polymeric component, a lipid component, and optionally an amino acid, a vitamin and/or a micro-nutrient. The polymeric component may be embedded in the lipid component. The particle may further comprise an inert core and/or an outer layer which rapidly disintegrates after oral ingestion. The invention further provides methods for preparing the ingestible particles and uses thereof.