Provided herein are methods of treating or ameliorating a pediatric cholestatic liver disease by non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTI) or a pharmaceutically acceptable salt thereof. Also provided are methods for treating or ameliorating a pediatric liver disease, decreasing the levels of serum bile acids or hepatic bile acids, treating or ameliorating pruritis, reducing liver enzymes, or reducing bilirubin comprising non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an ASBTI or a pharmaceutically acceptable salt thereof.

The present invention relates to controlled release pharmaceutical compositions comprising fumaric acid ester(s) as active substance(s). The compositions are suitable for use in the treatment of e.g. psoriasis or other hyperproliferative, inflammatory or autoimmune disorders and are designated to release the fumaric acid ester in a controlled manner so that local high concentrations of the active substance within the gastrointestinal tract upon oral administration can be avoided and, thereby, enabling a reduction in gastro-intestinal related side-effects.

The present invention provides formulations of (E)-6-(4-Phenylcyclohexyl)-5-(3-trifluoromethylbenzyl)-1H-pyrimidine-2,4-dione, and methods of making and using the same.

Disclosed are once-daily formulations containing tetracyclines, especially doxycycline. Such formulations are useful, for instance, for the treatment of collagenase destructive enzyme-dependent diseases, such as periodontal disease and acne, and acute and chronic inflammatory disease states, such as rosacea and arthritis.

The present invention relates to siponimod (BAF312) for use in the treatment of an autoimmune disease, wherein an immediate release dosage form is administered once daily to a patient as maintenance regimen and wherein the patient has experienced a specific titration regimen with siponimod beforehand.

The present disclosure is directed to chemical compounds and to the use of such compounds in the treatment of diseases associated with a serotonin 5-HT.sub.2 receptor.

The disclosed technology provides improved drug compositions that provide increased stability, higher drug loading potential, and suitable drug dissolution properties, and methods of making the same. The composition include: (a) a drug component comprising a therapeutically effective amount of a drug; (b) an extended release component comprising a cross-linked polyacrylic acid polymer that is a carbomer homopolymer, carbomer copolymer, carbomer interpolymer, polycarbophil or a mixture thereof; and (c) a buffering component comprising a magnesium containing buffering agent; wherein the drug component makes up at least 50% by weight of the composition.

The present invention relates to solid oral controlled-release pharmaceutical compositions comprising a core consisting of a complex monolithic matrix comprising at least one low/medium viscosity hydroxypropyl methylcellulose, at least one medium/high viscosity hydroxypropyl methylcellulose, one or more methacrylic polymers or copolymers and/or cellulose acetate phthalate and/or hydroxypropyl methylcellulose acetate succinate or shellac, and an outer coating of said core consisting of a layer comprising ethylcellulose, or of a gastroresistant layer or of a layer comprising ethylcellulose coated in turn with gastroresistant polymers.

Disclosed are an acid-resistant pharmaceutical composition including tamsulosin hydrochloride, and a method of preparing the same. The pharmaceutical composition is formulated into tablets by preparing core beads including tamsulosin hydrochloride as an active ingredient, coating the core beads with an entering coating solution including a specific amount of plasticizer, adding a post mixture portion including a buffer to adjust density and a lubricant to the enteric-coated core beads, and performing tableting. The enteric coating layer is not broken during the tableting process. Thus, the acid resistance of the pharmaceutical composition is maintained. The pharmaceutical composition can be easily formulated into tablets, ensures good uniformity of dosage unit, lowers dissolution rate of tamsulosin hydrochloride, has good acid resistance, and is stable not to exhibit signification decomposition of tamsulosin hydrochloride.

Disclosed herein are compounds of formula I and salts thereof. Also disclosed are compositions comprising compounds of formula I and methods using compounds of formula I. ##STR00001##