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.

An implantable medical device includes a body that has a flexible outer layer encapsulating a composition. The composition includes one or more first microspheres, one or more second microspheres, and a carrier. Each first microsphere includes a first therapeutic agent and a wall containing a first biodegradable polymer that encapsulates the first therapeutic agent. Each second microsphere includes a second therapeutic agent and a wall containing a biodegradable polymer that encapsulates the second therapeutic agent.

The present invention relates to a monolayer tablet for use in the treatment of tuberculosis comprising a mixture of: —granules comprising isoniazid, pyrazinamide, ethambutol or a pharmaceutically acceptable salt thereof and at least one granulation binder, —rifampicin in powder form, —extragranular excipients, wherein all of the granules have a particle size that is less than 0.599 mm, preferably less than 0.5 mm, more preferably less than 0.422 mm, and to its process of preparation.

A method of forming an erodible sustained release tablet comprising the steps of:—a. mixing one or more therapeutic agents, one or more disintegrant and one or more molten wax, whilst retaining the wax in molten form; b. solidifying and granulating the mixture; c. forming a tablet by compression of the granules. The invention also relates to a sustained release tablet made according to the method.

Disclosed are pharmaceutical particulates which release a pharmaceutical compound into the colon following oral administration. A particulate comprises a core comprising a pharmaceutical compound, an inner coating surrounding the core, wherein the inner coating comprises a pharmaceutically acceptable polysaccharide that is susceptible to enzymatic digestion by one or more enzymes present colonic microflora, and an outer coating surrounding the inner coating, wherein the outer coating comprises a polymer which is stable at upper gastrointestinal pH but can dissolve at colon luminal pH in less than about 60 minutes. The core of a particulate can further comprise an excipient such as a diluent, a binder, a disintegrant, a lubricant, a glidant or a combination thereof. Particulates can comprise pharmaceutical compounds for treating colonic diseases such as C. difficile colitis, ulcerative colitis, and Crohn's disease.

The present invention relates to a pharmaceutical preparation comprising omeprazole, an enantiomer thereof or a pharmaceutically acceptable salt thereof, and sodium bicarbonate, and a method for preparing the same. Specifically, the present invention relates to a pharmaceutical preparation in which sodium bicarbonate is first disintegrated so as to raise pH, and then omeprazole is dissolved such that the release properties of an active ingredient are improved, and thus the dissolution pattern and bioavailability of a drug can be enhanced.

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.

A method of making an L-menthol dosage form includes forming a wet granulation including an L-menthol source and at least one pharmaceutical excipient. The wet granulation is extruded into an extrudate and the extrudate is cut into individual core pieces. The individual core pieces are spheronized into individual spheronized cores and the individual spheronized cores are dried to form dried individual spheronized cores. The dried individual spheronized cores are spray coated with a liquid proteinaceous material that forms a film of a proteinaceous material over the dried individual spheronized cores. The film of proteinaceous material is dried over the dried individual spheronized cores to form individual subcoated cores. An enteric coating is applied and dried over the individual subcoated cores to form a plurality of individual enteric coated cores.

The present invention relates to an oral dosage form for administration of ketamine and a method of preparing an oral dosage form for administration of ketamine, preferably once or twice a day.

The present invention relates to a technical field of pharmaceutical preparation, in particular to a preparation method of naltrexone implants, including the following steps: (1) dissolving naltrexone and polylactic acid in an organic solvent to form naltrexone microspheres, and drying; (2) placing the naltrexone microspheres in a heated tableting mold for tableting, and obtaining naltrexone implant tablets; (3) dissolving the polylactic acid in the organic solvent to obtain a coating solution, and placing the coating solution in a coating pool, and then immersing the naltrexone implant tablets in the coating solution, and drying in a suspended state.