The present invention relates to a stable pharmaceutical composition comprising an omeprazole, an enantiomer thereof or a pharmaceutically acceptable salt thereof, and sodium bicarbonate. Specifically, the present invention relates to a pharmaceutical composition having improved stability, which includes a low content of sodium bicarbonate and has excellent dissolution rate and bioavailability and a reduced side effect due to a high content of sodium bicarbonate.

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.

Provided are a tablet and a method for producing the tablet, in particular, a technique for tablet production whereby the amount of an active ingredient to be contained in the tablet can be stably regulated without the need of a huge cost for the production. The tablet of the present invention is one obtained by compacting a mixture comprising a granulating composition including a medicinal ingredient or a biofunctional ingredient, and includes a first region, which comprises a binder including the medicinal ingredient or biofunctional ingredient, and a second region, which is adjacent to the first region and comprises the binder including the medicinal ingredient or biofunctional ingredient. The medicinal ingredient or biofunctional ingredient contained in each of the first region and second region is included in the binder, not in the form of a layer but in the state of having been dispersed or dissolved.

Disclosed is a pharmaceutical preparation in the form of granules having nuclear particles and a coating layer coating the nuclear particles, wherein the nuclear particles are composed of a drug, a first nuclear-particle component, a second nuclear-particle component and a surfactant; the drug is an aniline derivative represented by the following general formula (I):

##STR00001##

wherein W represents S or O,
or a pharmaceutically acceptable salt thereof, or a hydrate thereof; the first nuclear-particle component is at least one crystalline cellulose having a shape selected from a needle-shape and a substantially columnar shape; and the second nuclear-particle component is at least one pharmaceutically acceptable additive having a substantially spherical shape. The pharmaceutical preparation can contain a therapeutically effective amount of a poorly water-soluble drug (CDK9 inhibitor) and has excellent flowability sufficient for practical production.

This disclosure provides pharmaceutical compositions comprising atomoxetine, a pharmaceutically acceptable salt of atomoxetine, or a combination thereof, that can be administered to a human subject in need thereof. The disclosure also provides pharmaceutical compositions for the treatment of orthostatic hypotension.

A pellet contains a core, which contains one or more biologically active ingredients, and a coating layer on the core. The coating layer contains a mixture of a first polymer and a second polymer. The first polymer is a core-shell polymer, containing 50 to 90% by weight of a core, containing polymerized units of 60 to 85% by weight of ethyl acrylate and 20 to 40% by weight of methyl methacrylate; and 10 to 50% by weight of a shell, containing polymerized units of 40 to 60% by weight ethyl acrylate and 40 to 60% by weight methacrylic acid. The second polymer contains polymerized units of 40 to 60% by weight of methacrylic acid and 60 to 40% by weight of ethyl acrylate or methyl methacrylate. A Multi-Unit Pellet System (MUPS), preferably a compressed tablet, contains a multitude of the pellets.

Oral cannabinoid pharmaceutical compositions and methods of treating sleep disorders using the oral cannabinoid pharmaceutical compositions are described.

A method for the preparation of a composition includes dispersing particulate pimobendan in a molten carrier matrix to form particles coated with the carrier matrix, where the molten carrier matrix includes one or more pharmaceutically acceptable carriers selected from a polyglycolized glyceride, a polyethylene glycol, and combinations thereof, atomizing the dispersion of coated particles, and cooling and collecting the coated particles from the atomized dispersion.

Disclosed herein are immediate release oral dosage forms that contain abuse-deterrent and abuse-resistant features. In particular, the disclosed dosage forms can provide deterrence of abuse by ingestion of multiple individual doses. The disclosed dosage forms can likewise provide protection from overdose in the event of accidental or intentional ingestion of multiple individual doses. The dosage forms may also exhibit abuse resistant properties when physically manipulated, and also when physically manipulated and then administered in a manner not consistent with oral dosing. The dosage forms may also exhibit abuse resistant properties when administered in a manner intended to result in administration of the esketamine in a higher than therapeutic dose.

An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.