An orally administrable drug powder composition which forms a gastro-retentive RAFT having at least two trigger pulses is provided. The composition contains, at a minimum, (a) at least one drug in an immediate release pulse release form; (b) at least one drug in a delayed trigger release form; (c) at least one non-toxic gas generating agent and (d) a RAFT system, wherein following oral ingestion, the composition provides a self-assembling gastro-retentive RAFT having entrapped therein, the at least one drug of (a) and (b) and the gas generated in situ by the non-toxic gas generating agent, thereby providing a floating gastro-retentive RAFT having a dual pulse system wherein at least the second pulse is a trigger pulse and which retains the at least one drug in the stomach for at least about 3 hours, provided that the composition does not include a gamma hydroxybutyrate and its salts, hydrates, tautomers, or solvates, or complexes thereof.

Disclosed are compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of amantadine. Methods of administering the same are also provided.

The present invention relates to the field of pharmacy, particularly to a pharmaceutical composition for oral administration comprising an (a) inert substrate and a (b) mixture comprising a non-bile acid farnesoid X receptor (FXR) agonist, such as 2-[(1R,3r,5S)-3-({5-cyclopropyl-3-[2-(trifluoromethoxy)phenyl]-1,2-oxazol-4-yl}methoxy)-8-azabicyclo[3.2.1]octan-8-yl]-4-fluoro-1,3-benzothiazole-6-carboxylic acid, or a pharmaceutically acceptable salt thereof, and at least one binder. The present invention also relates to a process for preparing said pharmaceutical composition for oral administration; and to the use of said pharmaceutical composition in the manufacture of a medicament.

A method for treating an autoimmune neurological disease and/or a neurodegenerative disease is provided. The method includes administering an effective amount of at least one compound having Formula (I), Formula (II) or Formula (III), or its geometric isomer, enantiomer or diastereomer to a subject in need thereof: ##STR00001##
wherein is a single or double bond, X is NCH.sub.3 or CH.sub.2, Y is null, O or N, Z is O or N, R.sub.1 is H, OH, and R.sub.2 is null, H, C.sub.1-C.sub.8 alkyl, —(C═O)-alkyl, —(C═O)-aryl, —(C═O)-alkyl-aryl, —(C═O)-heteroaryl, cycloalkyl or heterocycloalkyl, which optionally substituted by one or more of —OH, —NO.sub.2, —NH.sub.2, —NR.sub.3R.sub.4, carbonyl, alkoxyl, alkyl or —OCF.sub.3, wherein R.sub.3 and R.sub.4 independently are H, alkyl, —SO.sub.2CH.sub.3, —(C═O)—CH.sub.3 or —(C═O)—NH.sub.2.

This wet coating agent for fine particles comprises a latex including particles that comprises a (meth)acrylate copolymer and have a 50% diameter of 10 nm to 150 nm in a volume-based particle size distribution, said (meth)acrylate copolymer being obtained by including a monomer unit derived from ethyl acrylate, a monomer unit derived from methyl methacrylate, and a monomer unit derived from 2-hydroxyethyl methacrylate.

The present disclosure relates to modified release formulations of 2-methyl-2-(3-methyl-4-(4-(methylamino)-5-(trifluoromethyl)pyrimidin-2-ylamino)-IH-pyrazol-1-propanenitrile or solvates, tautomers, and pharmaceutically acceptable salts thereof, and methods of treatment with the modified release formulations.

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 pharmaceutical compositions of sodium oxybate having improved pharmacokinetic properties when administered less than two hours after eating are provided, and therapeutic uses thereof.