Abstract: The present disclosure relates to methods for treating intestinal diseases presenting at least one inflammatory component such as inflammatory bowel disease or diverticular disease and/or maintaining remission of intestinal diseases presenting at least one inflammatory component such as inflammatory bowel disease (IBD) or diverticular disease using budesonide MMX compositions.

Abstract: An oral pharmaceutical composition in unit dosage form comprising: (1) a first portion comprising: an active ingredient and a pH-dependent component, and (2) a second portion comprising a pH-raising agent is provided. Methods of administering the composition are also provided.

Abstract: Controlled release and taste masking compositions containing one or more active principles inglobated in a three-component matrix structure, i.e. a structure formed by successive amphiphilic, lipophilic or inert matrices and finally inglobated or dispersed in hydrophilic matrices. The use of a plurality of systems for the control of the dissolution of the active ingredient modulates the dissolution rate of the active ingredient in aqueous and/or biological fluids, thereby controlling the release kinetics in the gastrointestinal tract.

Abstract: The present invention relates to pharmaceutical compositions containing a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide including formulations of the solid dispersions into powders, granules and mini-tablets, methods for manufacturing and processing the powders and mini-tablets and methods for treating cystic fibrosis employing the pharmaceutical composition.

Abstract: Disclosed is a misuse preventative, controlled release composition in the form of a multilayered oral dosage form. A first layer contains a plurality of controlled release microparticles having a pharmaceutically active agent (for example, an opioid analgesic) disposed therein. A second layer comprises a pharmaceutically active agent that can be the same or different from the pharmaceutically active agent in the microparticles. The composition further comprises a superabsorbent material disposed within the first layer, the second layer, or both the first layer and the second layer. When crushed, either intentionally or accidentally, and exposed to an aqueous medium, the superabsorbent material swells to encapsulate the microparticles, which remain substantially intact thereby retarding the release of the pharmaceutically active agent from the composition.

Abstract: Oral insulin formulations and processes for preparing oral insulin formulations are provided.

Abstract: Disclosed is a misuse preventative, controlled release composition in the form of a multilayered oral dosage form. A first layer contains a plurality of controlled release microparticles having a pharmaceutically active agent (for example, an opioid analgesic) disposed therein. A second layer comprises a superabsorbent material. When crushed, either intentionally or accidentally, and exposed to an aqueous medium, the superabsorbent material creates a hard gel that traps the microparticles. The hard gel and microparticles provide controlled release of the pharmaceutically active agent.

Abstract: This invention relates to pharmaceutical dosage forms, particularly to pH dependent pharmaceutical dosage forms with enhanced and/or prolonged distribution of a pharmaceutical compound at a target site. More specifically, this invention relates to a controlled release intravaginal pharmaceutical dosage form and, more particularly, to a pharmaceutical dosage form which comprises microspheres encapsulated and/or embedded within a bioerodible polymeric matrix, together the microspheres and the matrix are formed into a caplet and/or tablet.

Abstract: The present invention relates to a combined pharmaceutical formulation having therapeutic anti-inflammatory, analgesic, antipyretic and osteoarthritis activities. From another perspective, the present invention relates to a new solid oral dosage form comprising a pharmaceutically effective amount of NSAID and a pharmaceutically effective amount of diacerein and the solid oral dosage form according to the present invention is preferably in the form of tablet and more preferably in the form of multi-layer tablet.

Abstract: Highly compactable granulations and methods for preparing highly compactable granulations are disclosed. More particularly, highly compactable calcium carbonate granulations are disclosed. The granulations comprise powdered materials such as calcium carbonate that have small median particle sizes. The disclosed granulations are useful in pharmaceutical and nutraceutical tableting and provide smaller tablet sizes upon compression than previously available.

Abstract: The invention relates to oral pharmaceutical compositions containing flibanserin, methods for the preparation thereof and use thereof as a medicament.

Abstract: Disclosed is a misuse preventative, controlled release formulation comprising a core comprising a superabsorbent material (for example, polycarbophil), a controlled release coat surrounding the core, and a plurality of controlled release microparticles having a pharmaceutically active agent (for example, an opioid analgesic) disposed within the core, the coat, or both the core and the coat. When crushed, either intentionally or accidentally, and exposed to an aqueous medium, the superabsorbent material present in the coreswells to encapsulate the microparticles, which remain substantially intact thereby retarding the release of the pharmaceutically active agent from the formulation. Also disclosed is a method of using the misuse preventative, controlled release formulation to deliver a pharmaceutically active agent to a mammal, for example, a human, in need thereof.

Abstract: A paliperidone double-layered osmotic pump controlled release tablet and the preparation method thereof are disclosed. The double-layered osmotic pump controlled release tablet comprises a rigid membrane, a push layer, a drug layer, an isolation layer and an aesthetic coating, wherein the rigid membrane contains a semi-permeable polymer, a porogen and/or a plasticizer and has one or more drug release orifices on one end, the push layer comprises an expanding material, an osmotic agent, a binder, a colorant and a lubricant, the drug layer contains a pharmaceutically active ingredient, a hydrophilic polymer, an osmotic agent, a colorant, a lubricant and an antistatic agent, the isolation layer is located between the inner surface of the rigid membrane and the push layer, and contains a hydrophilic polymer. The paliperidone double-layered osmotic pump controlled release tablet shows an increasing drug release rate at early stage and keeps a constant drug release rate at later stage.

Abstract: Disclosed is a misuse preventative, controlled release formulation comprising a core comprising a first layer and a second layer. The core comprises a superabsorbent material (for example, polycarbophil), and a plurality of controlled release microparticles having a pharmaceutically active agent (for example, an opioid analgesic) disposed within the core. When crushed, either intentionally or accidentally, and exposed to an aqueous medium, the superabsorbent material present in the core swells to create a hard gel that traps the microparticles. The hard gel and microparticles provide controlled release of the pharmaceutically active agent. Also disclosed is a method of using the misuse preventative, controlled release formulation to deliver a pharmaceutically active agent to a mammal, for example, a human, in need thereof.

Abstract: The present invention relates to an in-situ multilayered tablet comprising at least one polymer layers and at least one drug layers wherein the said layers are physically separated from each other. After coming in contact with biological and/or aqueous fluids at least one of the polymer layers rapidly swells and sticks to one or more drug layers to form an in-situ multilayered tablet. Further, the polymer layer may optionally comprise a drug. Furthermore, the present invention relates to the processes for preparing said in-situ multilayered tablets.

Abstract: Provided are an extended release preparation for oral administration of bosentan including bosentan, a pharmaceutically acceptable salt thereof or a solvate thereof as an active ingredient and a hydrophilic polymer as a sustained release excipient, and a method of manufacturing the same. Accordingly, the number of administrations of the bosentan, a pharmaceutically acceptable salt thereof or a solvate thereof may be reduced, thereby enhancing ease of administration and patient compliance. In addition, the extended release preparation for oral administration of bosentan may be effectively manufactured.

Abstract: A controlled release pharmaceutical compositions comprising Milnacipran or pharmaceutically acceptable salts thereof is provided. The pharmaceutical composition comprises an immediate release core comprising Milnacipran or pharmaceutically acceptable salts thereof, pharmaceutically acceptable excipients and a coating on the immediate release core comprising rate controlling agents.

Abstract: The present invention relates to pharmaceutical formulations comprising at least one acid-labile proton pump inhibiting agent and at least one antacid, which have improved bioavailability, chemical stability, physical stability, dissolution profiles, disintegration times, safety, as well as other improved pharmacokinetic, pharmacodynamic, chemical and/or physical properties. The present invention is directed to methods, kits, combinations, and compositions for treating, preventing or reducing the risk of developing a gastrointestinal disorder or disease, or the symptoms associated with, or related to, a gastrointestinal disorder or disease in a subject in need thereof.

Abstract: A pre-compacted materiel comprising one or more calcium-containing compounds and one or more sugar alcohols, wherein the calcium-containing compound having a polycrystallic porous structure. The pre-compacted material is preferably obtained by roller compaction and is suitable for use in the further processing of the pre-compacted material into composition like e.g. tablets.

Abstract: Improved oral dosage forms of methyl hydrogen fumarate and prodrugs thereof are disclosed. Methods of treating diseases such as multiple sclerosis and psoriasis using such dosage forms are also disclosed.

Abstract: Improved oral dosage forms of methyl hydrogen fumarate and prodrugs thereof are disclosed. Methods of treating diseases such as multiple sclerosis and psoriasis using such dosage forms are also disclosed.

Abstract: The present invention relates to pharmaceutical compositions of lurasidone or salts thereof. In particular, the invention relates to pharmaceutical compositions of lurasidone or salts thereof with one or more water-insoluble pharmaceutical excipients. The invention also relates to processes for the preparation of such compositions and use thereof for treatment of schizophrenia, bipolar disorders or senile dementia.

Abstract: [Problem to solve] To provide an excipient for compressed tablets capable of diluting active components in the industries of foodstuffs, medicines, etc. applicable to various tablets like disintegrating agents, troches, etc., largely avoiding the conventional compressing troubles about mannitol like capping, sticking, etc., thereby assuring a high tablet hardness. [Means to solve the problem] An excipient for compressed tablets characterized in that it comprises spherical particles of crystalline mannitol having an aspect ratio of 1.0 to 1.2 and according to Test A, absorption rate 1 of 25 to 60% and absorption rate 2 of 15 to 40%.

Abstract: There is provided a single unit oral dose pharmaceutical composition comprising a) levodopa or salts thereof from about 50 mg to about 300 mg in extended release form, b) carbidopa or salts thereof from about 10 mg to about 100 mg in extended release and c) entacapone or salts thereof from about 100 mg to about 1000 mg in immediate release form, optionally with other pharmaceutically acceptable excipients. The invention also relates to process of preparation of such compositions.

Abstract: Controlled release and taste masking compositions containing one or more active principles inglobated in a three-component matrix structure, i.e. a structure formed by successive amphiphilic, lipophilic or inert matrices and finally inglobated or dispersed in hydrophilic matrices. The use of a plurality of systems for the control of the dissolution of the active ingredient modulates the dissolution rate of the active ingredient in aqueous and/or biological fluids, thereby controlling the release kinetics in the gastrointestinal tract.

Abstract: Dosing regimens, methods of treatment, controlled release formulations, and combination therapies that include bendamustine, or a pharmaceutically acceptable salt thereof and an HDAC inhibitor, or a pharmaceutically acceptable salt thereof, are described.

Abstract: Pharmaceutical dosage forms, particularly dosage forms in granular form having good palatability and capable of rapidly and completely dispersed in the mouth when orally administered.

Abstract: Controlled release oral dosage formulations containing calcium channel blocker and processes for preparation thereof, are provided for once a day treatment. The active agent is preferably a dihydropyridine calcium channel blocker, such as nisoldipine. In one embodiment, the formulation provides controlled release of micronized nisoldipine with one or more pH independent release controlling polymers. The controlled release matrix formulation is advantageous and can be prepared by a simple, economically viable process as compared to complex core-coat prior-art versions.

Abstract: Disclosed are novel pharmaceutical compositions containing 3?-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2?-hydroxy-[1,1?-biphenyl]-3-carboxylic acid bis-(monoethanolamine) (eltrombopag olamine) and processes for preparing the same.

Abstract: The present invention relates to a novel biocide composition for use in gravity fed water purification devices and suitable for purifying water for drinking purposes and a process for preparing the novel biocide composition. The biocide tablet composition comprises one or more halogenated 5,5-dialkylhydantoin compound; a chlorine biocide compound selected from trichloroisocyanuric acid (TCCA) or sodium dichloroisocyanurate (NaDCC) or mixtures thereof; 0.1-1.0% water soluble boron containing compound; wherein the ratio between the halogenated 5,5-dialkylhydantoin compound and chlorine biocide compound is in the range 85:15 to 65:35 and the average particle size of the halogenated 5,5-dialkylhydantoin compound and chlorine biocide compound is in the range 400 to 1200 microns.

Abstract: The present invention relates to a pharmaceutical composition for direct oral administration which is very easy to swallow especially for young children, comprising at least one pharmaceutically active compound. The pharmaceutical composition is present in the form of one or more particles. The particles comprise a core containing the active ingredient which has been provided with one or more coatings. The pharmaceutical composition is preferably administered in combination with a powder and/or granules which, when applied to the tongue, spontaneously generate additional saliva. With the extra saliva, the coated particles form a soft, smooth, but mechanically stable surface perceived as pleasant in the mouth within seconds so that they may be swallowed easily and practically in the right quantity with the extra saliva formed.

Abstract: A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.

Abstract: The present invention relates to metformin extended release (XR) formulations with improved compactability to provide reduced mass tablets, granulations, and capsules.

Abstract: Oral pharmaceutical formulations containing ditosylate salts of 4-quinazolineamines are described as well as methods of using the same in the treatment of disorders characterized by aberrant erbB family PTK activity.

Abstract: An extended release tablet formulation comprising pramipexole or a pharmaceutically acceptable salt thereof in a matrix comprising at least one water swelling polymer other than pregelatinized starch.

Abstract: The present invention provides a dry-coated tablet comprising: an inner core containing, as active ingredients, (a) tegafur, (b) gimeracil, and (c) oteracil potassium; and an outer shell.

Abstract: The present invention relates to a delayed release pharmaceutical composition containing doxylamine succinate and pyridoxine HCl for treatment of nausea and vomiting during pregnancy. More specifically, the present invention concerns a disintegrant-free delayed release pharmaceutical composition for oral administration comprising a core and an enteric coating, wherein said core comprising: a) at least one pharmaceutically active ingredient, and b) at least one pharmaceutically acceptable excipient, wherein said composition provides an in vitro drug release profile of about 80% of active ingredient dissolved within 20 minutes as measured by USP Type II apparatus and also a manufacturing process of said pharmaceutical composition.

Abstract: Acid-containing oral pharmaceutical compositions are provided wherein the pharmaceutical active agents are peptide compounds (i.e., those that include a plurality of amino acids and at least one peptide bond in their molecular structures). Certain barrier layers and/or particulate coated acid are used to reduce any adverse interactions that might otherwise occur between the acid of the compositions and other components of the composition. Use of these barrier layers and/or use of particulate coated acid is believed to promote a more simultaneous release of the components of the composition than is achieved by prior art acid-protection techniques, thus enhancing, and making more consistent, the bioavailability of the active peptide compounds.

Abstract: The present invention relates to pharmaceutical compositions containing a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide including formulations of the solid dispersions into powders, granules and mini-tablets, methods for manufacturing and processing the powders, granules and mini-tablets, and methods for treating cystic fibrosis employing the pharmaceutical composition.

Abstract: [Summary] [Problems] To provide extremely-spherical-three-dimensional-shaped particles of crystalline mannitol containing large hollows and gaps inside. [Solution] Spherical particles of crystalline mannitol made by spray drying, extremely spherical (having an aspect ratio of 1.0 to 1.2), high oil absorption rates according to test method A, wherein powder has a mean particle diameter of 15 to 165 ?m, a loose bulk density of 0.35 to 0.60 and an angle of repose of 30 to 50 degrees, and has a hardness of 7 to 20 kgf, when directly compressed.

Abstract: A tablet comprising a core containing an active agent, and a coating, the core being disposed within the coating such that the coating has a thickness about a longitudinal axis (X-Y) of about 4.85 to 4.95 mm. The position of the core within the coating dictating that the active agent is released rapidly after a lag time during which time no active agent is released.

Abstract: The present invention relates to oral controlled-release formulations of 5-(pyridinyl)-2(1H)-pyridinone compounds and their use in the treatment of a subject with heart failure, a stage, class or manifestation of heart failure, or at risk of developing or exhibiting symptoms of heart failure. The formulations of the invention release the compounds in the range of between 0.1 ?g/kg body weight/minute and 20 ?g/kg body weight/minute.

Abstract: Provided are tablet binding compositions for binding cleaning and/or disinfecting formulation components into tablets. The tablet binding compositions are suitable replacements for traditional tablet binder compounds, such as boric acid or zeolites. The tablet binding compositions provided herein can produce tablets of increased hardness at lower compression forces and, when dissolved, yield solutions of increased clarity compared to some traditional binder compounds. Also provided are processes for preparing the tablet binding compositions and methods for formation of tablets containing the tablet binding compositions.

Abstract: Provided herein is a pharmaceutical composition comprising an antagonist, an agonist, a seal coat, and a sequestering polymer, wherein the antagonist, agonist, seal coat and at least one sequestering polymer are all components of a single unit, and wherein the seal coat forms a layer physically separating the antagonist from the agonist from one another. Methods for manufacturing such a pharmaceutical composition are also provided.

Abstract: A novel approach for emesis control in cancer patients undergoing chemotherapy using pharmaceutical formulations comprising a chemotherapeutic agent and anti-emetic agent(s) in combination with different and optimized release profiles is disclosed.

Abstract: The invention relates to pharmaceutical compositions comprising rivaroxaban, suitable for immediate release, and processes of preparing such compositions, preferably by a melt-granulation process or by a specific direct-compression process.

Abstract: The invention relates to an oral pharmaceutical composition in the form of a sustained-release tablet comprising an active ingredient capable of being misused, which composition makes it possible to combat misuse by injection.

Abstract: Pharmaceutical compositions of a H2 receptor antagonist and ibuprofen are provided herein. The compositions comprise, e.g., a core and a shell separated by a barrier layer, bilayered or trilayered compositions, or liquid formulations. Also provided are methods of making the pharmaceutical compositions, and methods of treatment comprising administering the pharmaceutical compositions.

Abstract: The present invention deals with extended release pharmaceutical compositions comprising tolterodine, wherein the composition comprises: a) a drug layer comprising tolterodine tartrate, monosaccharide and/or disaccharide on an inert core; or a drug core comprising tolterodine tartrate, monosaccharide and/or disaccharide; and b) a polymer layer comprising extended release polymer(s). The invention also provides a process for the preparation of the above mentioned composition.

Abstract: Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.