Abstract: This invention provides a method of treating a subject afflicted with multiple sclerosis or presenting a clinically isolated syndrome comprising administering to the subject laquinimod as an add-on therapy to or in combination with fingolimod. This invention also provides a package and a pharmaceutical composition comprising laquinimod and fingolimod for treating a subject afflicted with multiple sclerosis or presenting a clinically isolated syndrome. This invention also provides laquinimod for use as an add-on therapy or in combination with fingolimod in treating a subject afflicted with multiple sclerosis or presenting a clinically isolated syndrome. This invention further provides use of laquinimod and fingolimod in the preparation of a combination for treating a subject afflicted with multiple sclerosis or presenting a clinically isolated syndrome.

Abstract: The present invention relates to a process for the preparation of a solid, orally administrable pharmaceutical composition, comprising 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)-phenyl]-1,3-oxazolidin-5-yl}-methyl)-2-thiophenecarboxamide in hydrophilized form, and its use for the prophylaxis and/or treatment of diseases.

Abstract: A controlled Release Pharmaceutical composition comprising an effective amount of Pravastatin and Fenofibrate, characterised in that the difference, in absolute value, between the times of maximal concentration (Tmax) of Pravastatin and Fenofibric acid is not less than 1.5 hours upon administration with food to humans.

Abstract: Drugs are formulated as oral dosage forms for controlled release in which the release rate limiting portion is a shell surrounding the drug-containing core. The shell releases drug from the core by permitting diffusion of the drug from the core. The shell also motes gastric retention of the dosage form by swelling upon imbibition of gastric fluid to size that is retained in the stomach during the postprandial or fed mode.

Abstract: An orally administrable pharmaceutical pellet formulation for the treatment of the intestinal tract is disclosed, which comprises a core and an enteric coating, the core including, as a pharmaceutical active compound, aminosalicylic acid or a pharmaceutically tolerable salt or a derivative thereof.

Abstract: The present invention relates to an abuse-proofed oral dosage form with controlled release of (1R,2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol for once daily administration, which comprises the active ingredient and/or one or more of the pharmaceutically acceptable salts thereof (A), at least one synthetic or natural polymer (C), delayed-release auxiliary substances, optionally physiologically acceptable auxiliary substances (B) and optionally a wax (D), component (C) or (D) in each case exhibiting a breaking strength of at least 500 N, preferably of at least 1000 N.

Abstract: Compositions and methods are provided that enhance cognition in a human to which the composition is orally administered. Remarkably, clinical studies have proven that contemplated compositions achieved the desired effects using a minimal number of active ingredients at or near threshold active dosages, wherein such compositions almost exclusively comprise huperzine A, vinpocetine or rhodiola, and acetyl-L-carnitine, and optionally further include alpha lipoic acid, rhodiola, and biotin.

Abstract: The present invention relates to multi component composition of dronedarone or pharmaceutically acceptable salts, esters, metabolites, prodrugs or enantiomers thereof and controlled release polymers. The use of multi component composition of Dronedarone would improve the bioavailability and the patient compliance with reduction in number of dosages to be taken per day.

Abstract: The present invention concerns a pharmaceutical product to induce endogenous exacerbated release of gut hormones, pyy and glp1, with therapeutic effect on obesity and type 2 diabetes mellitus. In tablets form, suitable dosage forms such as pills capable of disintegration from a certain range of Ph or specific Ph range between 6.0 and 7.0, so that the undigested or partially hydrolyzed content is released in the distal jejunum and preferably in the ileum/proximal colon. And by contact with macro-nutrient molecules, or their hydrolyzed fragments, such cells suffer intense amplified stimulus and secrete the said hormones, released at rates that are therapeutics for obesity of any degree and also for type II diabetes; mimicking that produced and performed in bariatric and metabolic surgeries by a noninvasive method.

Abstract: The present invention provides a pharmaceutical composition for the prevention or treatment of glaucoma, wherein the pharmaceutical composition includes angiogenin or a fragment thereof as an active ingredient. Angiogenin or a fragment thereof according to the present invention activates aqueous humor outflow due to NO generation increase, Schlemm's canal expansion, and intercellular interval widening, thereby reducing intraocular pressure. Accordingly, angiogenin and a fragment may be useful for the prevention and treatment of glaucoma.

Abstract: The present invention relates to a method for treating muscular dystrophy which comprises administering diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl)-naphthalen-2-yl-methyl]-ammonium chloride or other pharmaceutically acceptable salts and/or solvates thereof to a patient in need of such a treatment. The invention further relates to a method for treating muscular dystrophy which comprises administering diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl)-naphthalen-2-yl-methyl]-ammonium chloride or other pharmaceutically acceptable salts and/or solvates thereof in combination with one or more additional anti-inflammatory active agents to a patient in need of such a treatment.

Abstract: The present disclosure is directed to a method for delivering a pharmaceutical composition to a patient in need thereof, comprising: administering to said patient a pharmaceutical composition in unit dose form comprising acetylsalicylic acid, or pharmaceutically acceptable salt thereof, and omeprazole, or pharmaceutically acceptable salt thereof.

Abstract: The present invention relates to oral pharmaceutical compositions with controlled and/or programmed release containing at least one active ingredient having antimicrobial and/or anti-infectious activity for the treatment of infections of the large intestine, in particular the colon.

Abstract: An L-menthol-containing multiparticulate formulation includes a plurality of individual enteric coated cores containing L-menthol from an at least 80% pure L-menthol source. The enteric coated cores are effective to release at least about 35% of the L-menthol within about two hours, and at least about 80% of the L-menthol within about eight hours after being placed in an environment having a pH of 5 to 8. The L-menthol multiparticulate formulation can be used to treat gastrointestinal disorders.

Abstract: A pharmaceutical formulation comprising an erosion matrix comprising one or more fumaric acid esters as well as one or more rate-controlling agents, wherein erosion of said erosion matrix permits controlled release of said fumaric acid ester(s).

Abstract: The present invention provides an FTD and TPI-containing orally administrable pharmaceutical composition which can be orally administered and is stable even under high-humidity conditions. An orally administrable pharmaceutical composition which comprises ?,?,?-trifluorothymidine and 5-chloro-6-(2-iminopyrrolidine-1-yl)methyl-2,4(1H,3H)-pyrimidine dione hydrochloride as active ingredients and additives having a critical relative humidity of 85% or more at 25° C. as an excipient.

Abstract: The present invention relates to a pharmaceutical formulation for oral administration for preventing or treating allergic rhinitis or asthma, which comprises: (a) a first particle part comprising levocetirizine or a pharmaceutically acceptable salt thereof and an organic acid; and (b) a second particle part comprising montelukast or a pharmaceutically acceptable salt thereof. The pharmaceutical formulation according to the present invention comprises an organic acid as a stabilizing agent, which can effectively inhibit the production of levocetirizine and montelukast related substances, and thus, show good stability.

Abstract: The present invention provides a new preparation which is a tablet containing (1) ferric citrate, (2) a polyvinyl alcohol-polyethylene glycol graft copolymer, and (3) a polyvinyl alcohol-acrylic acid-methyl methacrylate copolymer

Abstract: The invention relates to a tamper-resistant pharmaceutical dosage form comprising one or more particles, wherein each of said one or more particles comprises a pharmacologically active ingredient and a physiologically acceptable polymer; has a breaking strength of at least 300 N; has a weight of at least 2 mg; and optionally, comprises a film-coating; wherein the total weight of the pharmaceutical dosage form is greater than the total weight of said one or more particles.

Abstract: Provided herein are compositions of 7-(6-(2-hydroxypropan-2-yl)pyridin-3-yl)-1-((trans)-4-methoxycyclohexyl)-3,4-dihydropyrazino[2,3-b]pyrazin-2(1H)-one, solid forms, isotopologues and metabolites thereof, and methods of their use for the treatment of a disease, disorder, or condition.

Abstract: Coated dosage forms comprising a tablet core, preferably in compressed form, that has a coating over its exterior surface and one or more patterns debossed in the tablet surface are disclosed. Methods for manufacturing such dosage forms are also disclosed.

Abstract: This invention relates to novel purified compounds of Formula I. The invention includes all stereoisomeric forms and all tautomeric forms of the compounds of Formula I and pharmaceutically acceptable salts and derivatives. The present invention further relates to processes for the production of the novel antibacterial compounds by fermentation of the microorganism belonging to Streptomyces species (PM0626271/MTCC 5447) and to pharmaceutical compositions containing one or more of the novel compounds as active ingredient and their use in medicines for treatment and prevention of diseases caused by bacterial infections.

Abstract: The invention provides methods for treating multiple sclerosis by administering biotin. The invention also provides methods for treating sequelae after multiple sclerosis attacks by administering biotin.

Abstract: The present invention provides a solid immediate release dosage form adapted for oral administration of GHB. The solid immediate release dosage form includes an immediate release formulation comprising a relatively high weight-percentage of GHB with a bioavailability similar to that of a liquid GHB dosage form.

Abstract: The present invention refers to the treatment of asthma by administering a delayed-release dosage form of a glucocorticoid to a subject in need thereof.

Abstract: Disclosed herein are methods of treating or preventing pain. Typically, a pharmaceutical composition having a therapeutically effective amount of the zoledronic acid is administered to a mammal suffering from pain. The pharmaceutical composition may further comprise an enhancer, which can be a medium chain fatty acid salt, an ester, an ether, or a derivative of a medium chain fatty acid and can have a carbon chain length of from about 4 to about 20 carbon atoms.

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: A multiparticulate composition includes a plurality of individual enteric coated cores containing one or more terpene-based active ingredients and having a continuous proteinaceous subcoating layer covering the individual cores and separating the individual cores from their respective enteric coatings. The continuous proteinaceous subcoating layer prevents volatile terpene-based active ingredients from leaving the core, even when the core is heated during processing or stored for long periods above room temperature. The multiparticulate composition may be used to treat gastrointestinal disorders.

Abstract: The invention relates to a bilayer composition for the delivery of acetaminophen and tramadol over at least a twelve hour period following initial administration. A single administration of the bilayer composition can provide analgesia starting in less than half an hour to about one hour after initial administration with a duration of at least twelve hours after initial administration.

Abstract: A composition comprising at least one substance coated with an agent wherein the agent forms a liquid impermeable but gas permeable layer surrounding the said substance and preventing the passage of the said substance through said coating, wherein in-use the said substance is not released into solution in the body, and wherein said substance is selected from one or more of the group consisting of calcium phosphate, sodium chloride, potassium chloride, magnesium chloride, calcium carbonate, and sodium bicarbonate for use in the treatment of osteoporosis and other bone conditions.

Abstract: An extended-release topiramate capsule that includes a capsule shell containing a single population of coated particles; wherein each coated particle includes a core and a coating thereon; wherein each particle core includes a homogeneous mixture comprising topiramate throughout its core; and wherein the coating includes one or more release controlling agent(s).

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: Provided is a dry coated tablet showing high stability of the active ingredient (proton pump inhibitor, acetylsalicylic acid), which stably and rapidly expresses the pharmacological effect of the active ingredient after administration. A dry coated tablet having an inner core and an outer layer, wherein the inner core is an enteric-coated tablet containing acetylsalicylic acid, and the outer layer contains enteric micro granules containing a proton pump inhibitor.

Abstract: The present invention relates to micronized crystals of atorvastatin hemi-calcium, a method for the preparation of micronized crystals of atorvastatin hemi-calcium and a pharmaceutical dosage form comprising said micronized crystals of atorvastatin hemi-calcium.

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: Composition for use in treating bacterial infections, comprising a concentrate or an extract of origanum in combination with at least one concentrate or extract of another plant.

Abstract: The present invention relates to a formulation for the controlled release of active ingredients after the passage of the ileo-cecal-valve, comprising one or more active ingredients or one or more active ingredient containing cores (W), enveloped by one or more envelopments (C), which are dissoluble or permeable above an individual defined pH value and are dissoluble or permeable below another individual defined pH value, again enveloped by an envelopment (E), which is dissoluble or permeable above still another individual defined pH value.

Abstract: The present invention provides an immediate release pharmaceutical formulation which includes a tablet or capsule formulation comprising metformin and the sodium dependent glucose transporter (SGLT2) inhibitor dapagliflozin or its propylene glycol hydrate. The present invention also provides methods of preparing the formulations and methods of treating diseases or disorders associated with SGLT2 activity employing these formulations.

Abstract: Tablets are prepared with friability reducing agents to yield tablets that are more resistant to breakage or crumbling, but with satisfactory hardness. The friability reducing agents include low molecular weight polyethylene glycol as well as similar agents exhibiting at least three percent (3%) hydroxide moieties and a water solubility of at least eighty percent (80%) (w/w %) in room temperature water. The tablets may comprise an active agent and excipient of almost any type, and about 0.1-about 0.5% by weight friability reducing agent. They exhibit a hardness of at least eighty percent (80%) of the same tablet prepared without the friability reducing agent.

Abstract: The present invention provides engineered phenylalanine ammonia-lyase (PAL) polypeptides and compositions thereof, as well as polynucleotides encoding the engineered phenylalanine ammonia-lyase (PAL) polypeptides.

Abstract: The present invention is directed to drug dosage forms that release an agent that raises the pH of a patient's gastrointestinal tract, followed by a non-steroidal anti-inflammatory drug. The dosage form is designed so that the NSAID is not released until the intragastric pH has been raised to a safe level. The invention also encompasses methods of treating patients by administering this coordinated release, gastroprotective, antiarthritic/analgesic combination unit dosage form to achieve pain and symptom relief with a reduced risk of developing gastrointestinal damage such as ulcers, erosions and hemorrhages.

Abstract: The disclosed invention provides oral pharmaceutical formulations of an acid labile benzimidazole derivative comprising (a) a core comprising an acid labile benzimidazole derivative, (b) a seal coating layer, and (c) an enteric coating layer, wherein the core of the composition is devoid of any disintegrant.

Abstract: Disclosed herein are controlled-release oral pharmaceutical dosage forms comprising MGBG, and their application for the improved treatment of diseases with reduced side effects and/or longer time at maximum concentration.

Abstract: The present invention is directed to drug dosage forms that release an agent that raises the pH of a patient's gastrointestinal tract, followed by a non-steroidal anti-inflammatory drug. The dosage form is designed so that the NSAID is not released until the intragastric pH has been raised to a safe level. The invention also encompasses methods of treating patients by administering this coordinated release, gastroprotective, antiarthritic/analgesic combination unit dosage form to achieve pain and symptom relief with a reduced risk of developing gastrointestinal damage such as ulcers, erosions and hemorrhages.

Abstract: The invention relates to tablet comprising granules dispersed in at least one hydrophilic compound or matrix. The granules contain an active agent, at least one amphiphilic compound and at least one lipophilic compound. The tablet may include a gastro-resistant film coating.

Abstract: According to this invention, compositions and methods for increasing the extent of penetration of a biologically active substance into the tissues and organs are proposed, the methods comprising administration of the biologically active substance in combination with one or more chaotropic agents, e.g., ammonium sulfate.

Abstract: The invention relates to a process for preparing a pharmaceutical tablet composition which comprises an active pharmaceutical ingredient of formula I wherein the definitions are described in claim 1, or pharmaceutically acceptable acid addition salts thereof and a water soluble poloxamer in which the compound of formula I and the water soluble poloxamer are processed by hot melt extrusion, and then the hot melt extrudate is mixed with other ingredients to form a tablet, that is optionally coated with a composition comprising an immediate release film coating system and purified water. The invention also relates to such pharmaceutical compositions and hot melt extrudates.

Abstract: The present invention is directed to drug dosage forms that release an agent that raises the pH of a patient's gastrointestinal tract, followed by a non-steroidal anti-inflammatory drug. The dosage form is designed so that the NSAID is not released until the intragastric pH has been raised to a safe level. The invention also encompasses methods of treating patients by administering this coordinated release, gastroprotective, antiarthritic/analgesic combination unit dosage form to achieve pain and symptom relief with a reduced risk of developing gastrointestinal damage such as ulcers, erosions and hemorrhages.

Abstract: The invention relates to niclosamide and derivates thereof, which effectively inhibit transcription of the S100A4 gene, resulting in inhibition and/or reduction of S100A4-induced cell motility, invasiveness, metastasis and proliferation of human cancer cells.

Abstract: The invention provides pharmaceutical compositions, methods for the treatment of and related diagnostics and computer-implementable systems that relate to, the treatment of a variety of metabolic syndromes, including hyperlipidemia, weight gain, obesity, insulin resistance, hypertension, atherosclerosis, fatty liver diseases and certain chronic inflammatory states. In an additional aspect of the invention, compositions and methods of treatment are calibrated to the ileal brake response to surgical intervention e.g. RYGB, as both activate the ileal brake, which acts in the gastrointestinal tract and the liver of a mammal to control metabolic syndrome manifestations and thereby reverse or ameliorate the cardiovascular damage (atherosclerosis, hypertension, lipid accumulation, and the like) resulting from progression of metabolic syndrome.