Abstract: Disclosed herein are controlled-release (GR, e.g., extended-release (ER) or prolonged-release (PR)) oral dosage formulation comprising an effective amount of Torsemide or a pharmaceutically acceptable salt thereof and at least one sustained release excipient comprising a polymer, wherein the at least one matrix component is selected from the group consisting of: hydroxy propyl cellulose (HPC), hydroxpropyl methyl cellulose (HPMC), glyceryl behenate, and a polyethylene glycol glyceride. Torsemide may be present in the formulation in a range of about 1 wt % to about 20 wt %, or about 5 wt % to about 10 wt % and the matrix component is present in the formulation in a range of about 5 wt % to about 50 wt %, or about 15 wt % to about 35 wt %. The formulation may further comprise at least one binder, lactose, talc and magnesium stearate. Methods of making and using the controlled-release oral dosage Torsemide formulation are also disclosed. A novel mechanism for Torsemide action in diuresis is further disclosed.

Abstract: Disclosed herein are solid oral dosage formulations comprising sodium sulfate, magnesium sulfate, and potassium chloride for inducing purgation of the colon of a subject. Furthermore, the disclosed compositions and formulations are useful to cleanse the colon when administered in sufficient quantities. Methods for inducing purgation of the colon and for cleansing the colon are also disclosed.

Abstract: The present invention relates to the use of a sustained release matrix containing at least one opioid for producing a solid oral formulation in table form suitable for reducing blood concentration fluctuations of said opioid.

Abstract: The present invention relates to a pharmaceutical composition comprising a sodium benzoate compound and clozapine; and a method for preventing, treating and/or reducing the risk of a neuropsychiatric disorder by administering such pharmaceutical composition.

Abstract: Methods are provided for efficient preparation of hydromorphone or hydrocodone by redox isomerization of morphine or codeine allylic alcohols, respectively, using transition metal aminophosphine catalysts formed in situ.

Abstract: Sustained release oral dosage forms of an R-baclofen prodrug are disclosed.

Abstract: Particulate ceragenin materials may be manufactured by (i) providing a ceragenin feed material comprised of ceragenin molecules, each having a sterol backbone and a plurality cationic groups attached thereto; (ii) fracturing the ceragenin feed material in a milling apparatus to produce a ceragenin particulate material having a particle size distribution with a median particle size in a range from 5 nm to 20 ?m; and (iii) during fracturing, maintaining the ceragenin feed with a moisture content of less than or equal to 10% by weight.

Abstract: Disclosed are pharmaceutical compositions, e.g., in the form of tablets, containing a therapeutically effective amount of an HIV protease inhibitor, e.g., ritonavir, a pharmaceutically acceptable aqueous-soluble polymer, and an erosion-enhancing agent having a particle size distribution in the range of about 1 ?m to about 350 ?m, wherein the composition is substantially free or free of surfactant. Methods of making the compositions, and methods of using them to treat HIV infection are also provided.

Abstract: A solid dosage form of meloxicam containing an acid and sugars or polyalcohols or a mixture thereof.

Abstract: The present invention relates to a cellulose powder usable for a satisfactory orally disintegrating tablet having excellent compression moldability and well-balanced tablet moldability and disintegration properties, which can obtain excellent ingestion feel without feeling roughness and dryness in the oral cavity, and more particularly to a cellulose powder with an average polymerization degree of 150 to 450, an average particle diameter of not less than 10 ?m but less than 100 ?m, and a primary particle ratio of 50% or more.

Abstract: The present invention relates to solid oral formulations comprising a compound of formula (3Z,5S)-5-(hydroxymethyl)-1-[(2?-methyl-1,1?-biphenyl-4-yl)carbonyl]pyrrolidin-3-one-O-methyloxime, and/or an active metabolite thereof, and the use of said formulations in the treatment and/or prevention of preterm labor, premature birth, dysmenorrhea and embryo implantation failure due to uterine contractions. The present invention is furthermore related to processes for their preparation.

Abstract: Described are compositions that may be orally administered that comprise a bioreversible derivative of hydroxy N-substituted-2-aminotetralin or an enantiomer or salt or prodrug thereof, and a pharmaceutically acceptable carrier suitable for oral administration in the amount present, wherein the composition is orally bioavailable when administered to a subject. The bioreversible derivative has an intrinsic lipophilicity C log P value of about 7 to about 11.5. A method comprises oral administering such composition to a human subject in need of hydroxy N-substituted-2-aminotetralin therapy.

Abstract: The present invention is directed to stable, oral pharmaceutical formulations of dipeptidyl peptidase-4 inhibitors, such as omarigliptin. Such pharmaceutical formulations comprise omarigliptin; and neutral excipients, wherein the neutral excipient is present in the amount of at least 75% by weight of the pharmaceutical formulation and comprises at least one non-reducible sugar diluent or a mixture of non-reducible sugar diluents.

Abstract: Co-agglomerates of crystalline mannitol and granular starch, characterized in that they have a compressibility, as determined according to a test A, higher than 120 N, and preferably of 200 to 450 N, and a flow time, as determined according to a test B, of 3 to 15 seconds, and preferably of 4 to 8 seconds.

Abstract: A layered microbead suitable for incorporating into a non-prescription consumable product is disclosed. The layered microbead may include a core and at least one active ingredient layer encapsulating the core. The active ingredient in the core can be different from the active ingredient in the encapsulating layer. The active ingredient in the core can be selected to counteract or enhance the effect of the active ingredient in the encapsulating layer. The layered microbead can further incorporate microspheres of active ingredient surrounded by polymer material. Method of manufacturing microspheres and microbeads are also described.

Abstract: It is desired to provide a pharmaceutical composition containing a compound represented by formula (I) or a pharmaceutically acceptable salt thereof, or a solvate thereof, which exhibits an inhibitory effect on activated blood coagulation factor X, and is useful as an agent for preventing and/or treating thrombosis, wherein the pharmaceutical composition exhibits favorable dissolution properties. The present invention provides a method for producing a pharmaceutical composition containing a compound represented by formula (I), comprising the step of mixing a compound represented by formula (I) or a pharmaceutically acceptable salt thereof, or a solvate thereof, one or more excipients selected from the group consisting of a sugar alcohol and a water-swelling additive, a disintegrant, and a binder under conditions for keeping the maximum water content of the granules during granulation at 10% or less.

Abstract: The present disclosure relates generally to compositions that comprise citrulline and leucine or a metabolite thereof including, for example, a synergistic amount of citrulline and leucine. Such compositions may be used in methods for the treatment of metabolic syndrome, hyperglycemia, and/or hyperinsulinemia.

Abstract: This invention relates to methods of preserving the integrity of peptides in the gut. In particular it concerns the use of certain compounds as inhibitors of gut proteases. Compounds identified as having gut protease inhibitory activity are biguanides, certain bile acids and pharmaceutically acceptable salts of these compounds. This activity makes these compounds useful for co-administration with prophylactic or therapeutic peptides. This invention relates to methods of inhibiting gut proteases and peptide formulations comprising these gut protease inhibitor.

Abstract: The present invention relates to prolonged release pharmaceutical dosage forms, the manufacture thereof as well as their use for administration to human being.

Abstract: Disclosed is a pharmaceutical combination formulation comprising a first discrete part containing amlodipine and rosuvastatin and a second discrete part containing losartan, which exhibits improved dissolution rate and stability. The inventive combination formulation comprising amlodipine, losartan and rosuvastatin having different action mechanisms from one another can be effectively used to prevent or treat a cardiovascular disorder. Designed to minimize an interaction among active ingredients, the pharmaceutical combination formulation exhibits excellent storage stability and dissolution rates of amlodipine, losartan and rosuvastatin, and thus can be useful in pharmaceutical industries.

Abstract: The present invention relates to solid pharmaceutical dosage forms for oral administration comprising sodium 1-[6-(morpholin-4-yl)pyrimidin-4-yl]-4-(1H-1,2,3-triazol-1-yl)-1H-pyrazol-5-olate (active ingredient (I)), characterized in that the active ingredient (I) is released, and also methods for the preparation thereof, use thereof as medicaments, and also use thereof for prophylaxis, secondary prophylaxis or treatment of disorders, particularly cardiovascular disorders, heart failure, anemia, chronic renal disorders and renal insufficiency.

Abstract: An example flavored wipe and method of manufacturing the flavored wipe includes a material configured for use as a wipe, and a solution comprising water and a flavoring component. The flavoring component may be stevia or other natural or artificial sweetener. An example dispensing system for the flavored wipe includes a compartment to hold a material configured for use as a wipe including a solution with at least a flavoring component. An opening is formed in the compartment to dispense the material and the solution from the compartment.

Abstract: The present invention provides an aqueous coating agent including a vinyl polymer (A) having a basic nitrogen atom-containing group and a carboxylic group, a quaternary ammonium salt (B), and an aqueous medium (C). Particularly, the present invention provides an aqueous coating agent including a compound represented by General Formula (1) below as the quaternary ammonium salt (B). The aqueous coating agent has excellent adhesiveness, warm water resistance, corrosion resistance, and chemical resistance, and can form a film that is capable of preventing the deterioration of various substrates. In General Formula (1), R1 to R4 each independently represent an alkyl group having 1 to 20 carbon atoms or an aryl group.

Abstract: The present invention relates to a pharmaceutical formulation comprising therapeutically effective amount of vildagliptin or pharmaceutically acceptable salt thereof and a diluent. Particularly, the ratio of vildagliptin to diluent is in the range of 0.04 to 0.24 (w/w).

Abstract: In one aspect the present invention features process for making a tablet comprising at least one pharmaceutically active agent, said method comprising the step of applying radiofrequency energy to a powder blend to sinter said powder blend into said tablet, wherein said powder blend comprises lossy coated particles and said at least one pharmaceutically active agent, wherein said lossy coated particles comprises a substrate that is at least partially coated with a lossy coating comprising at least one activator, wherein said substrate has a Q value of greater than 100 and said activator has a Q value of less than 75.

Abstract: A solid oral pharmaceutical composition in the form of a tablet consisting of a core including a Krebs cycle precursor salt as active ingredient, and of a coating including a coating agent, the composition including from 40% to 80% by weight of this precursor salt on the basis of the total weight of the composition, the composition being able to release this salt in vitro, both in purified water at pH 7 and in a solution buffered at pH 1.3, with a dissolution device in accordance with the European Pharmacopoeia, at a rate of from 2 to 15% in 15 minutes, from 15 to 25% in 30 minutes, and from 30 to 50% in one hour. The composition is a usefeul medicament, in particular in the treatment and/or prevention of urinary lithiasis occurring at a physiological pH and/or during urinary acidosis and/or during hypocitraturia and/or during hypercalciuria and/or during hyperoxaluria.

Abstract: There is provided pharmaceutical compositions for the treatment of pain e.g. short-term pain, which compositions comprise a mixture comprising: (a) microparticles of alfentanil, or a pharmaceutically acceptable salt thereof, which microparticles are presented on the surfaces of larger carrier particles; (b) a water-soluble weak base; and (c) a compound which is a weak acid, which acid is presented in intimate mixture with the microparticles of alfentanil or salt thereof. The composition may further comprise a disintegrant. The acid is preferably citric acid.

Abstract: The present invention is an orally consumed fixed combination formulation of both rosuvastatin and ezetimibe in one tablet that is expected to have the same Area Under Curve as two active ingredients taken together individually orally, and pharmaceutically acceptable additives suitable for the preparation. In preferred embodiments of this invention, the rosuvastatin is in the form of rosuvastatin calcium and the pharmaceutically acceptable additives are selected from diluents, disintegrants, glidants, lubricants, colorants and combinations thereof.

Abstract: A sustained-release formulation for an acetylcholinesterase inhibitor, comprising an acetylcholinesterase inhibitor and at least two gel-forming polymers, and methods of manufacture thereof. The acetylcholinesterase inhibitor preferably comprises donepezil.

Abstract: The present invention relates to pharmaceutical compositions intended to be used in the form of a solid unit such as a tablet, for oral administration, comprising a high content of fexofenadine and/or of at least one pharmaceutically acceptable salt thereof, and also to hot-melt processes for manufacturing solid units.

Abstract: A compressed tablet of a pharmaceutical compound which contains uncoated pellets containing a pharmaceutical compound, where the uncoated pellets are dispersed in a matrix containing the pellets and a swellable polymer.

Abstract: A resin composition includes cellulose derivatives, wherein, in a molecular weight distribution curve obtained by subjecting the cellulose derivatives to gel permeation chromatography (GPC), a maximum (PL) exists in a low molecular weight region of 10,000 to 40,000 and a maximum (PH) exists in a high molecular weight region of 100,000 to 180,000, and with respect to a total amount of a peak area (SL) of a peak including the maximum (PL) and a peak area (SH) of a peak including the maximum (PH), a ratio of the peak area (SL) is 1% to 99% and a ratio of the peak area (SH) is from 1% to 99%.

Abstract: A granular material which has a mean particle diameter of 150 to 800 micrometers; and an unsettled bulk density of 0.1 to 0.35 g/cm3 and/or a compactibility which results in a compact with a tensile strength of at least 1.7 MPa when the granular material is subjected to a compaction pressure of 266 MPa; and wherein the main component of the granular material is a cellulose derivative or an alkylene oxide homo- or copolymer or a blend thereof is useful for preparing dosage forms with a controlled release profile.

Abstract: An oral pharmaceutical composition comprises multiple populations of at least one of beads, pellets, tablets and granules provided in a capsule, the composition comprising: a first population of a pharmaceutical active comprising a pharmaceutical active substance releasable at a first rate; a population of a basic substance; and a second population of a pharmaceutical active comprising a pharmaceutical active substance releasable at a second rate. In another embodiment, the oral pharmaceutical composition comprises multiple populations of at least one of beads, pellets, tablets and granules provided in a capsule, the composition comprising: a population of a pharmaceutical active; a population of a basic substance; a population of enteric coated pharmaceutical active; and a population of enteric coated basic substance. The composition can provide multiple site specific delivery of a pharmaceutical active in a rapid, delayed and/or sustained release manner into the plasma.

Abstract: The invention provides coated particles with taste-masked N-acetylcysteine. The particles comprise a core with the active ingredient and a coating comprising a triglyceride and a surfactant. The particles exhibit rapid drug release and a stable release profile. Moreover, the invention provides a hot-melt coating method for manufacturing such particles, and pharmaceutical compositions comprising the particles. The method allows the coating of core particles at moderate temperatures, thereby preventing the degradation of the thermolabile active ingredient.

Abstract: The present invention features the present invention features a process for making a tablet by compacting a powder blend in a die platen to form a tablet shape, wherein the powder blend includes a pharmaceutically active agent and a water-containing material, and applying energy to the tablet shape for a sufficient period of time to heat the water-containing material within the tablet shape above its dehydration temperature to form the tablet.

Abstract: A tablet characterized by comprising 5-methyl-1-phenyl-2-(1H)-pyridone as the main ingredient and, based on the main ingredient, 10 to 50 wt. % excipient, 5 to 40 wt. % disintegrator, 1 to 10 wt. % binder, 0.5 to 5 wt. % lubricant, 2 to 6 wt. % coating basis, and 0.05 to 3 wt. % light-shielding agent, wherein the odor or bitterness of the 5-methyl-1-phenyl-2-(1H)-pyridone is masked and the light stability is improved.

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.

Abstract: The present invention provides extended release pharmaceutical compositions structured for once a day administration comprising skeletal muscle relaxant such as cyclobenzaprine or its pharmaceutically acceptable salt thereof that extends the release of the drug under in-vitro conditions for at least 8 to 12 hours. The invention also provides process for the preparation of such structured compositions.

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.

Abstract: The present invention relates to a pharmaceutical composition comprising a combination of 1-benzyl-3-hydroxymethylindazole derivative, a pressure lowering agent selected from ACE-inhibitors, renin inhibitors, ARBs and CCBs, and/or a cholesterol lowering agent selected from statin derivatives. The combination showed an additive and synergistic activity in reducing MCP-1 levels, thus significantly improving inflammatory response inhibition and consequently reducing complications occurring in patients suffering from inflammatory diseases.

Abstract: The invention regards the use of triiodothyronine sulfate, commonly named T3S, as a medicament having thyromimetic activity for the treatment of pathologies due to organic deficiency of triiodothyronine (T3), as such or in association with thyroxine (T4), and pharmaceutical formulations for oral administration thereof.

Abstract: A concentrated aqueous composition may be prepared by from a formulation including: a. from 10 to 30% by weight (% wt) of a depolymerized carboxymethyl cellulose having a weight average molecular weight of from about 10,000 to about 80,000 dalton (Da); b. from 15 to 50% of a compatibilizer selected from the group consisting of glycerol and sodium xylene sulfonate; and c. from about 0.5 to about 20% by weight of a surfactant. The concentrated aqueous solution may be employed to prepare an aqueous solution which is useful for moisturizing soil.

Abstract: A drug in a solubility-improved form is combined with a concentration-enhancing polymer in a sufficient amount so that the combination provides substantially enhanced drug concentration in a use environment relative to a control comprising the same amount of the same solubility-improved form of drug without the concentration-enhancing polymer.

Abstract: The present disclosure relates to delayed release capsules and methods of manufacturing the capsules. The capsules comprise a capsule shell comprising a combination of gelatin and alginate, wherein the capsule shell encapsulates or is filled with at least one agent, and the delayed release capsules are chosen from soft capsules and hard capsules.

Abstract: The invention regards the use of triiodothyronine sulfate, commonly named T3S, as a medicament having thyromimetic activity for the treatment of pathologies due to organic deficiency of triiodothyronine (T3), as such or in association with thyroxine (T4), and pharmaceutical formulations for oral administration thereof.

Abstract: The invention relates to pyridinone derivatives of general formula (I) as inhibitors of tissue transglutaminase, to methods for producing the pyridinone derivatives, to pharmaceutical compositions containing said pyridinone derivatives and to their use for the prophylaxis and treatment of diseases associated with tissue transglutaminase.

Abstract: Therapeutic compositions and methods for treatment of late-onset Gaucher disease are described herein. The compositions comprise compounds having activity as pharmacological chaperones for mutant forms of the beta-glucocerebrosidase. Methods of treatment involve providing therapeutically effective amounts of such compositions to subjects in need thereof.

Abstract: The instant invention relates to a process for the preparation of a pharmaceutical composition in sustained-release tablet form comprising from 600 milligrams to 2400 milligrams of Pirfenidone (PFD), in such a way that the drug is bioavailable during an extended period of time of 12 hours from its administration. In this way, the anti-fibrotic and anti-inflammatory action of the drug Pirfenidone is optimized. Moreover, the instant invention offers advantages and a higher therapeutic efficacy compared to other pharmaceutical forms of Pirfenidone for oral administration and its therapeutic application in the regression of chronic renal failure secondary to primary glomerulosclerosis; it shows a better activity with regard to the reduction and/or regression of deleterious effects in breast capsular contracture observed after the surgical implantation of breast implants in humans and has an important anti-TNF-? and anti-TGF-?1 action for the treatment of hepatic fibrosis.

Abstract: A process for the preparation of a solid, orally administrable pharmaceutical composition, comprising 5-chloro-N-({(5)-2-oxo-3-[4-(3-oxo-4-morpholinyl)-phenyl]-1,3-oxazolidin-5-yl}-methyl)-2-thiophenecarboxamide comprising preparing granules in hydrophilized form using fluidized bed granulation for moist granulation, adding additives, compressing to form a tablet, and coating the tablet.