Abstract: Provided herein are pharmaceutical formulations, comprising 4-((9-((3S)-tetrahydro-3-furanyl)-8-((2,4,6-trifluorophenyl)amino)-9H-purin-2-yl)amino)-trans-cyclohexanol, including pharmaceutically acceptable salts, solvates, isomers, isotopologues, tautomers and racemic mixtures thereof, and a pharmaceutically acceptable excipient; and their use for treating or preventing disease.

Abstract: The present invention provides a tablet comprising a compressed tablet core which comprises at least about 80% by weight of an aliphatic amine polymer. The invention also provides a method of producing a tablet core comprising at least about 80% by weight of an aliphatic amine polymer resin. The method comprises the step of compressing the aliphatic amine polymer to form the tablet core. The tablet core can further include one or more excipients. In this embodiment, the method of producing the tablet core comprises the steps of: (1) hydrating the aliphatic amine polymer to the desired moisture level; (2) blending the aliphatic amine polymer with the excipients in amounts such that the polymer comprises at least about 80% by weight of the resulting blend; and (3) compressing the blend to form the tablet core. The present invention further relates to a coated tablet comprising an aliphatic amine polymer core wherein the coating is a water based coating.

Abstract: The present invention is concerned with novel pharmaceutical compositions of itraconazole which can be administered to a mammal suffering from a fungal infection, whereby a single such dosage form can be administered once daily, and in addition at any time of the day independently of the food taken in by said mammal. These novel compositions comprise particles obtainable by melt-extruding a mixture comprising itraconazole and an appropriate water-soluble polymer and subsequently milling said melt-extruded mixture.

Abstract: The present invention relates to the use of a plant extract obtained from at least one plant of the Anacardiaceae family, for the preparation of a pharmaceutical composition used as a new herbal medicine for the prophylaxis and/or treatment of disorders associated with the digestive tract, and the relief of symptoms associated with these disorders. Additionally, through the scope of the present invention, the substances isolated from said extract also consist of the active ingredients of pharmaceutical compositions. A third objective of the invention is the use of said pharmaceutical compositions in the preparation of the class of herbal medicines for the prophylaxis and/or treatment of disorders associated with the digestive tract, in different stages, with posology and daily dosing.

Abstract: The present invention relates to a pharmaceutical composition in a solid unit dosage form for oral administration in a human or lower animal comprising: a. a safe and effective amount of a therapeutically active agent; b. an inner coating layer selected from the group consisting of poly(methacrylic acid, methyl methacrylate) 1:2, poly(methacrylic acid, methyl methacrylate) 1:1, and mixtures thereof; and c. an outer coating layer comprising an enteric polymer or film coating material; wherein the inner coating layer is not the same as the outer coating layer; wherein if the inner coating layer is poly(methacrylic acid, methyl methacrylate) 1:1 then the outer coating layer is not poly(methacrylic acid, methyl methacrylate) 1:2 or is not a mixture of poly(methacrylic acid, methyl methacrylate) 1:1 and poly(methacrylic acid, methyl methacrylate) 1:2; and wherein the inner coating layer and the outer coating layer do not contain any therapeutically active agent.

Abstract: The object of the present invention is to provide, as a solid preparation for making it easy to take, thus improving patient's compliance etc., an intraorally rapidly disintegrating tablet which can be produced easily without any particular problem by a usual method of producing tablets with a usual tabletting machine, has practically unproblematic hardness, and disintegrate rapidly in the oral cavity. This tablet is produced by tabletting cores coated with a pharmaceutical disintegrating agent, wherein the core is a granule containing a water-soluble medicament or containing a medicament and a sugar.

Abstract: A composition comprising from about 0.001% to about 0.4% cyclosporin A, a surfactant, and an oil having a specific gravity from 0.8 to 0.95 is disclosed herein.

Abstract: A composition is disclosed herein comprising from about 0.001% to about 0.

Abstract: Dual release oral tablet compositions of dexlansoprazole or pharmaceutically acceptable salts or hydrated forms thereof and processes for the manufacture of the tablet composition and its use in the treatment of gastrointestinal disorders.

Abstract: A method to improve the safety of handling of drug substances that are dispensed as solid oral dosage forms is described that does not alter the drug-release profile and the therapeutic efficacy of the pharmaceutical product.

Abstract: Solid dosage forms of methylthioninium chloride (MTC) further comprise at least one diluent suitable for direct compression. The MTC exists in a substantially pure and stable polymorphic form. The solid dosage forms may preferably be prepared by direct compression methods.

Abstract: The present invention provides for press-coated tablets of prednisone comprising a core comprising prednisone and a coating around the core. The present invention particularly discloses thickness of the coating applied to core having a convex shape for chronotherapeutic use. The present invention also provides for a process for preparing a press-coated tablet of prednisone and a method for treating conditions or pathology, the symptoms of which occur early in the morning.

Abstract: The invention provides multilayer tablets that contain rilpivirine hydrochloride, emtricitabine, and tenofivir disoproxil fumarate. The tablets are useful for the treatment of HIV.

Abstract: A composition comprising a therapeutically effective amount of cyclosporin A, a blend of oils having a specific gravity of from 0.90 to 1.07, and a surfactant is disclosed herein.

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: A dosage form from which a burst release of a drug contained within a tampered dosage form is reduced or retarded by the presence in or on the dosage form of a TPTA (Tamper Prone Therapeutic Agent) trap. If the dosage form has not been tampered with, the TPTA trap does not significantly interfere with the rate of release of the drug from the dosage form. However, if the dosage form has been physically tampered with, the TPTA trap reduces or retards burst release of the drug from the dosage form.

Abstract: There is provided in accordance with embodiments of the invention a method of treating or reducing the effects in a subject of a condition selected from fructose intolerance and impaired fructose metabolism, the method comprising administering to a subject in need of such treatment or reduction an efficacious amount of a glucose isomerase, other than in combination with 5-D-fructose dehydrogenase. Other embodiments are also disclosed.

Abstract: There is provided in accordance with embodiments of the invention a method of treating or reducing the effects in a subject of a condition selected from fructose intolerance and impaired fructose metabolism, the method comprising administering to a subject in need of such treatment or reduction an efficacious amount of a glucose isomerase, other than in combination with 5-D-fructose dehydrogenase. Other embodiments are also disclosed. There is provided a method for treating or reducing the effects of fructose intolerance and health problems associated with excessive fructose intake by administration of glucose isomerase. Other embodiments are also disclosed.

Abstract: The present invention concerns a method for coating granules comprising mesalazine, with a coating mixture comprising two polymers, polymer I and polymer II; said polymer I being selected to allow formation of a closing membrane around said granules in the absence of said polymer II, and said polymer II being selected to act as a water-soluble pore former in said coating mixture; wherein a) the amount of polymer I is adjusted to provide a closing membrane in the absence of polymer II, and b) the amount of polymer II in said coating mixture is adjusted to obtain coated granules which exhibit controlled release of mesalazine. The invention further concerns a product obtainable by the coating method.

Abstract: The invention relates to the use of an oral dosage form based on microgranules and/or microtablets to reduce the abusive use of at least one active principle contained therein. The aim of the invention is to prevent the diversion of an oral dosage form based on microgranules and/or microtablets containing at least one active principle capable of causing a dependency, a gelling agent, and a gelling activator. The gelling agent and the activator are only brought into contact with each other in the event of diversion by crushing. Said judiciously selected pair of excipients confers a viscosity to the formulation, such that said formulation cannot be administered by injection or does not release the active principle rapidly by forming a gel when it comes into contact with the mucous membrane if nasally administered.

Abstract: The invention relates to pharmaceutical compositions of ?N-(2-Chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, and to methods of using the pharmaceutical compositions in the treatment of oncological and immunological disorders

Abstract: The present invention relates to an enteric tablet with improved bioavailability, which is rapidly disintegrated after reaching the intestine to allow dissolution of the active ingredient, and which characteristically reduces the amount of talc to be used and is free of an alkali component.

Abstract: Oral administration forms are described for the controlled release of an antibiotic selected from the group consisting of rifampicin, rifabutin, rifapentine, rifalazil and mixtures thereof, for treating bacterial infections of the gastrointestinal tract, in particular travellers' diarrhoea, hepatic encephalopathy, ulcerative colitis, irritable bowel syndrome (IBS), Crohn's disease, and IBD (inflammatory bowel disease) in general. Moreover, said oral administration forms allow reduction of the amounts of antibiotic to be taken, with respect to the known administration forms and without reaching blood concentrations such as to select resistant strains of tuberculosis mycobacteria.

Abstract: The present invention relates to an enteric tablet with improved bioavailability, which is rapidly disintegrated after reaching the intestine to allow dissolution of the active ingredient, and which characteristically reduces the amount of talc to be used and is free of an alkali component.

Abstract: Aspects of the present invention are directed to abuse resistant oral dosage forms comprising a compressed microtablet that is coated with a water-retardant polymer. Additional aspects of the present invention are directed to an oral dosage form comprising an opioid agonist and at least one compressed microtablet coated with a water retardant polymer. The compressed microtablet may comprise an opioid antagonist.

Abstract: A sustained-release pharmaceutical composition in a form of an orally deliverable tablet comprises a water-soluble salt of pramipexole, dispersed in a matrix comprising a hydrophilic polymer and a starch having a tensile strength of at least about 0.15 kN cm?2 at a solid fraction representative of the tablet.

Abstract: A tablet for oral administration comprises a matrix of progressive and continuous released magnesium. For the administration of 90 to 110 parts by weight of magnesium, the matrix comprises 180 to 190 parts by weight of hydroxypropylmethylcellulose, 19.8 to 22.2 parts by weight of glyceryl behenate, 10 to 12 parts by weight of lactose and 10 to 12 parts by weight of colloidal silica. A non-enteric protective coating that slows down the gastric dissolution of the magnesium may comprise 15 to 75 parts by weight of shellac, cellulose ether or a mixture thereof. The tablet may be administered to patients in need thereof.

Abstract: A process for making hemoglobin based oxygen carrier (HBOC) containing pharmaceutical composition suitable for oral delivery and the composition formed thereby are described. There are three exemplary composition configurations which include (1) hemoglobin-loaded nanoparticles solution, (2) enteric-coated hemoglobin capsules and (3) enteric-coated hemoglobin tablets. To facilitate the bioavailability and bio-compatibility of hemoglobin, intestinal absorption enhancers are added in each of the HBOC formulations. Protective layers ensure delivery of an intact hemoglobin structure in intestinal tract without degradation in the stomach. The HBOC formulations may be used for preventive or immediate treatment of high altitude syndrome (HAS) or for treatment of hypoxic conditions including blood loss, anemia, hypoxic cancerous tissue, and other oxygen-deprivation disorders.

Abstract: Immediate-release formulations are described, consisting of double-layer tablets wherein one layers contains an opioid agonist and the other an opioid antagonist.

Abstract: A dosage form from which a burst release of a drug contained within a tampered dosage form is reduced or retarded by the presence in or on the dosage form of a TPTA (Tamper Prone Therapeutic Agent) trap. If the dosage form has not been tampered with, the TPTA trap does not significantly interfere with the rate of release of the drug from the dosage form. However, if the dosage form has been physically tampered with, the TPTA trap reduces or retards burst release of the drug from the dosage form.

Abstract: The present invention concerns a method for coating granules comprising mesalazine, with a coating mixture comprising two polymers, polymer I and polymer II; said polymer I being selected to allow formation of a closing membrane around said granules in the absence of said polymer II, and said polymer II being selected to act as a water-soluble pore former in said coating mixture; wherein a) the amount of polymer I is adjusted to provide a closing membrane in the absence of polymer II, and b) the amount of polymer II in said coating mixture is adjusted to obtain coated granules which exhibit controlled release of mesalazine. The invention further concerns a product obtainable by the coating method.

Abstract: The invention concerns a microgranule tablet comprising a low dose of active principle containing a directly compressible diluent. The invention is characterized in that the directly compressible diluent consists exclusively of neutral microgranules, and the active principle is set on the neutral microgranules and is not coated with an agent designed to modify its release or mask its taste.

Abstract: The present invention provides a tablet comprising a compressed tablet core which comprises at least about 80% by weight of an aliphatic amine polymer. The invention also provides a method of producing a tablet core comprising at least about 80% by weight of an aliphatic amine polymer resin. The method comprises the step of compressing the aliphatic amine polymer to form the tablet core. The tablet core can further include one or more excipients. In this embodiment, the method of producing the tablet core comprises the steps of: (1) hydrating the aliphatic amine polymer to the desired moisture level; (2) blending the aliphatic amine polymer with the excipients in amounts such that the polymer comprises at least about 80% by weight of the resulting blend; and (3) compressing the blend to form the tablet core. The present invention further relates to a coated tablet comprising an aliphatic amine polymer core wherein the coating is a water based coating.

Abstract: The invention relates to pharmaceutical compositions containing rosuvastatin calcium of formula (I) and processes for their manufacture.

Abstract: A controlled release pharmaceutical composition for oral use is provided in the form of a coated matrix composition, the matrix composition comprising i) a mixture of a first and a second polymer that have plasticizing properties and which have melting points or melting intervals of a temperature of at the most 200° C.

Abstract: The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.

Abstract: The purpose of the invention is to provide a press-coated orally-disintegrating tablet having a powder/granular material with poor formability in its inner core, which has an excellent disintegrability and a suitable hardness as a whole tablet. Furthermore, the invention is a press-coated orally-disintegrating with an outer layer surrounding an inner core wherein the inner core has a thickness in the range of 30 to 80% per that of the whole tablet, and the outer layer comprises (a) microcrystalline cellulose, (b) a sugar or a sugar alcohol, and (c) one or more particular ingredients selected from the group consisting of crospovidone, starches, low-substituted hydroxypropylcellulose and carmellose.

Abstract: A pharmaceutical matrix film tablet with controlled release of natural mixtures of conjugated estrogens which have been obtained from the urine of pregnant mares.

Abstract: The subject invention provides a pharmaceutical composition comprising N-ethyl-N-phenyl-1,2,-dihydro-4-hydroxy-5-chloro-1-methyl-2-oxoquinoline-3-carboxamide or the salt thereof; a pharmaceutically acceptable carrier; and not more than 0.5% w/w relative to N-ethyl-N-phenyl-1,2,-dihydro-4-hydroxy-5-chloro-1-methyl-2-oxoquinoline-3-carboxamide of 2-Chloro-6-(1-ethyl-N-methyl-2-oxoindoline-3-carboxamido)benzoic acid, 1H,3H-spiro[5-chloro-1-methylquinoline-2,4-dione-3,3?-[1]ethylindolin-[2]-one], or 5-Chloro-N-ethyl-3-hydroxy-1-methyl-2,4-dioxo-N-phenyl-1,2,3,4-tetrahydro-quinoline-3-carboxamide.

Abstract: Flavored dosage forms, e.g., lozenges and gums, are provided for sustained release of a flavoring agent in the mouth. The dosage forms provide sustained release by virtue of a wet matrix formed by admixture of a biocompatible, hydrophilic, water-insoluble polymer such as ethylcellulose and a flavoring agent, particularly an essential oil or a constituent thereof, e.g., a terpene or sesquiterpene. The dosage forms may also include a second beneficial agent in addition to the flavoring agent. Exemplary such beneficial agents include ionizable zinc compounds and other cold remedies, local anesthetic and anti-infective agents, diet aids, fluoride-releasing compounds, and nicotine. The dosage forms, when formulated as lozenges, may be somewhat adhesive or substantially nontacky, depending primarily on the molecular weight of the hydrophilic polymer. Adhesive lozenges can serve as dosage forms that adhere to the teeth or gums for delivery of a beneficial agent thereto.

Abstract: A pharmaceutical composition, comprising a thiazolidinedione, such as Compound (I), metformin hydrochloride and a pharmaceutically acceptable carrier, wherein the thiazolidinedione and metformin hydrochloride are each dispersed within its own pharmaceutically acceptable carrier in the pharmaceutical composition and the use of such a composition in medicine.

Abstract: Aspects of the present invention are directed to oral dosage forms comprising a compressed microtablet, wherein said microtablet has a major dimension that is between about 0.25 mm and about 1.0 mm and comprises at least about 0.01 weight percent of at least one pharmaceutically active agent that is distributed substantially throughout said microtablet. Additional aspects of the present invention are directed to methods for producing compressed microtablets having a major dimension that is between about 0.25 mm and about 1.0 mm.

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: Cellulose powder having an especially excellent balance among moldability, fluidity and disintegrating property is provided. Cellulose powder having an average polymerization degree of 150-450, an average L/D (the ratio of the major axis to the minor axis) value of particles of 75 ?m or less of 2.0-4.5, an average particle size of 20-250 ?m, an apparent specific volume of 4.0-7.0 cm3/g, an apparent tapping specific volume of 2.4-4.5 cm3/g, and an angle of repose of 55° or less.

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: This invention relates to antioxidants and combinations of antioxidants used to prevent oxidation of pharmaceutical and nutraceutical products in the form of powders, granulates, tablets, emulsions, gels and the like comprising one or more fatty acids and/or fatty acid derivatives and, optionally, at least one carbohydrate carrier alone or together with vitamins, minerals and/or pharmaceuticals. In particular, the invention concerns the use of antioxidants to reduce oxidation of powders, tablets, gels and emulsions comprising high concentrations and high doses of omega-3 fatty acids or derivatives thereof.

Abstract: The invention provides compositions for attracting noctuid moths, which include at least one pheromone and at least one synergist. The synergist is a naturally-occurring phytochemical compound. The synergist is preferably ?-caryophyllene, iso-caryophyllene, ?-humulene, or combinations thereof. The invention also provides traps containing the composition for attracting noctuid moths, and methods for attracting, capturing, killing or sterilizing noctuid moths using the composition.

Abstract: The present invention relates to a tablet composed of a core and a coating; said core is formed by two or more layers, wherein at least one of them contains an active agent (3). Wherein one of said layers is formulated as a swellable composition (2), the other one (4) is composed of inert compounds retaining its size at least until the coated tablet is emptied from the stomach. The coating composition is selected from the group comprising water insoluble polymers, ph dependent polymers or mixtures thereof. The active agent is released after rupture of the coating.

Abstract: A dosage form from which a burst release of a drug contained within a tampered dosage form is reduced or retarded by the presence in or on the dosage form of a TPTA (Tamper Prone Therapeutic Agent) trap. If the dosage form has not been tampered with, the TPTA trap does not significantly interfere with the rate of release of the drug from the dosage form. However, if the dosage form has been physically tampered with, the TPTA trap reduces or retards burst release of the drug from the dosage form.

Abstract: A water floatable tablet, which is either: (a) a tablet comprising at least one filler selected from the group consisting of a sugar alcohol, a sugar, a cellulose derivative, and a starch and a component which exhibits a hydrophobic effect, wherein the tablet has a hollow cavity in a center section; or (b) a tablet obtained by a process including: (1) forming a crust comprising at least one filler selected from the group consisting of a sugar alcohol, a sugar, a cellulose derivative, and a starch on an outer surface of a core comprising a sublimation solid, to obtain a dry coated tablet having the core positioned at a center section; (2) heating the dry coated tablet, to obtain a tablet having a hollow cavity; and (3) contacting the tablet having a hollow cavity with a component which exhibits a hydrophobic effect.