Abstract: Effervescent pharmaceutical compositions containing a high amount of N-acetylcysteine and a method of treating acetaminophen poisoning with effervescent pharmaceutical compositions containing a high amount of N-acetylcysteine are described.

Abstract: Disclosed herein are a composition and unit dosage form for the treatment of hepatitis C virus (HCV) infection comprising GS-7977 and at least one pharmaceutically acceptable excipient, as well as methods for making said composition and unit dosage form. Also disclosed herein is a method of treating a subject, preferably a human, infected with hepatitis C virus, said method comprising administering to the subject for a time period an effective amount of GS-7977 and an effective amount of ribavirin. In one aspect, the method comprises administering to the subject an interferon-free treatment regimen comprising an effective amount of GS-7977 and an effective amount of ribavirin. In a particular aspect, the method is sufficient to produce an undetectable amount of HCV RNA in the subject for at least 12 weeks after the end of the time period.

Abstract: A stable and/or synergistic pharmaceutical composition including: a) predinisolone metasulfobenzoate (PMSB) or its acceptable salts, preferably prednisolone metasulfobenzoate sodium and b) 5-ASA, derivatives or pharmaceutically acceptable salts thereof, which is suitable for rectal administration.

Abstract: The disclosure relates, in general, to treatment of fatty liver disorders comprising administering compositions comprising cysteamine products. The disclosure provides administration of enterically coated cysteamine compositions to treat fatty liver disorders, such as non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).

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 invention relates to a once a day formulation of trazodone or a trazodone derivative. The formulation contains trazodone or a trazodone derivative and a controlled release excipient so that, once administered orally, the trazodone or the trazodone derivative is maintained at a therapeutic plasma concentration from at least 1 hour to at least 24 hours after initial administration. After administration, the initial therapeutic action takes effect within the first hour and lasts at least about 24 hours. This therapeutic effect remains relatively and substantially stable for the remaining period of 24 hours. The formulations can be used for treating depression and/or sleeping disorders.

Abstract: The invention concerns a process for the production of a tableting excipient with the following process steps: At least two of the following components are made available: A filler/binding agent; A lubricant; A flow regulating agent; A disintegrant; The available components are mixed together.

Abstract: The invention relates to an oral pharmaceutical composition comprising an active agent, a macroscopically homogeneous structure and a gastro-resistant coating. The macroscopically homogeneous structure comprises at least one hydrophilic compound and at least one lipophilic compound and/or at least one amphiphilic compound. The macroscopically homogeneous structure controls the release of the active ingredient, and the gastro-resistant film prevents release of the active agent in the stomach.

Abstract: The present invention relates to the preparation of (R)—N-(3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-6-methoxyphenyl)-1-(2,3-dihydroxypropyl)cyclopropane-1-sulfonamide and (S)—N-(3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-6-methoxyphenyl)-1-(2,3-dihydroxypropyl)cyclopropane-1-sulfonamide.

Abstract: Provided herein are bitter taste receptor ligands, related agents, combinations, compositions, methods and systems for modulating release of a metabolic hormone in vitro or in vivo from cells of the GI tract of an individual.

Abstract: There is provided a composition or kit of parts comprising: one or more compounds capable of treating and/or preventing an inflammatory disease of the gastrointestinal tract: and an iron hydroxypyrone, for increasing the level of iron in a patient's bloodstream and/or treating and/or preventing anaemia such as iron deficiency anaemia. A composition comprising iron hydroxypyrone is also provided for administration to a subject: having or at risk of having achlorhydria; wherein the gastric pH of the subject is equal to or greater than about 4; or wherein the subject has an inflammatory disease of the gastrointestinal tract.

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: 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: Pharmaceutical compositions of methylphenidate complexed with ion-exchange resin particles to form drug-resin particles are provided. The compositions have a first plurality of drug-resin particles that are uncoated and a second plurality of drug-resin particles that are coated with a delayed release coating.

Abstract: Pharmaceutical compositions of methylphenidate complexed with ion-exchange resin particles to form drug-resin particles are provided. The compositions have a first plurality of drug-resin particles that are uncoated and a second plurality of drug-resin particles that are coated with a delayed release coating. Preferably, the second plurality of drug-resin particles are coated with a triggered-release coating triggered by a pH change and a diffusion barrier coating.

Abstract: The present invention concerns palatable veterinary compositions made from one or more pharmaceutical active ingredients having a smell and/or a taste that is repulsive to animals, and a preparation method for preparing said oral veterinary compositions.

Abstract: The present invention provides: a pharmaceutical composition having a superior physical property since fimasartan and hydrochlorothiazide, which are main components of a combination preparation, have superior content uniformity; and a preparation method thereof.

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 a multilayered coated tablet comprising at least three layers, i.e., first, second and third layer wherein the first and third layers contain at least one active pharmaceutical ingredient and the second layer is either a placebo or an immediate-release drug layer. Further, the tablet has a delayed-release coating, wherein the coating may contain one or more pore-forming agents and/or orifices on one or both sides. Furthermore, it may contain an immediate-release layer of the drug over the delayed-release coating layer. The present invention further relates to processes for preparing such a multilayered coated tablet.

Abstract: The instant application provides methods and compositions for the treatment of male subjects having ulcerative colitis.

Abstract: In certain embodiments, the invention is directed to composition comprising stable particles comprising ganaxolone, wherein the volume weighted median diameter (D50) of the particles is from about 50 nm to about 500 nm.

Abstract: The present disclosure is directed to methods for treating inherited or acquired mitochondrial disease using a cysteamine product, e.g., cysteamine or cystamine or derivatives thereof.

Abstract: The present invention relates to solid orally administrable pharmaceutical administration forms comprising 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}-methyl)-2-thiophenecarboxamide (rivaroxaban, active compound (I)), characterized in that a partial amount of the active compound (I) is released rapidly and a partial amount is released in a controlled manner (modified, retarded, delayed), and to processes for their preparation, their use as medicaments and their use for the prophylaxis, secondary prophylaxis or treatment of disorders.

Abstract: A stable composition with a benzimidazole derivative, such as Omeprazole, which does not contain a separating layer between the active compound and an enteric coating layer. Instead, the enteric coating layer is applied as a solution with a pH value of at least 6.5, and more preferably in a range of from about 7 to about 10, directly to the benzimidazole derivative substrate. This solution, with the optional addition of a plasticizer, can be directly coated onto the substrate without any necessity for an intermediate layer. Furthermore, in this pH range, the enteric coating is optionally applicable in an aqueous solution, thereby obviating the need for organic solvents for dissolving the enteric coating material. The resultant formulation maintains the stability of the benzimidazole derivative during storage and at the same time protects the product during passage through the acidic environment of the stomach.

Abstract: Embodiments relate to Rifaximin polymorphic, salt, and hydrate forms, methods of producing polymorphic forms and to their use in medicinal preparations and to therapeutic methods using them.

Abstract: The invention relates to the combination of a sulforaphane precursor, an enzyme capable of converting the sulforaphane precursor to sulforaphane, an enzyme potentiator, and magnesium or a salt or complex thereof. The invention also relates to the combination of a sulforaphane or a derivative thereof and magnesium or a salt or complex thereof. The invention also relates to the combination of a broccoli extract or powder and magnesium or a salt or complex thereof. The invention provides compositions and methods relating to these combinations.

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: The invention relates to the combination of a sulforaphane precursor, an enzyme capable of converting the sulforaphane precursor to sulforaphane, an enzyme potentiator, and a mushroom (preferably maitake, shiitake, or reishi mushroom) extract or powder. The invention also relates to the combination of sulforaphane or a derivative thereof and a mushroom (preferably maitake, shiitake, or reishi mushroom) extract or powder. The present invention also relates to the combination of a broccoli extract or powder and a mushroom (preferably maitake, shiitake, or reishi mushroom) extract or powder. The present provides compositions and methods relating to these combinations.

Abstract: The present invention pertains to a high drug load tablet comprising an active ingredient Compound I of formula or a pharmaceutically acceptable salt thereof in an amount from about 30% to 80% in weight of the active moiety based on the total weight of the tablet.

Abstract: A modified release formulation of lacosamide.

Abstract: A nicotine lozenge provided herein includes a body that is partially or wholly receivable in an oral cavity. The body includes a soluble-fiber matrix and nicotine or a derivative thereof dispersed in the soluble-fiber matrix. In some cases, a nicotine lozenge provided herein includes at least 40 weight percent of soluble fiber. In some cases, soluble fiber in a nicotine lozenge provided herein can include maltodextrin. The nicotine lozenge is adapted to release the nicotine or a derivative thereof from the body when the body is received within the oral cavity of an adult consumer and exposed to saliva. A method of making nicotine lozenges provided herein includes forming a molten mixture of at least 40 weight percent soluble fiber, nicotine, and less than 15 weight percent water while maintaining a mixture temperature of less than 150° C. and portioning the molten mixture into a plurality of nicotine lozenges. In some cases, the ingredients can be mixed to form the molten mixture in an extruder.

Abstract: A process for producing a compressed solid dosage form containing an active ingredient. The process includes a step of preparing core elements containing the active ingredient. Optionally the core elements are coated with a pharmaceutically acceptable coating layer to form coated pellets. The core elements or pellets are treated with an anti-static agent and compressed with suitable excipients to form the compressed solid dosage form. Particular anti-static agents are starch, microcrystalline cellulose, kaolin, bentonite, silicates, silicon dioxide, cellulose, stearic acid, sodium stearyl fumarate and glyceryl behenate.

Abstract: There is described a sub-analgesic amount of tramadol, or a salt thereof, in the treatment, alleviation or prevention of depression in a patient wherein the sub-analgesic amount is from about 60 to 80 mg, of tramadol or a salt thereof.

Abstract: A pharmaceutical composition is provided according to the invention which is suited for the production of tablets by direct compression and which contains donepezil hydrochloride of polymorphic form I. The polymorphic form I of donepezil hydrochloride in the directly compressed tablet is also stable during long storage.

Abstract: The invention relates to an area of the chemical-pharmaceutical industry and medicine, particularly to an agent for treatment of dementias, including Alzheimer's disease (AD), as well as to a method of treatment and pharmaceutical composition, which is effective for both treatment of dementias, including AD or dementias of Alzheimer type, and during manifestations of the first symptoms of memory disorder. The given invention consists of the development of a new therapeutic substance with minimal side effects that currently is a topical issue for treatment of the corresponding diseases. Attached is the use of polyprenols of formula (1) where n=8-20 as an active ingredient for the production of the therapeutic agent for the treatment of patients with dementia syndrome, including those who suffer from Alzheimer's disease. It is proposed to use a therapeutic agent for the treatment of patients with dementia syndrome, including those suffering from Alzheimer's disease, being polyprenols of formula (1).

Abstract: The present disclosure relates to food supplement, dietary supplement, nutritional supplement, over-the-counter (OTC) supplement, medical food, or pharmaceutical grade supplement compositions comprising omega-3 fatty acids and vitamin D for use in improving at least one parameter associated with acne and/or eczema (dermatitis).

Abstract: The present invention relates to novel tablet dosage forms and methods of preparing these forms, which can be used for different classes of pharmaceutical active ingredients posing stability issues in a single unit system. The dosage form includes a first layer, which includes a tablet of one or more active pharmaceutical ingredients, which is inlayed in the first layer along with other pharmaceutically acceptable excipients, and a second layer that includes one or more active pharmaceutical ingredients optionally with other pharmaceutically acceptable excipients.

Abstract: A film coating agent for a solid formulation includes a water-soluble cellulose derivative, swelling clay, a cationic surfactant, and a fatty acid, wherein mass ratio of the swelling clay to the water-soluble cellulose derivative is 2:8 to 8:2, and content of the cationic surfactant is not less than 0.5 equivalents and not more than 3.0 equivalents relative to a cation exchange equivalent of the swelling clay.

Abstract: Unit comprising neramexane, a pharmaceutically acceptable salt, solvate, conjugate, prodrug, polymorphic form, isomer, or derivative thereof; and a release-controlling excipient; wherein said unit has a diameter of from 0.1 to less than 6 mm.

Abstract: The subject invention relates to a variety of formulations of bipolar trans carotenoids including pharmaceutical compositions for oral delivery of a bipolar trans carotenoid comprising i) a bipolar trans carotenoid, ii) a cyclodextrin, and iii) a coating. The invention also relates to preparation of such formulations and their uses.

Abstract: Disclosed are solid dispersions comprising a compound having the formula: wherein the compound is dispersed within a polymer matrix formed by a pharmaceutically acceptable polymer, and further wherein the compound is substantially amorphous. Also disclosed are pharmaceutical compositions comprising the compound and methods of use for the compound.

Abstract: The invention relates to stabilized pharmaceutical composition comprising pregabalin and a disaccharide or higher polyol as stabilizer and optionally a conventional pharmaceutically acceptable carrier. The stabilized pharmaceutical composition according to the invention is useful in the treatment of a number of diseases such as epilepsy, Alzheimer's disease or Parkinson's disease.

Abstract: The invention provides new benzimidazole compositions, comprising: (a) a core containing said benzimidazole active ingredient; (b) an intermediate layer; and (c) an enteric layer; said core being substantially free of binder. The invention also provides a process for manufacturing the composition of the invention.

Abstract: The present invention provides oral formulations of poorly bioavailable and/or poorly absorbable, and/or poorly water soluble therapeutic agents. The invention features pharmaceutical composition including a biopolymer, a therapeutic agent, for example an antimicrobial agent such as ceftriaxone, and an absorption enhancer, for example a polyoxyethylene alkyl ether absorption enhancer. Methods of making and using the pharmaceutical compositions is also described.

Abstract: The present disclosure provides pharmaceutical compositions comprising cytidine analogs for oral administration, wherein the compositions release the cytidine analog substantially in the stomach. Also provided are methods of treating diseases and disorders using the oral formulations provided herein.

Abstract: The invention relates to a solid formulation for the oral administration of olanzapine that comprises a core of anhydrous olanzapine Form I or a pharmaceutically acceptable salt thereof and, optionally, pharmaceutically acceptable excipients, said core being coated with a functional polymer that acts as filmogenic agent. The method for obtaining it comprises: i) providing anhydrous olanzapine Form I or a salt thereof and, optionally, pharmaceutically acceptable excipients in solid form; ii) providing a functional polymer that acts as filmogenic agent; iii) preparing a dispersion of said functional polymer in an aqueous medium,—and applying the dispersion obtained in step iii) onto the solid form of step i).

Abstract: The presently described technology provides phenylethanoic acid, phenylpropanoic acid, phenylpropenoic acid, a salt thereof, a derivative thereof or a combination thereof chemically conjugated to hydrocodone (morphinan-6-one, 4,5-alpha-epoxy-3-methoxy-17-methyl) to form novel prodrugs or compositions of hydrocodone which have a decreased potential for abuse of hydrocodone. The present technology also provides methods of treating patients, pharmaceutical kits and methods of synthesizing conjugates of the present technology.

Abstract: The present invention provides methods for treating diarrhea-predominant irritable bowel syndrome comprising administering to a patient in need thereof, an inhibitor of chloride-ion transport in an amount sufficient to treat diarrhea-predominant irritable bowel syndrome (d-IBS). Treatment of d-IBS includes the treatment of the diarrhea component of d-IBS as well as the pain, abdominal discomfort and other symptoms associated with d-IBS. In one embodiment, the inhibitor of chloride-ion transport is crofelemer.

Abstract: Novel testosterone formulations are disclosed where testosterone is incorporated into a phospholipid/cholesterol system to produce a proliposomal powder dispersion. The proliposomal powder dispersions of the invention may be formulated with pharmaceutically acceptable excipients to form pharmaceutical compositions. Enterically coated oral dosage forms are disclosed as are methods of treatment for testosterone replacement therapy.

Abstract: The invention relates to the chemical and pharmaceutical industry and to medicine, in particular, to medicinal agents based on a mixture of natural oligomers of isoprenol (Ropren), which inhibits monoamine oxidase (MAO) activity; and to a method for treatment of patients suffering from diseases associated with the excessive activity of monoamine oxidase. The given invention consists of the development of a new therapeutic substance with minimal side effects that is currently a topical issue for treatment of the corresponding diseases. The proposed: Therapeutic substance consisted of polyprenols of formula (1) for treatment of patients with diseases associated with excessive activity of monoamine oxidase. with content of polyprenols of formula (1) in the given therapeutic substance from 0.1 to 80%.