Abstract: Embodiments of the invention generally provide pharmaceutical drug compositions, methods of preparing oral drug compositions, such as extended release dosage compositions, and methods for treating antidepressant or smoking cessation. In one aspect, the invention provides a pharmaceutical formulation comprising a core, including bupropion and its salt derivatives, and a coating. The coating may include from about 5% to about 99% by weight of the coating of a pharmaceutically acceptable pH-independent polymer. The coating may further include from about 0.001% to about 30% by weight of the coating of a surfactant. In another aspect, the invention provides methods for preparing and administering a pharmaceutical composition in oral dosage form, such as a tablet.

Abstract: Use of one strain of Lactobacillus plantarum for the manufacture of a composition for increasing the diversity of the gastrointestinal tract by administration of said strain to an individual with a view to producing an increased diversity index compared to placebo is disclosed, as well as use of one strain of Lactobacillus plantarum for the manufacture of a composition for prophylactic treatment of a healthy individual against developing a low bacterial diversity (LBD); of an individual having LBD against developing one or more physiologically disturbed conditions, large intestine bacterial overgrowth (LIBO) or small intestine bacterial overgrowth (SIBO); and of an individual having LIBO or SIBO against developing one or more physiologically disturbed conditions, and a method for increasing said diversity.

Abstract: Disclosed are novel pharmaceutical compositions containing N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide dimethyl sulfoxide solvate, methods of using the compositions in therapy and processes for preparing the same.

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 invention is directed to oral modified/controlled release drug formulations which provide a rapid initial onset of effect and a prolonged duration of effect. Preferably, the peak concentration is lower than that provided by the reference standard for immediate release formulations of the drug, and the duration of effect falls rapidly at the end of the dosing interval.

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

Abstract: The present application relates to compositions for use in a method of treating and/or preventing mental and behavioral disorders and/or improving mental health and cognitive functions in a subject, comprising: a) Docosahexaenoic acid (DHA) and/or the pharmaceutically acceptable derivatives and/or precursors thereof; b) Eicosapentaenoic acid (EPA) and/or the pharmaceutically acceptable derivatives and/or precursors thereof; c) ?-linolenic acid (GLA) and/or the pharmaceutically acceptable derivatives and/or precursors thereof; and at least a psychostimulant compound selected among methylphenidate HCl, atomoxetine, amphetamine, gamma-hydroxybutyrate, dextroamphetamine, sibutramine, methylenedioxymethamphetamine, and/or an anxiolytic compound selected among fluoxatine, sertraline, paroxetine, fluoroxamine, citralopram, venlafaxine, bupropion, nefazodone, and mirtazapine.

Abstract: The object of the invention consists of pharmaceutical formulations containing rifaximin in the shape of microgranules made gastroresistant by an insoluble polymer at pH values between 1.5 and 4.0 and soluble at pH values between 5.0 and 7.5, by their preparation and by their use in the manufacture of medicinal preparations useful in the treatment of inflammatory bowel diseases (IBD) and mainly Crohn's disease.

Abstract: Enteric coated multiparticulate formulations that use L-menthol as an active ingredient are disclosed. In one embodiment, the multiparticulate formulation comprises a plurality of particulates having a reduced release under gastric conditions and an elevated release at neutral pH. The particulates comprise a core comprising L-menthol as an active ingredient. The L-menthol is supplied to the core as an at least 80% pure L-menthol material. An enteric coating is over the core. The enteric coating is effective to release at least about 80% of the L-menthol within about two hours of being placed in a substantially neutral pH environment. Other aspects of the invention include methods of making and methods of using the multiparticulate formulations.

Abstract: Methods of administering a delayed release 6-mercaptopurine pharmaceutical composition to patients suffering from inflammatory bowel disease which provide for release of the 6-mercaptopurine after passage of the pharmaceutical composition through the stomach are disclosed. The methods result in significant clinical improvement despite leading to very little systemic absorption of 6-mercaptopurine and also result in very few undesirable side effects.

Abstract: The present invention is directed to oral pharmaceutical forms, the composition of which makes it possible to prevent possible misuse of the active principle present therein. The present invention thus relates to a pharmaceutical composition for oral administration intended to prevent abuse of use at the expense of a third party.

Abstract: The present invention is directed to oral pharmaceutical forms for rapid disintegration which make it possible to prevent possible misuse of the zolpidem present therein. The present invention thus relates to a zolpidem-based orodispersible tablet formulation intended to prevent abuse of use of the tablet at the expense of a third party.

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: The invention concerns a high water soluble product, containing a dehydrated material, obtained by fermenting wheat germ in aqueous medium in the presence of microorganisms of the Saccharomyces genus, forming amorphous crystal structure with inert auxiliary materials), commonly used in preparation of drugs. The invention also relates to the production process of said products, to immunostimulatory, immunomodulatory, antitumor and cardiovaskular pharmaceutical preparations containing them, and to the therapeutic methods for their use.

Abstract: The present invention relates to a solid phase pharmaceutical composition comprising one or more pharmaceutically acceptable excipients and an active pharmaceutical ingredient (“API”) which is a compound of formula A1 or A2 or a pharmacologically acceptable salt, solvate or hydrate thereof, wherein the API is not exposed to a basic compound.

Abstract: The present invention relates to compositions and methods for treating sialic acid deficiencies comprising extended release formulations.

Abstract: Naturally occurring lecithins and/or oleic acid stimulate the growth and lactic acid producing activity of Lactobacillus and Bifidobacterium species of probiotic bacteria, and replace polysorbate 80 for those products. They can be used in naturally occurring form, or where they are to be combined with probiotics in a carrier, or they can be treated to yield a stable powdered form of these naturally oily compounds. They can be sold as combined prebiotic/probiotic formulations in the same carrier, or sold as separate dietary supplements, e.g., in capsule or tablet form, to be used with the probiotic formulation as desired.

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 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: The present invention is directed to a sustained release pharmaceutical composition in oral dosage form consisting essentially of a pharmaceutically effective amount of a medicament and a hydrophobic material in the absence of a lactose or hydrophobic carbohydrate polymer, said medicament being present in an amount greater than about 25% of the pharmaceutical composition and having a water solubility greater than about 1 gram per 10 mL of water at 25° C., said hydrophobic material having a melting point ranging from at least about 40° C. to about 100° C. at 1 atm pressure, and being present in an amount ranging from about 3% to about 20% by weight of the pharmaceutical composition and in an amount less than the of the medicament, and said hydrophobic material not being present in coating of said pharmaceutical composition; said pharmaceutical composition being prepared by direct compression in the absence of or melting the hydrophobic material or the use of high shear mixer.

Abstract: A dosage form comprises: (a) at least one active ingredient: (b) a core having a first surface portion upon which resides a first coating and a second surface portion which is substantially free of the first coating; and (c) a shell which resides upon at least a portion of the second surface portion, wherein the shell comprises a different material from the first coating. In another embodiment, the dosage form comprises: (a) at least one active ingredient; (b) a core comprising a center portion having an exterior surface and an annular portion having an exterior surface and an interior surface, wherein the annular portion interior surface is in contact with at least a portion of the center portion exterior surface, and a coating resides on at least a portion of the annular portion exterior surface; and (c) a shell which resides upon at least a portion of the exterior surface of the center portion, wherein the shell comprises a different material than the impermeable coating.

Abstract: The present invention relates to a pharmaceutical dosage form containing the active substance BIBW 2992 as the dimaleate salt, providing an immediate release profile of the active substance, further, the invention relates to compacted intermediates comprising BIBW 2992 dimaleate salt (BIBW 2992 MA2) in form of a powder prepared using a combined roller compaction and sieving step from BIBW 2992 MA2, intermediate blends prepared from said compacted intermediate as well as solid oral formulations providing an immediate release profile of the active substance, made from said compacted intermediate or from said intermediate blends ready for use/ingestion, e.g. capsule and tablet formulations such as uncoated or film-coated tablets prepared by direct-compression, and methods for their production.

Abstract: A modified release formulation of lacosamide suitable for once-daily administration.

Abstract: The present invention refers to a process for obtaining a standardized extract having antinociceptive, anti-inflammatory and antipyretic properties, from at least one part of a plant of genus Aleurites. Furthermore, the present invention provides a pharmaceutical composition comprising an active ingredient of a pharmaceutically efficient quantity of standardized extract from at least one part of the plant of genus Aleurites. Finally, the present invention describes a method of treatment and use of the said extract, isolated or in a pharmaceutical composition, for the prevention, control or treatment of painful, inflammatory or febrile affections.

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: Provided are modified factor IX (FIX) polypeptides and methods of generating modified FIX polypeptides. Also provided are pharmaceutical compositions, including compositions formulation for oral administration, that contain the modified FIX polypeptides, and methods of treatment using modified FIX polypeptides.

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: Compositions comprising at least one bactericidal antibiotic from the group of macrolides and a non-steroid anti-inflammatory with selective inhibiting activity for cycloxygenase 2 (COX-2). The present invention also refers to a dosage form of said compositions, as well as a method to treat pet animals, particularly dogs and cats. Compositions of the present invention are particularly useful for administration to provide animals with dosages of about 1.0 to 50 mg of compound A/kg of body weight of the animal and about 0.05 to 5.0 mg of compound B/kg of body weight of the animal, being compound A preferably azithromycin and compound B, meloxicam.

Abstract: Provided is an oral dosage form comprising a bisphosphonate selected from the group consisting of a risedronate and salts thereof; an ethylenediaminetetraacetic acid (EDTA) or a pharmaceutically acceptable salt thereof; and a delayed release mechanism to deliver the risedronate and the EDTA in the lower gastrointestinal tract, wherein the oral dosage form is administered according to a scheduled dosing interval. The present invention substantially alleviates the interaction between bisphosphonates and food or beverages, which interaction results in the bisphosphonate active ingredient not being available for absorption. The resulting oral dosage form may thus be taken with or without food. Further, the present invention effects delivery of the bisphosphonate and the chelating agent to the lower GI tract, substantially alleviating the upper GI irritation associated with bisphosphonate therapies.

Abstract: The invention relates to an extract made of thyme (Thymus L.) in combination with primrose (Primula veris) or ivy (Hedera helix) for the prophylaxis and treatment of chronic obstructive pulmonary diseases (COPD) and to a corresponding medicinal product and the use thereof.

Abstract: The present invention relates to a combination comprising a substance with inhibiting effect on the ileal bile acid transport system (I BAT) and at least one other active substance selected from an IBAT inhibitor; an enteroendocrine peptide or enhancer thereof; a dipeptidyl peptidase-IV inhibitor; a biguanidine; an incretin mimetic; a thiazolidinone; a PPAR agonist; a HMG Co-A reductase inhibitor; a bile acid binder; and a TGR5 receptor modulator; wherein the IBAT inhibitor compound and the at least one other active substance are administered simultaneously, sequentially or separately.

Abstract: A composition for use in preventing and/or treating and/or reducing organic, including symptomatic, mental disorders, comprising: a) Docosahexaenoic acid (DHA) and/or the pharmaceutically acceptable derivatives and/or precursors thereof; b) Eicosapentaenoic acid (EPA) and/or the pharmaceutically acceptable derivatives and/or precursors thereof; c) ?-linolenic acid (GLA) and/or the pharmaceutically acceptable derivatives and/or precursors thereof; and at least one vitamin selected from vitamin B6, folic acid, vitamin B12, vitamin E, and/or vitamin D, at least one mineral which is selenium and/or zinc, optionally other vitamins, and optionally a polyphenolic plant extract with antioxidant properties.

Abstract: The invention relates to a peptide having the sequence SEQ.1: INWLKIAKKVAGML-NH2 and one or more of the variants thereof selected from among the sequences SEQ.2 to SEQ.25, or one of the mixtures thereof. The peptides are used especially as a medicament, in particular for the treatment of cancer. The invention also relates to a pharmaceutical composition including the peptides.

Abstract: The invention relates to a novel two-phase preparation for use as a food supplement, dietary substance, and/or medicament. The medical use thereof for helping the immune system fight against viral diseases, especially herpes, is particularly preferred. Said preparation may have two different phases which may be used in a chronologically staggered manner, mutually blocking agents being in different phases and mutually boosting agents being in the same phase.

Abstract: The present invention relates to solid, semisolid, or liquid formulations comprising water soluble antioxidants that prevent or reduce formic acid and/or formyl species generation in the dosage form during the manufacturing process and/or during shelf-life storage. The formulations of the present invention prevent or reduce formation of N-formyl impurities (and gelatin cross-linking) during the manufacturing process and/or during shelf-life storage.

Abstract: The invention relates to dry processes for producing oral dosage forms, more specifically tablets, comprising atazanavir and adhesion enhancers. The invention further relates to compacted intermediates comprising atazanavir and adhesion enhancers.

Abstract: A method for the treatment of chronic obstructive pulmonary disease (COPD), including administering to a patient suffering from COPD, a therapeutically effective amount of roflumilast having a purity of greater than or equal to 99% by weight, and N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-hydroxybenzamide present (relative to roflumilast) in an amount greater than zero and less than 0.1% by weight.

Abstract: The present invention provides coated tablet formulations comprising neratinib maleate, and improved methods for making such coated tablets.

Abstract: Extended release pharmaceutical compositions of levetiracetam or pharmaceutically acceptable salts thereof in the form of a tablet comprising glyceryl behenate and a polymethacrylate polymer with at least one pharmaceutically acceptable excipient.

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: A solid pharmaceutical composition containing AP23573 suitable for oral administration is disclosed.

Abstract: The invention relates to a pharmaceutical dosage form comprising (1r,4r)-6?-Fluoro-(N-methyl- or N,N-dimethyl-)-4-phenyl-4?,9?-dihydro-3?H-spiro-[cyclohexane-1,1?-pyrano[3,4,b]-indol]-4-amine or a physiologically acceptable salt thereof, for use in the treatment of fibromyalgia or chronic fatigue syndrome.

Abstract: The present invention relates to an oral pharmaceutical composition of amorphous darunavir.

Abstract: An orally adminsterable 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 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: ?-Hairpin peptidomimetics of the general formula Cyclo (-Xaa1-Xaa2-Xaa3-Xaa4-Xaa5-Xaa6-Xaa7-Xaa8-Xaa9-Xaa10-Xaa11-Xaa12-Xaa13-Xaa14-), enantiomers and pharmaceutically acceptable salts thereof, with Xaa1-Xaa14 being amino acid residues of certain types which are defined in the description and the claims, have anti-infective activity, e.g. to selectively inhibit the growth of or to kill microorganisms such as Bacillus subtilis and/or Shigella boydii. They can be used as medicaments to treat or prevent infections or as disinfectants for foodstuffs, cosmetics, medicaments or other nutrient-containing materials. These peptidomimetics can be manufactured by a process which is based on a mixed solid- and solution phase synthetic strategy.

Abstract: The present invention relates to pharmaceutical compositions of calanolides, their derivatives and analogues, and process for producing the same having enhanced solubility and bioavailability for oral or parenteral administration. The invention further provides for a method of using the disclosed compositions for the treatment and prevention of retroviral diseases such as human immunodeficiency, specifically HTV-1 and mycobacterial diseases especially tuberculosis infections in mammals, particularly humans.

Abstract: The present invention relates to a multiple unit pellet system (MUPS) in form of a tablet containing a pharmaceutically active ingredient, characterized in that the MUPS is an optionally coated immediate release pharmaceutical dosage form for oral administration.

Abstract: The present invention is directed to a storage stable insecticidal composition comprising one or more Chloronicotynyle compound, in an amount ranging from 0.1 to 5% by weight of the composition, one or more compounds falling within the group of Organophosphorus compounds in an amount ranging from 30 to 75% by weight of the composition and 69.9 to 20% by weight of conventional agriculturally acceptable carrier(s) and excepient(s) along with the process for obtaining the storage stable composition. At least one of the active ingredients is provided with a coating of a water soluble polymer.