Abstract: A pharmaceutical composition for oral administration comprising a core and a film coating on the core that exhibits enhanced disintegration characteristics is disclosed. The film coating comprises a film forming polymer, an organic solvent, a super-disintegrant and, optionally, an acid labile material.

Abstract: Pharmaceutical formulations containing a salt of (5S,8S)-8-[{(1R)-1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diazaspiro[4.5]decan-2-one, represented by Formula I, which are suitable for forming into a tablet dosage form, as well as tablet dosage forms are disclosed. Disclosed also are methods of treatment utilizing such dosage forms.

Abstract: The present invention features a method of manufacturing a tablet containing a pharmaceutically active agent by the steps of: (a) adding a powder containing a pharmaceutically-acceptable carrier to a die cavity; (b) injecting a liquid drug composition containing the pharmaceutically active agent into the die cavity such that the liquid drug composition contacts the powder; (c) compressing the combination of the powder and the liquid drug composition within the die cavity to form the tablet; and (d) removing the tablet from the die cavity.

Abstract: The present invention relates to the use of at least one strain of probiotic bacteria selected from Lactobacillus for the manufacture of a pharmaceutical composition for the treatment and/or prevention of a virus infection.

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

Abstract: The present invention describes rifaximin powder and to a process for preparing the same. The invention relates also to a pharmaceutical composition in solid form comprising said rifaximin, pharmaceutically acceptable excipients and optionally other ingredients. The compositions according to the invention are suitable for oral administration and are characterized by producing a controlled release of rifaximin, whereby a long-lasting effect is obtained in a patient.

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 present invention provides an enteric coated composition for oral administration of a chloride channel opener which can provide improved pharmaceutical activity with reduced adverse side effect such as nausea.

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 vapor deposition methods that overcome the kinetic restrictions imposed by more conventional vapor deposition processes and liquid-cooling techniques to form amorphous molecular solids with greatly enhanced stabilities. The present methods produce amorphous molecular solids having stabilities, as measured by fictive temperature, that cannot be achieved using liquid-cooling methods.

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

Abstract: The present invention provides a new composition for treating pain-associated sleep disturbances, especially shortened sleep duration, comprising ibuprofen and diphenhydramine. The composition is further prepared as a bilayer tablet or caplet, or alternatively as a soft gelatin capsule composition, to prevent interaction between the active ingredients.

Abstract: The invention provides stable controlled release monolithic coating compositions for use in coating pharmaceutical oral dosage forms comprising a polyglycol having a melting point greater than 55° C. and an aqueous dispersion of a neutral ester copolymer lacking functional groups.

Abstract: The present invention relates to a new racecadotril formulation in the form of tablets, the preparation process thereof and the use thereof to treat diarrhoea.

Abstract: The invention relates to novel processes for the preparation of high-purity roflumilast.

Abstract: It is an object of the present invention to provide a fine core particle, which comprises a coating layer having a uniform thickness, and which can be used to produce, at a high yield, a small granule causing no sandy feeling in the oral cavity when the fine core particle is applied to a fine granule or an orally-disintegrating tablet. According to the present invention, there is provided a core particle, which comprises 50% by mass or more of microcrystalline cellulose, and which has a mean particle diameter of less than 100 ?m, a relative flow index of 7.0 to 30.0, a specific surface area of less than 0.15 m2/g, and a tapped bulk density of 0.80 g/mL or more.

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: 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: Disclosed is a method of treating small intestinal bacterial overgrowth (SIBO) or a SIBO-caused condition in a human subject. SIBO-caused conditions include irritable bowel syndrome, fibromyalgia, chronic pelvic pain syndrome, chronic fatigue syndrome, depression, impaired mentation, impaired memory, halitosis, tinnitus, sugar craving, autism, attention deficit/hyperactivity disorder, drug sensitivity, an autoimmune disease, and Crohn's disease. Also disclosed are a method of screening for the abnormally likely presence of SIBO in a human subject and a method of detecting SIBO in a human subject. A method of determining the relative severity of SIBO or a SIBO-caused condition in a human subject, in whom small intestinal bacterial overgrowth (SIBO) has been detected, is also disclosed.

Abstract: The present invention relates to pharmaceutical formulations comprising a 1H-quinazoline-2,4-dione AMPA receptor antagonist. More particularly, the invention relates to immediate release formulations comprising such a compound.

Abstract: Embodiments include a composition to promote ocular health and a method of treatment for a subject exposed to a source of oxidative or visual stress to the eye or having a degradation of the eye. The composition may include amounts of vitamin A, which includes beta-carotene; vitamin C; vitamin D; vitamin E; zinc; copper; selenium; non-vitamin A carotenoids, which include lutein and zeaxanthin; omega-3 fatty acids, which include eicosapentaenoic acid and docosahexaenoic acid; taurine; alpha lipoic acid; pine bark extract; astaxanthin; and Piper spp. extract. The method includes the step of administering to the subject a daily dose of a composition to promote ocular health.

Abstract: A main object of the present invention is to provide a novel coated tablet which contains a drug having a guanidino group and does not suffer an obvious color change even when packed in a one-dose pack together with a drug having a (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl (DMDO) group. The present invention provides a coated tablet characterized in that an uncoated tablet containing a drug having a guanidino group has been coated with a polyvinyl alcohol for film coating which comprises polyvinyl alcohol, acrylic acid, and methyl methacrylate.

Abstract: Drug compositions comprising the compound HT-2157 and their therapeutic uses, including the treatment of CNS disorders and cognitive impairments and the modulation of cognitive function, are disclosed. More particularly, the present invention relates to enteric-coated formulations comprising HT-2157 that reduce the appearance of clinically relevant methemoglobinemia relative to administration of non-enteric-coated formulations comprising HT-2157.

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: The invention provides a solid dosage form, e.g. a tablet, comprising mycophenolic acid or mycophenolate salt and a process for its production.

Abstract: With an object of providing an orally administered agent (in particular a film-shaped orally administered agent) with which the ease and safety of taking the agent are improved, to attain this object, in an orally administered agent 1b having one drug-containing layer 11 and two water-swellable gel-forming layers 12, the water-swellable gel-forming layers 12 are provided, either directly or via intermediate layers, on the both faces of the drug-containing layer 11.

Abstract: Minocycline oral dosage forms containing a controlled release carrier are useful for the treatment of acne.

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 invention is directed to the use of a specific group of polysaccharides for reducing the symptoms of heartburn and gastroesophageal reflux isease. In addition, a pharmaceutical preparation is provided comprising a specific group of polysaccharides having a high hydration rate, a high viscosity, and a high stability at low pH. Such a preparation is particularly effective in reducing the symptoms of heartburn and/or gastro-oesophageal reflux disease, particularly when consumed in dry form.

Abstract: The present invention relates to pharmaceutical compositions of antihistamine-decongestant combination. Specifically the invention relates to bilayered tablet formulation comprising antihistaminic decongestant combination. More specifically present invention relates to the novel polymorph of fexofenadine or pharmaceutically accepted salts thereof, with at least one decongestant in the form of bilayered tablet. The preferred polymorphs are polymorph A and polymorph X of fexofenadine hydrochloride.

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 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 disclosure relates to a method of treating a hematological malignancy comprising administering to a subject in need thereof a synergistic combination of a first compound comprising an effective amount of one or more Avermectins and a second compound comprising a chemotherapeutic, preferably daunorubicin, cyarabine, doxorubicin, idarubicin mitoxantrone, amsacrine, and mixtures thereof.

Abstract: Minocycline oral dosage forms containing a controlled release carrier are useful for the treatment of acne.

Abstract: Oral dosage forms of a bisphosphonate comprised of a safe and effective amount of a pharmaceutical composition comprising a bisphosphonate, a chelating agent, and, means for effecting delayed release of the bisphosphonate and the chelating agent in the lower gastrointestinal tract provide delivery of the pharmaceutical composition to the lower gastrointestinal tract of the mammal subject and pharmaceutically effective absorption of the bisphosphonate with or without food or beverages. 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: 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: Embodiments of the invention relate generally to the use of formulations comprising DMSO and MSM to treat arthritis (such as osteoarthritis), pain, inflammation, and/or degeneration. DMSO and MSM formulations are administered orally and/or topically in several embodiments and provide effective treatment of both chronic and acute symptoms of arthritis (e.g., osteoarthritis), pain, inflammation, and/or degeneration. Solid forms of DMSO are provided in several embodiments.

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

Abstract: 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: This invention relates to a bilayer pharmaceutical compositions comprising fixed-dose combinations of a dipeptidyl peptidase-4 inhibitor and pioglitazone, methods of preparing such pharmaceutical compositions, and methods of treating Type 2 diabetes with such pharmaceutical compositions.

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: The present invention provides, among other things, compositions and methods suitable for the treatment of hyperphosphatemia based on phosphate-binding magnesium salts. In some embodiments, the present invention provides compositions and methods suitable for the treatment of hyperphosphatemia based on the combination of phosphate-binding magnesium and an enteric coating.

Abstract: Pharmaceutical compositions of 1-[2-(2,4-dimethyl-phenylsulfanyl)-phenyl]piperazine and pharmaceutically acceptable acid addition salts thereof adapted so that release does not take place in the stomach is provided.

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: 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: Any pharmaceutical preparation for oral administration with controlled release of active ingredient in the small bowel, on the basis of active ingredient carriers provided with at least one active ingredient which are provided with an inner layer to control the release of active ingredient and with a gastro-resistant coating layer disposed thereon, which is characterized in that the inner layer is formed from at least two diffusion layers whose permeability for the diffusing active ingredient decreases from the inside to the outside, and a method for the production thereof, are described.

Abstract: A method of converting a treatment for pain comprising intravenous administration of opioids, to a treatment for pain comprising oral administration of a first dose of an immediate release morphine-oxycodone combination in patients in need of analgesia. The method may comprise (1) determining a four-hour average oral morphine equivalents, a one-hour average oral morphine equivalents, or determining a net average hourly intravenous dose, and (2) orally administering to the patient a first dose of a morphine-oxycodone combination in a 3:2 ratio by weight every four to six hours. Also, a method of treating pain in patients who had been administered opioids intravenously, comprising using a dosing algorithm to determine the first dose of the immediate release morphine-oxycodone combination.

Abstract: A pharmaceutical composition is disclosed containing amorphous rosuvastatin calcium and at least one of the following stabilizing agents: magnesium hydroxide, calcium acetate, calcium gluconate, calcium glycerophosphate, or aluminum hydroxide, together with at least one pharmaceutically acceptable excipient.

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.