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: The present invention pertains to a high drug load tablet comprising as 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 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 is directed to solid stable pharmaceutical fixed dose compositions comprising irbesartan, amlodipine besilate and pharmaceutically acceptable excipients, to their preparation and to their therapeutic application.

Abstract: Described herein are compounds useful in the modulation of blood uric acid levels, formulations containing them and methods of using them. In some embodiments, the compounds described herein are used in the treatment or prevention of disorders related to aberrant levels of uric acid.

Abstract: The present invention provides compositions containing endoxifen, formulations and liposomes of endoxifen, methods of preparation of such agents and formulations, and use of such agents and formulations for the treatment of a subject having or at risk for psychiatric and neurodegenerative diseases, infectious diseases, fertility disorders, osteoporosis, osteoarthritis, and/or cardiovascular diseases. Specifically, the present invention relates to compositions comprising endoxifen for use in the treatment of such disorders or predisposition to such disorders, for use in manufacture of medicaments for treating such disorders, and methods comprising use of such compositions in such treatments.

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: Purified compounds of formula I are described. Compounds include all stereoisomeric forms and all tautomeric forms of the compounds of formula I and pharmaceutically acceptable salts and derivatives. Processes for the production of the antibacterial compounds by fermentation of the microorganism belonging to Streptomyces species (PM0626271/MTCC 5447) and to pharmaceutical compositions containing one or more of the novel compounds as active ingredient and their use in medicines for treatment and prevention of diseases caused by bacterial infections are described.

Abstract: Methods are provided which include converting oripavine to other opiates, including converting oripavine to naltrexone, buprenorphine, 14-hydroxymorphinone and/or converting 14-hydroxymorphinone to oxymorphone. Purification and salt formation are optionally included.

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 present invention is directed to multi-layered compositions for oral administration having at least one orally disintegrating layer and capable of maintaining layer cohesion. The present invention is also directed to methods of manufacturing such compositions.

Abstract: Processes for making polyesters in a polyester production facility are disclosed, that include the steps of: forming a reaction medium comprising at least one monomer that includes terephthalic acid (TPA) and/or an ester derivative of TPA; subjecting at least a portion of the reaction medium to one or more chemical reactions in the polyester production facility to thereby produce the polyester; heating at least a portion of the reaction medium via indirect heat exchange with high-pressure steam, wherein the heating causes at least a portion of the high-pressure steam to condense and thereby provide pressurized condensed water; flashing at least a portion of the pressurized condensed water to thereby produce lower-pressure steam; and heating one or more process fluid streams of the polyester production facility via indirect heat exchange with at least a portion of the lower-pressure steam, wherein the process fluid streams include any stream that is formed predominately of the reaction medium and/or the at lea

Abstract: The present invention relates to the use of a regulatory protein RS1 fragment or a nucleic acid molecule encoding said regulatory protein RS1 fragment for the preparation of a pharmaceutical composition for the amelioration, prevention and/or treatment of a metabolic disease or a secondary disorder caused by a (pathological) modification of homeostasis, wherein said RS1 fragment is characterized in comprising at least 3 consecutive amino acid residues as comprised in the amino acid sequence S-D-S-D-R-I-E-P (Serine-Aspartic acid-Serine-Aspartic acid-Arginine-Isoleucine-Glutamic acid-Proline) (SEQ ID NO: 9) or derivatives thereof.

Abstract: Integrated processes for making polyesters are disclosed, that include the steps of: (a) producing an aromatic polycarboxylic acid in a monomer production facility; (b) producing a polyester in a polyester production facility, wherein the producing of the polyester comprises the substeps of: (i) forming a polyester reaction medium comprising at least a portion of the aromatic polycarboxylic acid from the monomer production facility, (ii) subjecting at least a portion of the polyester reaction medium to one or more chemical reactions to thereby produce the polyester, (iii) heating the polyester reaction medium at one or more locations in the polyester production facility via indirect heat exchange with high-pressure steam, wherein the heating causes at least a portion of the high-pressure steam to condense and thereby provide pressurized condensed water, and (iv) flashing at least a portion of the pressurized condensed water to thereby produce lower-pressure steam; and (c) using at least a portion of the lower

Abstract: Multilayer minitablets for oral administration of an active pharmaceutical ingredient which release the active pharmaceutical ingredient at different pH ranges and/or in different release profiles are described.

Abstract: Disclosed herein is an improved process for preparation of Sevelamer hydrochloride having phosphate binding capacity of 4.7 to 6.4 mmol/g. Further, the invention discloses Sevelamer hydrochloride compositions and a novel process for preparation of said compositions comprising high shear non-aqueous granulation.

Abstract: The present invention provides a tablet core which comprises at least about 95% by weight of an aliphatic amine polymer. The invention also provides a method of producing a tablet core comprising at least about 95% 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 95% 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 relates to a pharmaceutical formulation of solid dosage forms comprising a therapeutically effective amount of a pyrrolidone anticonvulsant agent, and in particular Levetiracetam or a pharmaceutical acceptable salt or derivative thereof, in combination with an effective diluent, such as Dibasic Calcium Phosphate, and additional pharmaceutical excipients, and a process for the preparation thereof by wet granulation.

Abstract: The present invention provides novel calcium phosphate nanoparticles suitable for efficient encapsulation of biologically active molecules. The invention further provides pharmaceutical compositions comprising these nanoparticles, as well as methods of making such nanoparticles and using them as carriers for therapeutic delivery of biologically active macromolecules.

Abstract: Self-breaking core tablets and functionally coated tablets and capsule formulations are provided. Methods for production of these tablet and capsule formulations and their administration are also provided.

Abstract: Peptides of general formula (I): R1—Wn—Xm-AA1-AA2-AA3-AA4-AA5-AA6-Yp—Zs—R2 their stereoisomers, mixtures thereof and/or their cosmetically or pharmaceutically acceptable salts, their preparation process, cosmetic or pharmaceutical compositions which contain them and their use in the treatment and/or care of conditions, disorders and/or diseases that are a consequence of muscle contraction.

Abstract: The invention relates to the use of spermidine or a pharmaceutically acceptable derivative thereof as the active principle in a pharmaceutical, cosmetic or dietetic composition. The composition is used for promoting pigmentation of the hair, particularly the shaft of the hair. The invention also relates to the composition which promotes this pigmentation effect, the composition containing spermidine or a derivative thereof (such as a salt) as an active principle and is intended for topical or oral administration.

Abstract: The tablets, compositions and methods of the present invention, comprising a carbonate salt of an aliphatic amine polymer and s monovalent anion can prevent or ameliorate acidosis, in particular acidosis in patients with renal disease. The tablets and compositions of the present invention maintain a disintegration time of no greater than 30 minutes at 37° C. and at pH of at least 1 for a period of at least ten weeks at 60° C. Furthermore, the tablets are stable for extended periods of time without the need for specialized storage conditions.

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 relates to a granular pharmaceutical composition comprising an HCV protease inhibitor and at least one poloxamer.

Abstract: Disclosed are compositions comprising an inner core and at least two surrounding layers. The compositions are suitable for use in humans and other mammals, particularly wherein a component of the inner core is susceptible to moisture. The compositions comprise an inner core comprising one or more components; an inner layer which surrounds the inner core, wherein the inner layer is selected from continuous coatings insoluble at a pH of about 3 or less, continuous coatings having a coating weight of from about 3 mg/cm2, and combinations thereof; and an outer layer which surrounds the inner layer, wherein the outer layer is hydrophobic.

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: Provided are improvements in and relating to pharmaceutical compositions for oral administration of polymeric biological drug substances and to methods of treatment using such compositions. In particular, an oral and/or mucosal pharmaceutical composition is provided, said composition comprising an enteric-coated drug substance, and also comprising an enteric-coated oligouronate, wherein said drug substance is a polymeric biological drug substance.

Abstract: Disclosed are oral dosage forms containing a Ras antagonist including FTS and structural analogs thereof, and at least one pharmaceutically acceptable excipient other than a cyclodextrin, and methods of orally administering same to treat diseases and disorders responsive to the Ras antagonists.

Abstract: The present invention describes dietary compositions and methods of using such compositions to treat chronic viral infections, including hepatitis B and hepatitis C infections.

Abstract: Coated pellets which comprise an active pharmaceutical ingredient that is poorly soluble in water, release at least 80% of the active ingredient under in vitro conditions in phosphate buffer at pH 5.0 after 30 minutes and are bioequivalent to a liquid formulation of the active ingredient under in vitro fed status test conditions and/or are coated with a composition, which includes a lipophilic component (A) and a hydrogel former (B), wherein the pure lipophilic component (A) has (i) an HLB value of ?5, and/or (ii) a melting range of ?60° C., and/or (iii) a solidification range ? of less than 35° C., and/or (iv) a density of ?0.80 g cm?3.

Abstract: The invention relates to a pharmaceutical composition for oral or rectal administration, that contains phloroglucinol and paracetamol in a pharmaceutically acceptable carrier. The inventors have evidenced a synergy developed by these two active ingredients in antispasmodic therapy.

Abstract: The present invention relates to Rifaximin polymorphic, salt, hydrate, and amorphous forms, to their use in medicinal preparations and to therapeutic methods using them.

Abstract: Bio-functionalized magnetic particles have a non-magnetic material matrix which supports core/shell magnetic elements composed from a ferromagnetic core material and a shell material. The shell material can be chosen either among an antiferromagnetic material, a ferromagnetic material of a kind different from the core ferromagnetic material or a metal material. By a proper choice of materials and dimension tuning of both the core and the shell as well as the amount and the concentration of the magnetic elements within the non-magnetic matrix, the bio-functionalized magnetic particles is tailored to exhibit an enhanced magnetic energy. When subjected to an alternating magnetic field, the magnetic particles exhibit specific rotational dynamics in correspondence with the amplitude and the frequency of the applied magnetic filed. Aggregation structures of the magnetic particles are controlled and manipulated by the alternating magnetic field.

Abstract: Pharmaceutical formulations comprising niacin in a matrix comprising a hydrophobic polymer that modifies release of niacin.

Abstract: This invention discloses an orally administered pharmaceutical composition for the treatment of elevated levels of cholesterol and related conditions comprising a statin and fenofibrate in the form of microparticles of solid fenofibrate that are stabilized by phospholipid as a surface active substance, wherein a therapeutically effective amount of the composition provides the statin and a quantity of fenofibrate to a fasted human patient that is greater than 80% of the quantity of fenofibrate provided by the same amount of the composition when administered to the same patient who has been fed a high fat meal.

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

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: Pharmaceutical composition containing a combination of a non steroidal anti inflammatory drug and a colchicoside derivative, the active ingredients being present in the free state or in the form of a salt.

Abstract: Disclosed is a method of treatment of chronic obstructive pulmonary disease associated with chronic bronchitis in a patient at risk of exacerbations. The method includes administering to a patient with a history of chronic obstructive pulmonary disease associated with chronic bronchitis and at risk of exacerbations, a maintenance dose of 500 micrograms per day of roflumilast. Also disclosed is a method of increasing pre-bronchodilator FEV1 or post-bronchodilator FEV1 in such a patient, and increasing pre-bronchodilator FVC or post-bronchodilator FVC in such a patient. Further disclosed is a method of reducing the rate of exacerbations in such a patient.

Abstract: A solid dosage form for oral administration comprising azithromycin in an amount below that which causes gastrointestinal side effects, which dosage form is a controlled release dosage form.

Abstract: 2-(Aminomethyl)-5-chlorobenzylamide derivatives and their use as inhibitors of coagulation factor Xa are provided. The compounds are suitable for the treatment and prophylaxis of cardiovascular and thrombotic events.

Abstract: The present invention refers to pharmaceutical composition comprising a DPP-IV inhibitor.

Abstract: A capsule-like dosage form, method for producing such dosage form and apparatus are disclosed. Such dosage form is achieved by applying a sleeve over the caplet to provide a coating which is smoother and easier to swallow than an uncoated caplet. The production of the capsule-like dosage form is readily facilitated by simple and inexpensive modifications to existing empty gelatin capsule making equipment.

Abstract: The present invention provides compositions for use in the prophylaxis or treatment of a condition arising from gluten intolerance, the compositions including at least partially purified caricain (or a biologically active fragment, analogue or variant thereof) alone or in combination with other suitable enzymes including bromelain, and/or an intestinal extract, as herein described. The present invention also provides methods of using such compositions for the prophylaxis or treatment of a condition arising from gluten intolerance.

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: This invention relates to a process for preparing a pharmaceutical composition comprising four antitubercular drugs: rifampin or a pharmaceutically acceptable salt thereof, isoniazid or a pharmaceutically acceptable salt thereof, pyrazinamide or a pharmaceutically acceptable salt thereof and ethambutol or a pharmaceutically acceptable salt thereof, wherein rifampin and isoniazid are in separate layers. The invention also provides a pharmaceutical composition prepared therefrom having advantageous stability and bioavailability.

Abstract: This invention relates to sustained release pharmaceutical compositions comprising O-desmethyl-venlafaxine, in particular to sustained pharmaceutical compositions comprising O-desmethyl-venlafaxine orotate and/or O-desmethyl-venlafaxine glucuronate.

Abstract: A pharmaceutical product containing an active pharmaceutical ingredient and having a controllable release of the active pharmaceutical ingredient. The pharmaceutical product comprises yeast that is capable of fermentation. The carbon dioxide production of the fermentation releases the active pharmaceutical ingredient from the pharmaceutical product.