Abstract: The present invention provides a method for treating a human subject afflicted with multiple sclerosis or a single clinical attack consistent with multiple sclerosis with a pharmaceutical composition comprising glatiramer acetate and a pharmaceutically acceptable carrier, comprising the steps of: a) determining whether the human subject is a glatiramer acetate responder by evaluating expression of a biomarker selected from the group consisting of ERAP2, SIGLEC1, AAK1, KIAA1671, PLEKHA2, LOC730974, IFIT3, RWDD3, MYO6 SCARA3 and IFI44L, or a combination thereof, in human subject; and b) administering the pharmaceutical composition comprising glatiramer acetate and a pharmaceutically acceptable carrier to the human subject only if the human subject is identified as a glatiramer acetate responder.

Abstract: Modified or extended release formulations containing mesalamine compounds and associated methods are disclosed and described. In some aspects, such formulations may be substantially bioequivalent to known FDA approved mesalamine formulations such as PENTASA®.

Abstract: Compositions intended for the percutaneous administration of physiologically active agents, e.g. drugs or a veterinary agents, are disclosed. Said compositions are characterized forming a non-sticky, very flexible film that ‘has excellent long term efficacy.

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: Novel drug carriers capable of targeted and/or pH dependent release of biologically active agents into selected pH environments including the gastrointestinal (GI), ophthalmic, urinary, or reproductive tracts. Unexpectedly, carriers including free fatty acids (FFA) are able to deliver biologically active agents to various pH environments. Such targeted delivery is tailorable and useful for active agents that are: (a) injurious to the upper GI tract (esophagus, stomach, and duodenum), (b) acid labile, (c) impermeable/insoluble compounds in GI fluids, (d) susceptible to first pass metabolism, and/or (e) cause stomach irritation, upset, or dyspepsia.

Abstract: This invention pertains to a multi-layered tablet for a triple combination release of active agents to an environment of use. More particularly, the invention pertains to a multi-layered tablet (1) comprising two external drug-containing layers (2 and 3) in stacked arrangement with respect to and on opposite sides of an oral dosage form (4) that provides a triple combination release of at least one active agent. In one embodiment of the invention the dosage form is an osmotic device. In another embodiment of the invention the dosage form is a gastro-resistant coated core. In yet another embodiment of the invention the dosage form is a matrix tablet. In a different embodiment the dosage form is a hard capsule.

Abstract: The present invention relates to methods for producing particles of diclofenac using dry milling processes as well as compositions comprising diclofenac, medicaments produced using diclofenac in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of diclofenac administered by way of said medicaments.

Abstract: Polymeric matrices for the controlled release of medicaments for the topical transdermal use comprising copolymers of acrylic and/or methacrylic acid or esters thereof having a Tg lower than 0.degree. C., whose free carboxy groups are salified with compatible organic or inorganic bases. The matrices of the invention allow to prepare therapeutical systems for the controlled-release of active principles through the transdermal route, thus solving stability, solubility and/or bioavailability problems of the active ingredient within the matrix.

Abstract: The present invention relates to new compositions and methods for protecting neuronal cells from ischemic or hypoxic events. More precisely, this invention provides new combinatorial therapies that efficiently protect neuronal cells from ischemia or hypoxia.

Abstract: The present application relates to novel substituted 8-alkoxy-2-aminotetraline derivatives, to processes for their preparation, to their use for the treatment and/or prevention of diseases and to their use for preparing medicaments for the treatment and/or prevention of diseases, in particular for the treatment and/or prevention of cardiovascular disorders.

Abstract: A nasal delivery device for and method of delivering a substance, preferably comprising oxytocin, non-peptide agonists thereof and antagonists thereof, preferably as one of a liquid, as a suspension or solution, or a powder to the nasal airway of a subject, preferably the posterior region of the nasal airway, and preferably the upper posterior region of the nasal airway which includes the olfactory bulb and the trigeminal nerve, and preferably in the treatment of neurological conditions and disorders.

Abstract: Levothyroxine, also known as L-thyroxine, synthetic T4, or 3,5,3?,5?-tetraiodo-L-thyronine, CAS number 51-48-9, is a synthetic form of thyroxine, used as a hormone substitute for patients with thyroid conditions. The invention relates to a method for the preparation of an oral levothyroxine composition. The method according to the invention results in liquid levothyroxine formulations that have improved storage stability compared to known liquid levothyroxine formulations.

Abstract: Disclosed are methods of treating subjects having conditions related to angiogenesis including administering an effective amount of a polymeric form of thyroid hormone, or an antagonist thereof, to promote or inhibit angiogenesis in the subject. Compositions of the polymeric forms of thyroid hormone, or thyroid hormone analogs, are also disclosed.

Abstract: A method for a prevention and/or treatment of irritable bowel syndrome or amelioration of a symptom thereof in a subject, comprises administering to said subject an effective amount of a compound of formula I:

Abstract: Tetrasubstituted benzenes that act as modulators of gamma secretase and their use in the treatment of one or more symptoms of treating neurodegenerative disorders, e.g., Alzheimer's disease, are described.

Abstract: Novel calcilytic compounds and methods of using them are provided.

Abstract: Methods of treating or reducing biofilms, treating a biofilm-related disorder, and preventing biofilm formation using polyamines is described.

Abstract: An ophthalmic preparation and method, usable to treat conjunctivochalasis. The ophthalmic preparation comprises an aqueous solution of glycerol. The preparation may also include additional components including high molecular weight polymers for viscosity control and pharmacologically active substances. The method includes administering an ophthalmic preparation including an aqueous solution of glycerol to a patient.

Abstract: Methods of treating or reducing biofilms, treating a biofilm-related disorder, and preventing biofilm formation using polyamines is described.

Abstract: A process for obtaining therapeutically active 2-[4-(3- and 2-(fluorobenzyloxy)benzylamino]propanamides, and their salts with pharmaceutically acceptable acids with high purity degree, in particular, with a content of dibenzyl derivatives impurities lower than 0.03%, preferably lower than 0.01% by weight. The process is carried out by submitting the Schiff bases intermediates 2-[4-(3- and 2-fluorobenzyloxy)benzylideneamino]propanamides to a reduction reaction with a reducing agent selected from sodium borohydride and potassium borohydride in an appropriate amount of an organic solvent selected from C1-C5 lower alkanols, allowing the formation and presence during a substantial position of the reduction reaction course of a suspension of the Schiff base into the saturated solution of the Schiff base into the same organic solvent.

Abstract: The invention relates to beneficial topical pharmaceutical compositions comprising diclofenac sodium salt in unusually low amounts. The compositions represent opaque emulsion-gels, in which diclofenac is kept fully dissolved.

Abstract: The present application discloses a sustained release composition in pellet form, wherein the core of the pellet comprises: (a) a therapeutically effective amount of a medicament; (b) 0.5 to 50% by weight of a water-soluble polymer; and (c) 1 to 25% by weight of a water-insoluble polymer applied as an aqueous latex dispersion and subsequently the water is removed, wherein the sum of the percentages of the medicament, the water-insoluble polymer and the water-soluble polymer is equal to or less than 100%. It also discloses methods of making this composition.

Abstract: Provided are bromfenac organic salts and preparation method, composition and use thereof. The bromfenac organic salt has the structure as shown in the following Formula I, wherein A represents an organic base. Also provided are a method for the preparation of the bromfenac organic salt, a composition comprising the bromfenac organic salts, a use of the bromfenac organic salts or the composition thereof in manufacture of a medicament for treatment and/or prophylaxis of an inflammation or for analgesia, and a method for treatment and/or prophylaxis of an inflammation or for analgesia.

Abstract: A medicament tablet containing paracetamol (acetaminophen) as the (or an) active ingredient, and an encapsulated flavorant. The tablet may be swallowed in tablet form or may be dissolved or dispersed in water to form a palatable drink.

Abstract: The use of sGC stimulators, sGC activators alone, or in combination with PDE5 inhibitors for the prevention and treatment of fibrotic diseases, such as systemic sclerosis, scleroderma, and the concomitant fibrosis of internal organs.

Abstract: A transdermal gel including a complementary array of medicinal components has beneficial effects for pain relief in muscular and connective tissues. The medicinal components include active ingredients having a synergistic effect for permitting musculoskeletal movement by countering the symptoms of musculoskeletal pain and being non-narcotic for avoiding dependency, and are combined in a liposomal base with a wetting agent to form a gel consistency suitable for skin application. The transdermal gel allows topical application of greater quantities and concentrations of the active ingredients than could safely be obtained via conventional oral administration.

Abstract: A pharmaceutical composition for the treatment or acute disorders is described. The composition comprises an essentially water-free, ordered mixture of at least one pharmaceutically active agent in the form of microparticles which are adhered to the surfaces of carrier particles which are substantially larger than the particles of the active agent or agents, and are essentially water-soluble, in combination with the bioadhesion and/or mucoadhesion promoting agent. The invention also relates to a method for preparing the composition and to the use of the composition for the treatment of acute disorders.

Abstract: Formulation of long-acting and controlled release preparations of 2-[(3-chlorophenyl)amino] phenylacetic acid (23CPPA) are disclosed. Long-acting preparations comprise a slow-release formulation coated onto a pharmaceutical composition containing 23CPPA, protect against gastric irritation, slow absorption of 23CPPA, extend release of 23CPPA, protect against excessively high 23CPPA blood concentrations, and prolong maintenance of blood concentrations of 23CPPA after administration. Controlled release formulations comprise (a) a core element which is a compressed tablet containing a therapeutic dose of 23CPPA and an amount of a solubility modulating substance that controls the release of said 23CPPA in order to provide a therapeutic level over a period of about 24 hours; and (b) on the outer surface of the core element, a sufficient amount of an enteric coating that causes the 23CPPA to release at a rate that permits the use of once-a-day dosing to maintain steady state therapeutic levels of 23CPPA.

Abstract: A method for relieving menstrual pain and reducing menstrual blood loss in a female is provided. The method comprises administering intravaginally to the female a first therapeutically effective amount of a non-steroidal anti-inflammatory drug (NSAID) that relieves menstrual pain and a second therapeutically effective amount of an active agent that reduces menstrual blood loss, wherein the NSAID and the active agent are simultaneously administered by the same drug delivery device, wherein the active agent is any one of an antifibrinolytic agent and a hemostatic agent.

Abstract: The present invention provides a gel formulation comprising diclofenac sodium which has superior transdermal flux properties, which may be used for the topical treatment of pain, such as in osteoarthritis.

Abstract: The invention provides for the use of an accordion pill comprising levodopa for the treatment of symptoms of Parkinson's disease in a subject in need thereof over a 24 hour period, to be administered to the subject in a twice daily administration regimen, with an interval of about 8 to about 10 hours between the first dose and the second dose, and with an interval of about 14 to about 16 hours between the second dose and the first dose of the following day. The twice daily administration regimen provides a stable blood plasma level of levodopa in the subject after multiple administrations and is effective in treating the symptoms of Parkinson's disease over a 24 hour period.

Abstract: Food or beverage compositions fortified with thyronines and/or thyronamines, processes for increasing T2, T1AM, and/or T0AM in a subject by administering a food or beverage composition that is fortified with at least one thyronine and/or thyronamine compound, and processes for promoting a healthy state by administering a food or beverage composition to a subject that is fortified with at least one thyronine and/or thyronamine compound. Increased levels of T2, T1AM, and/or T0AM in a subject can be associated with at least one of healthy cholesterol levels, healthy triglyceride levels, healthy blood sugar levels, cardiovascular health, healthy sleep patterns, healthy mood, healthy skin, healthy nails, or healthy endocrine function and/or a number of other markers of associated with general health and well-being.

Abstract: Different polymorphs of bromfenac sodium may be prepared and interconverted using crystallization/recrystallization, drying and/or hydration techniques.

Abstract: Different polymorphs of bromfenac sodium may be prepared and interconverted using crystallization/recrystallization, drying and/or hydration techniques.

Abstract: The present invention relates to compositions and methods for the treating and empirically investigating conditions associated with neuronal dysfunction (e.g., chronic pain, epileptic neuronal activity). In particular, the present invention provides compositions and methods for using flufenamic acid in the treatment and empirical investigation of conditions associated with neuronal dysfunction (e.g., chronic pain, epileptic neuronal activity).

Abstract: A method is provided for treating pain in patients recovering from post-surgical trauma by administering between about 13 to about 30 mg of diclofenac potassium in a liquid dispersible formulation over a period of at least 24 hours, wherein the daily total amount of diclofenac potassium administered is less than or equal to about 100 mg. The method is particularly useful in treating acute pain in bunionectomy patients.

Abstract: The present invention provides pladin (plasma anti-diabetic nucb2 peptide) polypeptide and functional equivalent thereof that are useful for treating diabetes. The present invention provides a method of treating diabetes by administering to a subject nesfatin-1, pladin, or a functional equivalent thereof. The present invention also provides a method of treating diabetes by administering to subject plasmin inhibitors.

Abstract: Described are stable liquid formulations of nitrogen mustards. The nitrogen mustard includes mechlorethamine, cyclophosphamide, ifosfamide, melphalan, chlorambucil, uramustine, thiotepa and combinations thereof. The formulation includes a non-aqueous liquid having at least a first solvent either individually or in combination with one or more additional solvents. The formulation further includes an antioxidant, an organic acid, and a source of chloride ions.

Abstract: A pharmaceutical dosage form for the release of at least one pharmaceutically active ingredient is claimed. The pharmaceutical dosage form includes a polymer matrix, polymer-lipid nanoparticles incorporated within the matrix and the pharmaceutically active ingredient(s). The polymer matrix is formed from at least two crosslinked cationic and anionic polymers, such as Eudragit® E100 and sodium carboxymethlycellulose. It can also include a neutral polymer, such as one derived from locust bean. The polymer-lipid nanoparticles are formed from at least one polymer, such as Eudragit® E100 and/or chitosan, and at least one phospholipid, such as lecithin. The polymer(s) and phospholipid are crosslinking with a chelating agent, such as sodium tripolyphosphate. The active ingredient or ingredients can be any pharmaceutically active compound(s), and in particular poorly absorbed compounds such as levodopa for the treatment of Parkinson's disease.

Abstract: A synergistic combination of a vanilloid receptor VR-1 antagonist and an NSAID or a pharmaceutically acceptable salt or solvate of either or both compounds thereof.

Abstract: A pH responsive and mucoadhesive pharmaceutical dosage form for the release of a pharmaceutically active agent is described. The dosage form includes a mucoadhesive layer for site-specific mucoadhesion, a water-insoluble outer layer, and an intermediate layer including one or more pharmaceutically active agents for site-specific delivery. The different membranous layers perform different functions in order to create a drug delivery system which is able to deliver a drug to a specific site, for a particular period of time and with a specific drug release pattern. The dosage form can have two or more intermediate layers, each layer comprising an active agent. The mucoadhesive layer can also include an active agents. The dosage form is preferably an oral or buccal delivery form for release of the active agent into the gastro intestinal tract. The intermediate layer can be an electrospun fibrous membrane layer containing the active agent.

Abstract: The present disclosure is drawn to topical formulations, transdermal systems, and related methods. In one embodiment, a topical formulation is provided that includes a local anesthetic, a first compound, and a second compound. The first compound and second compound are different and each is selected from the group consisting of N-lauroyl sarcosine, sodium octyl sulfate, methyl laurate, isopropyl myristate, oleic acid, glyceryl oleate, and sodium lauryl sulfoacetate.

Abstract: Stable aqueous solutions comprising concentrations of baclofen in the range of greater than 2.0 mg/mL up to about 10 mg/mL are disclosed. These solutions can be used as pharmaceuticals for parenteral or oral administration. The invention also provides methods of preparing said stable aqueous baclofen solutions.

Abstract: This disclosure relates to methods and compositions for modulating disease resistance in plants and transgenic plants.

Abstract: The present invention relates to methods of treatment for Parkinson Disease (PD) in a person by identifying gene variants which may indicate a more favorable response to specific medicaments, thereby allowing for personalized or individualized treatment. The present invention relates to a method of screening for a genetic predisposition to PD in a person. The present invention is also directed to a method of testing a person for the presence of particular gene variants, wherein the presence of a gene variant indicates a higher predisposition to PD, and the absence of a gene variant indicates a lower predisposition to PD, compared to a control sample. The present invention further relates to methods and kits for treating, or inhibiting the development of, PD in a person. The present invention is also directed to a method of identifying the heritage of an individual based on the genetic profile of the individual.

Abstract: The present invention is directed to pharmaceutical compositions comprising antispasmodic C4-C8aliphatic-1,2-diols and C4-C8aliphatic-1,2,3-triols and their use to relieve the spasms associated with pain. These agents may be administered topically or orally and may be combined with anti-inflammatory agents such as a non-steroidal anti-inflammatory drug or a corticosteroid. Administration of the C4-C8aliphatic-1,2-diols and C4-C8aliphatic-1,2,3-triols with vitamin D3 is indicated for conditions such as bone loss, weight gain and autoimmune diseases such as lupus and rheumatoid arthritis.

Abstract: AKR1B1 (EC 1.1.1.21) is an aldose reductase that has mainly been associated with the polyol pathway, and more recently with lipid deperoxidation. We have discovered that the primary activity of this enzyme is rather a PGFS activity, catalyzing the transformation of PGH2 into PGF2?. AKR1B1 as a therapeutic target, and method for modulating its expression and activity are provided. Methods for regulating the expression and activity of PGF2? are also provided.

Abstract: Embodiments are directed to compositions and related methods for treating gastrointestinal disorders with a granulated mesalamine formulation. In some embodiments, the gastrointestinal disorder being treated is irritable bowel syndrome (IBS). In some embodiments, the gastrointestinal disorder being treated is diarrhea-predominant IBS (d-IBS).

Abstract: A plant disease control composition comprising, as an active ingredient, a compound of formula (I) or a salt thereof, and one or more anilinopyrimidine compounds selected from the group consisting of 4,6-dimethyl-N-phenyl-2-pyrimidinamine, 4-methyl-N-phenyl-6-(1-propynyl)-2-pyrimidinamine and 4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine has an excellent plant disease control effect.

Abstract: A pharmaceutical composition for application in human and animals, with at least one systemically and/or locally acting, topically applicable active ingredient and with at least one phospholipid, improving the transport of the active ingredient trough the cell membrane and containing a concentration of at least 60% by weight phosphatidylcholine, referring to the phospholipid, is described. The composition shows such a liquid consistency, that it is able to be sprayed as droplets or as a foam, whereas in the composition such a phospholipid is included, that additionally contains oil in a concentration of maximum 7.5% by weight besides the at least 60% by weight phosphatidylcholine.