Abstract: Compositions and methods for the treatment of pain in a mammal are described. More specifically, a dosage form designed for release of acetaminophen and an opioid is described, wherein the dosage form provides delivery of the drugs to the upper gastrointestinal tract (“GI”) of a mammal for an extended period of time.

Abstract: The invention relates to methods for treating T cell mediated autoimmune diseases, such as psoriasis and multiple sclerosis, in a human in need thereof, wherein a therapeutically effective amount of a substance which lowers the cellular glutathione content is administered to the human.

Abstract: The agrin protein was shown to be important in preventing the development of neuropathic pain, as well as in treating neuropathic pain. Both agrin protein and gene expression were shown to be down-regulated in mammals with neuropathic pain. Increasing either agrin gene expression or protein resulted in a decrease in the development of neuropathic pain. Agrin protein or the C-terminal agrin fragments can be administered in a number of ways, preferably by intrathecal injection. In addition, agrin can be increased by administering a compound shown to affect agrin gene expression or agrin protein concentration, e.g., SCP-I and SCP-M1 (also known as JMM). Agrin protein decrease was shown to be prevented by administering an NMDA receptor antagonist, e.g., MK801. Agrin and a C-terminal agrin fragment also induced phosphorylation of the NMDA receptor subunit NR1 at the serine residue site which led to suppression of neuropathic pain.

Abstract: A dual adhesive layer dosage form for delivery of active agent to and across, the mucosa is disclosed. Particularly, bioadhesive tablets for administration at the vaginal mucosa are disclosed as having a central active layer sandwiched between two bioadhesive layers.

Abstract: This invention relates to an oramucosal pharmaceutical dosage form in the form of a wafer. The wafer comprises a porous, hydroscopic, muco-adhesive polymeric matrix with at least one desired pharmaceutically active compound added thereto. The polymer is selected from a number of polymers having different dissolution rates and, in use when taken orally, the matrix adheres to an oramucosal surface to dissolve over a predetermined period of time to release the pharmaceutically active compound. The invention also extends to a method of manufacturing an oramucosal pharmaceutical dosage form in the form of a wafer which involves freeze drying or lyophilisation.

Abstract: The present invention provides a pellet formulation comprising colloidal silicon dioxide (CSD) and one or both of a surfactant and a plasticiser. A process for the production of 5 said formulation is also provided.

Abstract: This invention pertains to an orally disintegrating multilayer tablet wherein it comprises at least two discrete layers, one of which comprises at least one active agent that promotes the oxidation of opioids, preferably acetaminophen, and the other of which contains granules including an inert core which is coated with at least one opioid and at least one binder, wherein said opioid coating is coated with a subcoat comprising a compound soluble in gastric fluids, said subcoat being coated with a taste-masking coating comprising a polymer or copolymer comprising dialkylaminoalkyl(meth)acrylate units and optionally a pore-forming agent.

Abstract: The present, invention provides an oral delivery system for a therapeutic compound that is an acid, a salt of an acid or an unionized compound or a proactive form thereof with pharmacological, physiological or biochemical activity. The present invention particularly provides a swallow formulation comprising a therapeutic compound that is an acid, a salt of an acid or an unionized compound or a proactive form thereof which facilitates the rapid delivery of the therapeutic compound to the circulatory system.

Abstract: The present invention relates to a method of reducing a VR1-antagonist-induced increase in body temperature in a mammal in need thereof, comprising the step of administering an antipyretic agent to the mammal and the like.

Abstract: A method of combating prostate cancer in a mammalian individual, the method comprising administering an inhibitor of glycogen synthase kinase-3 (GSK-3), or a polynucleotide which encodes an inhibitor of GSK-3, to the individual. A further anti-cancer agent can also be administered. Use of an inhibitor of GSK-3, or a polynucleotide which encodes an inhibitor of GSK-3, in the preparation of a medicament for combating prostate cancer. The medicament may contain a further anti-cancer agent.

Abstract: The invention relates to a composition that includes a first agent selected including an agent that possesses anti-inflammatory activity or acetaminophen, phenacetin, tramadol and the like; a second agent selected from the group consisting of an oxidative phosphorylation inhibitor, an ionophore, and an adenosine 5-monophosphate-activated Protein kinase (AMPK) activator; a third agent that possesses or maintains serotonin activity.

Abstract: Palatable, solid oral formulations or compositions include at least one bioactive agent capable of chemical sterilization of human and animal males. Depending on the targeted species, the bioactive formulations comprise suitable additives, excipients, water-swellable compositions, and/or processing aids and can be made into uncoated or coated forms to modulate the release profile of the bioactive agents. Among the bioactive agents are zinc compounds and complexes and organic drugs with established pharmacological activities, which are traditionally unrelated to any form of contraception.

Abstract: Methods for concomitant administration of colchicine together with one or more macrolide antibiotics, e.g., clarithromycin or erythromycin, are disclosed. Such methods reduce the dangers commonly associated with such concomitant administration and provide additional benefits. Methods of notifying health care practitioners and patients regarding appropriate dosing for co-administration of colchicine together with macrolide antibiotics are also provided.

Abstract: The present invention is directed to co-administration of a non-steroidal anti-inflammatory agent (NSAID) and acetaminophen for the treatment of pain and inflammation with reduced gastrointestinal irritation. A pharmaceutical composition suitable for the co-administration contains a therapeutically effective amount of at least one non-steroidal anti-inflammatory agent, and a therapeutically effective amount of acetaminophen or a pharmaceutically acceptable salt thereof. A ratio of the non-steroidal anti-inflammatory agent to acetaminophen in the composition is within a range that provides greater pain relief and reduction of inflammation with less gastrointestinal irritation than that obtainable by the administration of the non-steroidal anti-inflammatory agent or acetaminophen alone. Examples of pharmaceutical compositions for co-administration of the agents are those containing ibuprofen in combination with the acetaminophen.

Abstract: A method for reducing the friability of soft substrates by applying an effective amount of a water soluble, polymeric dispersion to at least a portion of a treatment surface of the substrate, such that less than about 90% of the exterior surface has the dispersion applied thereto.

Abstract: Methods for treating gout flares comprising concomitant administration of colchicine together with one or more macrolide antibiotics, e.g., clarithromycin or erythromycin, are disclosed. Such methods reduce the dangers commonly associated with such concomitant administration and provide additional benefits. Methods of notifying health care practitioners and patients regarding appropriate dosing for co-administration of colchicine together with macrolide antibiotics are also provided.

Abstract: The present invention provides a taste-masking oral dosage form which comprises a taste-masked microparticle and an excipient. The taste-masked microparticle comprises a taste-masked crystal containing an active pharmaceutical ingredient masked by a hydrophilic polymer and a starch. The present invention also provides a method for making the taste-masked microparticles and taste-masking oral dosage form.

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: Stable ultrapure colchicine compositions comprising ultrapure colchicine and a pharmaceutically acceptable excipient are described. The compositions can be tablets. Methods for preparing such compositions and methods of use are also disclosed. Methods of treating gout flares with colchicine compositions are also disclosed.

Abstract: The invention relates to an aqueous paracetamol solution for administration by means of infusion with a pH of between 4.5 and 6, containing at least one substance that can react with fenolates to produce the O-derivatives thereofor other co-ordination compounds. The injectable paracetamol solution has high stability, does not become coloured over time and has a minimum impurity content.

Abstract: An aqueous pharmaceutical suspension comprising: (i) at least one non-steroidal anti-inflammatory drug; (ii) an aqueous buffer system; (iii) xanthan gum; (iv) polyvinyl pyrrolidone; and (v) glycerol wherein the suspension is free from pregelatinised starch, amino polycarboxylic acid, microcrystalline cellulose, hydroxypropylmethyl cellulose, polyoxyethylene sorbitan monooleate, silicon dioxide and taste modifying agents selected from the group consisting of bulk sweeteners, intense sweeteners, flavouring agents and mixtures thereof.

Abstract: Compounds of formula (I) wherein R1, R2, R3, m, and Y are defined in the specification are TRPA1 antagonists. Compositions comprising such compounds and methods for treating conditions and disorders using such compounds and compositions are also disclosed.

Abstract: This invention provides compounds which specifically inhibit TRPA1 but not other members of the thermoTRP ion channel family. Also provided in the invention are methods of using TRPA1-specific inhibitors to treat or alleviate pains mediated by noxious mechanosensation.

Abstract: The present invention relates to polymorphic forms of (3R,4R,5S)-5-amino-4-acetylamino-3-(1-ethyl-propoxy)-cyclohex-1-ene-carboxylic acid ethyl ester phosphate, which is a potent inhibitor of viral neuraminidase.

Abstract: Methods and compositions are provided which comprise effective amounts of analgesic to treat a subject, including reducing or eliminating an adverse effect associated with the analgesic.

Abstract: The invention provides a novel ?2 adrenergic receptor agonist in crystalline salt form. The invention also provides pharmaceutical compositions comprising the novel ?2 adrenergic receptor agonist in crystalline salt form, formulations containing the pharmaceutical compositions, methods of using the crystalline salt to treat diseases associated with ?2 adrenergic receptor activity, and processes useful for preparing such crystalline compounds.

Abstract: A microfiber extrudate and delivery process includes a bio-compatible polymer matrix forming a body of the microfiber extrudate, an exogenously excitable material arranged within the body, and an active load arranged within the body.

Abstract: A pharmaceutical composition such as a swallow tablet or capsule formulation is described comprising paracetamol, calcium carbonate, at least one binding agent and at least one disintegrating agent in the form of a granulate, optionally combined with one or more pharmaceutically acceptable extragranular components.

Abstract: A microcrystalline cellulose-based excipient having improved compressibility, whether utilized in direct compression, dry granulation or wet granulation formulations, is disclosed. The excipient is an agglomerate of microcrystalline cellulose particles and from about 0.1% to about 20% silicon dioxide particles, by weight of the microcrystalline cellulose, wherein the microcrystalline cellulose and silicon dioxide are in intimate association with each other. The silicon dioxide utilized in the novel excipient has a particle size from about 1 nanometer to about 100 microns. Most preferably, the silicon dioxide is a grade of colloidal silicon dioxide.

Abstract: The present invention discloses methods of application employing B5/B6 vitamins in molecular transport creams or gels to deliver B6 in a high dose to bring about therapeutic ways in human or mammal tissues to reverse a disease process or injury to bring about normal function of the affected tissues. Examples of disease changes to normal include, but are not limited to strokes, cellulitis, facial acne, precancerous lesions, nerve injury like paresthesia, periorbital hematoma, pentathol general anesthesia recovery, headaches, improved sight, hypothyroidism, dental pain, dental gingivitis, insect bites, delayed hypersensitivity states, phlebitis of veins and synergism of steroid activity.

Abstract: The invention relates to a capsule containing a heterogeneous mixture of active agents in the form of particles suspended in a liquid matrix and optionally active ingredients in the liquid matrix; the liquid matrix occupying less than the total internal volume of the capsule. The present invention further describes a capsule to allow the controlled-release of one or more active agents for specific desired benefits.

Abstract: A process for producing a granular composition comprising a plurality of solidified melt granules including a non-steroidal anti-inflammatory drug (NSAID) and paracetamol (acetaminophen), the process comprising the steps of: (a) forming a melt mixture by mixing a molten NSAID free acid and paracetamol, optionally with one or more excipients; and (b) forming the melt mixture into solidified melt granules. The granules are useable in compositions for treating pain and/or inflammation and/or fever.

Abstract: Described herein are compositions and methods for intravenous administration of acetaminophen at a single dose level of less than about 1000 mg for the treatment or prevention of pain (e.g., postoperative pain) and/or fever.

Abstract: A bimodal bioabsorbable polymer composition. The composition includes a first amount of a bioabsorbable polymer polymerized so as to have a first molecular weight distribution; a second amount of said bioabsorbable polymer polymerized so as to have a second molecular weight distribution having a weight average molecular weight between about 10,000 to about 50,000 Daltons, the weight average molecular weight ratio of said first molecular weight distribution to said second molecular weight distribution is at least about two to one; wherein a substantially homogeneous blend of said first and second amounts of said bioabsorbable polymer is formed in a ratio of between about 50/50 to about 95/5 weight/weight percent. Also disclosed are a medical device, a method of making a medical device and a method of melt blowing a semi-crystalline polymer blend.

Abstract: Certain 2-keto-oxazole compounds are described, which are useful as FAAH inhibitors. Such compounds may be used in pharmaceutical compositions and methods for the treatment of disease states, disorders, and conditions mediated by fatty acid amide hydrolase (FAAH) activity. Thus, the compounds may be administered to treat, e.g., anxiety, pain, inflammation, sleep disorders, eating disorders, or movement disorders (such as multiple sclerosis).

Abstract: Stable ultrapure colchicine compositions comprising ultrapure colchicine and a pharmaceutically acceptable excipient are described. The compositions can be tablets. Methods for preparing such compositions and methods of use are also disclosed. Methods of treating gout flares with colchicine compositions are also disclosed.

Abstract: The present invention is related to a lipid composition contained in and/or containing a carrier comprising at least a first lipid component, at least a first helper lipid, and a shielding compound which is optionally removable from the lipid composition under in vivo conditions, whereby the lipid composition containing carrier has an osmolarity of about 50 to 600 mosmole/kg, preferably about 250-350 mosmole/kg, and more preferably about 280 to 320 mosmole/kg, and/or whereby liposomes formed by the first lipid component and/or one or both of the helper lipid and the shielding compound in the carrier have a particle size of about 20 to 200 nm, preferably about 30 to 100 nm, and more preferably about 40 to 80 mm.

Abstract: The present invention relates to a process for stabilizing phenylephrine including drying an acidic solution of phenylephrine and pharmaceutical compositions including stabilized phenylephrine.

Abstract: Improved treatments of joint diseases, such as, e.g.

Abstract: There is described a compound selected from the group consisting of tramadol, resveratrol, acetaminophen, xorphanol, cinfenoac, furcloprofen, bismuth subsalicylate, enofelast, triflusal, ketorfanol, indriline, furofenac, cizolirtine, dacemazine, demelverine, and fenethazine, and derivatives and/or combinations thereof, for the treatment or alleviation of depression. There is also described a method of treating a patient suffering from depression.

Abstract: Disclosed herein is a orally disintegrating and/or dissolving oral pharmaceutical composition, comprising one or more active pharmaceutical ingredients, one or more fillers having particle size of 100 microns or above, a high and desirable amount of silicon dioxide, one or more disintegrating agents, optionally effervescent couple, wherein said composition has good organoleptic properties like desired mouth feel and fast oral disintegration time.

Abstract: The present invention relates to compositions, kits and methods for administration of a first component of fumaric acid ester(s), or a pharmaceutically acceptable salt thereof, and a second component which is a substance that reduces or eliminates flushing.

Abstract: The invention in question is a novel pharmaceutical formulation that comprises a one percent weight by volume Paracetamol in a phosphate buffer adjusted to pH 7.4 by addition of few drops of 1.0 N NaOH. The concentrations of the ingredients were chosen such that the resulting solution is isotonic with body fluids. Said concentrations were theoretically calculated based on their sodium chloride equivalents. The formulation is meant to be used as a nasal spray.

Abstract: Disclosed are improved cooling compositions comprised of N-(2-hydroxyethyl)-2,3-dimethyl-2-isopropylbutyramide and at least one other cooling agent. The cooling compositions may be used alone or in products such as a chewing gum or a confection.

Abstract: This invention related to methods of treating, preventing and managing various pulmonary diseases or disorders using formoterol in combination with calcium activated potassium channel openers. Pharmaceutical compositions comprising formoterol and calcium activated potassium channel openers are also disclosed.

Abstract: The present invention relates to a pharmacologic dosage unit which includes a multi-functional particulate system and a pharmacologically active agent. The multi-functional particulate system includes solid biologically-safe particles incorporated into a matrix and having a characteristic that each individual particle retains its original size. The invention also relates to methods of preparing, enhancing flow properties and compacting properties of a pharmacologic composition, increasing capacity for inclusion of ingredients, and increasing dispersion of actives. Finally, the invention includes a method for delivering an active agent to a patient.

Abstract: The present disclosure provides methods for preventing or treating illness, improving responsiveness to immunization, and improving the efficacy of gene therapy in a patient by disrupting sex steroid signalling in the patient, wherein the bone marrow and other immune cell functionality is improved without, prior to, or concurrently with, thymic regeneration. In some embodiments, sex steroid signalling is interrupted or ablated in the patient by the administration of LHRH agonists, LHRH antagonists, anti-LHRH receptor antibodies, anti-LHRH vaccines, anti-androgens, anti-estrogens, selective estrogen receptor modulators (SERMs), selective androgen receptor modulators (SARMs), selective progesterone response modulators (SPRMs), ERDs, aromatase inhibitors, or various combinations thereof.

Abstract: The present invention describes 1-aminoadamantane derivatives and 3-aminoadamantane-1-carboxylic derivatives in which the 5- or 7-position of the basic adamantane structure can be optionally substituted, methods for the production of the compounds based on the present invention, and methods for the coupling of the monomeric 3-aminoadamantane-1-carboxylic derivatives thus obtained to oligomers. The compounds based on the present invention are suitable for the utilisation as antiviral active ingredients, artificial ion channels, as well as for the therapy, diagnostics and prophylaxis of diseases in which a dysfunction of the GABA system occurs.

Abstract: Disclosed are multibinding compounds which are ?2 adrenergic receptor agonists and are useful in the treatment and prevention of respiratory diseases such as asthma, bronchitis. They are also useful in the treatment of nervous system injury and premature labor.

Abstract: The present invention relates to a compound of formula I, or a pharmaceutically acceptable salt thereof. Formula (I), wherein R1 and R2 are each independently H or alkyl; Y is an alkyl group. CONR3R4, COOR5SO2NR16R17, NHSO2R18 or CN; X is an aryl or heteroaryl group, each of which may be optionally substituted with one or more substituents selected from (CH2)mZ where Z is halogen, OH, CN, alkyl, alkoxy, NO2, CF3, CONR6R7, CN, NR8R9, COOR10 or NHCOR11 and m is 0 to 3; R3 to R11 are each independently H, alkyl or aryl, wherein said alkyl and aryl groups are optionally substituted by one or more substituents selected from halogen, OH, CN, alkyl, alkoxy, NO2, CF3, CONR12R13, CN, NH2, COOR14, NHCOR15, and CN; R12 to R18 are each independently H or alkyl, more preferably H or Me; n is 1 to 6; wherein the compound is other than 3?,5?-dimethyl-4-(1,1-dimethylheptyl)-1,1?-biphenyl-2-ol.