Abstract: The invention provides pharmaceutical stable semisolid topical compositions comprising between 0.2 to 5% of a des-fluoroquinolone compound, and a suitable carrier to manufacture an ointment or a cream.

Abstract: Nanolipidic Particles (NLPs) having average mean diameters of 1 nm to 20 nm are made from a precursor solution. NLPs can be loaded with a desired passenger molecule. Assemblies of these particles, called NLP assemblies, result in a vehicle population of a desired size. Single application or multifunction NLP assemblies are made from the loaded NLPs and range in size from about 30 nm to about 200 nm. A method of using preloaded NLPs to make larger carrier vehicles or a mixed population provides increased encapsulation efficiency. NLPs have application in the cosmetics, pharmaceutical, and food and beverage industries.

Abstract: The invention provides a peptide derivative of formula A-B-C wherein A is a polycationic nucleic acid-binding component; B is a spacer element peptide that is susceptible to cleavage within a cell; and C is a cell surface receptor binding component. The invention also provides a lipid derivative of general formula (I): (PEG)q-Linker-Spacer-Cationic headgroup-carbon skeleton-(hydrophobic chain)o wherein: the Linker is a group susceptible to cleavage within a cell; the Spacer is a group linking the Linker to the Cationic headgroup; q denotes the number of PEG chains and q=1, 2 or 3; o denotes the number of hydrophobic chains and o=1, 2 or 3; the carbon skeleton is a group linking the hydrophobic chains to the cationic headgroup. The peptide and lipid derivatives find use in non-viral gene delivery systems.

Abstract: Acid-containing oral pharmaceutical compositions are provided wherein the pharmaceutical active agents are peptide compounds (i.e., those that include a plurality of amino acids and at least one peptide bond in their molecular structures). Certain barrier layers and/or particulate coated acid are used to reduce any adverse interactions that might otherwise occur between the acid of the compositions and other components of the composition. Use of these barrier layers and/or use of particulate coated acid is believed to promote a more simultaneous release of the components of the composition than is achieved by prior art acid-protection techniques, thus enhancing, and making more consistent, the bioavailability of the active peptide compounds.

Abstract: Described herein are implant devices, kits comprising the implant devices, and methods of making and using the devices and kits. In one aspect, a plurality of implant devices comprises at least two implants that exhibit a different release profile of a bioactive agent. In another aspect, an implant device comprises one or more adjoined polymer bodies, wherein at least two of the polymer bodies provide a different release profile of a bioactive agent. In another aspect, a kit comprises one or more disclosed implant devices. In another aspect, methods of delivering a bioactive agent to a subject comprise administering to the subject one or more disclosed implant devices.

Abstract: The described invention provides a biodegradable, biocompatible delivery system of flowable sustained release microparticulate composition of a substantially pure crystalline form of a bioactive agent such as, for example, nimodipine, a process of preparing a therapeutic form of a substantially pure crystalline form of the bioactive agent and a method for treating an interruption of a cerebral artery in a subarachnoid space at risk of interruption caused by brain injury in a mammal, which reduces signs or symptoms of at least one delayed complication associated with brain injury.

Abstract: The instant invention provides hydrophilic matrix beadlet compositions that include at least one fat soluble nutrient and an effective amount of cellulose polymer with low viscosity. The invention also provides a process for the preparation of the hydrophilic matrix composition by employing a fluid bed system or extrusion spheronization technique. This hydrophilic matrix beadlet composition is comprised of at least 5% to about 25% carotenoid wherein free lutein is present in combination with zeaxanthin. The free flowing nature of the composition allows it to be compressed into tablets or to be filled into two piece capsules or blended as a dry premix for beverage applications. These hydrophilic matrix compositions exhibit desired dissolution characteristics and at least 1.6 times more bioavailability as compared with marketed reference formulations containing modified starch, thus making it advantageous for nutraceutical applications.

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: Pharmaceutical compositions are provided which comprise effective amounts of analgesic to treat a subject, including to reduce or eliminate an adverse effect associated with the analgesic.

Abstract: A new pharmaceutical formulation for retinoid-containing soft gelatin capsules is disclosed. The new formulation comprises a soft gelatin capsule filled with a fill mass comprising a retinoid as an active ingredient, a natural vegetable oil, a partially hydrogenated natural vegetable oil and medium chain triglycerides. Optionally, the new formulation also comprises a natural wax. In a particularly preferred embodiment, the soft gelatin capsule comprises pig gelatin in the capsule shell in combination with the above fill mass.

Abstract: A konjac formulation in the form of a capsule, including between 85 and 95 parts by weight of konjac gum, between 5 and 10 parts by weight of black rice, between 0.5 and 2 parts by weight of biological Fe, and between 0.5 and 2 parts by weight of vitamin.

Abstract: A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc.) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once-daily oral administration to maintain an adequate plasma concentration—time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.

Abstract: Disclosed herein are methods and compositions for alleviating side effects of statin administration, such as myopathic or myalgic side effects, short-term memory loss, abnormal liver function, glucose intolerance, hyperglycemia, increased risk for diabetes, or cumulative trauma disorder, comprising administration of ?-hydroxy ?-methylbutyrate (HMB) to an individual taking a statin. Also disclosed are methods and compositions for alleviating acute rhabdomyolysis comprising administration of HMB. The disclosure further provides uses of HMB in combination with a statin to alleviate side effects of statin administration.

Abstract: An organ protectant solution which is intravenously administered includes a high concentration of cell-impermeant molecules and at least one oncotic agent. The cell-impermeant molecules preferentially load into the interstitial space and the oncotic agent(s) is/are restricted to the vasculature space. Together, they promote transfer of water from cells to interstitium and into the capillaries, thereby preventing or reducing cell swelling, and maintaining blood circulation and oxygenation of tissues. The organ protectant solution extends the “Golden Hour” for traumatic and/or hemorrhagic shock patients, thereby allowing more time for those patients to reach a point of care facility to receive medical treatment.

Abstract: The present invention discloses novel agents and methods for diagnosis and treatment of melanoma. Also disclosed are related arrays, kits, and screening methods.

Abstract: An object of the present invention is to provide a regulatory dendritic cell inducing agent applicable to the treatment of immune disease as well as an immune tolerance inducing agent such as a preventive and/or therapeutic agent for allergic disease and a preventive and/or therapeutic agent for autoimmune disease, both of which are safe and have the mechanism of action different from that of conventional drugs. As a means for achieving the above object, an immune tolerance inducing agent comprising 5-aminolevulinic acid (ALA) or a derivative thereof, or a salt of the 5-ALA or the derivative and an iron compound as active ingredients is prepared. Preferable examples of the ALAs can include ALA and various esters such as methyl ester, ethyl ester, propyl ester, butyl ester, and pentyl ester of ALA, and their hydrochlorides, phosphates, and sulfates. Preferable examples of the iron compound can include sodium ferrous citrate.

Abstract: A topically applied circulation enhancing agent suited for application over the entire body which has good transdermal absorptivity and causes little irritation is provided.

Abstract: A therapy for renal diseases characterized by alterations of the kidney function, such as Chronic Kidney Disease (CKD), acute and chronic renal impairment, and renal diseases that develop in diabetic patients or in patients who underwent an anticancer chemotherapic treatment with a platinum derivative. The invention is a combination of compounds selected from mono- or diamide of a C12-C20 monocarboxylic acid, saturated or monounsaturated, or a C4-C14 dicarboxylic acid, saturated or monounsaturated, with an aminoalkanol, and compounds selected from Silymarin, derivatives thereof or conjugates or complexes thereof, for use in the treatment of renal diseases.

Abstract: Model systems have shown that shifting a cell's reliance from oxidative phosphorylation (OXPHOS) to glycolysis can protect against cell death. Exploiting the therapeutic potential of this strategy, however, has been limited by the lack of clinically safe agents that remodel energy metabolism. The present invention identifies non-toxic small molecules (e.g., drug-like compounds) that are capable of modulating oxidative metabolism. One identified compound comprises meclizine. As described herein, meclizine, and its enantiomer S-meclizine, redirects OXPHOS to glycolysis. Such compounds could be protective or therapeutic in degenerative disorders such as diabetes, Huntington's, Parkinson's, and Alzheimer's disease and/or ischemic disorders including, but not limited to, stroke, heart attack, or reperfusion injuries.

Abstract: The invention relates to (among other things) oligomer-containing pyrrolidine compounds. A compound of the invention, when administered by any of a number of administration routes, exhibits one or more advantages over corresponding compounds lacking the oligomer.

Abstract: Methods of sedating a patient undergoing critical care treatment using intravenous gaboxadol are provided.

Abstract: The invention provides compositions and methods for the induction of cell death, for example, cancer cell death. Combinations of compounds and related methods of use are disclosed, including the use of compounds in therapy for the treatment of cancer and selective induction of apoptosis in cells. The disclosed drug combinations can have lower neurotoxicity effects than other compounds and combinations of compounds.

Abstract: The invention provides improved methods for coadministration of colchicine with drugs metabolized by CYP3A4 (anciently referred to as cytochrome P450 isozyme 3A4) or the P-glycoprotein transporter, but not both. The method enables non-toxic coadministration of colchicine and the second drug at their ordinary levels safely and effectively without reducing the dose or frequency for either drug.

Abstract: The present invention relates to the use of triazinones such as triazinediones and triazinetriones for triazinetriones for the preparation of compositions for treating animals, in particular treating animals prophylactically, against parasitic protozoans, and to these compositions.

Abstract: A method for preventing or treating a disease selected from the group consisting of visceral pain, inflammatory pain, osteoarthritis pain, neuropathic pain, and fibromyalgia in a subject in need thereof, comprising administering to said subject an effective amount of the compound of the following formula (I) or a salt thereof: wherein R1, R2, R3, R4, R5, X and n are as described herein.

Abstract: The subject invention concerns materials and methods for treating depression, stress disorders, such as PTSD, anxiety disorders, and/or a neurodegenerative disease or condition in a person or animal. In one embodiment, a person or animal in need of treatment is administered one or more compounds or drugs, or a composition comprising the one or more compounds or drugs, that inhibit FKBP51 activity or function. The subject invention also concerns a method for inhibiting activity of the FKBP51 protein in a cell. The subject invention also concerns methods of screening for compounds or drugs that inhibit the FKBP51 protein.

Abstract: Solutions for perioperative intraocular application by continuous irrigation during ophthalmologic procedures are provided. These solutions include multiple agents that act to inhibit inflammation, inhibit pain, effect mydriasis (dilation of the pupil), and/or decrease intraocular pressure, wherein the multiple agents are selected to target multiple molecular targets to achieve multiple differing physiologic functions, and are included in dilute concentrations in a balanced salt solution carrier.

Abstract: Provided is a fat or oil composition, comprising the following components (A) and (B): (A) 0.4 to 6 mass % of a free type triterpene alcohol; and (B) 0.2 to 3 mass of a free type phytosterol containing 20 mass % or more of ?-sitosterol, in which a content mass ratio of the free type triterpene alcohol (A) to the free type phytosterol (B), [(A)/(B)], is 0.9 or more.

Abstract: The invention described herein relates to the use of an aqueous composition containing at least one phospholipid. at least one glycyrrhizic acid or salts of glycyrrhizic acid for the manufacture of mediciments for the removal of subcutaneous fat accumulation.

Abstract: An object of the present invention is to provide an orally ingestible composition that has a lipolysis-promoting effect and an angiotensin-converting enzyme (ACE) inhibitory effect and has no problems with safety as a food such as side effects or toxicity, and a food or drink and a supplement comprising the composition. As a result of diligent studies on various food materials to provide a composition for foods having a lipolysis-promoting effect and an ACE inhibitory effect, the present inventor has found that a composition prepared by using a salmon milt extract, a beer yeast extract, a barley grass extract, and chicken collagen in combination has an excellent lipolysis-promoting effect and an ACE inhibitory activity. A food or drink and a supplement having a lipolysis-promoting effect and an ACE inhibitory effect can be provided by using the composition of the present invention as an active ingredient.

Abstract: Antimicrobial, non-hemolytic cationic polyamines were prepared by treating partially N-acylated polyethylenimines and/or partially oxidized polyethylenimines with a protic acid. The cationic polyamines can have a linear or branched polyethylenimine backbone structure. Preferably, the cationic polyamines comprise pendant urea groups, which can be introduced via a cyclic carbonate comprising a pendant urea group. The cationic polyamines can be active against a tuberculosis mycobacterium at low concentration. The cationic polyamines are also effective against Gram-negative Escherichia coli and Pseudomonas aeruginosa, Gram-positive Staphylococcus aureus, and fungus Candida albicans in solution and in the form of a film.

Abstract: Methods of treatment of diseases that include or are characterized by inappropriate or pathological neovascularization are disclosed. These diseases include diseases of the eye, such as diabetic retinopathy, retinopathy of prematurity, and choroidal neovascularization which can occur in age-related macular degeneration (AMD). Disclosed methods include applying to macrophages in cell culture an agent that causes upregulation of ABCA1 transporter protein, and administering the macrophages to a subject. The agents include, without limitation, LXR agonists. Administration routes can include, without limitation, intraocular, periocular, and systemic administration.

Abstract: There is provided a method of inducing differentiation of bone marrow stromal cells to neural cells or skeletal muscle cells by introduction of a Notch gene. Specifically, the invention provides a method of inducing differentiation of bone marrow stromal cells to neural cells or skeletal muscle cells in vitro, which method comprises introducing a Notch gene and/or a Notch signaling related gene into the cells, wherein the finally obtained differentiated cells are the result of cell division of the bone marrow stromal cells into which the Notch gene and/or Notch signaling related gene have been introduced. The invention also provides a method of inducing further differentiation of the differentiation-induced neural cells to dopaminergic neurons or acetylcholinergic neurons. The invention yet further provides a treatment method for neurodegenerative and skeletal muscle degenerative diseases which employs neural precursor cells, neural cells or skeletal muscle cells produced by the method of the invention.

Abstract: A dietary supplement composition and associated method has its composition formulated in a therapeutic amount to treat and alleviate symptoms of joint pain in a person having joint pain. The composition includes astaxanthin, low molecular weight hyaluronic acid or sodium hyaluronate (hyaluronan) having a molecular weight of 0.5 to 300 kilodaltons (kDa), and a phospholipid rich egg roe extract having phospholipid bound EPA and DHA admixed with seed and/or fish oil having an ALA to LA ratio of 1:1 to 6:1 and in an oral dosage form.

Abstract: The invention provides a new lactic acid bacteria (LAB) strain with immunomodulatory and anti-inflammatory activity and a composition containing and method using the same. The LAB of the invention can be administrated for modulating an immune response in order to restore or prevent metabolic disorders caused by obesity or chronic inflammation.

Abstract: The present invention is directed to the field of phage therapy for the treatment and control of bacterial infections. In particular, the present invention is directed to the novel bacteriophage F387/08, F391/08, F394/08, F488/08, F510/08, F44/10, and F125/10, isolated polypeptides thereof, compositions comprising one or more of the novel bacteriophage and/or isolated polypeptides, as well as to methods for the treatment and prevention of bacterial infections using same, either alone or in combination with other antibacterial therapies, e.g., antibiotics and/or other phage therapies.

Abstract: The present invention utilizes the pre-sporulation (preconidial) mycelial stage of entomopathogenic fungi and extracts of the preconidial mycelium as insect and arthropod attractants and/or pathogens. The preconidial preparations can be employed to limit the zoonotic and plant diseases they transmit. The fungus can be cultivated on grain, wood, agricultural wastes or other cellulosic material and extracts can be made thereof. More than one fungus and substrate can be used in combination with one or more antimicrobial, antiprotozoal, antiviral, or genetically modified agents that result in reduced spread of contagions and lessens the damage they inflict on animals and plants.

Abstract: The present invention aims to provide a DPP-4 inhibitor that is obtained by using a food as a raw material and that is suitable for oral ingestion from the viewpoints of flavor and absorbability, and a composition for the prevention and/or amelioration of diabetes which contains the DPP-4 inhibitor. The present invention provides a DPP-4 inhibitor obtained by treating an azuki bean or a kidney bean with a microorganism or a proteolytic enzyme produced by the microorganism. In particular, a preferable DPP-4 inhibitor can be obtained by hydrolyzing an azuki bean with a koji mold or a proteolytic enzyme derived from the koji mold to fragment a protein in the azuki bean.

Abstract: The present invention provides nucleic acids encoding B7-related factors that modulate the activation of immune or inflammatory response cells, such as T-cells. Also provided are expression vectors and fusion constructs comprising nucleic acids encoding B7-related polypeptides, including BSL1, BSL2, and BSL3. The present invention further provides isolated B7-related polypeptides, isolated fusion proteins comprising B7-related polypeptides, and antibodies that are specifically reactive with B7-related polypeptides, or portions thereof. In addition, the present invention provides assays utilizing B7-related nucleic acids, polypeptides, or peptides. The present invention further provides compositions of B7-related nucleic acids, polypeptides, fusion proteins, or antibodies that are useful for the immunomodulation of a human or animal subject.

Abstract: Embodiments are directed to compositions and methods of treating migraine and related neurological disorders. In certain aspects, methods and compositions are for reducing cortical spreading depression and/or suppressing the neurochemical basis for chronic and acute migraine events, and provide methods and pharmaceutical compositions related to both acute and preventive therapies for migraine events and related headaches. In particular embodiments, treatment involves IL-11, interferon-gamma, or an IGF inducer such as IGF-1 or insulin.

Abstract: The present invention provides a composition (e.g., a pharmaceutical composition) comprising at least one delivery agent compound and at least one of peptide YY (PYY) and a PYY agonist. Preferably, the composition includes a therapeutically effective amount of peptide YY or the PYY agonist and the delivery agent compound. The composition of the present invention facilitates the delivery of PYY, a PYY agonist, or a mixture thereof and increases its bioavailability compared to administration without the delivery agent compound. PPY and PYY agonists possess activity as agents to reduce nutrient availability, including reduction of food intake.

Abstract: The present invention encompasses a composition capable of delivering and expressing a nucleic acid encoding UDP-Glucuronosyltransferases, p53 or a combination thereof into a cell, and methods for treating tumors.

Abstract: Provided herein are consensus amino acid sequences of prostate antigens that are capable of breaking tolerance in a targeted species, including PSA, PSMA, STEAP and PSCA antigens. Also provided are nucleic acid sequences that encode one or more consensus amino acid sequences of prostate antigens PSA, PSMA, STEAP and PSCA, as well as genetic constructs/vectors and vaccines expressing the sequences. Also provided herein are methods for generating an autoimmune response against prostate cancer cells by administering one or more of the vaccines, proteins, and/or nucleic acid sequences that are provided.

Abstract: The present invention relates to novel Salmonella mutants, to a process for producing same and to vaccines containing same, wherein said Salmonella mutants are characterized in that they elicit a humoral response that can be distinguished from the humoral response elicited by the wild type strains. It is accordingly an object of the present invention to provide the use of said Salmonella mutants as serological marker strains in the vaccination of animals, in particular mammals and birds, more in particular cattle, poultry and pigs. The serological marker vaccine is of special value in animal farming and provides a (long-lasting) immunization against a wide range of Salmonella strains. The novel mutants are non-reverting and can be used for the efficient immunization of mammals and birds.

Abstract: There is provided a vaccine for controlling Clostridium perfringens in animals, and particularly necrotic enteritis in poultry. The vaccine may comprise a C. perfringens antigenic polypeptide or variant thereof, a nucleic acid encoding the C. perfringens antigenic polypeptide or variant thereof, or a recombinant cell producing the C. perfringens antigenic polypeptide or variant thereof.

Abstract: The invention provides expression vectors and virus-like particles (VLPs) containing Newcastle Disease Virus Sequences in combination with sequences encoding proteins of interest. The vectors are useful in, for example, generating virus-like particles (VLPs) that contain proteins of interest. In one embodiment, the expressed VLPs elicit an immune response by an animal host against the protein. The invention's VLPs are useful as, for example, vaccines.

Abstract: An immunogenic composition having 13 distinct polysaccharide-protein conjugates and optionally, an aluminum-based adjuvant, is described. Each conjugate contains a capsular polysaccharide prepared from a different serotype of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) conjugated to a carrier protein. The immunogenic composition, formulated as a vaccine, increases coverage against pneumococcal disease in infants and young children globally, and provides coverage for serotypes 6A and 19A that is not dependent on the limitations of serogroup cross-protection.

Abstract: The invention provides methods, uses and compositions for the treatment of rheumatoid arthritis. The invention describes methods and uses for treating rheumatoid arthritis wherein a TNF? inhibitor, such as a human TNF? antibody, or antigen-binding portion thereof. Also described are methods for determining the efficacy of a TNF? inhibitor for treatment of rheumatoid arthritis in a subject.

Abstract: PVRL4 is a tumor marker that is highly expressed on the surfaces of many carcinomas. Disclosed herein are compositions and methods that provide impetus for using measles virus as an oncolytic agent against PVRL4+ carcinomas and use of PVRL4-binding agents to interfere with viral infection.

Abstract: The present invention provides methods and compositions for the remote control of cell function based on the use of radiofrequency waves to excite nanoparticles targeted to specific cell types. The nanoparticles may be applied to the target cell extracellularly and/or expressed intracellularly. The cell type of interest expresses a temperature sensitive channel wherein excitation of the nanoparticles results in a localized temperature increase that is transduced into a cellular response. Such cellular responses may include, for example, increases in gene expression resulting in production of one or more physiologically active proteins. The expression of such proteins can be used to treat a variety of different inherited or acquired diseases or disorders in a subject. Accordingly, the invention provides a generic approach for treatment of any disease associated with a protein deficiency.