Abstract: The present invention relates to polypeptide variants of the HMGB-1 high affinity binding domain Box-A (HMGB1 Box-A) or to a biologically active fragment of HMGB1 Box-A, which are obtained through systematic mutations of single amino acids of the wild-type HMGB1 Box-A protein and which show an increased resistance to proteases and which are therefore characterized by more favourable pharmacokinetic and pharmacodynamic profiles. Moreover, the present invention concerns the use of said polypeptide molecules of HMGB1 Box-A to diagnose, prevent, alleviate and/or treat pathologies associated with extracellular HMGB1 and associated with RAGE.

Abstract: A copolymer comprising a block of an elastin pentapeptide and method of making and using the copolymer are provided.

Abstract: A bone replacement material that is, in particular, paste-like and is characterized in that particulate calcium carbonate is suspended in an aqueous solution that contains at least one water-soluble hemostatic agent, whereby the aqueous solution contains an amount of the hemostatic agent at which it is isotonic.

Abstract: An implantable or insertable medical device suitable for gene or cell therapy regimens, and method of making and using same are disclosed. The medical device contains a biocompatible structure carrying a genetic material. The biocompatible structure includes a polymeric coating that coats at least a portion of the structure. The genetic material includes a first therapeutic agent comprising a vector containing a first polynucleotide sequence that establishes a gene expression sufficient to produce a therapeutically sufficient amount of one or more products encoded by said first polynucleotide; and a second therapeutic agent comprising at least one of (i) a second polynucleotide carried by a carrier, (ii) a protein; (iii) a non-genetic therapeutic agent, or (iv) cells. The medical device and method of this invention facilitate successful integration as and a long term expression of one or more genetic-based and non-genetic based products within a patient's body.

Abstract: A method of treating tissue lyophilizes a biocompatible polymer having a functionality equal to or greater than three. The method provides a protein solution. The method mixes the protein solution with the lyophilized polymer to reconstitute the polymer and form a mixture, wherein, upon mixing, the protein solution and the polymer cross-link to form a material composition. The method applies the material composition to a tissue region. The biocompatible polymer can comprise, e.g., poly(ethylene glycol) PEG. The protein solution can comprise, e.g., albumin.

Abstract: Compositions and methods are provided for treatment of cartilage defects in animals and humans. The compositions of the invention include synovial tissue, synovial cells and matrices containing synovial (or cambium) tissue or cells for use in filling a cartilage defect. The matrix and synovial tissue or cell preparations may also contain a proliferation agent, transforming factor or other active agents to promote healing. A controlled-release delivery system may be used to administer the transforming factor. The compositions of the invention also include a synovial covering membrane or devitalized fascial sheet for covering the cartilage defect. The methods of this invention are those in which a minimally invasive surgical intervention is performed to remove a small portion of synovial membrane from a joint. Portions of the synovial membrane, or cells expanded in vitro, are implanted alone or within a matrix, into the defect site, where they produce new cartilage tissue and repair the defect.

Abstract: A method of treatment, including separately delivering a treatment agent and a barrier having a binding member to a tissue, the binding member having a property adapted to couple to a surface of the tissue, wherein the barrier is present in an amount sufficient to permit transport of the treatment agent from the tissue at a lower rate than transport in the absence of the barrier component, wherein the barrier is biodegradable and hinders transport of the treatment agent away from the tissue but allows the treatment agent to migrate toward the tissue.

Abstract: This invention provides for biocompatible and biodegradable syringeable liquid, implantable solid, and injectable gel pharmaceutical formulations useful for the treatment of systemic and local disease states.

Abstract: Lacrimal canalicular inserts include a polymeric component and a therapeutic component. The therapeutic component is released from the inserts for extended periods of time, such as for more than about 2 weeks after placement in a lacrimal canaliculus of an individual. The polymeric component may include one or more non-biodegradable polymers, one or more biodegradable polymers, or combinations thereof. The therapeutic component may include one or more therapeutic agents. Therapeutically effective amounts of the therapeutic component are released from the insert and provide sustained drug delivery to the eye and/or the nasolacrimal system of the individual.

Abstract: The invention relates to the use of a food-approved emulgator in the preparation of a preparation intended for the prevention of fat absorption, to a nutrient composition containing an emulgator for the prevention of fat absorption, and to a functional food characterized in that it contains an effective amount of a food-approved emulgator.

Abstract: Disclosed herein are antigens that stimulate protective antibodies against enterotoxigenic Escherichia coli. Also disclosed herein are proteins encoded by cssA and cssB genes as well as constructs containing the genes and methods of using thereof.

Abstract: Compositions and methods to achieve vasodilation through nitric oxide production pathways and Angiotensin II inhibition pathways using bovine lactoferrin and whey derived angiotensin converting enzyme inhibiting peptides are provided. Other nitric oxide ingredients may be added as well for sports nutrition applications. Such compositions and methods achieve a “pump”, which is increased blood flow and blood engorging the muscles.

Abstract: There are provided a prophylactic and/or therapeutic composition for a liver disease which contains an amino acid having an insulin-sensitivity enhancing action as an active ingredient, and a prophylactic and/or therapeutic composition for a liver disease which contains at least one amino acid selected from the group consisting of aspartic acid, alanine, cystine, glutamine, glycine, histidine, and salts thereof.

Abstract: Stabilized bacteriophage compositions, and methods for preparing stabilized bacteriophage compositions are provided. The method for producing an antibacterial composition involves adsorbing an aqueous solution of one or more bacteriophages, or one or more phage components, onto a matrix to produce a composition, and drying the composition to produce the antibacterial composition. An antibacterial composition comprising one or more strain of bacteriophage, or one or more phage component, adsorbed onto a matrix is also provided. The antibacterial composition may also be encapsulated. The antibacterial composition, or the encapsulated antibacterial composition, may be used within a cream, lotion or gel, be admixed with a pharmaceutical carrier and administered topically, orally, nasally, used as a powdered inhalant, or the antibacterial composition or encapsulated antibacterial composition, may be added to a feed for animal, aquatic or avian uses.

Abstract: A method for improving liver clearance of xenobiotic substances in an animal by feeding the animal lipoic acid in amounts of from about 10 mg to about 1000 mg per day.

Abstract: [Problem] Lotion tissue paper made of thin paper impregnated with a moisturizing component, which is able to leave a skin moist to keep a moisturizing feeling in the skin and in which the moisture hardly transpires even under a dry condition. [Means for Resolution] Hygienic thin paper for household use made of thin paper impregnated with a moisturizing component, wherein at least one member selected from the group consisting of a natural moisturizing factor and an intercellular lipid of a stratum corneum is contained as the foregoing moisturizing component, and a difference in the moisture content between a lapse of 4 hours and a lapse of 8 hours when allowing to stand within a dryer setup at 105° C. is not more than 5%. The foregoing component selected from the group consisting of a natural moisturizing factor and an intercellular lipid of a stratum corneum can be combined with, for example, at least one member of an amino acid, an amino acid salt, an amino acid derivative, and ceramide.

Abstract: Disclosed are therapeutic hydrogels for atopic dermatitis and a method for preparing the same. The hydrogels comprises a biocompatible polymer, a polyalcohol, and a medicinal plant extract. The hydrogels can carry medicinally effective ingredients for a sustained period of time and absorb wound exudates properly. The hydrogels have suitable gel strength and, when applied to a wound, can prevent bacterial infection of the wound. Moreover, the methods employing radiation allow the polymer chains to be crosslinked to each other, and also bring about a sterilization effect in the final hydrogel. There are no problems of toxic residues in the hydrogels. They are easy to attach to the skin and concomitantly provide a cool feeling. Supported by the laminate of hydrophilic non-woven fabric sheet and polyethylene film, the hydrogel retain water for a prolonged period of time and thus are useful in the treatment of contact dermatitis and atopic dermatitis.

Abstract: The invention relates to dosing systems which involve water-soluble or water dispersible products containing ingredients embedded within and/or coated upon a water-soluble film which are released at a prescribed rate into an aqueous environment through one or more perforated less readily soluble water-soluble films. The dosing system can be used for delivering pharmaceutical active ingredients externally or internally to a human or animal body, and can be embodied in the form of a patch that is applied to a site to be treated via a water soluble adhering layer (1) that adheres to the site with ingredients(s) provided by a carrier layer (3) sandwiched between a perforated layer (2) for delivery of the ingredients to the site and a non-perforated protecting layer (4).

Abstract: The invention relates to a would care product that provides a biochemical environment around a wound to promote wound healing. The wound care product includes a keratin protein fraction material in which the protein fraction is intact, is from the intermediate filament protein family or the high sulfur protein family and in which the protein fraction is S-sulfonated. The invention also described a method of making a wound care product.

Abstract: The patch preparation of the present invention is a patch preparation comprising a backing and an adhesive layer provided on the backing; wherein, the adhesive layer contains (A) a volatile organic acid and (B) a basic drug; the molar concentration ratio [(MA)/(MB)] between the molar concentration (MA) of the component (A) and the molar concentration (MB) of the component (B) in the adhesive layer is 0.5 or more; and the component (B) contains a basic drug formed as an ion pair with an anion component.

Abstract: The present invention provides a T cell activator comprising an antigen-bound phospholipid membrane, wherein the phospholipid membrane comprises a phospholipid having an acyl group having one unsaturated bond and 14 to 24 carbon atoms or a hydrocarbon group having one unsaturated bond and 14 to 24 carbon atoms, and a phospholipid membrane stabilizer, and wherein the antigen is bound to the surface of the phospholipid membrane.

Abstract: Use of an anti-inflammatory agent such as povidone iodine for the preparation of a pharmaceutical composition for the treatment of diseases of the lower respiratory tract which are susceptible to the administration of such agents.

Abstract: Enantiomerically pure S-etifoxine and pharmaceutically acceptable salts, solvates, hydrates or prodrugs thereof are provided. Also provided are pharmaceutical compositions comprising the compounds and methods of treating disorders associated with central nervous system using the compounds and pharmaceutical compositions.

Abstract: The invention relates to a stable pharmaceutical formulation comprising an intimate admixture or admixture of crystalline or amorphous atorvastatin calcium, and a stabilizing-effective amount of a water-insoluble alkaline excipient or a combination of one or more water-insoluble alkaline excipients thereof, a stabilizing-effective amount of an antioxidant or a combination of one or more antioxidants thereof, and at least one or more additional pharmaceutically acceptable inert excipients or carriers, and a method for the preparation of the said formulation by wet and dry granulation. The invention further relates to a stabilized intimate admixture of atorvastatin calcium, a water-insoluble alkaline excipient and an antioxidant and a method for the preparation of the said intimate admixture by co-precipitation and co-milling.

Abstract: The present invention provides a drug delivery system comprising nanoparticles or microparticles of a water poorly soluble drug dispersed in a polymeric bead containing essentially only of hydrophilic polymers (i.e. without hydrophobic polymers). The present invention further provides a method of producing the drug delivery system of the invention.

Abstract: A system for producing a hot-filled softgel capsule utilizes a chilled liquid. The chilled liquid is routed through a chilled liquid conveyor tray into a chilled liquid bath. The chilled liquid conveyor tray directs the flowing chilled liquid into a flowing chilled liquid layer. Softgel capsules having a heated fill material are deposited in the flowing chilled liquid layer. The chilled liquid layer cools the capsule by transferring heat from the capsule to the chilled liquid. The flowing chilled liquid layer transports the capsule out of the chilled liquid conveyor tray into a chilled liquid bath. A capsule transfer conveyor transports the capsule out of the chilled liquid bath to a chilled liquid removal device. The chilled liquid removal device removes the chilled liquid from the capsule.

Abstract: This invention relates to the development of a composition formulation and method employed to alter the absorption site of orally administrated drugs, to promote the absorption of bioactive lipophilic and/or hydrophilic compounds from the gastrointestinal tract, and as a result to increase drug bioavailability. Applications of the methods and formulations according to the invention are also described. The composition formulation comprises pharmaceuticals or nutraceuticals (hydrophilic and/or lipophilic compounds) in combination with one or more organic solvents and one or more acid protectants. The composition formulation is formulated into a dosage form, which is in conformity with pharmaceutical or nutraceutical requirements, is administrated orally to facilitate the absorption, and can avoid undesired degradation and metabolism of pharmaceuticals and nutraceuticals in the gastrointestinal tract thereby increasing their overall bioavailability.

Abstract: This invention relates to a solid pharmaceutical composition that include a regulating agent of digestive and/or intestinal motility which has an agonist effect on peripheral ?, ? and ? opiate receptors; and an antiflatulent for the treatment and regulation of intestinal motility and flatulence in mammals. More in particularly, the pharmaceutical composition includes: (a) at least a regulating agent of intestinal motility such as trimebutine; (b) at least an antiflatulent such as simethicone; (c) at least a flowability promoter; (d) one or more lubricant; (e) at least an extender/diluent; (f) at least a disintegrant; and, (g) at least a binder.

Abstract: A smectite dispersible tablet and the preparation progress thereof are disclosed, which is a new pharmaceutical formulation of smectite comprising smectite, a filler and a disintegrant. The dispersible tablet is stable in quality, can disintegrate quickly and disperse homogeneously, which is easy in dosage control, convenient in transportation and packaging, and has a flavor taste, a smooth surface as well as a uniform color.

Abstract: The invention provides a rapidly disintegrating and dissolving multilayer tablet comprising at least a tetracycline in a first layer, a buffer in a second layer, and optionally, an inert layer separating the first and second layers. The multilayer tablets of the invention are useful for treating or preventing mucositis, when administered topically to the oral cavity.

Abstract: Provided are a solid dosage form comprising a solid dispersion that allows a drug in the preparation to be rapidly dissolved without compromising the solubility of the solid dispersion, and a method for producing the same. More specifically, provided is a solid dosage form comprising a solid dispersion, the dispersion comprising: a poorly soluble drug, a water-soluble polymer and a disintegrant, wherein the disintegrant is low-substituted hydroxypropylcellulose having an average particle size of 10 to 100 ?m and a specific surface area measured by BET method of at least 1.0 m2/g. Moreover, provided is a method for producing a solid dosage form comprising a solid dispersion, the method comprising steps of: spraying a water-soluble polymer solution in which a poorly soluble drug has been dispersed or dissolved, on a powder of low-substituted hydroxypropylcellulose having an average particle size of 10 to 100 ?m and a specific surface area measured by BET method of at least 1.

Abstract: Provided are a solid dosage form comprising an enteric solid dispersion that allows a drug in the preparation to be rapidly dissolved without compromising the solubility of the solid dispersion, and a method for producing the same. More specifically, provided is a solid dosage form comprising an enteric solid dispersion comprising a poorly soluble drug, an enteric polymer and a disintegrant, wherein the disintegrant is low-substituted hydroxypropylcellulose having an average particle size of 10 to 100 ?m and a specific surface area measured by BET method of at least 1.0 m2/g. Moreover, provided is a method for producing a solid dosage form comprising an enteric solid dispersion, the method comprising steps of: spraying an enteric polymer solution in which a poorly soluble drug has been dispersed or dissolved, on a powder of low-substituted hydroxypropylcellulose having an average particle size of 10 to 100 ?m and a specific surface area measured by BET method of at least 1.

Abstract: Dipeptidylpeptidase IV inhibitor (herein referred to as DPP-IV) that may be 98.5-100% pure is a high-dose drug capable of being directly compressed with specific excipients into sold form dosage forms, such as tablets and capsules having desired, hardness, disintegrating ability and acceptable dissolution characteristics. DPP-IV is not inherently compressible and thus presents formulation problems. Excipients used in the formulation enhance the flow and compaction properties of the drug and tableting mix. Optimal flow contributes to uniform die fill and weight control. The binder used ensures sufficient cohesive properties that allow DPP-IV to be compressed using the direct compression method. The tablets produced provide an acceptable in vitro dissolution profile.

Abstract: The present invention relates to a stable pharmaceutical composition comprising an ACE inhibitor or a pharmaceutically acceptable salt or derivative thereof. In particular, the invention relates to a pharmaceutical composition, which comprises an ACE inhibitor, or a pharmaceutically acceptable salt or a derivative thereof, and a C16-C28 glyceride. ACE inhibitors useful in the present invention are susceptible to heat and/or mechanical stress-induced degradation. Preferred ACE inhibitors are ramipril, trandolapril, quinapril and pharmaceutically acceptable salts and derivatives thereof. The composition of the present invention may be for use as a medicament for the treatment or prevention of a cardiovascular disease, a coronary heart disease, a cerebrovascular disease, a peripheral vascular disease, arrhythmia, hypertension, cardiac failure, cardiovascular death, myocardial infraction, stroke or angina.

Abstract: The present invention relates to solid pharmaceutical compositions, in particular to oral contraceptives, comprising a progestogen, such as drospirenone; an estrogen, such as ethinylestradiol; a tetrahydrofolic acid or a pharmaceutically acceptable salt thereof, such as calcium 5-methyl-(6S)-tetrahydrofolate; and at least one pharmaceutical acceptable excipient or carrier. The compositions of the invention provide good stability of the tetrahydrofolic acid upon storage while still ensuring a fast and reliable release of the estrogen and the progestogen present in the composition.

Abstract: To provide a sustained-release solid pharmaceutical preparation having a quick-release part and a sustained-release part and stably having an excellent quick releasing characteristic with little pH dependency in an initial dissolution. The present invention relates to that, in a preparation containing a medical ingredient as an effective ingredient, particularly active analgesic ingredient, a sustained-release solid pharmaceutical preparation which is characterized in that it is a solid pharmaceutical form having a quick-release part and a sustained-release part and contains effective ingredient in both parts and the quick-release part contains a partly pregelatinized starch and a low substituted hydroxypropylcellulose as additives.

Abstract: The present invention relates to pharmaceutical compositions, formulations and medicaments comprising a bupropion salt, in particular, modified-release tablets comprising an effective amount of bupropion hydrobromide, and the use of the bupropion salt to prepare a medicament to treat a condition.

Abstract: The invention is directed to a Pharmaceutical extended release system, particularly for oral administration, of a pH-dependent water-soluble active substance, comprising or essentially consisting of a) flibanserin or a pharmaceutically acceptable derivative thereof as active substance; b) one or more pharmaceutically acceptable pH-dependent polymers; c) one or more pharmaceutically acceptable pH-independent polymers; d) one or more pharmaceutically acceptable acids; and e) optionally one or more additives. The present invention provides a release profile of flibanserin which is independent on the pH in the gastrointestinal tract when administered orally resulting in a significantly improved bioavailability.

Abstract: The present invention provides pharmaceutical release systems comprising an therapeutically effective amount of flibanserin and at least one pharmaceutically acceptable excipient, characterized in that said pharmaceutical release systems exhibit a pharmacokinetic profile that is characterized by an average maximum flibanserin plasma concentration Cmax lower than 300 ng/mL, preferably lower than 200 ng/mL after administration of a single dose to healthy volunteers in fasted state or directly after a meal.

Abstract: The present invention relates to pharmaceutical compositions, formulations and medicaments comprising a bupropion salt, in particular, modified-release tablets comprising an effective amount of bupropion hydrobromide, and the use of the bupropion salt to prepare a medicament to treat a condition.

Abstract: Peptide Nucleic Acid (PNA) antisense specific for inducible nitric oxide (iNOS) wherein the PNA compound is composed from nucleic acid sequence targeting iNOS, a peptide ligand which binds to a specific receptor, a positively charge moiety and an hydrophobic moiety. The invention also relates to the use of these compounds for the treatment of multiple sclerosis, neurodegenerative disorders, acute brain insults or other diseases where iNOS is involved.

Abstract: The peroral medication for prevention of conception contains as one active ingredient crystalline 17?-cyanomethyl-17?-hydroxyestra-4,9-dien-3-one (dienogest) at a daily dosage equal to or less than 2.0 mg and as another active ingredient 17?-ethinyl estradiol at a daily dosage of less than 0.030 mg, together with one or more pharmaceutically acceptable carriers. The active ingredient dienogest is contained in the medication in crystalline form with an average particle size of preferably 25 to 70 ?m. The other active ingredient ethinyl estradiol is incorporated during granulation in micronized form or by spraying an ethanolic solution containing it.

Abstract: A carrier matrix may be delivered to a target position within a patient in a minimally invasive manner by first cutting a collagen sponge sheet into a plurality of relatively small pieces. These pieces are sized so that, when wet, they are capable of flowing through a cannula and/or reduced-diameter syringe tip. The pieces are placed into a syringe and wetted, say with a morphogenic solution, and optionally mixed with a bulking material, which is similarly sized to fit through the cannula. The thoroughly mixed and wetted product forms a viscous aggregate which may then be injected into the patient at the target site.

Abstract: The invention is directed to formation and use of electroprocessed collagen, including use as an extracellular matrix and, together with cells, its use in forming engineered tissue. The engineered tissue can include the synthetic manufacture of specific organs or tissues which may be implanted into a recipient. The electroprocessed collagen may also be combined with other molecules in order to deliver substances to the site of application or implantation of the electroprocessed collagen. The collagen or collagen/cell suspension is electrodeposited onto a substrate to form tissues and organs.

Abstract: The present invention is in the field of polymer-based nano-carriers for the solubilization and delivery of hydrophobic drugs, and relates to methods of making said carriers, and to pharmaceutical compositions comprising said carriers. Novel PEO-b-PCL micelles and micelles containing cyclosporine A or analogs thereof are provided as well as a novel method for making said micelles that reduces aggregation and enhances delivery, the toxicity profile and biodistribution of hydrophobic drugs.

Abstract: The present invention is directed to polymeric matrices for the controlled release of a hydrophilic bioactive agent. Generally, the elution control matrix includes a polymeric matrix having a first polymer and a plurality of microparticles that include the hydrophilic bioactive agent. In one embodiment, the matrix includes a polymer comprising hydrophilic and hydrophobic portions. In another embodiment, the microparticles include a crosslinked hydrophilic polymer.

Abstract: Bioadhesive steroid nanoparticles are used to prepare a rapidly disintegrating solid oral dosage form of steroid. The bioadhesive steroid nanoparticles have a bioadhesive polymer surrounding the steroid nanoparticles and with an average diameter of less than 1000 nm. Hence, the solid oral dosage form, containing the bioadhesive steroid nanoparticles, a disintegrant and an effervescent agent, instantly disintegrates in the oral cavity and adheres on the periodontal pocket and oral mucosa to release steroid rapidly.

Abstract: A process for producing a powder comprises spray freeze-drying an aqueous solution or suspension comprising a pharmaceutical agent, said solution or suspension having a solids content of 20% by weight or more. The spray freeze-dried powder may be administered to a subject via a needleless syringe.

Abstract: The invention relates to an inhalation powder for treating migraine, containing the CGRP antagonist 1-[N2-[3,5-dibromo-N-[[4-(3,4-dihydro-2(1H)-oxoquinazolin-3-yl)-1-piperidinyl]carbonyl]-D-tyrosyl]-L-lysyl]-4-(4-pyridinyl)-piperazine [BIBN4096] of formula I as the active substance base in the form of spherically nanostructured microparticles, and a process for the manufacture thereof.

Abstract: Dry powder formulations of drugs such as antihistamine for nasal administration are provided where the drug is retained in the nasal cavity, and systemic side effects minimized or eliminated, through the selection of a narrow particle size range, between approximately 10 and 20 microns in diameter. In a preferred embodiment wherein the drug is an antihistamine, retention of the antihistamine at the nasal mucosa is improved and the bitter aftertaste associated with liquid antihistamine formulations significantly reduced. By making a dry powder formulation of an antihistamine (e.g., azelastine) having an average particle size of between 10 and 20 microns, the antihistamine is restricted primarily to the desired target organ, the nasal mucosa. Because the active ingredient stays in the nasal region, a lower dose can be used to achieve the same desired effect.