Abstract: The invention provides Helicobacter polypeptides, designated GHPO 1360 and GHPO 750, which can be used in vaccination methods for preventing or treating Helicobacter infection, and polynucleotides that encode these polypeptides.

Abstract: Compounds and methods for inducing protective immunity against tuberculosis are disclosed. The compounds provided include polypeptides that contain at least one immunogenic portion of one or more M. tuberculosis proteins and DNA molecules encoding such polypeptides. Such compounds may be formulated into vaccines and/or pharmaceutical compositions for immunization against M. tuberculosis infection, or may be used for the diagnosis of tuberculosis.

Abstract: The present invention relates to a new D-carbamoylase and the gene sequences which code for this from the organism Arthrobacter crystallopoietes DSM 20117. Plasmids, vectors, microorganisms, particular primers and specific possible uses of the enzymes according to the invention are also mentioned. The invention moreover describes a new process for the discovery of enzymes which can be employed in a process for the preparation of D-amino acids starting from 5′-substituted hydantoins.

Abstract: Compositions and methods for making and using therapeutic formulations of multivalent hybrid polypeptides comprising immunogenic peptides of M proteins from various different serotypes of group A streptococci and antibodies thereto are provided. Also provided are nucleic acids encoding such hybrid polypeptides. The hybrid polypeptide formulations may be used, for example, in methods for treating or preventing a microbial infection and eliciting a protective immune response having broadly protective opsonic antibodies in the absence of tissue cross-reactive antibodies.

Abstract: The present invention provides a method for treating a mammal with immunological disorders, particularly autoimmune disease, and most preferably systemic lupus erythematosus (SLE). The method includes oral administration of germination activated Ganoderma lucidum spores (“GLSs”) to the mammal. Additionally, a corticosteroid, such as prednisolone, can be co-administered with the GLSs to the mammal to achieve synergistic effect of treatment.

Abstract: A defined target for hepatitis and picornaviruses, and other viruses which utilize binding of the ribosomes to the internal ribosome entry site (“IRES”) of eukaryotic cells for viral protein translation, has been identified. Useful anti-viral compositions are compounds which block binding, physically or sterically, of the eukaryotic ribosome to the IRES to prevent translation of the viral proteins. The inhibitory molecule may bind to any ribosome subunit, initiation factor, or exposed site on the 40 S, 60 S, 48 S complex or 80 S complex in order to alter specificity of binding of the ribosome. The compounds are identified using the screening methods described herein from libraries of known compounds, including antibiotics. These compounds are then formulated for administration to a patient infected with or exposed to the virus.

Abstract: The present invention relates to polynucleotides encoding immunogenic HIV polypeptides. Uses of the polynucleotides in applications including immunization, generation of packaging cell lines, and production of HIV polypeptides are also described. Polynucleotides encoding antigenic HIV polypeptides are described, as are uses of these polynucleotides and polypeptide products therefrom, including formulations of immunogenic compositions and uses thereof.

Abstract: The invention provides a method for treatment of pain, the method comprising administering to the intrinsic spinal muscles of a mammal an amount of an agent sufficient to paralyze said muscles.

Abstract: Pharmaceutical compositions comprising a cyclosporin, e.g. Ciclosporin or [Nva]2-Ciclosporin, in “microemulsion pre-concentrate” and microemulsion form. The compositions typically comprise (1.1) a C1-5alkyl or tetrahydrofurfuryl di- or partial-ether of a low molecular weight mono- or poly-oxy-alkane diol, e.g. Transcutol or Glycofurol, as hydrophilic component. Compositions are also provided comprising a cyclosporin and (1.1) and, suitably, also a saccharide monoester, e.g. raffinose or saccharose monolaurate. Dosage forms include topical formulations and, in particular, oral dosage forms.

Abstract: As dermatological topical preparations formulated therein melanin production inhibitors which, unlike the conventional melanin production inhibitors, are stable with respect to heat and oxidation and which do no cause decomposition or pigmentation over time when added to topical agents, hydroquinone-&agr;-D-glucopyranoside, which shows superior inhibitory activities on human tyrosinase, is added as a melanin production inhibitor.

Abstract: &bgr;-Diketone/hydroxylated or carbonated activated cation inorganic/organic complexes are well suited for preventing, avoiding or reducing skin irritation, notably that elicited by exposure to irritant active agents/species or to the external environment.

Abstract: A skin care composition comprising about 20% to about 85% by weight water, about 2% to about 40% by weight stearic acid and about 2% to about 40% by weight glycerin, diglycerin, grapeseed oil or a combination thereof is described. The composition is particularly useful as a shaving cream.

Abstract: The present invention relates to the use of 24-membered cyclodepsipeptides of the formula (I) 1

Abstract: The invention relates to a material suitable for the reconstruction of an individual's tissue, in particular supportive tissue such as bone tissue, insertable into the tissue. It is characteristic that it is made up of wood heat-treated within the temperature range of 100-220° C. in the presence of water vapor. The invention also relates to the use of the material.

Abstract: Bio-decomposable polymer composition shows good thermal decomposition, wherein a drop of weight-average molecular controls within 30% of the initial after treatment of molding and radial sterilization, by adding free radical scavenger to the bio-decomposable polymer, in order to resolve the problem.

Abstract: The invention is directed to a drug delivery device for controlled release of a drug, comprising a core that has a cylindrical plug embedded therein; and a coating that at least partially surrounds the core. The core is comprised of a drug and excipients. The coating surrounding the core is essentially impermeable to the drug. The cylindrical plug, which is embedded in the core, may be hollow or solid. The drug delivery device enables zero-order drug release profiles as well as more complicated release profiles to be obtained. The invention is also directed to a method of making the drug delivery device.

Abstract: An improved demineralized bone matrix (DBM) or other matrix composition is provided that has been mixed with a stabilizing agent that acts as (1) a diffusion barrier, (2) a enzyme inhibitor, (3) a competitive substrate, or (4) a masking moiety. A diffusion barrier acts as a barrier so as to protect the osteoinductive factors found in DBM from being degraded by proteolytic and glycolytic enzymes at the implantation site. Stabilizing agents may be any biodegradable material such as starches, modified starches, cellulose, dextran, polymers, proteins, and collagen. As the stabilizing agents degrades or dissolves in vivo, the osteoinductive factors such as TGF-&bgr;, BMP, and IGF are activated or exposed, and the activated factors work to recruit cells from the preivascular space to the site of injury and to cause differentiation into bone-forming cells. The invention also provides methods of preparing, testing, and using the inventive improved osteodinductive matrix compositions.

Abstract: Azalide antibiotics such as azithromycin are useful in the treatment and prevention of infections by bacteria and other parasites. Stabilized aqueous compositions containing azithromycin suitable for administration without reconstitution are provided for. Also provided for are aqueous formulations suitable for ocular administration in a employing a convenient dosing formulation suitable for administration in depot formats.

Abstract: The present invention relates to a method for supplying bioavailable methionine to a cow which comprises supplying to the cow an ester of methionine or methionine amide and/or an ester of the hydroxy analogue of methionine or a salt thereof.

Abstract: Methods of reducing exposure to latex comprise forming an item comprising a biodegradable polyhydroxyalkanoate copolymer comprising two randomly repeating monomer units.

Abstract: A hygiene tissue to be used for cleaning and caring of the skin and the urogenital area, simultaneously delivers lactic acid producing bacteria, thereby establishing and maintaining a healthy microbial flora in these areas. The hygiene tissue is impregnated with a composition including a lactic acid producing bacterium/bacteria suspended in a lipid and optionally additional components. Encapsulating the lactic acid producing bacterium in a lipid provides a moisturefree environment enhancing the survival of the bacterium and keeping the bacterium fit for growth after delivery to the skin. By this approach, hygiene tissues, including lactic acid producing bacteria can be stored for long time periods. Also, the hygiene tissue improves the efficiency of transfer of the lactic acid producing bacterium to the skin and urogenital area. In addition, the lipid provides a cleaning function, so that the skin is cleaned simultaneously as the lactic acid bacteria is delivered.

Abstract: A disposable, single use dry cleansing cloth or wipe is provided. The cleansing cloth has a water insoluble substrate and a deposited cleansing composition having a lathering surfactant. The cleansing composition is deposited in an amount such that the cleansing composition rinses out after several re-wettings of said cloth.

Abstract: A pre-vaccination or pre-procedural topical anesthetic/antiseptic patch which functions not unlike a nicotine patch and which is essentially an adhesive bandage containing a topical anesthetic and a topical antiseptic. The bandage anesthetic/antiseptic carrying device may be of any shape or size. It is applied to a person's skin at a site where a needle is to be inserted such that the site will have a topical anesthetic and a topical antiseptic applied. When the bandage is removed from the site prior to a needle being inserted a visible delineation of a target area is visible on the skin. That is, that side of the bandage which contacts the skin will contain a demarcating fabric material, in the form of a circle or any other geometric shape, smaller than the diameter or size of the adhesive bandage, that will remain on the wearer's skin whereby when the bandage is removed the demarcating fabric material will delineate the site which is the “target” area.

Abstract: It has unexpectedly been found that the administration of high doses of riboflavin or derivatives thereof (including, but not limited to salts and prodrugs), results in an effective treatment for sepsis. Thus, the present invention provides methods for treating sepsis by administering to a subject in need thereof a high dose of a composition comprising riboflavin or derivatives thereof.

Abstract: The effective introduction of foreign genes and other biologically active molecules into targeted mammalian cells is a challenge still facing those skilled in the art. Gene therapy, for example, requires successful transfection of target cells in a patient. The present invention relates to novel micellar complexes of cationic amphiphilic compounds that facilitate delivery of biologically active molecules to the targeted cells of a mammal. The novel micellar complexes are comprised of a cationic amphiphile, a biologically active molecule, a derivative of polyethylene glycol (PEG), and optionally, a co-lipid. A further aspect of the invention is the use of targeting agents in any of the methods that effectuate the delivery of biologically active molecules into the cells of mammals. A targeting agent is usually any molecule, peptide sequence, or large protein that preferentially targets or binds to specific mammalian celis.

Abstract: The present invention provides a sugar-modified liposome having a sugar chain bonded to its membrane surface, preferably through a linker protein, and having excellent absorption qualities, particularly in the intestine. The molecular structure and quantity of the sugar chain is selectively varied to allow the liposome to be delivered in a targeted manner to selected cells and tissues. The liposome is applicable to medicinal drugs, cosmetics and other various products in the medical/pharmaceutical fields, and it is especially useful in a therapeutic drug delivery system that recognizes target cells and tissues, such as cancer cells, and in the delivery of drugs or genes locally to a selected region, or in a diagnostic cell/tissue sensing probe.

Abstract: A uniaxially compressed dosage form manufactured by three-dimensional printing that preserves the predetermined internal architecture of the dosage form while producing an improved surface finish. The compression compacts the dosage form, eliminating at least some of the void space that remains at the end of conventional three-dimensional printing. Surface finish obtained as a result of the uniaxial compression process can be essentially equal to that obtained from conventional tablet pressing. Additionally, the internal structure or spatial variation of composition of the dosage form is preserved during the pressing operation, with geometric shrinkage occurring mostly in the direction of the axis of pressing. Further, as a result of compression, a greater quantity of API can be packed into a given final volume of dosage form.

Abstract: Disclosed is an oral dosage form comprising (i) an opioid agonist in releasable form and (ii) a sequestered opioid antagonist which is substantially not released when the dosage form is administered intact, such that the ratio of the amount of antagonist released from said dosage form after tampering to the amount of said antagonist released from said intact dosage form is about 4:1 or greater, based on the in-vitro dissolution at 1 hour of said dosage form in 900 ml of Simulated Gastric Fluid using a USP Type II (paddle) apparatus at 75 rpm at 37 degrees C. wherein said agonist and antagonist are interdispersed and are not isolated from each other in two distinct layers.

Abstract: The present invention relates to a once daily extended release pharmaceutical preparation of Tramadol or its acceptable pharmaceutical salts.

Abstract: A pharmaceutical composition comprises one or more discrete orally deliverable dosage forms, each comprising a poorly soluble coxib component in an amount effective when administered once daily for treatment or prevention of a COX-2 mediated disorder, an aspirin component in a cardioprotective effective amount when administered once daily, and at least one pharmaceutically acceptable excipient; the dosage forms having no substantial barrier to intimate commingling of the coxib and aspirin components. A method of simultaneously treating or preventing a COX-2 mediated disorder and providing cardioprotection comprises orally administering such a pharmaceutical composition to a subject in need thereof.

Abstract: A pharmaceutical tablet as well as a process for manufacturing the tablet is described herein. More specifically, a tablet and process of manufacture is described where a drug having a defined rate of delivery is applied by compression onto a compressible coating deposited on a tablet having the same or a different in vivo drug release profile. For the compressible coating, an acrylic acid, methacrylic acid, or ester of either is the preferred monomer for making the polymer in the coating.

Abstract: Disclosed is an osmotic pharmaceutical delivery system comprising (a) a semi-permeable wall that maintains its integrity during pharmaceutical delivery and which has at least one passage therethrough; (b) a single, homogeneous composition within said wall, which composition consists essentially of (i) a pharmaceutically active agent, (ii) at least one non-swelling solubilizing agent which enhances the solubility of the pharmaceutically active agent; (iii) at least one non-swelling osmotic agent and (iv) a non-swelling wicking agent dispersed throughout the composition which enhances the surface area contact of the pharmaceutical agent with the incoming aqueous fluid.

Abstract: Balanced pH, hyperosmotic, hypoosmotic, or isoosmotic gels are ideal vehicles for drug delivery. They are especially suited for topical body cavity or injection application of drugs or diagnostic agents; for drug or diagnostic agent delivery to the eye of a mammal; as protective corneal shields; or as ablatable corneal masks useful in laser reprofiling of the cornea. The compositions without the addition of a drug or diagnostic agent are useful as medical devices, for instance, in separating surgically or otherwise injured tissue as a means of preventing adhesions.

Abstract: The invention relates to a composition for topical use containing, in a physiologically acceptable medium having an aqueous phase, at least one oxidation-sensitive hydrophilic active principle and at least one non-crosslinked N-vinylimidazole polymer or copolymer, the active principle and the said polymer or copolymer both being in the aqueous phase.

Abstract: Oral progesterone unit dosage forms comprising micronized progesterone and a solid polymeric carrier are provided. The dosage forms, upon oral administration, provide a therapeutically effective blood level of progesterone to a subject. The therapeutically effective blood level of progesterone may range from about 0.1 ng/ml to about 400 ng/ml. The dosage forms can be prepared for immediate as well as sustained release. The oral progesterone dosage form can be combined with an estrogen dosage form to provide combination hormone therapy.

Abstract: The invention provides bioadhesive composition having increased bioadhesive properties, decreased irritation, and the capacity for higher drug loading. The compositions of the invention comprise intimate mixtures of a polysaccharide and a polycarboxylated polymer, and optionally also an absorption enhancer.

Abstract: Drug delivery compositions which are suitable for vaginal administration for the treatment of diseases and disorders in the urogenital tract are described. The compositions may be in the form of a tablet, liquid suspension or dispersion, dried powder, topical ointment, cream, foam, suppository, or aerosol.

Abstract: A method for preparing microparticles having a selected polymer molecular weight. The hold time and temperature of a solution containing a nucleophilic compound and a polymer having a starting molecular weight are controlled in order to control the molecular weight of the polymer in the finished microparticle product. In this manner, a selected polymer molecular weight in the finished microparticle product can be achieved from a variety of starting material molecular weights.

Abstract: A treatment for dry eye and other eye problems using a plug system or a delivery system. The plug system comprises solid, porous or hollow microcapsules composed of a biodegradable biocompatible polymer. The capsules are stored in the form of a powder that can be suspended in an aqueous carrier solution or dispersed in a gel or an ointment. Alternatively a biodegradable biocompatible capsule having a treating agent encapsulated within a polymer shell or a polymer sphere, again stored in the form of a powder that can be suspended in an aqueous carrier solution or dispersed in a gel or an ointment. The plug system prevents excretion of the capsules and their size is larger then the punctum and to prevent entrance to the lachrymal excretory system. The treatment is slowly released into the eye through the polymer shell or sphere and/or gets secreted as the polymer degrades.

Abstract: Compositions of matter are described which contain restricted cancer cells. When so restricted, the cells produce an unexpectedly high amount of material which suppresses cancer cell proliferation. The phenomenon crosses cancer type and species lines. Processes for making these compositions, and their use, are also described.

Abstract: The present invention relates to a naturally occurring low molecular weight adenosine A3 receptor agonist (LMW-A3RAg) which is preferably obtained from a vertebrate tissue or a vertebrate-derived cell by extraction in a liquid medium. The LMW-A3RAg of the invention is characterized by the following feature: (i) it is obtainable from animal-derived tissue or cells; (ii) it filters through a filter with a maximal molecular weight cut-off of about 3,000 Daltons; (iii) it is water soluble, heat stable, non-proteinaceous and resistant to adenosine deaminase activity.

Abstract: A method and composition for repairing bone in a human. A high-molecular hydrogel such as a hyaluronate is mixed with a bovine or other animal bone particulate or with artificial bone such as hydroxyapatite particulate. A growth-inducing peptide may also be included.

Abstract: The invention generally relates to the use of natural anti-secretory proteins (NASP) for the preparation of NASP-enriched functional food products or pharmaceutical products for the treatment and prophylaxis of disease-like conditions caused by extreme body fluid discharge. In particular, the invention relates to the use of NASP-enriched egg yolk as source of NASP.

Abstract: The invention generally relates to the use of natural anti-secretory protein (NASP) for the preparation of NASP-enriched functional food products or pharmaceutical products for the treatment and prophylaxis of disease-like conditions caused by extreme body fluid discharge. In particular, the invention relates to the use of NASP-enriched egg yolk as a source of NASP.

Abstract: The present invention provides comestibles and related aspects for use in maintaining canine urinary tract health. In particular the comestibles and related aspects are useful in preventing the initial occurrence of canine calcium oxalate urolithiasis. The present invention also provides a comestible, which when fed to a small breed canine animal results in a urine specific gravity of 1.025 or below, for use in preventing the initial occurrence of calcium oxalate urolithiasis in the canine animal and related aspects. The comestible includes the following ingredients in the ranges indicated, for use in preventing the initial occurrence of calcium oxalate urolithiasis in a canine animal and related aspects: 1 Nutrient g/400 kcal Calcium 0.65-1.3 Phosphorus 0.5-1.2 Magnesium from 0.04 Potassium from 0.5 Sodium 0.6-1.

Abstract: Described herein is a nutritional supplement to be incorporated into the diet of an overweight or obese patient comprising a low glycemic index carbohydrate source, a source of protein, and a source of fat, and further comprising a source of green tea extract, a source of 5-hydroxytryptophan (5-HTP), and a source of chromium. The supplement provides active food-grade ingredients to improve the management weight loss, prevention of weight gain, and a feeling of satiety.

Abstract: Topical anti-inflammatory compositions are described that include effective amounts of a linseed extract and a licorice extract. In addition, methods of reducing inflammation are described, which include applying topically to a site of inflammation an effective amount of a composition comprising a linseed extract and a licorice extract.

Abstract: The present invention relates to herbal compositions and herbal extracts useful for treating cerebral vascular disease, including stroke, intracranial hemorrhage, intracranial infarction, and vascular dementia. The present invention can be used to reduce mortality rate and improve the quality of life of an individual after pathological injury that results in cerebrovascular and/or neuronal disorders. Further, the invention relates to the treatment of acute intracerebral hemorrhage by the novel herbal formulation PHY828 and provides methods of making PHY828 compositions.

Abstract: The present invention is related to pharmaceutical composition essentially comprising herbal extract of Chaenomelis Fructus, Achyranthis Radix, Acanthopanax, Phlomidis Radix, Gentianae Radix, Clematidis Radix, and additionally comprising herbal extract selected from group consisting of Angelicae Radix, Cnidii Rhizoma, Gastrodiae Rhizoma, Safflower, Cinnamomi Cortex, Job's tear, Aurantii nobilis Pericapium, Ledebouriellae Radix, Lonicera japonica, Akebiae caulis, Caragana chamlagu, Licorice root, Notopterygium incisum, Persicae semen, Eucommia ulmoides, Atractylodes Rhizoma, Torilis japonica according to the need for the prevention and treatment of arthritic diseases and methods of using the above extracts and composition as potent anti-inflammatory and anti-arthritic agents.

Abstract: Herbal compositions and methods suitable for weight loss management and for treating diabetes are disclosed. The compositions comprise Ferula hermonis or an extract thereof, or Ferula hermonis with selected herbs, extracts thereof, and mixture thereof. The methods of reducing weight, and treating diabetes in patients involve oral administration of the compositions. The invention further relates to a method of extracting and standardizing Ferula hermonis extracts and tincture useful for human health.