Abstract: The present invention relates to a pharmaceutical composition comprising a combination of active principles. More specifically: a stable pharmaceutical composition comprising a combination of tramadol and ketoprofen. Furthermore, a combination in solid form in which the active principles are vehicled in pharmaceutical forms and/or products that prevent contact between them. Complementarily, the present invention also relates to the combined use of ketoprofen and tramadol in the preparation of an oral medicine useful for relieving pain as well as a method for relieving pain with an oral pharmaceutical composition comprising a combination of tramadol and ketoprofen.

Abstract: Methods for improving solubility and bioavailability of lipophilic compounds are described. Particularly, described are stabilized supersaturated solid solutions, particularly in power from, of lipophilic drugs, such as steroidal molecules.

Abstract: An apparatus and a method for dispersing particulate materials prone to agglomeration, in a liquid. Particulate materials are exposed to a liquid and put into that liquid to form a suspension or a dispersion in a controlled method thereby minimizing agglomerates. The method uses mechanical/hydro mixing that prevents the physical deterioration of the particulate material and inhibits agglomeration of the particles. In many cases, these materials may be nanomaterials. Almost all particulate materials can be handled in this manner. This method has been found to be especially useful for preparing solutions of exfoliated graphene and certain drugs.

Abstract: A solid oral controlled-release dosage form of hydrocodone is disclosed, the dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and controlled release material.

Abstract: Pharmaceutical formulations are provided which are in the form of capsules or tablets for oral use and which include a medicament dapagliflozin or its propylene glycol hydrate and a pharmaceutical acceptable carrier therefor, which formulation is designed for immediate release.

Abstract: A vector for the oral administration of at least one pharmacologically active substance enabling the active substance to move from the intestinal lumen to the blood, optionally via interstitial liquid, without any substantial degradation of the substance, includes an essentially hydrophilic matrix having an outer surface which is modified by one or several chemical species providing the vector with an essentially lipophilic quality and containing one or several active substances. The vector is associated with a gastroresistant vehicle enabling it to pass into the stomach without any denaturation and/or degradation of the active substance. The invention also relates to pharmaceutical compositions containing the vector. The vectors can be used to produce medicaments used in human or veterinary medicine.

Abstract: In various embodiments, the present invention provides compositions and methods for treating and/or preventing cardiovascular-related diseases in subject in need thereof.

Abstract: The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.

Abstract: A method of preparing enteric hard capsules, and an enteric hard capsule prepared by the method. The method may include: dissolving an enteric base material, a capsule forming aid, and a neutralizing agent in water at room temperature to prepare an aqueous composition; heating the aqueous composition to a first temperature that is higher than a gelation start temperature of the aqueous composition; cooling the heated aqueous composition to a second temperature that is lower than the gelation start temperature; immersing a mold pin heated to a third temperature that is higher than the gelation start temperature into the aqueous composition; removing the mold pin from the aqueous composition to obtain a film coated on the mold pin; maintaining the film on the mold pin at a fourth temperature that is higher than the gelation start temperature for a first time period to fix the film onto the mold pin; and drying the fixed film at a fifth temperature for a second time period to obtain a capsule shell.

Abstract: This invention relates to prophylactic and/or therapeutic application of microorganism species that are, for example, administered orally as delayed release formulation designed to release its microbial content to the distal small intestine and/or colon in high quantities and density, which is a “normalized” approach to repopulate the colonic flora as a method of prevention and/or treatment of, for example, Clostridium difficile colitis.

Abstract: The present invention relates to metformin glycinate salt and pharmaceutical compositions thereof for the treatment of diabetes mellitus. The method includes administration of the metformin glycinate salt by various routes selected from oral, intravenous injectable, intramuscular injectable, nasal, intraperitoneal, or sublingual, in order to achieve a reduction in blood glucose levels. The invention further relates to the synthesis of a new 1,1-dimethylbiguanide glycinate salt, called Metformin Glycinate. The resulting salt exhibits advantages over other metformin salts. These advantages are due, in the first place, to the fact that the glycine counterion exhibits hypoglycemic effects by itself. Moreover, the salt exhibits more rapid absorption, reaching higher plasma concentrations than those produced with metformin hydrochloride.

Abstract: Methods and compositions for reducing the frequency of urination are disclosed. One method comprises administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising an analgesic agent formulated in a delayed-release formulation. Another method comprises administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising multiple active ingredients. Yet another method comprises administering to a subject in need thereof an effective amount of a diuretic followed with another administration of a pharmaceutical composition comprising an analgesic agent.

Abstract: The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.

Abstract: An object of the present invention is to provide a small-sized light-stabilized soft capsule formulation, which has a shell that ensures effective light shielding of an active ingredient encapsulated thereby. The present invention provides a light-stabilized soft capsule formulation comprising a shell containing a non-water-soluble light-shielding agent and having an average thickness of 200 ?m or less, and a medicament encapsulated by the shell.

Abstract: A capsule-in-capsule system comprising at least two segregated chemical reactants is described. An inner capsule contains one reactant and is itself contained, with a second chemical reactant, in an outer capsule. The inner capsule and its contents is fabricated first; then it is incorporated into the second reactant; and the combination of the second reactant and inner capsule is encapsulated in the outer capsule. The reactants may be hydrophobic or hydrophilic and present as fluids, solids or combinations of solid(s) and fluids(s). When subjected to suitably high pressure, the capsule wall materials will fracture or rupture, releasing and preferably mixing all encapsulates to enable their prompt reaction. The utility of the invention is illustrated by its application to development of a corrosion inhibiting passive film on magnesium auto body material and to the adhesive bonding of members where precise positioning is desired.

Abstract: A composition as disclosed is comprised of a plurality of particles and a pharmaceutically acceptable carrier. The particles are comprised of (1) an adjuvant; (2) a biocompatible polymer which maybe a co-polymer such as PLGA, and (3) a peptide of a sequence of interest, e.g. a sequence which corresponds to a sequence presented on a surface of a cell infected with a virus. The carrier includes an adjuvant such as a monophosphoryl lipid A (MPL) different from the adjuvant in the particles. The particles may be sized such that they are sufficiently large so as to prevent more than the contents of a single particle from being presented to a single immune system cell.

Abstract: The present invention relates to novel calcium-containing microporous zirconium silicate compositions that are formulated to remove toxins, e.g. potassium ions, from the gastrointestinal tract at an elevated rate without removing calcium from the patient's body. Also disclosed are methods of using calcium-free or low calcium microporous zirconium silicate compositions for the treatment of hyperkalemia in patients also suffering from hypercalcemia.

Abstract: This document provides methods and materials related to Prevotella histicola preparations. For example, Prevotella histicola preparations in the form of an oral medicament or dietary supplement (e.g., a pill, tablet, capsule) are provided. In addition, methods and materials for using a Prevotella histicola preparation provided herein as an anti-inflammatory agent are provided.

Abstract: This invention provides capsules and, more specifically soft capsules, wherein the fill material comprises an emulsified syrup. In particular, the present invention provides a means of encapsulating honey in a gelatin, modified-gelatin or gelatin-free shell material. Furthermore, the capsules described herein are capable of being manufactured using a rotary die apparatus.

Abstract: The present invention relates to a technique for delivering gases into the human body or generating gases inside the human body, such as a method for encapsulating gases and a gas storage vessel. The present invention relates to a gas storage capsule and to a method for producing the gas storage capsule, wherein the capsule is dissolved in water such that the air-tightness thereof is gradually degraded and the gas contained in the capsule can be gradually leaked to the outside of the capsule. The present invention also relates to a hydrogen-generating material which directly generates hydrogen gases in vivo, and to a hydrogen-generating candy for directly encapsulating hydrogen using the material and delivering the thus-encapsulated hydrogen into the intestines, as well as to a method for producing the candy.

Abstract: The present disclosure relates to, inter alia, methods of treating mixed dyslipidemia with ethyl eicosapentaenoate.

Abstract: Bone cages are disclosed including devices for biocompatible implantation. The structures of bone are useful for providing living cells and tissues as well as biologically active molecules to subjects.

Abstract: A cosmetic peeling preparation which comprises a plurality of capsules. A capsule comprises a casing and a filling. The casing material is solid at 25° C. and selected from cosmetically conventional lipids, waxes, emulsifiers, natural polymers, synthetic polymers, and mixtures thereof. The filling comprises an oil or lipid mixture having a viscosity at 25° C. of from 3 to 50,000 mPas and one or more solid substances having an abrasive effect.

Abstract: The present invention relates to the use of compositions comprising trans-clomiphene for treating men with hypogonadism. The invention is also directed to methods for treating males with hypogonadism.

Abstract: Provided herein are controlled release oral dosage forms of poorly soluble drugs, methods of making the dosage forms, and methods of their use for the treatment of various diseases and/or disorders.

Abstract: A solid administration form, protected from parenteral abuse and containing at least one viscosity-increasing agent in addition to one or more active substances that have parenteral abuse potential. The agent forms, when a necessary minimum amount of an aqueous liquid is added, on the basis of an extract obtained from the administration form, a preferably injectable gel that remains visually distinct when introduced into another quantity of an aqueous liquid.

Abstract: The invention relates to microcapsules, and a continuous micro-encapsulation water-in-oil-in-water microencapsulation process through in situ and interfacial polymerization of the emulsion. The formulation comprises a continuous water phase having a dispersion of microcapsules which contain oil drops and wherein the inside of each oil phase drop—containing optionally oil-soluble materials—there is a dispersion of water, or aqueous extract or water dispersible material or water soluble material. The oil drops are encapsulated with a polymerisable material of natural origin. Such microcapsules are appropriated for spray-dry processes, to be used as dry powder, lyophilised, self-emulsifiable powder, gel, cream and any liquid form. The active compounds included in the microcapsules are beneficial to the health and other biological purposes.

Abstract: The present invention provides a capsule containing an inhalable powder composition wherein the composition comprises about 75% by weight or more levodopa, dipalmitoylphosphatidylcholine (DPPC) and a salt characterized by a working density of less than about 100 g/L. The invention further provides a capsule containing an inhalable powder composition wherein the composition comprises about 75% by weight or more levodopa, dipalmitoylphosphatidylcholine (DPPC) and a salt characterized by a working density of less than about 100 g/L wherein the capsule material comprises hydroxypropylmethylcellulose (HPMC) and titanium dioxide.

Abstract: The present invention is concerned with Capsicum plants producing greater than about 0.4% zeaxanthin, by weight in the dried, ripe fruit pod flesh, which plants have been developed from commercially grown Capsicum cultivars by plant breeding techniques. Zeaxanthin is the dominant carotenoid in the dried ripe fruit pod flesh, when measured in non-esterified forms. Alternatively, these plants may be characterized as exhibiting a high pigmentation measured as an ASTA value and further characterized by the predominant presence of zeaxanthin. The zeaxanthin derived from these Capsicum plants can be used in applications that include nutritional supplements, foods, functional foods, cosmetics, animal feeds, aquaculture feeds, and pharmaceuticals.

Abstract: The present disclosure relates to, inter alia, methods of treating mixed dyslipidemia with ethyl eicosapentaenoate.

Abstract: Dry powder vancomycin compositions and methods for administering and preparing such compositions are provided.

Abstract: The invention provides formulations comprising isolated lacto-N-tetraose (LNT) or galactooligosaccharides (GOS) or variants, isomers, analogs and derivatives thereof and a pharmaceutically acceptable carrier.

Abstract: The present invention provides compositions, preparations, formulations, kits, and methods useful for treating subjects having cancer or at risk of developing cancer. Some embodiments of the invention may comprise a composition comprising a plurality of particles comprising a platinum(IV) therapeutically active precursor.

Abstract: Provided herein are methods of culturing cells in vitro in order to exploit the biochemical production ability of the cells to make metabolites that are evaluated and harvested for their biological effects. Also provided are systems for evaluating extracts from such cultured cells to characterize their biological activity(s), particularly with regard to impact on health, wellbeing, longevity, DNA maintenance, mitochondrial health and/or biogenesis, and so forth. Biologically active extracts, components thereof, and compositions (such as cosmetic or pharmaceutical preparations) made comprising such, are also provided.

Abstract: The present invention is directed to novel pharmaceutically acceptable polymeric compositions suitable for injection molding of single or multi-component pharmaceutical dosage forms comprising a plurality of drug substance containing sub-units, being capsule compartments and/or solid sub-units comprising a solid matrix of a polymer which contains a drug substance, the sub-units being connected together in the assembled dosage form by a weld between parts of the assembled dosage form.

Abstract: The invention is directed in part to oral dosage forms comprising a combination of an orally analgesically effective amount of an opioid agonist and an orally active opioid antagonist, the opioid antagonist being included in a ratio to the opioid agonist to provide a combination product which is analgesically effective when the combination is administered orally, but which is aversive in a physically dependent subject. Preferably, the amount of opioid antagonist included in the combination product provides at least a mildly negative, “aversive” experience in physically dependent addicts (e.g., precipitated abstinence syndrome).

Abstract: A method of treatment for epilepsy and other disease states is described, which comprises the delivery of gabapentin in a gastric retained dosage form.

Abstract: Formulations and unit dose forms of TH-302 and other hypoxia activated prodrugs suitable for oral administration are useful for treating cancer.

Abstract: In various embodiments, the present invention provides compositions and methods for treating and/or preventing cardiovascular-related diseases in subject in need thereof.

Abstract: A controlled release dosage form of venlafaxine that comprises an immediate release pellet and an extended release pellet.

Abstract: The present invention relates to a personal care product comprising a protein matrix wherein said protein matrix comprises at least one protein, at least one probiotic and a carrier fluid. The present invention also relates to the personal care product being a feminine care product particularly aimed at female urogenital health to treat or prevent vaginal infections. Oral and sinus infections, however, may also be benefited by the composition.

Abstract: Taste masked dosage forms for oral administration of roflumilast are described.

Abstract: The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.

Abstract: A device which facilitates the absorption of nicotine in order to reduce the incidence of tobacco smoking is disclosed. The device includes a tube defining an interior space. The tube has a first end with an opening and a second end. An inhalable, flowable liquid or gel composition is disposed in the interior space of the tube. The composition may include water, at least one vitamin, a flavoring agent, and nicotine. The flavoring agent may include an intense sweetener such as sucralose, and a natural or artificial fruit flavor. A user inhales on the first end of the tube of the device as a substitute oral activity to tobacco smoking and thereby ingests a source of nicotine that reduces the withdrawal symptoms experienced when smoking is stopped.

Abstract: The present invention relates to capsules for housing pharmaceutical preparations for powder inhalers with increased medicinal product safety and capsules for pharmaceutical preparations for powder inhalers with improved adaption to use in powder inhalers. The capsules consist of non-water-soluble, hydrophobic plastics, which themselves do not substantially influence the pharmaceutical quality of the contents, but improve the usability of the filled capsules in respect of their operation, the period of use and/or the geographical location of their use and are advantageous in various steps from manufacture to use.

Abstract: The present invention relates to an oral pharmaceutical dosage form comprising micronized progesterone, an edible oil, a disintegrant, and a hydrophilic excipient. Particularly, the invention relates to a pharmaceutical dosage form wherein the dosage form is in a powder form and is contained in a pharmaceutically acceptable capsule. The present invention is also directed toward methods of making the dosage form, methods of using the dosage form, and kits comprising the dosage form.

Abstract: Provided herein is a pharmaceutical composition comprising an antagonist, an agonist, a seal coat, and a sequestering polymer, wherein the antagonist, agonist, seal coat and at least one sequestering polymer are all components of a single unit, and wherein the seal coat forms a layer physically separating the antagonist from the agonist from one another. Methods for manufacturing such a pharmaceutical composition are also provided. Methods for treating pain using such compositions is also demonstrated.

Abstract: Spontaneously dispersible N-benzoyl-staurosporine compositions are discussed for oral administration having high bioavailability levels and reduced variability of bioavailability levels of N-benzoyl-staurosporine, as well as their preparation and use in medical treatment.

Abstract: An aqueous liquid suspension containing a coated drug-ion exchange resin complex comprising a core composed of an amphetamine complexed with a pharmaceutically acceptable ion-exchange resin and an uncoated amphetamine-ion exchange resin complex is provided. The coated amphetamine-ion exchange resin complex is in admixture with a polymer to form a matrix. Methods of making the coated complex and the liquid suspension are described.

Abstract: Oral dosage forms and granulations with a high loading of a methyl hydrogen fumarate prodrug are disclosed.