Abstract: The present invention is directed to orally administered corticosteroid compositions. The present invention also provides a method for treating a condition associated with inflammation of the gastrointestinal tract in an individual. The method comprises administering to an individual in need thereof a pharmaceutical composition of the present invention.

Abstract: A gastroretentive drug formulation for the sustained release of an active agent in the gastrointestinal tract comprises an internal layer or compartment comprising an active agent and one or more pharmaceutical excipients, of which at least one is a polymer and two membranes forming together an envelope around the inner membrane, each membrane comprising at least one polymeric combination of an enteric polymer which is not soluble in gastric juice, and an hydrophilic swelling polymer, and at least one plasticizer.

Abstract: The present invention provides a pharmaceutical composition of a practically insoluble drug, wherein the composition may be administered with food or without food. The composition may be in the form of a solid dispersion of the practically insoluble drug and a polymer having acidic functional groups, and the composition may in vitro form a suspension.

Abstract: In various embodiments, the present invention provides compositions comprising eicosapentaenoic acid or a derivative thereof and obeticholic acid or a derivative thereof. In other embodiments, the present invention provides methods of treating and/or preventing NASH and/or PBC comprising co-administering to a subject in need thereof eicosapentaenoic acid or a derivative thereof and obeticholic acid or a derivative thereof.

Abstract: The invention disclosed herein includes nanocomplexes that are designed include enzymes that have complementary functional attributes and methods for using these nanocomplexes. Illustrative examples include nanocomplexes that comprise both an alcohol oxidase enzyme as well as a catalase enzyme. These nanocomplexes can be used in methods designed to lower blood alcohol levels in vivo, and/or to break down the toxic byproducts of alcohol metabolism. Consequently these nanocomplexes can be used to treat a variety of conditions resulting from the consumption of alcohol, including for example, acute alcohol intoxication.

Abstract: Provided herein are steroid containing composition suitable for providing therapeutically effective amount of at least one steroid to individuals. Also provided herein are compositions comprising testosterone and/or testosterone derivatives suitable for providing therapeutically effective and safe amounts of testosterone over periods of time. Further provided are methods of treating andro- and/or testosterone deficiency in individuals by administering to the individuals compositions described herein.

Abstract: Methods of treating, preventing and/or managing cancer as well as and diseases and disorders associated with, or characterized by, undesired angiogenesis are disclosed. Specific methods encompass the administration of an immunomodulatory compound alone or in combination with a second active ingredient. The invention further relates to methods of reducing or avoiding adverse side effects associated with chemotherapy, radiation therapy, hormonal therapy, biological therapy or immunotherapy which comprise the administration of an immunomodulatory compound. Pharmaceutical compositions, single unit dosage forms, and kits suitable for use in methods of the invention are also disclosed.

Abstract: An inhalable medicament is provided, in particular a new solid-state form of tiotropium bromide. The medicament can be in the form of solid amorphous particles containing an intimate admixture of tiotropium bromide together with a pharmaceutically acceptable co-solid having a glass transition temperature of at least ?50° C., such as a sugar and/or sugar alcohol.

Abstract: This document discloses molecules having the following formula (“Formula One”): and processes associated therewith.

Abstract: Provided is a capsule having a shell of material that is a supramolecular cross-linked network. The network is formed from a host-guest complexation of cucurbituril (the host) and one or more building blocks comprising suitable guest functionality. The complex non-covalently crosslinks the building block and/or non-covalently links the building block to another building block thereby forming the supramolecular cross-linked network. The capsules are obtained or obtainable by the complexation of a composition comprising cucurbituril and one or more building blocks having suitable cucurbituril guest functionality thereby to form a supramolecular cross-linked network.

Abstract: The disclosure provides compositions treating traumatic brain injuries such as concussions. In one embodiment, the composition comprises phosphatidylserine, phosphatidylcholine, quercetin, astaxanthin, R-alpha lipoic acid, N-acetyl cysteine, taurine, L-glutamine, carnitine, D-ribose, creatine, epigallocatechin gallate, melatonin, ginkgo leaf extract, curcumin and L-glycine. The disclosure also provides methods for treating traumatic brain injuries such as concussions by administering an effective amount of the compositions described within.

Abstract: This document discloses molecules having the following formula (“Formula One”): and processes associated therewith.

Abstract: Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing.

Abstract: Disclosed is a capsule formulation for preventing or treating allergic rhinitis and asthma, which comprises two separate layers of: (1) a Montelukast layer comprising montelukast or a pharmaceutically acceptable salt thereof; and (2) a Levocetirizine layer comprising levocetirizine or a pharmaceutically acceptable salt thereof; and a method for the preparation thereof. The capsule formulation according to the present invention can completely separate two active ingredients, thereby minimizing the reactivity between them and improving product stability against aging effects, and thus, can optimize the therapeutic effects.

Abstract: This document discloses molecules having the following formula (“Formula One”): and processes associated therewith.

Abstract: The present invention relates to a reduced form of Coenzyme Q also known as ubiquinol in oral dosage form such as a gelatin capsule, preferably a soft gelatin capsule. Compositions according to the present invention include storage stable compositions comprising effective amounts of ubiquinol in combination with an amount of a reducing agent effective to maintain ubiquinol in its reduced state when formulated in capsules, tablets and other orally administrable form. Methods of using these compositions in the treatment of a number of disease states or conditions are also disclosed.

Abstract: Described embodiments include a final dosage form for administering a medicament to an animal, an article of manufacture, and method. A described final dosage form includes a dosage portion having a medicament and a release element in a first medicament-release state. The medicament has a first bioavailability to the animal. The release element is modifiable ex vivo to a second medicament-release state by an exposure to a stimulus, wherein the medicament has a second bioavailability to the animal. The final dosage form includes another dosage portion having another medicament and another release element in another first medicament-release state. In the another first medicament-release state, the another medicament has another first bioavailability to the animal. The another release element is modifiable ex vivo to another second medicament-release state by an exposure to another stimulus, wherein the another medicament has another second bioavailability to the animal.

Abstract: The present invention generally relates to the field of membranes. In particular, the present invention relates to a composition comprising bodies surrounded by a membrane. The composition are for example edible compositions. One embodiment of the present invention relates to a composition containing an oily fraction, a hydrophilic fraction, and at least one body, wherein the body comprises a shell comprising several molecular layers of chitosan and at least one lipidic phosphatidic acid surfactant; and a content comprising an internal phase containing a hydrophilic component and/or a hydrophobic component. The Composition may be used to protect a food product or to deliver specific properties to a product, for example.

Abstract: Provided are methods, systems and apparatuses for producing delivery devices, for example, for oral intake of an agent. The method can include assembling one or more layers including one or more materials with an agent or an agent-releasing formulation to form an intergraded device; folding the intergrated delivery device to form a folded integrated delivery device; and at least partially enclosing the folded delivery device to a form suitable for oral delivery.

Abstract: A new method for the preparation of microencapsulated essential oils is disclosed. The microcapsules containing essential oils or a formulation containing thereof may be used for various non-agricultural applications.

Abstract: Various embodiments of the invention relate to compositions comprising vitamins, minerals and trace elements, antioxidants, amino acids, probiotics, and other components and methods for using such compositions to treat or prevent diseases associated with oxidative stress, including cardiovascular disease.

Abstract: The present invention is to obtain capsules which do not disintegrate in stomach and intestine after orally administrating them and which disintegrate specifically in large intestine. The present invention thus provides a capsule which disintegrates specifically in large intestine, comprising a content comprising a main agent, and a shell, covering the content, comprising a natural water-soluble polymer as a shell base material and chitosan powder dispersing in the natural water-soluble polymer.

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: In certain embodiments, the invention is directed to composition comprising stable particles comprising ganaxolone, wherein the volume weighted median diameter (D50) of the particles is from about 50 nm to about 500 nm.

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

Abstract: Microparticle formulations are produced by contacting an aqueous solution of a protein or other active agent with an organic solvent, a counterion and a scavenging agent, and chilling the solution. The microparticles are useful for preparing stable, uniform pharmaceuticals of predetermined defined dimensions.

Abstract: The present invention relates to generation of cell lines expressing recombinant proteins for use in naked and encapsulated cell biodelivery of secreted therapeutic molecules. In one embodiment the cell line is human. In another aspect of the invention the transposon system is used for generating a cell line for secretion of a biologically active polypeptide.

Abstract: The present invention provides an active targeting polymer micelle encapsulating a drug, preventing an inappropriate release of a drug which may damage a normal cell. A polymer micelle 100 includes a backbone polymer unit 10 that has a target binding site 11 and a backbone polymer unit 20 that has a drug 14 and is free from the target binding site 11, such polymer units 10 and 20 being disposed in a radial arrangement in a state where the target binding site 11 is directed outward and the drug 14 is directed inward, in which: i) when the micelle is bound to a target 40 while maintaining the radial arrangement, the micelle is taken up into a cell 50 supplying the target 40 through endocytosis, and the drug 14 is released into the cell 50 by collapse of the radial arrangement in the cell 50; and ii) when the radial arrangement collapses in blood 60 before the micelle is bound to a target 40, the unit 20 is excreted through metabolism, to thereby prevent a normal cell from being damaged by the drug 14.

Abstract: The invention provides a method of manufacturing and packaging a room temperature stable cannabinoid dosage in an oil-based carrier, wherein the method employs the use of blister packaging and an inert gas atmosphere during blister packaging. The invention also provides a room temperature stable cannabinoid dosage prepared by the methods of the invention.

Abstract: An encapsulated material containing an oxidation-sensitive core is covered by at least a dried phospholipid layer, and contains at least one phytosterol in the core, the phospholipid layer or in a further layer or layers. By using microencapsulation, oxidatively unstable materials may be provided with a synthetic protective barrier and rendered less susceptible to oxidative degradation.

Abstract: Use of Pargyline for the production of a medicament for influencing the metabolism of hair follicles and the modulation of their vital cycle.

Abstract: An aligned polymer article including substrates, wherein the substrates are not covalently bonded to the aligned collagen and a method of forming such articles wherein substrates are mixed with a polymer in solution to form a polymer-substrate mixture. The mixture is placed in an electrochemical cell and a voltage is applied to the cell generating a pH gradient, wherein the polymer aligns in the cell and migrates to the isoelectric plane of the polymer solution.

Abstract: The present invention relates to an abuse-proofed oral dosage form with controlled release of (1R,2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol for once daily administration, which comprises the active ingredient and/or one or more of the pharmaceutically acceptable salts thereof (A), at least one synthetic or natural polymer (C), delayed-release auxiliary substances, optionally physiologically acceptable auxiliary substances (B) and optionally a wax (D), component (C) or (D) in each case exhibiting a breaking strength of at least 500 N, preferably of at least 1000 N.

Abstract: The invention relates to liquid compositions for production of soft sustained-release capsules. According to the invention, the sustained release of the active agent is obtained by in situ formation of a matrix, more or less consolidated and biodegradable, by physical modification of the capsule contents on coming into contact with digestive juices on the opening thereof. The above leads to a release time of more than one hour for the active agent previously dissolved or dispersed by means of solvents, said release being modulated by addition of appropriate adjuncts. The invention further relates to a method for production of said liquid compositions. The above finds application in the pharmaceutical, cosmetic and dietary fields.

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 invention relates to concentrated therapeutic phospholipid compositions; methods for treating or preventing diseases associated with cardiovascular disease, metabolic syndrome, inflammation and diseases associated therewith, neurodevelopmental diseases, and neurodegenerative diseases, comprising administering an effective amount of a concentrated therapeutic phospholipid composition.

Abstract: A dosage form comprising a capsule containing one or more tablets of 5-aminosalicylic acid or a salt thereof as an active ingredient where each of the one or more tablets is enterically coated is disclosed.

Abstract: The present invention relates to medical devices containing time-release drug substance, and more particularly, to medical tubing, catheters, stents, cables (including fiber optic cables), pills, capsules, sheaths, threads, clamps, sutures, and endotracheal devices. The invention also generally relates to a method for extruding multiple laminated flow streams using microlayer coextrusion to create these various time-release drug delivery products.

Abstract: The invention provides a method for imparting antiviral properties to a hydrophilic polymeric material comprising preparing a hydrophilic polymeric slurry, dispersing an ionic copper powder mixture containing cuprous oxide and cupric oxide in said slurry and then extruding or molding said slurry to form a hydrophilic polymeric material, wherein water-insoluble particles that release both Cu++ and Cu+ are directly and completely encapsulated within said hydrophilic polymeric material.

Abstract: An orally deliverable pharmaceutical composition comprises a Bcl-2 family protein inhibitory compound, e.g., ABT-263, a heavier-chalcogen antioxidant and a substantially non-aqueous lipid carrier, wherein said compound and said antioxidant are in solution in the carrier. The composition is suitable for oral administration to a subject in need thereof for treatment of a disease characterized by overexpression of one or more anti-apoptotic Bcl-2 family proteins, for example cancer.

Abstract: The present invention relates to pharmaceutical compositions comprising entacapone or pharmaceutically acceptable salts thereof along with one or more sugar alcohols; wherein the entacapone is co-micronized with one or more sugar alcohols. The invention also relates to processes of making such compositions.

Abstract: A biocompatible capsule comprising a biological material encapsulated by a covalently stabilized coating and a method of making the same are disclosed. The biological material can be a material selected from the group consisting of cells, such as islets of Langerhans, pharmaceuticals, and biological agents. The coating can be formed by reacting an alginate-[polyalkylene glycol (PAG)-X1]n, and a multi-functional PAG-X2, to form covalent bonds, wherein n is an integer greater than 0, a first one of X1 and X2 is N3, and a second one of X1 and X2 is selected from the group consisting of: wherein R1=CH3, CH2CH3, CH(CH3)2, R2=N(CH3)2, OCH3, OH, CH3, H, F, Cl, Br or NO2, and R3=OCH3, CH3, H, F, Cl or NO2.

Abstract: The present invention relates to a novel drug delivery and release system, i.e. Self-emulsifying Drug Delivery System (SEDDS), of butylphthalide, to a preparation process thereof, and to a use thereof in a pharmaceutical formulation. The drug delivery system comprises as essential ingredients 1% to 65% of butylphthalide and 10% to 65% of a emulsifying agent, together with various excipients as required depending on the desired dosage forms. The present invention significantly increases the contact area between butylphthalide and the mucous membrane of the gastrointestinal tract, and therefore improves the absorptivity of the drug.

Abstract: This invention provides for compositions, methods and devices for rapidly converting silk fibroin solution into a silk fibroin gel using direct application of voltage, in a process called electrogelation. The silk fibroin gel may be reversibly converted back to liquid form by applying reverse voltage or may be converted further to ?-sheet structure by applying shear force or other treatments. The electrogelated silk may be used as an extracted bulk gel, spray or stream of gel for processing into materials or devices, or may be used as silk gel coating to devices. Active agents may be embedded in the silk gel for various medical applications. This invention also provides for methods and compositions for preparing adhesive silk pH-gels. For example, the method comprises reducing pH level of a silk fibroin solution to increase the bulk or local proton concentration of the silk fibroin solution, thereby forming adhesive silk gels.

Abstract: The present invention includes a method of delivering a therapeutic agent into and across an endothelial cell (EC) in a subject in need thereof, comprising: identifying a subject in need for treatment of a cancer in the brain; attaching to a TCR mimic an active agent to form a therapeutic agent; and administering to the subject the therapeutic agent in a pharmaceutically acceptable carrier, wherein the therapeutic agent effectively crosses the blood-central nervous system microvascular barrier.

Abstract: The invention provides a composition comprising a matrix of chitosan and a tannin wherein the chitosan is electrostatically bonded to the tannin to form a chitosan-tannin composite material. The chitosan can be partially or fully deacetylated, and the tannin can be a monomeric or an oligomeric proanthocyanidin or a hydrolysable tannin. The chitosan-tannin composite material can be a nanoparticle, a hydrogel film, a bio-foam, or a biogel, or the chitosan-tannin composite material can coat a liposome. The composite materials can be used for drug delivery, for antibacterial and/or antifungal applications, for tissue engineering applications, for wound healing applications, or they can be used as adjuvants for vaccination, including oral vaccinations. The invention also provides methods of preparing the composite materials and their various forms.

Abstract: The present invention provides, compositions, devices, and methods for affecting, among other things, weight loss and/or weight control, by sequestering nutrients or other compounds such as toxins from absorption in the digestive tract. The compositions, devices, and methods employ one or more members made of a compressible, absorbent matrix material. In various embodiments, the matrix material is suitable for routine use. The compressible absorbent matrix material has a size, shape and/or geometry configured for efficient packing into a small space, and/or configured to absorb and substantially retain digested material in the stomach. The devices and compositions may further comprise one or more hydrogel(s), soluble or insoluble fibers, waxes and/or gums to provide the desired mechanical properties and/or absorptive or shielding properties.

Abstract: Compositions and methods for lightening and/or depigmenting skin are provided, the compositions comprising compounds having the structure: or having the structure: as defined herein.

Abstract: Disclosed are devices and methods for encapsulating living cells, microencapsulated cells produced by the disclosed devices and methods, as well as methods of using the disclosed microencapsulated cells.

Abstract: In various embodiments, the present invention provides pharmaceutical compositions comprising fatty acids and methods for treating subjects using same.