Abstract: The present invention relates to pharmaceutical compositions containing a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide including formulations of the solid dispersions into powders, granules and mini-tablets, methods for manufacturing and processing the powders, granules and mini-tablets, and methods for treating cystic fibrosis employing the pharmaceutical composition.

Abstract: The present invention provides a simple and improved dosage form that provides a controlled release of methylphenidate contained in the core thereof. The invention also provides methods of administering the dosage form and of treating conditions that are therapeutically responsive to methylphenidate. The dosage form exhibits improved resistance to alcohol-related dose dumping.

Abstract: The present disclosure provides a stable solid pharmaceutical dosage form for oral administration. The dosage form includes a substrate that forms at least one compartment and a drug content loaded into the compartment. The dosage form is so designed that the active pharmaceutical ingredient of the drug content is released in a controlled manner.

Abstract: A heparin-mimicking sulfonated reverse thermal gel (SRTG) as a heparin-binding therapeutic protein delivery system. This system is designed to turn from low viscous liquid to a physical gel by exposure to body temperature alone. This allows direct deployment through a small gauge needle or catheter at target area with minimal surgical intervention. A unique aspect of this system is that it possesses a net negative charge due to the presence of sulfonate groups. This allows the SRTG to mimic heparin function, binding and preserving the bioactivity of positively charged therapeutic proteins, providing localized and sustained release of such proteins.

Abstract: Compositions, systems and methods for administration of small volume sufentanil drug dosage forms to the sublingual mucosa of a subject for treatment of pain using a device are disclosed.

Abstract: This invention provides novel peptides and methods to prevent, control, and treat an inflammation, cancer and other disorders, particularly of the gastrointestinal tract and the lung by administering at least one agonist of guanalyte cyclase receptor either alone or in combination with a compound selected from i) 5-aminosalicyclic acid (5-ASA) or a derivative or a pharmaceutically acceptable salt thereof; ii) mercaptopurine; or iii) an anti-TNF therapy.

Abstract: Novel thyroid hormone oral dosage forms and methods of making and using the thyroid hormone oral dosage forms are disclosed.

Abstract: A composition includes a polysaccharide at least one retinoid linked to at least one monosaccharide subunit of the polysaccharide with a covalent linkage. The linkage being degradable by hydrolysis during digestion of the composition to provide controlled, delayed, and/or sustained delivery of the at least one retinoid upon enteral administration of the composition to a subject.

Abstract: The invention relates to novel liquid pharmaceutical compositions comprising at least one SGLT-2 inhibitor and one or more polar organic solvents, wherein the at least one SGLT-2 inhibitor comprises 1-cyano-2-(4-cyclopropyl-benzyl)-4-(?-D-glucopyranos-1-yl)-benzene according to formula (I): as well as corresponding processes of manufacturing such liquid pharmaceutical compositions and their medical uses.

Abstract: This invention provides methods, processes, compounds and compositions for modulating the gene expression or secretion of adhesion proteins, angiopoietins or their receptors to cure diseases, for anti-angiogenesis and for treating parasites, wherein the adhesion proteins or receptors comprise fibronectin, integrins family, myosin, vitronectin, collagen, laminin, glycosylation cell surface proteins, polyglycans, cadherin, heparin, tenascin, CD 54, CAM, elastin and FAK; wherein the angiopoietins comprise angiopoietin 1, angiopoietin 2, angiopoietin 3, angiopoietin 4, angiopoietin 5, angiopoietin 6, angiopoietin 7, angiopoietin-like 1, angiopoietin-like 2, angiopoietin-like 3, angiopoietin-like 4, angiopoietin-like 5, angiopoietin-like 6, and angiopoietin-like 7; wherein the cancers comprise breast cancer, leukocyte cancer, liver cancer, ovarian cancer, bladder cancer, prostate cancer, skin cancer, bone cancer, brain cancer, leukemia cancer, lung cancer, colon cancer, CNS cancer, melanoma cancer, renal cancer, c

Abstract: The present invention relates to pharmaceutical compositions containing one or more compounds of formula 1 wherein R1 is H, C1-6-alkyl, C0-4-alkyl-C3-6-cycloalkyl, C1-6-haloalkyl; R2 is H, C1-6-alkyl; X is an anion selected from the group consisting of chloride or ½ dibenzoyltartrate j is 1 or 2. processes for the preparation thereof, and their use to treat diseases connected with the CCR3 receptor.

Abstract: Therapeutic compositions deliver a therapeutic amount of methylphenidate in a delayed and extended release formulation. The dosage form exhibits a lag time prior to release of from 6 to 8 hours or longer, followed by a sustained release period.

Abstract: Various embodiments disclosed herein relate to an implantable device, systems, and methods related thereto, that includes at least one sensor and/or therapeutic agent delivery depot. In one embodiment, the system and device include means for detecting general or specific biological agents in a subject's intestinal tract, and utilizing the information from the detection for determining the timing and content of any therapeutic treatment needed by the subject.

Abstract: Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) and other CNS stimulant responsive conditions include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 5 to 8 hours or longer, followed by an extended release.

Abstract: Provided is a method for producing low-substituted hydroxypropyl cellulose with less yellowing. More specifically, the method for producing purified low-substituted hydroxypropyl cellulose includes the steps of: reacting alkali cellulose and an etherifying agent to obtain a reaction mixture; dispersing the reaction mixture in water containing a portion of acetic acid necessary for neutralizing the total amount of the reaction mixture to neutralize a portion of the reaction mixture, and then completely neutralizing with the remaining acetic acid to cause precipitation, to obtain a slurry containing crude low-substituted hydroxypropyl cellulose; disintegrating a solid component in the slurry through a cutter pump, the solid component containing the crude low-substituted hydroxypropyl cellulose, and discharging the slurry containing the disintegrated solid component; washing the discharged slurry with water to obtain a cake of purified low-substituted hydroxypropyl cellulose; and drying the cake.

Abstract: Formulations and methods of manufacturing formulations for use in colonic evacuation are disclosed herein, in an embodiment, a solid dosage formulation includes an intra-granular fraction intermingled with an extra-granular fraction, wherein the intra-granular fraction includes granules comprising at least one osmotic evacuant agent, at least one antacid, and a first pharmaceutically acceptable excipient component, and wherein the extra-granular fraction includes one or more organic acids, a non-metallic lubricating element, and a second pharmaceutically acceptable excipient component.

Abstract: Compositions of the invention contain, in a cosmetically acceptable aqueous medium, a) a cationic polyelectrolyte, b) at least one surfactant; and (c) from about 0.01 to about 1.2 weight percent of an anionic polyelectrolyte, where the weight ratio of the anionic polyelectrolyte to the cationic polyelectrolyte is from about 0.05 to about 1.2, and where the composition exhibits a viscosity change that is below a minimum significant-change-threshold (??min) and exhibits no measurable yield stress or increase in yield stress value when compared to a substantially identical composition that does not contain from about 0.01 to about 1.2 weight percent of the anionic polyelectrolyte, at a weight ratio of anionic polyelectrolyte to cationic polyelectrolyte of from about 0.05 to about 1.2.

Abstract: A topical pharmaceutical composition containing diacerein and/or its analogs is provided. Also provided is a method for treating various diseases using this topical pharmaceutical composition.

Abstract: The present invention relates to a composition, in particular a solid pharmaceutical composition comprising a compound having the formula I, as a free base or a salt thereof, and a mixture comprising a vehicle and a non-ionic surfactant in an amount sufficient to achieve solubilization of compound (I); and typically wherein the composition is coated with an enteric coating. Such composition is particularly useful in treatment of cancer.

Abstract: Disclosed are a controlled release pharmaceutical composition, comprising a melt-extruded pellet including a water-insoluble ammonium methacrylate copolymer, a polyvinyl acetate, and an active ingredient; and a polymer coating layer including a water-insoluble ammonium methacrylate copolymer formed on the surface of the pellet, and an oral formulation including the pharmaceutical composition.

Abstract: The invention relates to the use of L-carnitine, a salt of L-carnitine, a derivative of L-carnitine and/or salt of a derivative of L-carnitine, as well as respective methods and compositions, for reducing or preventing fatigue and/or for improving cognitive function in an animal. The animal is preferably a healthy individual and the use is preferably a non-therapeutic use.

Abstract: A new use or method of use of a thylakoid extract, for oral route of administration, and a composition comprising the thylakoid extract in adjunction with an acceptable carrier for oral administration. Also described is a method for treating or preventing a disease or disorder involving the formation of reactive oxygen species inflammation in an individual, which comprises the step of orally administering an effective dose of a thylakoid extract. Also described is an oral composition comprising purified thylakoids and a carrier for oral ingestion or oral administration, with the proviso that the carrier does not essentially consist of water, physiological saline or propylene glycol. The thylakoid extract or composition is also provided as a food or a food supplement or as a pellet, or encapsulated granules or powder.

Abstract: Provided is a method of preparing a stimuli-responsive multifunctional nanoparticle, including in sequence the steps of: (a) conjugating covalently an active targeting moiety to a hydrophilic polymer to form a targeted polymer, (b) conjugating covalently a redox-responsive moiety to the hydrophilic polymer of the targeted polymer to form a targeted redox-responsive polymer, (c) conjugating covalently a pH-responsive moiety of a drug complex to the redox-responsive moiety of the targeted redox-responsive polymer to form a targeted stimuli-responsive polymer-drug conjugate, wherein the drug complex includes a hydrophobic drug covalently linked to the pH-responsive moiety, and (d) adding the targeted stimuli-responsive polymer-drug conjugate and optionally an imaging agent into an aqueous liquid to allow self-assembly into a stimuli-responsive multifunctional nanoparticle, wherein the hydrophobic drug of the stimuli-responsive multifunctional nanoparticle forms a hydrophobic core, and the imaging agent is incorp

Abstract: This invention provides novel guanylate cyclase C (GC-C) agonists and their therapeutic use. The agonists may be used either alone or in combination with one or more additional agents.

Abstract: The present invention relates to antisense oligonucleotides and/or compounds that modulate the expression of and/or function of Filaggrin (FLG), in particular, by targeting natural antisense polynucleotides of Filaggrin (FLG). The invention also relates to the identification of these antisense oligonucleotides and/or compounds and their use in treating diseases and disorders associated with the expression of FLG.

Abstract: This disclosure relates to transdermal pharmaceutical compositions containing progesterone in combination with one or more solubilizing agents and penetration enhancers, wherein the pharmaceutical compositions are formulated as creams for topical administration. In some embodiments, the transdermal pharmaceutical compositions contain progesterone, a medium-chain oil, and d-limonene. In some embodiments, the transdermal pharmaceutical compositions contain progesterone, a medium-chain oil, a penetration enhancer (e.g., propylene glycol, a fatty acid ester of propylene glycol, a glycol ether), and optionally d-limonene. In certain embodiments, the pharmaceutical compositions further include estradiol. Methods for treating conditions associated with hormone deficiency in a subject are also described.

Abstract: Methods, systems and apparatuses are provided for producing delivery devices, preferably for oral intake of an agent. In the broadest aspect, the method comprises assembling one or more layers comprising one or more materials with an agent or an agent-releasing formulation to form an intergraded, preferably laminated device; folding said integrated delivery device to form a folded integrated delivery device; and at least partially enclosing said folded delivery device to a form suitable for oral delivery. Preferably, the integrated device comprise a first external layer of a first material; a frame of a second material mounted on the first external layer; an agent-releasing formulation housed within the frame; and a second external layer of the first material mounted on the frame.

Abstract: Disclosed are novel processing methods for green coffee beans that result in novel green coffee bean products, including products that incorporate whole green coffee beans. Methods include selecting whole coffee beans in their fresh green unroasted state with naturally-occurring levels of phytonutrients, sterilizing and drying them, applying iterative grinding processes and stabilization techniques, all while avoiding high temperatures. Whole green coffee bean products created and defined by these methods have unexpectedly been found to increase focus and concentration in users, and are believed useful in the treatment of attention and concentration deficits and related disorders, such as attention deficit (AD), attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and various related and/or comorbid disorders.

Abstract: The invention involves the use of compounds from the class of aroyl-2H-imidazol-2-ones such as enoximone or a pharmaceutically acceptable salt thereof for modulating the immune system involved in a topic and immune-related disorders. In particular, the invention involves the use of (1,3-dihydro-4-methyl-5-[4-(methylthio)benzoyl]-2H-imidazol-2-on) or a pharmaceutically acceptable salt thereof. The invention also involves a pharmaceutical composition including aroyl-2H-imidazol-2-on or a pharmaceutically acceptable salt thereof in an active quantity for the treatment of a topic and immune-related disorders, by modulating the immune system involved in a topic and immune-related disorders. Preference is especially given to a pharmaceutical composition in a dosage unit of 5, 10 or 20 mg, based on the quantity of the active ingredient.

Abstract: The disclosure is directed to drug delivery devices that provide for combinations of extended and pulsed controlled release delivery of active pharmaceutical ingredient(s) APIs. The described drug delivery devices for oral administration of therapeutic compositions can include two or more populations of unit dosage forms including one or more API's in various combinations of pulsed and delayed/extended delivery formulations. The population of unit dosage forms are provided in a variety of different vehicles such as granules, beads, pellets, or tablets and can be contained within a drug delivery device of the present disclosure.

Abstract: The present invention relates to a pharmaceutical preparation comprising entecavir as an active ingredient, wherein an antioxidizing agent is added to enhance stability of entecavir, and a method for preparing the same. According to the present invention, the invention has an effect that entecavir can be stably maintained in a pharmaceutical preparation containing a certain amount or more of moisture by adding the antioxidizing agent, thereby a pharmaceutical preparation can be provided as a formulation containing a certain amount or more of moisture, for example, an orally disintegrating film formulation.

Abstract: A unit multiparticulate dosage form for delivering one or more basic, active pharmaceutical ingredients into the body in need of such medications to achieve target PK (pharmacokinetics) profiles is described. The dosage form comprises one or more multicoated drug particles (beads, pellets, mini-/micro-tablets) having a barrier coating and a lag-time coating. Each Timed Pulsatile Release (TPR) bead population exhibits pre-determined lag-time followed by differing release characteristics. The composition and thickness of the barrier coating, composition and thickness of the lag-time coating, ratio of IR beads to one or more TPR bead populations and total dose may be varied depending on the alkalinity, pH-dependent solubility and elimination half-life of the active ingredients to achieve target PK profiles (suitable for a once or twice daily dosing regimen) in patients in need of such medications.

Abstract: The invention provides a composition comprising, a compound of formula (I): or a pharmaceutically acceptable salt thereof and a plurality of solid carrier particles, as well as methods for using the composition to inhibit the activity of cytochrome P-450.

Abstract: Disclosed herein are compositions and methods for the treatment of pulmonary hypertension, including pulmonary arterial hypertension. The methods include administering to a patient in need thereof an effective amount of anagrelide or derivative thereof. The compositions include an effective amount of anagrelide or derivative thereof, in some instances combined with one or more additional agents for the treatment of pulmonary hypertension.

Abstract: Prostacyclin compounds and compositions comprising the same are provided herein. Specifically, prostacyclin compounds comprising treprostinil covalently linked to a linear C5-C18 alkyl, branched C5-C18 alkyl, linear C2-C18 alkenyl, branched C3-C18 alkenyl, aryl, aryl-C1-C18 alkyl or an amino acid or a peptide (e.g., dipeptide, tripeptide, tetrapeptide) are described. The linkage, in one embodiment, is via a carbamate, amide or ester bond. Prostacyclin compounds provided herein can also include at least one hydrogen atom substituted with at least one deuterium atom. Methods for treating pulmonary hypertension (e.g., pulmonary arterial hypertension) and portopulmonary hypertension are also provided.

Abstract: A composition for manufacture of hard hydroxypropyl methyl cellulose capsules comprising a film forming material of hydroxypropyl methyl cellulose having a methoxy content of 27.0-30.0% (w/w), and a hydroxypropoxy content of 4.0-7.5% and as a 2% weight solution, a viscosity of 3.5-6.0 cPs at 20° C., dipping compositions, process for manufacture of hard hydroxypropyl methyl cellulose capsules according to a dip coating process and hard capsule shells.

Abstract: The invention provides poly(ethylene glycol)-lipid conjugates for use in drug delivery.

Abstract: The present disclosure concerns embodiments of a combination and/or composition comprising bacillus, and yucca, quillaja or both. Embodiments of methods of making and using the combination and/or composition also are disclosed herein. In some embodiments, the combination and/or composition may be used to improve feed conversion rates in animals. In some embodiments the animals are avians; in other embodiments, the animals are non-avians. Embodiments of the disclosed combination can comprise a first composition comprising Quillaja saponaria, Yucca schidigera, or both, and Bacillus coagulans. Embodiments of the disclosed composition can comprise Quillaja saponaria, Yucca schidigera, or both, and Bacillus coagulans.

Abstract: A composition comprising (a) and (b), and a food or drink or a medicine comprising the composition, wherein (a) is at least a kind of polyphenols selected from the group consisting of a polyphenol containing 15 mass % or more of proanthocyanidin having a polymerization degree of 1 to 3, hesperidin, a hesperidin derivative, and hesperetin; and (b) is at least a kind of xanthine derivatives, the mass ratio of (a):(b) in the composition being 1:(0.001 to 5), are useful for the prevention, amelioration, or treatment of metabolic syndrome, disorders of lipid metabolism (for example, fatty liver, hyperlipidemia), obesity (for example, visceral fat accumulation, subcutaneous fat accumulation), or the like.

Abstract: The invention relates to the use of an oral dosage form based on microgranules and/or microtablets to reduce the abusive use of at least one active principle contained therein. The aim of the invention is to prevent the diversion of an oral dosage form based on microgranules and/or microtablets containing at least one active principle capable of causing a dependency, a gelling agent, and a gelling activator. The gelling agent and the activator are only brought into contact with each other in the event of diversion by crushing. Said judiciously selected pair of excipients confers a viscosity to the formulation, such that said formulation cannot be administered by injection or does not release the active principle rapidly by forming a gel when it comes into contact with the mucous membrane if nasally administered.

Abstract: The invention is directed to a pediatric oral suspension composition containing amoxicillin and clavulanate potassium where the clavulanate potassium is present in an amount equal to or less than about 21.5 mg/5 mL, and a method of treating bacterial infections by providing between about one to about fourteen dosage days of the composition.

Abstract: Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.

Abstract: Provided is a composition for preparing a soft capsule shell that includes a non-animal material, and more particularly a composition for preparing a soft capsule shell, which includes modified starch composed of modified waxy corn starch and modified waxy potato starch, thereby realizing a soft capsule shell having appropriate hardness and elastic strength and delaying a browning phenomenon. The composition includes modified starch composed of modified waxy corn starch and modified waxy potato starch at a weight ratio of 2:8 to 8:2, a modified starch hydrolysate, a gelling agent, a plasticizer and purified water.

Abstract: There is provided a transnasal anticonvulsive pharmaceutical composition including a poorly soluble anticonvulsant. The anticonvulsive pharmaceutical composition comprising a poorly soluble anticonvulsant as an active component, which is transnasally spray-administered, comprises diethylene glycol monoethyl ether and fatty acid ester, wherein the fatty acid ester is selected from the group consisting of caprylocaproyl polyoxylglyceride, isopropyl palmitate, oleoyl polyoxylglyceride, sorbitan monolaurate 20, methyl laurate, ethyl laurate, and polysorbate 20. Also, the anticonvulsive pharmaceutical composition comprising a poorly soluble anticonvulsant as an active component, which is transnasally spray-administered, comprises diethylene glycol monoethyl ether, fatty acid ester, methylpyrrolidone, water and alcohol. Therefore, the transnasal anticonvulsive pharmaceutical composition may be useful to highly enhance the bioavailability of the poorly soluble anticonvulsant.

Abstract: The present invention is directed to compositions comprising physiologically active phenolic compounds and methods for making and using the same. In particular embodiments, the compositions described herein include suspension formulations including a physiologically active phenolic compound provided as a nanoparticulate material and dispersed within an edible lipid.

Abstract: Method for the realization Hof a calcium phosphate-based biomaterial in form of granules and/or agglomerates of re-absorbable granules which can be used in the biomedical industry as, e.g., bone fillers, for increasing the bone mass, as a sealing for the internal orthopaedic prosthesis, for releasing drugs and/or medicaments and/or other substances beneficial for the organism. A calcium phosphate-based biomaterial in form of granules and/or aggregates thereof obtained according to such method.

Abstract: A urine handling system capsule (105) for releasing an oil mixture in the lumen of a urine handling system, the capsule (105) comprising a capsule wall defining a space filled with an oil mixture, wherein the oil mixture comprises 90-100% of an oil selected from the group consisting of silicone fluids and mineral oils or a mixture thereof, and having a viscosity of at most 600 cSt, and wherein the capsule wall is made of a water-soluble material. A urine measurement system (101) comprising an oil mixture arranged in the luminal space of the measurement system. A method for inhibiting impairment of functionality and measurement accuracy in a urine measurement system comprising applying an oil mixture to the inner surfaces of the urine measurement system. Use of an oil mixture in treatment of luminal surfaces of a urine handling system.

Abstract: A process includes utilizing biorenewable resveratrol or a resveratrol-derived material as a bio-derived crosslinker to form a crosslinked polymeric material.

Abstract: A microsphere and method for forming the same are disclosed. The microsphere includes modified cellulose and at least one of a visualization agent, a magnetic material, or a radioactive material.

Abstract: The field of the invention is that of oral pharmaceutical medicinal products or compositions, more particularly of the type of those comprising one or more active principles. The aim of the invention is to provide an improved oral medicinal product that can be administered in one or more daily doses, with modified release of active principle (in particular an active principle), for improving the prophylactic and therapeutic efficacy of such a medicinal product. This aim is achieved by means of the multimicrocapsular oral pharmaceutical form according to the invention in which the release of the AP is controlled by means of a double mechanism of triggering the release: “time triggering” and “pH triggering”. This medicinal product comprises microcapsules with modified release of active principle, each containing a core comprising the active principle and one or more swelling agents, and at least one coating making possible the modified release of the active principle.