Abstract: The present invention relates to a dietary supplement, composition, nutraceutical, and/or system for inducing or treating biological responses or conditions (namely sleep or sleep disorders) which utilize ultra-low dosage amounts of vitamins, minerals, amino acids, co-enzymes, stimulants, and/or similar ingredients in a highly bio-active delivery system which bypasses first pass metabolism. In particular, the present invention relates to a nutraceutical composition/formulation which substantially bypasses first pass metabolism and such as, but not limited to, activation of the glymphatic system to facilitate clearance of neuronal metabolites from the CSF and interstitial fluids in the brain.

Abstract: The present invention provides methods and compositions for treating cancer, reducing side effects, and reducing postmenopausal symptoms comprising anordrin or analog thereof (such as anordrin) alone or in combination with at least one other agent selected from the group consisting of tamoxifen, raloxifene or functional equivalent thereof, and an aromatase inhibitor.

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: The disclosure relates to a pharmaceutical formulation comprising hydrocortisone and its use in the treatment of conditions that would benefit from a delayed release of hydrocortisone, in particular conditions such as adrenal insufficiency, inflammatory conditions and depression.

Abstract: The invention relates to a tamper-resistant pharmaceutical dosage form comprising one or more particles, wherein each of said one or more particles comprises a pharmacologically active ingredient and a physiologically acceptable polymer; has a breaking strength of at least 300 N; has a weight of at least 2 mg; and optionally, comprises a film-coating; wherein the total weight of the pharmaceutical dosage form is greater than the total weight of said one or more particles.

Abstract: The invention relates to tablet comprising granules dispersed in at least one hydrophilic compound or matrix. The granules contain an active agent, at least one amphiphilic compound and at least one lipophilic compound. The tablet may include a gastro-resistant film coating.

Abstract: The present disclosure relates to anhydrous hydrogels useful as mucoadhesive (oral compositions) or as topical agents and may be used to deliver an active agent such as active pharmaceutical agents (API's), coagulants, fragrances, flavors, and other actives and excipients.

Abstract: Controlled-release therapeutic compositions including melatonin combined with sedative and/or analgesic ingredients are described. The compositions have a solid core including melatonin in an acidified polymeric matrix. A sedative ingredient such as GABA receptor agonist may also be in the acidified polymeric matrix. The composition may include an expedited release portion providing a burst release of active ingredients and a sustained release portion providing a sustained release of active ingredients.

Abstract: The invention relates to tablet comprising granules dispersed in at least one hydrophilic compound or matrix. The granules contain an active agent, at least one amphiphilic compound and at least one lipophilic compound. The tablet may include a gastro-resistant film coating.

Abstract: Pharmaceutical compositions for reducing frequency of urination are disclosed. The pharmaceutical compositions comprise one or more prostaglandin pathway inhibitors and a pharmaceutically acceptable carrier. Also disclosed are methods of making and using the pharmaceutical compositions.

Abstract: Compositions for reducing the frequency of urination and methods of manufacturing the compositions are disclosed. The compositions comprises a first component having an immediate-release subcomponent and an extended-release subcomponent, wherein the first component is formulated to release the subcomponents immediately after administration; and a second component comprising an immediate-release subcomponent and an extended-release subcomponent, wherein the second component is formulated for a delayed-release of the subcomponents.

Abstract: Disclosed is a digestive tract patency capsule, comprising an outer membrane (2) and a supporting material (1) which is soluble in digestive juices. The outer membrane (2) is a sealed soft capsule body made from a sustained-release enteric material, and the dissolution time of the outer membrane (2) is greater than the normal emptying time of the human digestive tract. The cavity of the capsule body of the outer membrane (2) is provided with an indicator (5) which can be absorbed by the body and enables the discharged urine to change color. The supporting material (1) is provided in the cavity of the capsule body of the outer membrane (2) to support the outer membrane (2) in a capsule form. The digestive tract patency capsule can safely and effectively check the feasibility of performing a capsule endoscopic examination on a user.

Abstract: Valproate is useful as an antifungal agent. The valproate compositions can be used to treat fungal infections. The valproate compositions can be formulated as topical antifungals.

Abstract: Methods and compositions are provided which comprise effective amounts of an analgesic to treat a subject, including reducing or eliminating an adverse effect associated with the analgesic.

Abstract: The invention relates to tablet comprising granules dispersed in at least one hydrophilic compound or matrix. The granules contain an active agent, at least one amphiphilic compound and at least one lipophilic compound. The tablet may include a gastro-resistant film coating.

Abstract: The present invention provides sialic acid analogs and their compositions useful for the treatment of sialic acid deficiencies.

Abstract: The present invention relates to compositions and methods for prophylactic and/or therapeutic treatment of conditions related to mitochondrial function. In various aspects, the present invention comprises administering one or more compounds selected from the group consisting of epicatechin, an epicatechin derivative, catechin, a catechin derivative, nicorandil, and a nicorandil derivative in an amount effective to ameliorate mitochondrial toxicity caused by administration of a chemical, food, or drug.

Abstract: Controlled release and taste masking compositions containing one or more active principles inglobated in a three-component matrix structure, i.e. a structure formed by successive amphiphilic, lipophilic or inert matrices and finally inglobated or dispersed in hydrophilic matrices. The use of a plurality of systems for the control of the dissolution of the active ingredient modulates the dissolution rate of the active ingredient in aqueous and/or biological fluids, thereby controlling the release kinetics in the gastrointestinal tract.

Abstract: A method for synchronizing ovulation in sows and gilts by a single injection of hormones is disclosed. A hormone, gonadotropin releasing hormone (GnRH), luteinizing hormone (LH), follicle stimulating hormone (FSH), human chorionic gonadotropin (hCG), analogs, derivatives, agonists or combinations thereof is administered to an open sow post weaning at a specific time to stimulate ovulation of mature responsive follicles. The sow is then bred, without heat detection, at a specific subsequent timed interval after injection with hormone, with one or two artificial or natural breedings. In gilts, the hormone is injected at a timed interval from onset of estrus or at a specific timed interval following Prostaglandin F2a for those gilts which have been held in a state of pseudopregnancy.

Abstract: The invention provides novel nanoscale delivery vehicles and composite nanoassemblies built from distinct nanoassembly units (e.g., block copolymer micelles and nanogels) with stoichiometric control. These intelligent composite nanoassemblies independently retain the key features of the nanoassembly units and greatly expand the potential functional features attainable based on the surface functionalization. The invention provides a novel approach to constructing nano-vehicles with controllable morphology based on combination of cooperative releasing mechanisms (e.g., redox sensitive nanogels and pH sensitive micelles). Two kinds of guests can be seperately and stably encapsulated in the composite nanocontainers, and then released sequentially under the stimulation of pH change and reduced glutathione.

Abstract: A water-swellable linear polyurethane polymer is formed by reacting a polyethylene oxide (e.g. PEG 4000 to 35,000), a difunctional compound (e.g. a diamine or diol such as 1,10-decanediol) with a diisocyanate. The ratio of the three components is generally in the range 0.1-1.5 to 1 to 1.1-2.5. The polyurethane is water-swellable in the range 300 to 1700% and soluble in certain organic solvents such as dichloromethane. It can be loaded with pharmaceutically active agents, particularly of high molecular weight, to produce controlled release compositions, such as pessaries etc.

Abstract: There is provided a novel process for the preparation of a hydrocodone salt. In particular, there is provided a novel process for the preparation of a free-flowing slurry of a hydrocodone salt, for example, a free-flowing slurry of hydrocodone bitartrate hemipentahydrate.

Abstract: The invention is directed to a process for measuring the amount of digestive enzymes released from a solid composition in a dissolution medium by fluorescence spectroscopy. The invention is also directed to a combined method for measuring both the dissolution and gastroresistance of a solid compositions comprising pancrelipase.

Abstract: Techniques are disclosed for treating or reducing symptoms associated with abdominal dysfunction or ileus following surgery or other abdominal episode by treating the area with a combination of one or more protease, antibacterial compound, and inflammatory lipid mediator.

Abstract: The instant invention relates to a process for the preparation of a pharmaceutical composition in sustained-release tablet form comprising from 600 milligrams to 2400 milligrams of Pirfenidone (PFD), in such a way that the drug is bioavailable during an extended period of time of 12 hours from its administration. In this way, the anti-fibrotic and anti-inflammatory action of the drug Pirfenidone is optimized. Moreover, the instant invention offers advantages and a higher therapeutic efficacy compared to other pharmaceutical forms of Pirfenidone for oral administration and its therapeutic application in the regression of chronic renal failure secondary to primary glomerulosclerosis; it shows a better activity with regard to the reduction and/or regression of deleterious effects in breast capsular contracture observed after the surgical implantation of breast implants in humans and has an important anti-TNF-? and anti-TGF-?1 action for the treatment of hepatic fibrosis.

Abstract: The present invention relates to, in part, methods and compositions for the treatment of methanogen-associated disorders such as, for example, Irritable Bowel Syndrome (IBS). Particularly, modified-release formulations comprising at least one antimethanogenic statin are provided which release the antimethanogenic statin in the intestines.

Abstract: A composition and an associated method for hepatic targeted delivery of thyroid receptor beta1 (TR?1) agonist to a liver of a subject. The composition includes hydrophobic nanoparticles, a liver targeting moiety exterior to each nanoparticle and covalently bonded to each nanoparticle, and at least one TR?1 agonist encapsulated within each nanoparticle. The nanoparticles include chitosan hybrid nanoparticles, amine-modified PLGA nanoparticles, solid lipid nanoparticles, and combinations thereof. The liver targeting moiety includes Glycyrrhetinic acid (GA), Lactobionic acid (LA), or combinations thereof.

Abstract: A method is described for the treatment of systemic diseases in cats. A composition is administered to a cat, where the composition includes a therapeutically effective amount of angiotensin II receptor 1 (AT-1) antagonist (sartan).

Abstract: The present invention relates to oral sustained release formulations of tofacitinib and pharmaceutical acceptable salts thereof. The formulations described herein have desirable pharmacokinetic characteristics.

Abstract: A novel pharmaceutical composition, which comprises a therapeutically effective amount of active principle(s) or a pharmaceutically acceptable salt or enantiomer or polymorph thereof, optionally one or more release controlling agent(s) and pharmaceutical acceptable excipient(s) thereof, wherein the composition is formulated to increase the residence time of the said pharmaceutical composition and/or active principle(s) in the gastrointestinal tract. A novel pharmaceutical composition comprising at least two entities wherein one entity is an immediate release/fast release and the other is controlled release. A pharmaceutical composition comprising at least two entities wherein one entity is an immediate release/fast release and the other is bioadhesive. A pharmaceutical composition comprising: at least two entities wherein one entity is controlled release and the other is bioadhesive All the three compositions are formulated to increase the residence time of active principle(s) in the gastrointestinal tract.

Abstract: An oral product includes a body that is wholly receivable in an oral cavity. The body includes a mouth-stable polymer matrix, cellulosic fibers embedded in the mouth-stable polymer matrix, and nicotine or a derivative thereof dispersed in the mouth-stable polymer matrix. The oral product is adapted to release the nicotine or derivative thereof from the body when the body is received within the oral cavity and exposed to saliva.

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: It is an object of the present invention to provide an orally disintegrating tablet that has desirable oral disintegrability and excellent tablet hardness, a process for producing the same, and the like. The present invention provides an orally disintegrating tablet comprising: at least one diluent selected from D-mannitol, lactose, trehalose, xylitol, maltitol, and erythritol; a drug; a disintegrant; and at least one binder selected form methacrylic acid copolymer S, methacrylic acid copolymer L, methacrylic acid-ethyl acrylate copolymer, ethyl acrylate-methyl methacrylate copolymer, and methyl methacrylate-butyl methacrylate-dimethylaminoethyl methacrylate copolymer.

Abstract: Methods and compositions are provided which comprise effective amounts of an analgesic to treat a subject, including reducing or eliminating an adverse effect associated with the analgesic.

Abstract: Solid dosage formulations of nitazoxanide or a nitazoxanide analogue are provided that comprise a controlled release portion and an immediate release portion. The pharmaceutical composition is typically in the form of a bilayer solid oral dosage form comprising (a) a first layer comprising a first quantity of nitazoxanide or analogue thereof in a controlled release formulation; and (b) a second layer comprising a second quantity of nitazoxanide or analogue thereof in an immediate release formulation. Method of using the formulations in the treatment of hepatitis C are also provided.

Abstract: Described are immediate release oral dosage forms that contain abuse-deterrent features. In particular, the disclosed dosage forms provide deterrence of abuse by ingestion of multiple individual doses. In addition, the disclosed dosage forms provide protection from overdose in the event of accidental or intentional ingestion of multiple individual doses.

Abstract: The invention provides compounds that are chemically modified by covalent attachment of a water—soluble oligomer. A compound of the invention, when administered by any of a number of administration routes, exhibits characteristics that are different from those of the compound not attached to the water—soluble oligomer.

Abstract: An antiseptic solution including, a cationic antiseptic agent, a film forming polymer, an anionic tinting agent, and a solvent, wherein the cationic antiseptic agent, the film forming polymer and the anionic tinting agent each remain solubilized within the solution for greater than about 1 hour at 25° C. and 60% relative humidity. The antiseptic agent is preferably octenidine dihydrochloride or chlorhexadine gluconate. The film forming polymer is preferably an acrylate polymer. The solvent is preferably ethanol, isopropanol, and n-propanol. When a drape is adhered to a dried surgical film via the antiseptic solution, the force required to peel the drape from the surgical film is at least about 105 g/25 mm.

Abstract: The present invention provides a dosage form, particularly a tamper resistant dosage form, comprising: melt-extruded particulates comprising a drug; and a matrix; wherein said melt-extruded particulates are present as a discontinuous phase in said matrix.

Abstract: A surface-treated heavy calcium carbonate is provided which is useful for a film exactly controlled in its pore diameter and for easily hydrolyzable polyester resins. A heavy calcium carbonate is also provided which is compounded in a curable resin such as a one-component moisture-curable adhesive and a sealant either without any pre-drying treatment or by simple pre-drying treatment. A surface-treated heavy calcium carbonate satisfying 13,000?A?25,000, 0.8?B?3.0, C?0.55, and 0?D1?1000, or 8,000?A?25,000, 0.8?B?15, 0?C1?1000, and 0?C2?150 wherein: A: specific surface area (cm2/g), B: average particle diameter (?m): 50% particle diameter (d50) (?m), C: 10% particle diameter (?m), D1, C1: water content at between 25° C. and 300° C. by a Karl-Fischer method (heating vaporization method) (ppm), and C2: water content at between 200° C. and 300° C. by the same method.

Abstract: This invention relates to swallowable tablets containing at least 80% by weight of N-acetylcysteine (NAC) and at least one pharmaceutically acceptable excipient, in particular tablets in which the sulfurous odor is absent, characterized in that the said tablets are assembled using a granulate prepared by means of a process of dry granulating the active ingredient alone, with which the excipients are mixed before compression.

Abstract: A multi-particle dosage form that can deliver phenylephrine in controlled pulsed doses. The dosage form can contain an immediate release form that can contain phenylephrine or a salt thereof and a plurality of delayed release particles with a coating that can contain phenylephrine or salt thereof and a pH sensitive coating.

Abstract: The present invention relates to long acting pharmaceutical compositions of betulin derivatives or pharmaceutically acceptable salts thereof, useful in the treatment or prevention of Human Immunodeficiency Virus (HIV) infections.

Abstract: The present invention provides a therapeutic compound of formula (I) and their pharmaceutically acceptable salts for the prevention and treatment of lipodystrophy caused because of HIV infection or combination therapy of HIV-1 protease inhibitors (PIs) and/or reverse transcriptase inhibitors (nRTIs) by neutralizing lipohypertrophy, lipoatrophy and metabolic abnormalities in HIV patient.

Abstract: Compositions comprising biomedical polymers, and in particular unique blends of poly(lactic-co-glycolic acid) (PLGA) and poly(ethylene glycol) (PEG) are provided. Methods of forming polymer fibers using such compositions and solution blow spinning techniques are also provided, as well as methods of delivering the blow spun polymer fibers onto a surface (e.g., such as tissue for use as a surgical scaffold, sealant or tissue adhesive).

Abstract: The present invention relates to a method of suppressing organ rejection in a patient receiving an organ transplant by initiating oral treatment with a once-daily extended release tacrolimus dosage form, for example, at an initial dose of from about 0.15 to about 0.20 mg/kg/day within 24 or 48 hours following transplantation. The once-daily extended release tacrolimus dosage form (i) provides low fluctuation and/or swing of tacrolimus, (ii) provides a significantly lower Cmax than an immediate release formulation of tacrolimus while providing the same or greater area under the curve (AUC), (iii) releases the tacrolimus substantially in the colon and/or the lower ileum, (iv) releases at most 63.5% of the tacrolimus in the dosage form at the 12 hour time point, or (v) any combination of any of the foregoing.

Abstract: Methods for improving the gastrointestinal tolerability of biguanide compounds and for treating metabolic disorders and/or inducing weight loss in patients in need thereof, particularly in individuals having a contraindication for treatment with biguanide compounds, are provided comprising administering delayed release formulations of such biguanide compounds, including metformin, targeted to the small intestine.

Abstract: The present invention relates to compositions containing a combination of a cell proliferation-stimulating agent with vasokinetic properties and an antimicrobial, antifungal and antiviral agent with an anti-inflammatory/analgesic, which is useful in the treatment of peripheral ulcers of various origins, such as diabetic ulcers, ulcers caused by venous stasis of the limbs, bedsores and the associated skin infections. Said combination could be presented as formulations for topical or systemic use.

Abstract: Described are immediate release oral dosage forms that contain abuse-deterrent features. In particular, the disclosed dosage forms provide deterrence of abuse by ingestion of multiple individual doses. In addition, the disclosed dosage forms provide protection from overdose in the event of accidental or intentional ingestion of multiple individual doses.

Abstract: The disclosure relates to a pharmaceutical formulation comprising hydrocortisone and its use in the treatment of conditions that would benefit from a delayed release of hydrocortisone, in particular conditions such as adrenal insufficiency, inflammatory conditions and depression.