Abstract: Disclosed in certain embodiments is a solid oral dosage form comprising a plurality of particles, each particle comprising (i) a core comprising an active agent susceptible to abuse and an internal adhesion promoter, wherein the cores are (i) dispersed in a matrix comprising a controlled release material or (ii) coated with a controlled release material. The dosage form can also include an alcohol resistant material.

Abstract: The present invention relates to a method for producing a stable dispersion of nano-particles, comprising the steps: a) mixing a suspension of nano-particles with an aqueous solution of gelatine hydrolysate; and b) adding an aqueous solution of gelatine to the mixture. Furthermore, the invention relates to a stable dispersion of nano-particles as well as the use thereof.

Abstract: Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) 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 7 hours or longer, followed by an ascending release rate. When administered at night the composition provides early morning improvement in symptoms of ADHD and sustained improvement over a period of at least 12 hours.

Abstract: Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) 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 a prolonged release.

Abstract: Fumarate compounds, pharmaceutical compositions comprising the fumarate compounds, and methods of using fumarate compounds and pharmaceutical compositions for treating neurodegenerative, inflammatory, and autoimmune disorders including multiple sclerosis, psoriasis, irritable bowel disorder, ulcerative colitis, arthritis, chronic obstructive pulmonary disease, asthma, Parkinson's disease, Huntington's disease, and amyotrophic lateral sclerosis are disclosed.

Abstract: An oral composition comprising minicapsules wherein the minicapsules comprise one or more therapeutic or prophylactic substances in a liquid, semi-liquid, or solid core. The minicapsules have release profiles to release the substance in an active form at one or more sites along the gastro-intestinal tract to maximize absorption and/or therapeutic efficiency.

Abstract: In various embodiments, the present invention provides methods of lowering triglycerides in subject on statin therapy and having baseline fasting triglycerides of about 200 mg/dl to less than 500 mg/dl, the methods comprising administering to the subject a composition comprising ethyl eicosapentaenoate.

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: A multiparticulate composition includes a plurality of individual enteric coated cores containing one or more terpene-based active ingredients and having a continuous proteinaceous subcoating layer covering the individual cores and separating the individual cores from their respective enteric coatings. The continuous proteinaceous subcoating layer prevents volatile terpene-based active ingredients from leaving the core, even when the core is heated during processing or stored for long periods above room temperature. The multiparticulate composition may be used to treat gastrointestinal disorders.

Abstract: A dosage form article suitable for oral administration, comprising more than one compartments each delimited by a plurality of distinct segments selected from the group consisting of body parts, cap parts and combinations thereof. The dosage form article comprises: at least one first body part and at least one first cap part each comprising inner and outer surfaces, wherein the first body and cap parts are telescopically engageable; and at least one second body part, comprising inner and outer surfaces, being telescopically engageable with the at least one first body or cap parts or both. The at least one of the second body parts is arranged within the at least one first body part or cap part or both such that a distinct first compartment is formed between the outer surface of the second body part and the inner surface of the first body part or cap part or both.

Abstract: The present invention relates to modified release pharmaceutical composition comprising metoprolol succinate, one or more release modifying agent(s) and one or more pharmaceutically acceptable excipient(s). More specifically, the invention relates to modified release pharmaceutical compositions comprising metoprolol succinate and a process for preparation thereof.

Abstract: A hydrogel bead for intra-articular supplement made by: providing a solution of alginate, providing a solution with chitosan having a Mw between lower than 60 kD, mixing the solution of alginate and the solution of chitosan, wherein the mixed solution comprises between 0.5 and 0.7% (w/v) of chitosan and between 1 and 1.4% alginate (w/v), introducing droplets of the mixed solution into a solution with Ca2+ or Sr2+ cations and isolating polymerised beads from the solution with cations.

Abstract: The present invention relates to the implementation of a new method for manufacturing solid dosage forms for oral administration comprising poorly water soluble active ingredients which overcomes the associated solubility problems and affords improved dissolution profile.

Abstract: Dried powder solid particles are disclosed containing a probiotic microorganism and a carrier phase wherein the probiotic microorganism is encapsulated, and wherein the carrier phase further comprises at least a nutritious source. The dried powder solid particles have a particle size distribution between n and (n+400) ?m, wherein n is comprised between 100 and 10,000 ?m, preferably between 300 and 5000 ?m, more preferably between 400 and 1000 ?m.

Abstract: The invention concerns a storage stable pharmaceutical preparation comprising oxycodone and naloxone for use in pain therapy, with the active compounds being released from the preparation in a sustained, invariant and independent manner.

Abstract: The present invention relates to combination therapy for cancer with a WT1 peptide vaccine and temozolomide.

Abstract: A pharmaceutical formulation containing a glycosaminoglycan is provided. In this pharmaceutical formulation, a glycosaminoglycan layer surrounding a drug layer is used to improve the treatment efficiency of enteric diseases.

Abstract: Fumarate compounds, pharmaceutical compositions comprising the fumarate compounds, and methods of using fumarate compounds and pharmaceutical compositions for treating neurodegenerative, inflammatory, and autoimmune disorders including multiple sclerosis, psoriasis, irritable bowel disorder, ulcerative colitis, arthritis, chronic obstructive pulmonary disease, asthma, Parkinson's disease, Huntington's disease, and amyotrophic lateral sclerosis are disclosed.

Abstract: Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral pharmaceutical compositions comprising fumarate esters are described.

Abstract: The present invention provides imidazothiadiazole compounds of Formula (I); Wherein W, Y, R0, R2, R4, Ra, Rb, X1, X2, X3 and X4 are as defined herein, or a stereoisomer, tautomer, pharmaceutically acceptable salt, prodrug ester or solvate form thereof, wherein all of the variables are as defined herein. These compounds are inhibitors of platelet aggregation and thus can be used as medicaments for treating or preventing thromboembolic disorders.

Abstract: Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral pharmaceutical compositions comprising fumarate esters are described.

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: Bioavailability of peptide active agents to be administered orally is enhanced by a pharmaceutical composition providing targeted release of the peptide to the intestine by combining the composition with an absorption enhancer. Bioavailability is further significantly increased by administering the composition in an acid-resistant protective vehicle which transports components of the invention through the stomach. The composition may optionally further include a sufficient amount of a pH-lowering agent to lower local intestinal pH. All components are released together into the intestine with the peptide.

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: A method of treating rhinitis and rhinorrhea includes taking a daytime oral dosage unit containing a non-sedating antihistamine for treating rhinitis and an anticholinergic agent having limited capacity to cross blood-brain barrier for treating rhinorrhea, and taking a nighttime oral dosage unit containing a non-sedating anticholinergic agent that has limited capacity to cross blood-brain barrier and that is in a lower amount than the amount in the daytime oral dosage unit for treating rhinorrhea or no anticholinergic agent.

Abstract: An ingestible pill includes a coating configured to dissolve in a small intestine; a core, which includes a medication-delivery element, which (a) has a compressed shape when disposed within the coating, and (b) is configured to assume, after the coating dissolves, an expanded shape; a medication; and a mucoadhesive. When unconstrained in the expanded shape, the medication-delivery element (a) is shaped so as to define first and second surfaces on opposite sides of the medication-delivery element, which have respective outer perimeters, which surround respective spaces of the respective surfaces, which spaces have respective greatest dimensions equal to between 2 and 10 cm, and each of which spaces has an area equal to at least 50% of the square of the greatest dimension; and (b) has an average thickness between the first and the second surfaces of less than 6 mm. Each of the medication and the mucoadhesive at least partially coats the first surface.

Abstract: Flavored chewable wafers containing nutritional supplement formulations suitable for enhancement of cell and mitochondrial function as well as providing antioxidants and aiding in weight loss and other desirable nutritional benefits comprises enriched formulations of phospholipids, specifically identified concentrations of phosphatidylglycerol, phosphatidic acid, phosphatidylethanolamine, phosphatidylcholine, glycolipids and phosphatidylserine along with inulin and other desirable active ingredients. These edible wafer lipid combinations can be used to treat mitochondrial disorders and other nutritional deficiencies associated with medical pathologies, chronic illnesses and syndromes, or to maintain lipid balance for normal mitochondrial function, and can be administered in pleasant tasting chewable wafers.

Abstract: A capsule of, for instance, hard gelatin for holding a substance such as medicine, food supplements or similar materials includes a capsule body having a closed and an opposed open end with a predetermined length defined between the ends. A diaphragm having a closed end and an opposed open end and a predetermined length there between seals off the body and provides a first compartment to hold a first medicine, food supplement, etc. A cap is applied to the body as is conventional in capsules. The space between the inner portion of the cap and the diaphragm defines a second compartment for holding a second medicine, food supplement, etc. The contents of each compartment may be wet or dry (e.g., powder or liquid.

Abstract: The present invention provides an acid resistant capsule shell composition comprising a water-soluble enteric polymer, a water-soluble film forming polymer, a coagulant, and a gelling aid. The water-soluble enteric polymer comprises hydrophobic functional groups and hydrophilic functional groups. The present invention further provides a process for preparing an acid resistant capsule shell comprising: dissolving said acid resistant capsule shell composition in deionized water to form a capsule shell solution; heating and then cooling the capsule shell solution to form a capsule shell stock solution; dipping a pin into the capsule shell stock solution and then removing the pin to form a film-coated pin; and drying the film-coated pin to form the acid resistant capsule shell. The acid resistant capsule shell has acidic resistance and the process for preparing the acid resistant capsule shell involves no organic solvent; hence, the problem of organic solvent residues can be prevented.

Abstract: An implant, artificial or semi-artificial at implantation, for repairing an articular cartilage and osteochondral defect site in a mammalian, such as a human. The implant having at least a first surface and a second surface. The first surface shaped for being press-fitted into the defect site to create an interface between the first surface and a bone-cartilage region of the defect site, and the second surface shaped for being press-fitted into the defect site to create an interface between the second surface and an articular cartilage region of the defect site. The implant being seeded, prior to implantation, with chondroprogenitor cells, including superficial zone chondroprogenitor cells.

Abstract: A method of manufacturing a medical drug of alleviating damage of gastrointestinal mucosal induced by a non-steroidal anti-inflammatory drug, NSAID, the medical drug being able to induce anti-inflammatory effect of the NSAID and being able to alleviate damage induced by the NSAID includes dissolving trehalose and the NSAID into one or more solutions, so as to obtain an approximately homogenously-mixed liquid mixture of the trehalose and the NSAID; in which the liquid mixture contains an intermolecular compound with the trehalose and the NSAID; and drying the liquid mixture so as to obtain the medical drug.

Abstract: Described is a controlled-release formulation for treating disturbed sleep or insomnia in a subject. The formulation is formulated to release a compound or combination of compounds in sequence at multiple stages.

Abstract: The present invention provides compositions for encapsulation of biomaterials in a silica-matrix. The present invention also provides methods of making silica-matrix encapsulated biomaterials, and to methods of using silica-matrix encapsulated biomaterials. In one embodiment, the present invention provides a method of encapsulating mammalian cells in a silica-matrix while maintaining metabolic activity. In another embodiment, the present invention provides a method of purifying cancer cells using a silica-matrix.

Abstract: Embodiments disclosed herein generally relate to acamprosate formulations, methods of use of the formulations, to methods of using the formulations in combination with at least one other medication, and to combination products and compositions comprising the formulations and at least one other medication, such as neuroleptic (antipsychotic) and/or antidepressant drugs.

Abstract: Embodiments disclosed herein generally relate to acamprosate formulations, methods of use of the formulations, to methods of using the formulations in combination with at least one other medication, and to combination products and compositions comprising the formulations and at least one other medication, such as neuroleptic (antipsychotic) and/or antidepressant drugs.

Abstract: Methods and compositions for reducing frequency of urination are disclosed. One method comprises administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising one or more analgesic agents.

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: A multiparticulate composition is formed from a plurality of individual cores including a hydrophobic phase containing peppermint oil dispersed in a microcrystalline cellulose-based gel and a hydrophilic phase containing a hydrogel. An enteric coating is over the individual cores. The multiparticulate composition can be used to treat gastrointestinal disorders.

Abstract: An oral cyclosporin composition comprises minicapsules having a core containing a cyclosporin, especially cyclosporin A in a solubilized liquid form. The minicapsules have a release profile to release the pre-solubilized cyclosporin, at least in the colon. The composition may be used for treating a range of intestinal diseases [FIG. 10].

Abstract: The present invention provides improved formulations of 6-mercaptopurine that exhibit better bioavailability and faster dissolution than previous formulations.

Abstract: The present invention includes methods and compositions for the treatment and prevention of protozoal parasitic infections utilizing Diindolylmethane-related indoles. Additive and synergistic interaction of Diindolylmethane-related indoles with other known anti-parasitic and pro-apoptotic agents is believed to permit more effective therapy and prevention of protozoal parasitic infections. The methods and compositions described provide new treatment of protozoal parasitic diseases of mammals and birds including malaria, leishmaniasis, trypanosomiasis, trichomoniasis, neosporosis and coccidiosis.

Abstract: An oligomer-contained nanoparticle complex is provided. The oligomer-contained nanoparticle complex of the invention comprises (a) a nanoparticle, (b) a polymer with high molecule weigh, (c) a target molecule, (d) an oligomer, wherein the oligomer is crosslinked with the polymer by the intermolecular hydrogen bonds or electron bonds, and e) a space for active substances, wherein the space for active substances is encapsulated by the nanoparticle. The oligomer-contained nanoparticle complex of the invention has the high stability and fast drug release rate, and would not be largely accumulated in normal tissues. The invention also provides a method for preparing the oligomer-contained nanoparticle complex and the method for releasing drug.

Abstract: A method for treating intestinal fibrosis in a subject, wherein the subject is medically considered to be suffering from intestinal fibrosis, the method comprising enterally administering a steroid to the subject, wherein the steroid is selected from: (i) steroids susceptible to first pass metabolism, (ii) corticosteroids, and (iii) aclometasone, aclometasone dipropionate, aldosterone, amcinonide, beclomethasone, beclomethasone dipropionate, betamethasone, betamethasone dipropionate, betamethasone sodium phosphate, betamethasone valerate, budesonide, clobetasone, clobetasone butyrate, clobetasol propionate, cloprednol, cortisone, cortisone acetate, cortivazol, deoxycortone, desonide, desoximetasone, dexamethasone, dexamethasone sodium phosphate, dexamethasone isonicotinate, difluorocortolone, fluclorolone, flumethasone, fluocinolone, fluocinolone acetonide, fluocinonide, fluocortin butyl, fluorocortisone, fluorocortolone, fluocortolone caproate, fluocortolone pivalate, fluorometholone, fluprednidene, flupr

Abstract: The use of tPA to treat hemorrhagic transformation, neurotoxicity has been limited to short treatment time windows because a high dose of tPA required to generate sufficient amounts of the enzyme plasmin for clot lysis. The present invention combines tPA with recombinant Annexin A2 resulting in thrombolysis without hemorrhagic transformation at delayed times after stroke. This embodiment allows the administration of a lower, non-neurotoxic, tPA dose. Our results suggest this novel combination for stroke therapy may greatly improve both efficacy and safety, and prolong tPA therapeutic time window.

Abstract: This invention is based on unexpected effect of at least one thickener to maintain suspension or dispersion of solid particles in an oil medium. Such effect of thickener enables significant higher weight ratio of solid particles in such suspension composition as compared to previously known compositions. As a consequence, the suspension compositions provided herein enable more active ingredient in the solid particle to be present in a fixed volume or weight of such composition as compared to previously known compositions. One advantage of the suspension composition provided herein can be for aerial spraying of active ingredient such as herbicides, insecticides, or other growth regulating compounds.

Abstract: A delivery system for water-insoluble pharmaceutical active ingredients is provided. The delivery system includes water-insoluble pharmaceutical active ingredient(s), organic solvent(s) and amphiphilic co-solvent(s), and a mixture of hydrophilic and hydrophobic non-ionic surfactants. Upon dilution in an aqueous medium, this formulation forms spontaneously dispersion of non-ionic surfactant nanoparticles.

Abstract: The present invention relates to a use of a biological surfactant as an anti-inflammatory agent and a tissue preservative solution. More particularly, the present invention is directed to an anti-inflammatory agent and a tissue preservative solution comprising a biological surfactant which blocks a reaction of a proinflammatory factor with a receptor by emulsifying the proinflammatory factor.

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 relates to a process developed for production of a dry powder medicament used in respiratory tract diseases such as asthma and COPD.

Abstract: An embodiment of the present disclosure provides a composition that comprises hyaluronic acid, or its salt or derivative thereof, and an antimicrobial agent, such as zinc citrate, that does not degrade the hyaluronic acid molecule.