Abstract: The stable pharmaceutical compositions comprising a compound of Formula (I) or a stereoisomer or a pharmaceutically acceptable derivative thereof are disclosed.

Abstract: There is provided a solid dosage form adapted for the release of a biologically active material in the oral cavity wherein the dosage form includes at least one biologically active material, and at least one matrix forming agent, wherein the dosage form substantially dissolves in the oral cavity. A method of producing the same and a kit including the same are also provided.

Abstract: An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.

Abstract: Provided herein are capsules containing pimavanserin, processes for manufacturing said capsule, and pharmaceutical compositions containing pimavanserin.

Abstract: Co-crystals comprising at least one nutraceutical compound and at least one co-crystal former with or without impurities. These co-crystals may be included in compositions (optionally also including other components such as pharmaceutically acceptable excipients, other nutritional supplements, etc.) having utility as pharmaceuticals, nutraceuticals, nutritional supplements, and foodstuffs.

Abstract: The present disclosure is directed to compositions and methods for the production of a fast dissolving tablets to be used for the delivery of an agent. An agent can be an active pharmaceutical agent or a non-pharmacological agent, which is needed to be delivered by means of a fast dissolving delivery system. The invention solves many industry challenges within the field of fast dissolve technologies, specifically coupling of fast dissolve properties with required physical attributes of strength/robustness required for commercial production and distribution.

Abstract: The present invention relates to mannitol granules that are of use for the preparation of tablets by direct compression, which do not require a small amount of lubricant in order to be processed. The present invention also relates to a process for preparing such granules. The present invention also encompasses pulverulent compositions comprising these granules, and also direct compression processes using these pulverulent compositions. Finally, the present invention relates to tablets composed of these pulverulent compositions.

Abstract: A composition of oily, pungent and odoriferous substances and a process for preparation thereof are described, in particular an extended and sustained release of a stable, free flowing, solid composition of one or more of substances such as capsicum, black pepper, ginger, mustard, cinnamon, garlic, onion, paprika, turmeric and the like, extracts thereof, and/or components thereof, and a process for preparation thereof are described. For example, compositions comprise a substance such as capsicum containing capsaicinoid components, which include for example capsaicin, dihydro-capsaicin, and/or nor-dihydro-capsaicin.

Abstract: The present invention relates to oral care compositions and to method of maintaining oral health. The oral care composition of the present invention comprises at least one carbon dioxide source, at least one acid source, at least one abrasive and one or more pharmaceutically acceptable excipients.

Abstract: The disclosure is directed to methods of treating subjects infected with HIV, once daily, with single unit dosage forms that include darunavir (or a hydrate or solvate thereof), cobicistat, emtricitabine, and a tenofovir prodrug, or salt thereof.

Abstract: Improved oral dosage forms of methyl hydrogen fumarate and prodrugs thereof are disclosed. Methods of treating diseases such as multiple sclerosis and psoriasis using such dosage forms are also disclose.

Abstract: A method for the preparation of a highly polarized nuclear spins containing sample of an organic or inorganic material, containing H or OH groups or adsorbed water molecules. Such highly polarized nuclear spins containing samples can be subjected to nuclear magnetic resonance (NMR) measurement and/or can be thawed and immediately administered to an individual undergoing a magnetic resonance imaging (MRI) scan. The method is based on generating unstable radicals on the surface of the sample in the presence of ionized environment followed by cooling the sample to cryogenic temperatures. A device for carrying out a particular step of said method is also discloses.

Abstract: The present invention relates to stabilization of a certain benzothia(dia)zepine derivative in a solid formulation containing the same. In the present invention, in a solid formulation containing the benzothia(dia)zepine derivative mentioned above, a combination of polyethylene glycol and polyvinyl alcohol is not blended, or alternatively, in the case of blending polyethylene glycol and polyvinyl alcohol in the solid formulation, the aforementioned derivative is isolated from the combination of polyethylene glycol and polyvinyl alcohol.

Abstract: An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.

Abstract: The present invention relates to biomaterial in the form of dispersion of cellulose nanofibrils with extraordinary shear thinning properties which can be converted into desire 3D shape using 3D Bioprinting technology. In this invention cellulose nanofibril dispersion, is processed through different mechanical, enzymatic and chemical steps to yield dispersion with desired morphological and rheological properties to be used as bioink in 3D Bioprinter. The processes are followed by purification, adjusting of osmolarity of the material and sterilization to yield biomaterial which has cytocompatibility and can be combined with living cells. Cellulose nanofibrils can be produced by microbial process but can also be isolated from plant secondary or primary cell wall, animals such as tunicates, algae and fungi. The present invention describes applications of this novel cellulose nanofibrillar bioink for 3D Bioprinting of tissue and organs with desired architecture.

Abstract: A process for producing tyres including building a green tyre having two bead structures. Each bead structure includes a bead filler. The bead filler or another rigid component of the green tyre includes a final elastomeric compound produced by the following: feeding elastomeric polymer and reinforcement filler to a first batch mixing device; mixing and dispersing the reinforcement filler in the elastomeric polymer and unloading the obtained elastomeric compound; feeding the obtained elastomeric compound, along with at least 5 phr of reinforcement resin, to a continuous mixing device of intermeshing and co-rotating twin-screw or multi-screw type or of planetary type; mixing the reinforcement resin in the elastomeric compound and unloading the obtained elastomeric compound; and feeding the obtained elastomeric compound along with the components capable of facilitating the cross-linking to a second batch mixing device and mixing to obtain the final elastomeric compound.

Abstract: The present invention relates to a pharmaceutical composition comprising linagliptin or a pharmaceutically acceptable salt thereof as active ingredient, wherein the pharmaceutical composition does not comprise a binder and wherein the pharmaceutical composition is obtained by direct compression.

Abstract: The present invention provides compositions and methods for treating and preventing an A?-modulated disease. In certain embodiments, the invention provides an inhibitor of Fyn tyrosine kinase, and methods of using the same. In certain embodiments, the inhibitor of the invention inhibits A? oligomer induced signaling and reduces or halts the progression of Alzheimer's Disease.

Abstract: The present invention is directed to oral neuro-attenuating ketamine (NAKET) tablet formulations, and methods of administration, which ensure the steady release of a therapeutically effective concentration of ketamine from an oral tablet without neurologically toxic spikes in ketamine concentration. In particular, the present invention provides single layer oral tablet formulation of NAKET. In a specific embodiment, the NAKET tablet formulation, and methods of administration provide steady administration of NAKET to a subject for 24 hours or greater, for example, up to 36 hours, after a single administration event.

Abstract: The present invention provides a composite granulated product that is optimal for allowing a tablet, preferably an orally disintegrating tablet (OD tablet) to be excellent in disintegrability and have proper hardness. The composite granulated product includes a sugar or a sugar alcohol, a swelling binder, a disintegrating agent, and a highly absorbent excipient.

Abstract: Compositions (e.g., pharmaceutical compositions or nutraceutical compositions) comprising a benzoate compound and an excipient, wherein the excipient is tannic acid, and uses thereof for treating central nervous system disorders.

Abstract: The present invention relates to the field of coating pharmaceutical substrates. In particular, the invention relates to methods of coating of pharmaceutical substances, pharmaceutical ingredients or a blend of them. The invention also provides a method of making a pharmaceutical formulation which may be processed into a pharmaceutical dosage form, which utilizes solid pharmaceutical particles and a pharmaceutical formulation obtained by the method. The methods of the invention utilize atomic layer deposition technology. The novel methods allow difficult, moisture sensitive and electrically charged pharmaceutical substrates to be easily processable.

Abstract: Compositions are disclosed for improved sleep quality and quantity including ingredients for both immediate release and controlled release. The invention provides improved supplemental compositions, and methods for administering same to a user, for enhancing the onset, quality, and duration of sleep in humans and animals. The supplemental composition may contain a combination of ingredients in proportions calculated to relieve stress, promote relaxation, and enhance sleep, including at least the following ingredients: L-Theanine, Skullcap Herb (Scutellaria lateriflora L.), Rhodiola (Rhodiola rosea L.), and Chamomile Flower (Matricaria Recutita). In addition, the supplemental composition may include the secondary ingredient Melatonin. The selection and amounts of the ingredients of the supplemental composition promote sleep onset, quality, and duration and may be provided for consumption at least one time daily, e.g., prior to sleep.

Abstract: The invention relates to the preparation and characterization of novel forms of (1-hydroxy-2-imidazol-1-yl-1-phosphono-ethyl) phosphonic acid. The invention also relates to the use of the novel forms of (1-hydroxy-2-imidazol-1-yl-1-phosphono-ethyl) phosphonic acid in pharmaceutical compositions in drug delivery systems for humans. The invention further relates to the use of the novel forms of (1-hydroxy-2-imidazol-1-yl-1-phosphono-ethyl) phosphonic acid or the pharmaceutical compositions thereof to treat and/or prevent a disease state associated with osteoporosis, tumor induced hypercalcemia (TIH), cancer-induced bone metastasis, Paget's disease or for adjuvant or neoadjuvant therapies.

Abstract: The present application relates to pharmaceutical compositions comprising retinoic acid or its derivatives such as isotretinoin and processes for preparing thereof. It also provides methods for treating acne by administering such pharmaceutical composition to a patient in need thereof.

Abstract: The present disclosure is directed to compositions and methods for the production of a fast dissolving tablets to be used for the delivery of an agent. An agent can be an active pharmaceutical agent or a non-pharmacological agent, which is needed to be delivered by means of a fast dissolving delivery system. The invention solves many industry challenges within the field of fast dissolve technologies, specifically coupling of fast dissolve properties with required physical attributes of strength/robustness required for commercial production and distribution.

Abstract: An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.

Abstract: The invention relates to an oral formulation for targeted delivery of cholestyramine to the colon, comprising a plurality of cholestyramine pellets that are coated with a colon release coating. The invention also relates to the use of this formulation in the treatment of bile acid malabsorption.

Abstract: The present invention relates to solid oral formulations comprising a compound of formula (3Z,5S)-5-(hydroxymethyl)-1-[(2?-methyl-1,1?-biphenyl-4-yl)carbonyl]pyrrolidin-3-one-O-methyloxime, and/or an active metabolite thereof, and the use of said formulations in the treatment and/or prevention of preterm labor, premature birth, dysmenorrhea and embryo implantation failure due to uterine contractions. The present invention is furthermore related to processes for their preparation.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade to release the drug into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: The present invention is directed to orally administered compositions of topically acting corticosteroids for the treatment of inflammation of the gastrointestinal tracts such as eosinophilic esophagitis. The present invention also provides a method for treating conditions 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 as orally disintegrating tablets comprising a topically active corticosteroid adsorbed onto a pharmaceutically acceptable carrier such as silicified microcrystalline cellulose.

Abstract: An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product.

Abstract: The invention relates to a microcapsule comprising at least one active substance selected from lutein and lutein esters embedded in a matrix comprising fish gelatine and optionally one or more other matrix components, wherein the content of said at least one active substance calculated as free lutein is from 0.5 to 25% of total weight of the microcapsule, and which microcapsule does not comprise any added emulsifier. The invention further relates to a process of preparing the microcapsule as well as uses and products comprising the microcapsule.

Abstract: An object of the present invention is to provide an orally disintegrating tablet (ultrafast-disintegrating tablet) having an extremely high disintegrability (short disintegration time), and a high tablet hardness, and to provide a simple method for the production of said ultrafast-disintegrating tablet without such a complicated process as freeze-drying. This invention relates to an orally disintegrating tablet having a specific surface area of from 1.50 to 2.50 mm2/mg and a weight of from 10 to 50 mg, particularly having a disintegration time in water of 7 seconds or less and an oral disintegration time of 5 seconds or less, a method for the production of said orally disintegrating tablet, and to a disintegrative particulate composition for use in said method.

Abstract: A composite particle comprising from 50 to 80 parts by mass of cellulose, from 10 to 40 parts by mass of an inorganic compound and from 4 to 11 parts by mass of hydroxypropyl cellulose based on 100 parts by mass of a total of contents of the cellulose, the inorganic compound and the hydroxypropyl cellulose.

Abstract: Disclosed is a controlled-release solid preparation, which consists of an internal core and a coating layer, wherein part of the surface of the internal core is not covered with the coating, and is exposed to the surface of the solid preparation. Since the medicament just releases at the exposed part, the aim of controlled release can be achieved by controlling this exposed surface area.

Abstract: Provided herein are compositions and methods for treating myelofibrosis in a subject. The methods comprise administering to the subject an effective amount of compound which is which is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide or a pharmaceutical salt thereof or a hydrate thereof.

Abstract: Co-crystals comprising at least one nutraceutical compound and at least one co-crystal former with or without impurities. These co-crystals may be included in compositions (optionally also including other components such as pharmaceutically acceptable excipients, other nutritional supplements, etc.) having utility as pharmaceuticals, nutraceuticals, nutritional supplements, and foodstuffs.

Abstract: A method of delivering a daily dose of hydroxycitric acid in the form of a salt as a single bolus that is as effective or more so than the same amount of active delivered via two or three administrations (b.i.d. or t.i.d.) using current delivery modalities. The method reduces the rate of occurrence of common adverse events with hydroxycitric acid salts, and reduces the occurrence of reverse effects on diets high in fat and/or alcohol. The method improves the uptake of the active compound thereby reducing the dose required.

Abstract: Solid dosage formulations containing a combination of rosuvastatin and ezetimibe, as well as methods of making such solid dosage forms and method of treating patients with fixed combination solid dosage forms of rosuvastatin and ezetimibe are provided here.

Abstract: The present invention relates to diuretic pharmaceutical compositions and methods and in particular to certain derivatives of the formula I wherein R1, R2, R3, R5, R6 and R7 are independently X3R where R is selected from the group consisting of H, halo; optionally substituted saccharide, aliphatic, cycloalkyl, heterocycloalkyl, aryl and heteroaryl; —P(O)(ORa)(ORb) and —NRaRb, where Ra and Rb are independently H, optionally substituted aliphatic, cycloalkyl, heterocycloalkyl, aryl or heteroaryl; X1, X2 and X3 are independently —C(O)O—, —OC(O)—, —C(O)NH—, —NHC(O)—, —OC(O)NH—, —NHC(O)O—, —OS(O)y—, —S(O)y—, —O—, —NHC(O)—, —NHC(O)O—, —S(O)2NH—, a bond or absent; where y is an integer from 0 to 3; and R4 and R8 are independently H, (?O); hydroxy; or optionally substituted saccharide, aliphatic, cycloalkyl, heterocycloalkyl, aryl or heteroaryl; or —P(O)(ORa)(ORb) or —NRaRb, where Ra and Rb are independently H, or optionally substituted aliphatic, cycloalkyl or heterocycloalkyl, aryl or heteroaryl; or a prodrug

Abstract: Disclosed is an optimized pharmaceutical formulation for the treatment of inflammatory conditions of the esophagus. A pharmaceutical formulation in the form of an orodispersible effervescent tablet is stable, easy to produce, and can be used without dissolving same in a liquid. It is not necessary to drink anything with the tablet as this would reduce the time that the budesonide solution remains in the affected regions of the esophagus. The effervescent tablet of the invention surprisingly resulted in an unexpectedly high rate of histological remission in patients with active eosinophilic esophagitis.

Abstract: The present invention relates to pharmaceutical compositions and methods of manufacturing the same, comprising a eutectic of Cyclobenzaprine HCl and mannitol.

Abstract: A hard shell capsule includes a body and a cap cooperatively defining a hollow core hard shell capsule. Each of the body and the cap has a composition that includes a polymer forming a hard polymer structure of the body and of the cap, at least one of the body and the cap composition including a therapeutically effective amount of a drug(s) loaded throughout the body and/or cap.

Abstract: An improved solubility of a pharmaceutical composition or formulation containing a large amount of 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile or a salt thereof can be achieved by forming granules of the compound or salt thereof and allowing the granules to be present together with a disintegrating agent.

Abstract: An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product.

Abstract: The present invention relates to pharmaceutical compositions and methods of manufacturing the same, comprising a eutectic of Cyclobenzaprine HCl and mannitol or Amitriptyline HCl and mannitol.

Abstract: Disclosed herein are compositions and methods for preventing or treating acute or chronic oral mucositis, esophagitis, enteritis, colitis, or gastrointestinal acute radiation syndrome (GI-ARS) caused by radiation exposure, using one or more enteron sorbent polymers administered gastrointestinally (e.g. orally, via feeding or gastric tube, via ostomy, or rectally).

Abstract: Methods and systems for administration of pharmaceuticals using a unit dosage package that includes a first unit dosage that has a first drug and a second drug, a second unit dosage that has the first drug and the second drug, where the second unit dosage includes a different amount of the second drug than the first unit dosage and a unit dosage package is configured to hold the first unit dosage and the second unit dosage. In preferred embodiments the methods and systems are used for administration of weight loss medications.

Abstract: The present invention relates to an orally disintegrating tablet (ODT) containing asenapine maleate and to a process for preparing the ODT. In a first aspect, the present invention relates to an ODT containing asenapine maleate and low substituted hydroxypropylcellulose. In a second aspect, the present invention relates to an ODT containing crystalline asenapine maleate and the ODT is prepared using conventional tabletting techniques as direct compression and granulation. In a third aspect, the present invention relates to an ODT containing asenapine maleate and a carboxylic acid, and to the use of a carboxylic acid for enhancing storage stability of an asenapine maleate containing ODT.