Abstract: This invention relates to an oral immunotherapy (OIT) composition comprising granules that contain an allergenic protein, such as peanut protein, along with a humectant, such as trehalose, and a binder, such as hypromellose. The composition may further comprise a filler, such as mannitol and a lubricant, such as stearic acid. OIT compositions, methods of preparing OIT compositions and methods of treatment of food allergy using OIT compositions are provided.

Abstract: The present invention relates to extended release pharmaceutical dosage forms of oxcarbazepine.

Abstract: Compositions for development of matrix type extended release mesalamine minitablets without use of any modified release coating, comprising a) mesalamine or its prodrug or derivatives thereof having a weight percentage in a range of 65-85 weight percentage with respect to the composition; b) at least one intragranular excipient having a weight percentage in a range of 3.5-22.5 weight percentage with respect to the composition; c) at least one binder having a weight percentage in a range of 2-6.5 weight percent with respect to the composition; and d) at least one extra granular excipient having a weight percentage in a range of 2-5 weight percentage with respect to the composition such that largest dimension in the minitablet is range of 1.00 mm to 2.8 mm. In another aspect of the present disclosure provides for a process of preparation of composition.

Abstract: This present invention relates to pharmaceutical composition comprising Deutetrabenazine. The invention also relates to the methods of preparation of the composition having improved stability and dissolution profile and used for the treatment of chorea associated with Huntington disease and tardive dyskinesia.

Abstract: The invention provides a wound dressing made by an ex vivo formed combination of fibrinogen and/or fibrin containing-liquid formulation and an oxidized cellulose (OC) backing; and use thereof.

Abstract: A method for coating a medical device includes applying a second layer that includes a second drug on a first layer of on the medical device. The first layer includes a first drug, which may be in crystalline form. By selecting an appropriate solvent use in applying the second layer and appropriate process conditions, the second layer may be applied such that the first drug retains one or more therapeutic properties. For example, the second layer may be applied such that the first drug maintains its crystalline form. The first and second layers may be free of polymer.

Abstract: Described herein, in part, are tablets, such as immediate release multi-layer or bilayer tablets for orally delivering olanzapine and samidorphan, methods of using said tablets in the treatment of disorders described herein, and kits comprising said tablets.

Abstract: Ingestible devices can directly deliver therapeutic agents to desired tissue(s) of the GI tract of a subject, such as the submucosa, the mucosa, and/or the mucus layer of the GI tract, and methods of using the same. The ingestible devices can deliver therapeutic agents in a safe, effective, and reliable manner. The disclosure also provides pharmaceutical compositions for use in methods of treating a disease or condition in a subject in need thereof.

Abstract: Disclosed is a personal care product customized by one or more solid discrete particles of a mixture composition, wherein the mixture composition comprises a surfactant and a high melting point fatty compound, and wherein the mixture composition contains less than about 50% of water. Also disclosed is a method of applying such customized personal care products to a target surface. The present invention provides at least one of the following benefits: Boosting rheology especially storage modulus (G?); Boosting conditioning benefits; Adding a new benefit such as aesthetic benefit, anti-dandruff benefit, sensate such as heating/cooling, and scent; and Providing at least one of the above benefits, while having improved stability.

Abstract: The present invention provides novel compositions, methods of treatment and methods of manufacture of large scale, commercially viable ibuprofen and acetaminophen tablets. The unique characteristics and synergistic effects resulting from the disclosed compositions, methods of treatment and methods of manufacture demonstrate a product with optimal analgesia, anti-pyresis, safety profiles and large-scale manufacturability. The inventions described herein surprisingly show the unique composition and method of manufacturing for a large-scale commercial batch of a novel ibuprofen and acetaminophen tablet.

Abstract: The present invention relates to solid oral fixed dose compositions of metformin, atorvastatin, and valsartan, or their pharmaceutically acceptable salts, processes for the preparation thereof, and the use of the composition to treat certain diseases.

Abstract: Disclosed is an extended-release lacosamide preparation which can be taken once a day. Also disclosed is a method for treating a subject with epilepsy including administering the extended-release lacosamide preparation once a day.

Abstract: The present invention relates to a composite preparation in a core tablet form, composed of an inner core containing rabeprazole as an effective ingredient; an outer layer portion including the bilayer structure of a sustained release layer and an immediate release layer and containing mosapride as an effective ingredient. The core tablet composite preparation according to the present invention is characterized by exerting sufficient pharmacological activity of rabeprazole and mosapride even upon administration of one tablet once a day.

Abstract: The invention relates to compositions for removing nail polish comprising at least at least about 10% by weight of at least one polyhydric alcohol compound, at least one low carbon alcohol, at least one high boiling point ester compound, at least one thickening agent, and at least one abrasive compound, as well as to methods of removing nail polish from nails using such compositions.

Abstract: Compositions comprising a therapeutic agent encapsulated by an edible plant-derived microvesicle are provided. Methods of treating an inflammatory disorder and methods of treating a cancer are further provided and include administering an effective amount of a composition comprising a therapeutic agent encapsulated by an edible plant-derived microvesicle to a subject. Further provided are methods of diagnosing a colon cancer that include the steps of administering an edible plant-derived microvesicle incorporating a detectable label to a subject and then determining an amount of the detectable label in an intestine of the subject.

Abstract: A dosage form of lacosamide and a pharmaceutical dosage form thereof is disclosed. The dosage form includes an extended release portion and optionally an immediate release portion. Also provided are methods of providing extended release of lacosamide and treatment of a neurological or psychiatric disease or condition.

Abstract: The present disclosure relates generally to bilayer tablets comprising a combination of two active pharmaceutical ingredients, and more specifically to bilayer tablets comprising acetylsalicylic acid, pseudoephedrine, and a dissolution aid. The bilayer tablets utilize a combination of granulated and non-granulated acetylsalicylic acid along with a unique distribution of sodium carbonate as a dissolution aid that provide acetylsalicylic acid and pseudoephedrine in a single dosage form having rapid dissolution and long-term storage stability (low degradation). The present disclosure also provides methods of preparing and of using the bilayer tablets.

Abstract: A composition for human consumption that combines various ingredients that boost stem cell activity. Illustrative ingredients may for example include high cacao content chocolate, medicinal mushroom extracts, substances containing or promoting DHEA, pine bark extract to convert arginine from cacao into nitric oxide to improve circulation. DHEA boosting substances may include truffle powder and/or pine pollen. An illustrative composition may have about 75% chocolate by weight, with cacao content of 73% or more, at least 10% truffle powder or pine pollen, at least 10% medicinal mushroom extracts, the remainder pine bark extract. The composition may be formulated into sublingual tablets of about 1 gram, and daily consumption may for example consist of 5 tablets for 5 grams total. Includes a method of supporting cardiovascular health, improving sexual performance and sexual health, and improving athletic performance by administering a therapeutic amount of the compound to a subject.

Abstract: This disclosure relates to administration of a combination of: 1) about 100-110 mg, about 104-106 mg, or about 105 mg of bupropion hydrochloride, or a molar equivalent amount of a free base form or another salt form of bupropion; and 2) about 40-50 mg, about 44-46 mg, or about 45 mg of dextromethorphan hydrobromide, or a molar equivalent amount of a free base form or another salt form of dextromethorphan in certain patient populations, such as patients having moderate renal impairment, patients having mild or moderate hepatic impairment, patients receiving a concomitant strong CYP2D6 inhibitor, patients who are known CYP2D6 poor metabolizers, those in need of an NMDA antagonist that does not cause dissociation, and those at risk of QT prolongation.

Abstract: There is provided a pharmaceutical dosage form that is suitable for peroral administration to the gastrointestinal tract, which dosage form comprises a pharmaceutical composition in the form of a particulate mixture comprising solid particles of N-butyloxycarbonyl-3-(4-imidazol-1-ylmethylphenyl)-5-iso-butylthiophene-2-sulfonamide (C21), or a pharmaceutically-acceptable salt thereof, admixed with a blend of carrier particles with weight- and/or a volume-based mean diameter, and/or a structural/particle density, that is/are similar to the weight- and/or volume-based mean diameter, and/or the structural/particle density, of the solid particles of C21, and a glidant, which composition is contained within a capsule that is suitable for such peroral administration. Preferred carrier particles have a weight- and/or a volume-based mean diameter that is less than about 100 ?m. Preferred carrier particle materials include mannitol. Preferred glidants comprise colloidal silica.