Abstract: Use of particular substituted heterocycle fused gamma-carboline compounds as pharmaceuticals and pharmaceutical compositions comprising them for the treatment of one or more disorders involving the 5-HT2A, SERT and/or dopamine D2 pathways are disclosed. In addition, the compounds may be combined with other therapeutic agents for the treatment of one or more sleep disorders, depression, psychosis, dyskinesias, and/or Parkinson's disease or any combinations.

Abstract: A layered body comprising: a core region; at least one intermediate layer disposed around the core region; and an outer layer disposed around the at least one intermediate layer, wherein at least one of the at least one intermediate layers comprises a gas, the layered body having at least one dimension, measured across the body and through the core region, of 100 ?m or less.

Abstract: Novel peptides having antimicrobial activity, and compositions containing the same.

Abstract: A film-forming starchy composition for the film-coating of solid forms or the preparation of films. The inventive composition has an amylose content of between 25 and 45%, preferably between 30 and 44% and still more preferably between 35 and 40%, the percentages being expressed by dry weight in relation to the dry weight of starch contained in the composition, and includes at least one stabilized starch. A method for the film-coating of solid forms is disclosed and includes spraying the film-forming composition onto a moving nuclei bed. The film-forming composition is used for the production of films and capsules.

Abstract: Disclosed in certain embodiments is an oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse; and an effective amount of an irritant to impart an irritating sensation to an abuser upon administration of said dosage form after tampering.

Abstract: The present invention is directed to a pharmaceutical composition in unit dose form for orally delivering doxycycline to a human, the pharmaceutical composition comprising: a capsule, wherein the capsule is coated with a delayed release layer; wherein the delayed release layer comprises about 4 to 6 mg of doxycycline monohydrate and a binding agent, and wherein the delayed release layer is coated with an enteric coating; wherein the enteric coating dissolves at pH of about 5 to 6, and wherein the enteric coating is coated with an immediate release layer; wherein the immediate release layer comprises about 32 mg of doxycycline monohydrate and a binding agent, wherein the relative mean Cmax of the pharmaceutical composition is within 80.00% to 125.00% of a Cmax value of 510±220.7 ng/mL, after administration of a single dose of the pharmaceutical composition to humans in a fasting state; and wherein the relative mean AUC(0-?) of the pharmaceutical composition is within 80.00% to 125.

Abstract: A flowable, stable silica capsule formulation composed of a silica capsule suspension and an adjuvant for use in a personal care product, a beauty care product, a fabric care product, a home care product, a personal hygiene product, an oral care product is provided.

Abstract: The present invention relates provides pharmaceutical compositions comprising an amorphous carvedilol salt and one or more pharmaceutically acceptable excipients, wherein the amorphous carvedilol salt is formed in situ during the preparation of the pharmaceutical composition. The amorphous carvedilol salt is preferably an amorphous carvedilol phosphate salt. The pharmaceutical compositions can be prepared by providing one or more inert cores; contacting the core or cores with a solution or a dispersion comprising carvedilol, an acid component and optionally a binder, in a solvent; removing the solvent; and optionally coating the core or cores with an extended release composition. Preferred pharmaceutical compositions contain both immediate-release pellets and at least one population of extended-release pellet.

Abstract: The present disclosure relates to a capsule having a core and a shell surrounding the core. The shell comprises a polymeric material produced by reacting a component (A) with a component (B). Component (A) comprises a polysiloxane bearing one or more amino groups and component (B) comprises one or more polyisocyanates. The disclosure also relates to processes for producing the capsules, methods of using the capsules, and to products containing the capsules.

Abstract: The invention provides a method of ameliorating systemic inflammation in a patient involving administering to the patient a therapeutically effective dose of composition including polystyrene divinyl benzene copolymer and a polyvinyl pyrrolidone polymer. More particularly, the method relates to using these polymers as an enteral sorbent preparation to remove inflammatory mediators, such as cytokines, from the intestinal lumen. The polymers can be in the form of a preparation of polystyrene divinyl benzene copolymer beads with a biocompatible polyvinyl pyrrolidone polymer coating.

Abstract: A solid oral controlled-release dosage form of hydrocodone is disclosed, the dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and controlled release material.

Abstract: Provided herein are pharmaceutical compositions comprising an antagonist, an agonist, a seal coat, and a sequestering polymer, wherein the antagonist, agonist, seal coat and at least one sequestering polymer are all components of a single unit, and wherein the seal coat forms a layer physically separating the antagonist from the agonist from one another. Methods for manufacturing such a pharmaceutical composition are also provided. Methods for treating pain using such compositions are also demonstrated.

Abstract: The invention relates to a method of treating a subject in need of treatment for multiple sclerosis including orally administering to the subject in need thereof a delayed release pharmaceutical composition using an increasing dose regimen, wherein an initial daily amount of drug administered is increased later to a higher daily amount and the pharmaceutical composition consists essentially of (a) dimethylfumarate and (b) one or more pharmaceutically acceptable excipients.

Abstract: Described are various methods for stabilizing pharmaceutical formulations of a specific Hepatitis C Viral (HCV) inhibitor against the formation of a particular genotoxic degradation product. Such methods include temperature control, moisture control, excipient control, capsule shell control, basification and a reconstitution approach.

Abstract: The invention relates to drug delivery systems comprising a water-soluble polymer matrix and a bioactive agent entrained therein, said water soluble polymer matrix containing at least 50 wt. % of polyoxazoline having a molar mass of at least 5 40,000 g/mol. The drug delivery systems of the present invention offer the advantage that the bioactive agent is readily released when the drug delivery system is contacted with water. The drug delivery system can be in the form of a solid dispersion, a mucoadhesive sheet, a tablet, a powder, a capsule.

Abstract: Compositions and methods useful in administering nucleic acid based therapies, for example association complexes such as liposomes and lipoplexes are described.

Abstract: The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.

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

Abstract: This invention provides compounds, compositions and methods for treating a cognitive disorder or memory disorder in animals that result from aging or other neurodegenerative condition. In particular, compounds of this invention can stimulate neural cell growth, increased amounts of cells containing a key enzyme needed for production of the cholinergic neurotransmitter, and can improve memory and cognitive function in animals who have experienced a loss of memory or cognitive function.

Abstract: Provided is a method for improving day photopic vision and/or cone-derived visual field and visual function in a subject suffering from a retinal disease or trauma including administering to the subject a pharmaceutically effective amount of crude Dunaliella powder. Also provided is a method for improving night vision and/or rod derived visual field in a subject suffering from a retinal disease including administering to the subject a pharmaceutically effective amount of crude Dunaliella powder. A pharmaceutical composition for improving day vision and/or visual field in a subject suffering from a retinal disease including crude Dunaliella powder is also provided.

Abstract: The present invention includes a controlled-release composition having a matrix. The matrix contains a pharmaceutically effective amount of an active agent or a pharmaceutically acceptable salt, solvate, ester, and/or prodrug thereof, an ionic non-gelling matrix polymer, and a pH modifier. The ionic non-gelling matrix polymer is practically insoluble and unswellable at a first aqueous fluid pH and is soluble at a second aqueous fluid pH. The pH modifier is present in an amount to control the release of the active agent from the composition. The controlled-release composition is substantially free of a gelling or swellable excipient. The present invention also provides methods of making and using the controlled-release compositions.

Abstract: The current invention relates to encapsulation methods comprising alginate-based microencapsulation for the immune-protection and long-term functioning of biological material or therapeutics. The biological material or the therapeutics are encompassed by a membrane formed by jellifying an alginate polymer. Specifically, although by no means exclusively, the encapsulation system is intended for use in allo-or xenotransplantation. The membrane provides for a protective barrier of the encapsulated material, ensuring the longevity and preventing unwanted influences from outside the barrier, such as inflammatory reactions or immune-responses. The invention is furthermore directed to methods of producing and providing the encapsulated products for use in cell therapies. The therapeutic products obtained by the encapsulation method may provide a method for ameliorating of treating a range of conditions.

Abstract: The present invention relates to a structured liquid composition comprising anionic surfactant, nonionic surfactant and a plurality of stable and evenly suspended encapsulated actives. The liquid composition is externally structured by incorporating a cross-linked acrylic copolymer.

Abstract: The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.

Abstract: The invention provides for the use of an accordion pill comprising levodopa for the treatment of symptoms of Parkinson's disease in a subject in need thereof over a 24 hour period, to be administered to the subject in a twice daily administration regimen, with an interval of about 8 to about 10 hours between the first dose and the second dose, and with an interval of about 14 to about 16 hours between the second dose and the first dose of the following day. The twice daily administration regimen provides a stable blood plasma level of levodopa in the subject after multiple administrations and is effective in treating the symptoms of Parkinson's disease over a 24 hour period.

Abstract: Microcapsules including a capsule shell encapsulating a suspension of a therapeutically effective amount of liver cells in physical contact with a liver cell stimulating amount of erythropoietin.

Abstract: A medicine delivery system includes an inner capsule containing carotenoids and an outer capsule in which the inner capsule is contained within the outer capsule and the outer capsule containing a therapeutically effective amount of krill oil. In one example, the carotenoids comprise at least S,S?-astaxanthin derived from Haematococcus pluvialis, and one or more of lutein and/or trans-zeaxanthin or meso-zeaxanthin. The medicine delivery system also includes 0.5 to 8 mg of astaxanthin, 2 to 15 mg of lutein and 0.2 to 12 mg of trans-zeaxanthin contained within the inner capsule. In a specific example, the medicine delivery system includes about 4 mg of astaxanthin, about 10 mg of lutein and about 1.2 mg of trans-zeaxanthin contained within the inner capsule.

Abstract: The disclosed method involves preparation of a composition containing a poorly water soluble substance. The composition has a median diameter of not more than 1 ?m, and includes (i) a poorly water soluble substance, (ii) polyvinylpyrrolidone or a vinylpyrrolidone-vinyl acetate copolymer, and (iii) an auxiliary dispersion stabilizer. By employing such constitution, a poorly water soluble substance is sufficiently micronized and a composition containing a poorly water soluble substance showing good absorbability of the poorly water soluble substance can be provided.

Abstract: The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.

Abstract: The present invention relates to a suspension formulation containing the active substance 3-Z-[1-(4-(N-((4-methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-anilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulphonate, to a capsule pharmaceutical dosage form containing said suspension formulation, to a process for preparing said suspension formulation, to a process for preparing said capsule comprising said suspension formulation and to the packaging material for the finished capsule.

Abstract: In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease in a statin-intolerant subject in need thereof and, in particular, a method of blood lipid therapy in a statin-intolerant subject in need thereof, comprising administering to the subject a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.

Abstract: Provided herein are methods of treating, preventing and/or managing sarcoidosis by the administration of (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methanesulfonylethyl]-4-acetylaminoisoindolin-1,3-dione, alone or in combination with other therapeutics.

Abstract: The present invention provides coated tablet formulations comprising neratinib maleate, and improved methods for making such coated tablets.

Abstract: The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.

Abstract: The present invention relates to solid pharmaceutical compositions, in particular to oral contraceptives, comprising a progestogen, such as drospirenone; an estrogen, such as ethinylestradiol; a tetrahydrofolic acid or a pharmaceutically acceptable salt thereof, such as calcium 5-methyl-(6S)-tetrahydrofolate; and at least one pharmaceutical acceptable excipient or carrier. The compositions of the invention provide good stability of the tetrahydrofolic acid upon storage while still ensuring a fast and reliable release of the estrogen and the progestogen present in the composition.

Abstract: In certain embodiments, the invention is directed to composition comprising stable particles comprising ganaxolone, wherein the volume weighted median diameter (D50) of the particles is from about 50 nm to about 500 nm.

Abstract: The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.

Abstract: The present invention provides methods and compositions for the treatment of ion imbalances using core-shell composites and compositions comprising such core-shell composites. In particular, the invention provides core-shell particles and compositions comprising potassium binding polymers, and core-shell particles and compositions comprising sodium binding polymers, and in each case, pharmaceutical compositions thereof. Methods of use of the polymeric and pharmaceutical compositions for therapeutic and/or prophylactic benefits are also disclosed. The compositions and methods of the invention offer improved approaches for treatment of hyperkalemia and other indications related to potassium ion homeostasis, and for treatment of hypertension and other indicates related to sodium ion homeostasis.

Abstract: Methods of selectively targeting a p53-deficient cancer cell, comprising administering to a patient suffering from cancer (i) a reversible cell cycle arrest-inducing agent for inducing cell cycle arrest in a p53-positive cell; and (ii) an aurora kinase inhibitor, wherein said reversible cell cycle arrest-inducing agent is administered prior to administration of said aurora kinase inhibitor, and pharmaceutical combinations, kits and oral dosage forms for the same.

Abstract: The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.

Abstract: The invention is directed to coated solid pharmaceutical preparations having a very thin coating in the nanometer range and a method for producing such preparations. The coated solid pharmaceutical preparation can be prepared by using atomic layer deposition (ALD).

Abstract: Discloses a novel synergistic herbal composition comprising combination of therapeutically effective amount of Vrun bhavit, Kadalikshar, Apamargkshar, Yavkshar and optionally Gomutrakshar along with pharmaceutical acceptable additives, useful for the treatment of kidney stone and other urinary disorders like inflammation and urinary stent related problems.

Abstract: A method and drug delivery device for reducing menstrual blood loss in a female are provided. The method comprises administering intravaginally to the female a therapeutically effective amount of an active agent on a delivery device directly to uterine cavity during a menstrual period, wherein the active agent is any one of an antifibrinolytic agent and a hemostatic agent.

Abstract: The present invention is directed to pharmaceutical compositions and methods of treatment that relate to the inhibition, resolution and/or prevention of an array of the manifestations of metabolic syndromes, including Type 2 diabetes, hyperlipidemia, weight gain, obesity, insulin resistance, hypertension, atherosclerosis, fatty liver diseases and certain chronic inflammatory states that lead to these manifestations, among others. In additional aspects, the present invention relates to compositions and methods which may be used to treat, inhibit or reduce the likelihood of hepatitis viral infections, including Hepatitis B and Hepatitis C viral infections, as well as the secondary disease states and/or conditions which are often associated with such viral infections, including hepatic steatosis (steatohepatitis), cirrhosis, fatty liver and hepatocellular cancer, among other disease states or conditions.

Abstract: Described herein are medical devices and medical implements with high lubricity to flesh (or biological fluid) and/or inhibited nucleation on its surface. The device has a surface comprising an impregnating liquid and a plurality of micro-scale and/or nano-scale solid features spaced sufficiently close to stably contain the impregnating liquid therebetween. The impregnating liquid fills spaces between said solid features, the surface stably contains the impregnating liquid between the solid features, and the impregnating liquid is substantially held in place between the plurality of solid features regardless of orientation of the surface.

Abstract: Abuse-resistant oral dosage forms suitable for administration of pharmacologically active agents are provided.

Abstract: A formulation comprising T3/VIP nanoparticles, wherein the T3/VIP nanoparticle comprises both T3 and VIP encapsulated or immobilized on a bioabsorbable polymer. The invention further provides for methods of making a formulation comprising a T3/VIP nanoparticle. The invention further provides for methods of treatment utilizing said T3/VIP nanoparticle.

Abstract: Administering a therapeutically effective dose of lithium ions mitigates the side effects of a psychoactive substance such as a cannabinoid. The therapeutically effective dose of lithium ions includes greater than 4 milligrams of lithium and less than 170 milligrams of lithium, or includes between 8 and 32 milligrams of lithium ions per milligram of the psychoactive substance. The therapeutically effective dose of lithium ions is administered using lithium carbonate, lithium citrate, lithium chloride, lithium orotate, lithium aspartate, or analogs thereof using a delivery vehicle selected from pills, tablets, capsules, gelcaps, liquids, syrups, injectable liquids, powders, or foods and administered prior to, with, or after administration of the psychoactive substance. The psychoactive substance includes one or more of anandamide, 2-arachidonoyl glycerol, 2-arachidonoyl glycerol ether, tetrahydrocannabinol, cannabinol, cannabidiol, or analogs thereof and may be administered using the delivery vehicle.

Abstract: Provided are methods, systems and apparatuses for producing delivery devices, for example, for oral intake of an agent. The method can include assembling one or more layers including one or more materials with an agent or an agent-releasing formulation to form an intergraded device; folding the intergrated delivery device to form a folded integrated delivery device; and at least partially enclosing the folded delivery device to a form suitable for oral delivery.

Abstract: The present invention discloses a novel soft capsule of butylphthalide and a process for preparing the same. The soft capsule of butylphthalide is composed of a capsule wall material and a drug-containing oil, wherein the drug-containing oil is essentially composed of butylphthalide and a vegetable oil as the diluent in a weight ratio of about 1:0˜10. The capsule wall material is composed of a capsule wall matrix, a plasticizer and water in a weight ratio of 1:0.2˜0.4:0.8˜1.3. The soft capsule of butylphthalide described in the present invention can mask the strong and special flavor of butylphthalide, and overcome the difficulties associated with formulating oily active ingredient into other oral formulation. The disintegration time of the soft capsule satisfies the requirement of Pharmacopoeia of P.R. China.