Abstract: The present invention provides oral dosage compositions, and methods of making thereof, which contain an edible oil, preferably containing an omega-3 fatty acid, and admixed therein one or more water soluble vitamins and/or minerals, for example vitamins B6, B9, and/or B12. The present invention also provides a method of making the composition comprising mixing the edible oil and one or more water-soluble vitamins and/or minerals to form a suspension or emulsion of the water-soluble vitamins and/or minerals in the edible oil. The mixture can be inserted into capsules, gelcaps, or caplets for oral consumption. An additional aspect of the invention is that the edible oil can coat particles of the water-soluble vitamins and/or minerals, which may preferably provide the vitamins and/or minerals improved absorption in the body due to increased resistance to degradation in the acidic environment of the stomach.

Abstract: The present invention relates to pharmaceutical compositions containing a solid dispersion of N—[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide including formulations of the solid dispersions into powders, granules and mini-tablets, methods for manufacturing and processing the powders, granules and mini-tablets, and methods for treating cystic fibrosis employing the pharmaceutical composition.

Abstract: The invention relates to dry processes for producing oral dosage forms, more specifically tablets, comprising atazanavir and adhesion enhancers. The invention further relates to compacted intermediates comprising atazanavir and adhesion enhancers.

Abstract: Disclosed are oral dosage forms, comprising (i) a therapeutically effective amount of an opioid agonist; (ii) an opioid antagonist in releasable form; and (iii) a sequestered opioid antagonist which is not released when the dosage form is administered intact, and methods thereof.

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

Abstract: Herein described is a novel crystalline form of the hydrochloride of the (4-hydroxycarbamoyl-phenyl)-carbamic acid (6-dimethylamino methyl-2-naphtalenyl) ester. In particular, herein described is a polymorph of the hydrochloride of the (4-hydroxycarbamoyl-phenyl)-carbamic acid (6-dimethylamino methyl-2-naphtalenyl) ester, characterized by a Powder X Ray Diffraction spectrum as indicated in FIG. 1, and/or by a DSC profile as indicated in FIG. 2, and/or by a TGA profile as indicated in FIG. 3 and/or by an IR spectrum as indicated in FIG. 4.

Abstract: The present invention provides solid dispersions or solid dispersion pharmaceutical preparations containing a water-soluble polymeric substance(s) and a phenylalanine compound of the formula (1) or pharmaceutically acceptable salts thereof, wherein A represents the formula (2) and the like, B represent an alkoxy group and the like, E represents a hydrogen atom and the like, D represents a substituted phenyl group and the like, T, U and V represent a carbonyl group and the like, Arm represents a benzene ring and the like, R1 represents an alkyl group and the like, R2, R3, and R4 may be the same or different from one another and each represent a hydrogen atom, a substituted amino group and the like, and J and J? represent a hydrogen atom and the like; production methods thereof; and solubilized pharmaceutical preparations containing a solubilizer(s) and the compound (I) or pharmaceutically acceptable salts thereof.

Abstract: The present invention concerns a prolonged release bioadhesive mucosal therapeutic system containing at least one active principle, with an active principle dissolution test of more than 70% over 8 hours and to a method for its preparation. Said bioadhesive therapeutic system comprises quantities of natural proteins representing at least 50% by weight of active principle and at least 20% by weight of said tablet, between 10% and 20% of a hydrophilic polymer, and compression excipients, and comprising between 4% and 10% of an alkali metal alkylsulphate to reinforce the local availability of active principle and between 0.1% and 1% of a monohydrate sugar.

Abstract: Extended release pharmaceutical compositions of levetiracetam or pharmaceutically acceptable salts thereof in the form of a tablet comprising glyceryl behenate and a polymethacrylate polymer with at least one pharmaceutically acceptable excipient.

Abstract: The invention relates to a pharmaceutical tablet for oral administration comprising ulipristal acetate together with the following excipients: a diluent in an amount of 60 to 95 wt %, a binding agent in an amount of 1 to 10 wt %, croscarmellose sodium in an amount of 1 to 10 wt %, and magnesium stearate in an amount of 0 to 5 wt %.

Abstract: Sustained release micropellets showing a stable controlled-release of a drug without being affected by the changes in pH value etc., characterized by being produced by coating core particles with a layer containing a water-soluble drug and further forming a film layer containing a water-insoluble polymer compound and a plasticizer on the thus obtained particles, locating a water-soluble filler layer between the water soluble drug-containing layer and the film layer, and having an average particle size of 300 ?m or less; medicinal compositions containing these micropellets; and a process for producing the same.

Abstract: The invention relates to a pharmaceutical dosage form exhibiting a breaking strength of at least 500 N, said dosage form containing a pharmacologically active ingredient (A); an inorganic salt (B); and a polyalkylene oxide (C) having a weight average molecular weight of at least 200,000 g/mol, wherein the content of the polyalkylene oxide (C) is at least 20 wt.-%, based on the total weight of the dosage form; wherein the pharmacologically active ingredient (A) is present in a controlled-release matrix comprising the inorganic salt (B) and the polyalkylene oxide (C) and wherein, under in vitro conditions, the release profile of the pharmacologically active ingredient (A) from said matrix comprises at least a time interval during which the release follows zero order kinetics.

Abstract: A solid, oral controlled release pharmaceutical dosage form has a water-soluble active ingredient dispersed in a matrix and releases the active ingredient at such a rate upon administration that the median tmax is 2.5 to 6 hours and the ratio of mean Cmax to mean plasma level of the active ingredient at 24 hours is in the range of 1.5 to 3.5.

Abstract: Provided are methods of treating pain, including neuropathic pain, in human and veterinary individuals. These methods employ locally administrable pharmaceutical gallium compositions, including pharmaceutical gallium compositions suitable for administration to the skin and mucous membranes. The compositions comprise pharmaceutically acceptable gallium compounds, such as gallium maltolate or gallium nitrate, together with pharmaceutically acceptable carriers suitable for local administration, including those suitable for topical administration. The administration of such compositions provides relief from pain, itching, allodynia, hyperalgesia, and related symptoms.

Abstract: The invention relates to a preparation comprising a creatine component, which has excellent bio-availability and leads to improved creatine retention in the human and animal body. The present invention further relates to a method for the production of said preparation, and to the use thereof as a nutritional supplement, functional food, animal feed additive, pharmaceutical, and as an additive for cosmetic and dermatologic formulations.

Abstract: There is provided in accordance with embodiments of the invention a method of treating or reducing the effects in a subject of a condition selected from fructose intolerance and impaired fructose metabolism, the method comprising administering to a subject in need of such treatment or reduction an efficacious amount of a glucose isomerase, other than in combination with 5-D-fructose dehydrogenase. Other embodiments are also disclosed.

Abstract: There is provided in accordance with embodiments of the invention a method of treating or reducing the effects in a subject of a condition selected from fructose intolerance and impaired fructose metabolism, the method comprising administering to a subject in need of such treatment or reduction an efficacious amount of a glucose isomerase, other than in combination with 5-D-fructose dehydrogenase. Other embodiments are also disclosed. There is provided a method for treating or reducing the effects of fructose intolerance and health problems associated with excessive fructose intake by administration of glucose isomerase. Other embodiments are also disclosed.

Abstract: The present invention relates to delayed release oral disintegrating pharmaceutical compositions of lansoprazole or pharmaceutically acceptable salts thereof. The invention also relates to processes for the preparation of such compositions.

Abstract: Dicalcium phosphate anhydride powder of which at least 50% by weight is of a grain size of between 45 and 150 ?m, a maximum of 50% by weight is of a grain size of <45 ?m and a maximum of 5% by weight is of a grain size >150 ?m and which has a bulk density of between 1000 and 1500 g/l and a specific surface area of <5 m2/g is used for direct tabletting or capsule filling of pharmaceutical preparations.

Abstract: Memantine compositions and methods of use are described herein. In some embodiments, the compositions comprise memantine and an absorption enhancer, or memantine and an elimination enhancer, or memantine and an absorption enhancer and an elimination enhancer.

Abstract: A carotenoid substance called zeaxanthin, when ingested orally at suitable dosages, can provide effective protection against sunburns and darken the skin to emulate a healthy suntan. Zeaxanthin may induce: (i) a mild but noticeable tinting, shading, or darkening of skin color, comparable to a mild suntan; (ii) a substantial increase in the person's ability to withstand elevated levels of sun or UV exposure; and, (iii) an increased ability of reddened and sunburned skin to convert into intact skin that looks browned and healthily tanned. Topical formulations containing zeaxanthin can be administered to the skin during the time period of ingesting the oral formulation to further protect the skin and provide an additional darkening of the skin.

Abstract: Stabilized controlled release pharmaceutical preparations are disclosed in which active ingredient degradation is prevented without the use of a stabilizer. The active ingredient is sealed away from excipients that can adversely affect stability by sealing the excipients rather than the active ingredient. The preparations are substantially unaffected by exposure to storage conditions of elevated temperature and/or elevated relative humidity.

Abstract: Methods and delivery vehicles are provided for providing throat relief.

Abstract: Disclosed is a misuse preventative, controlled release formulation comprising a core comprising a superabsorbent material (for example, polycarbophil), a controlled release coat surrounding the core, and a plurality of controlled release microparticles having a pharmaceutically active agent (for example, an opioid analgesic) disposed within the core, the coat, or both the core and the coat. When crushed, either intentionally or accidentally, and exposed to an aqueous medium, the superabsorbent material present in the core swells to encapsulate the microparticles, which remain substantially intact thereby retarding the release of the pharmaceutically active agent from the formulation. Also disclosed is a method of using the misuse preventative, controlled release formulation to deliver a pharmaceutically active agent to a mammal, for example, a human, in need thereof.

Abstract: Disclosed is a misuse preventative, controlled release composition in the form of a multilayered oral dosage form. A first layer contains a plurality of controlled release microparticles having a pharmaceutically active agent (for example, an opioid analgesic) disposed therein. The second layer, which can be adjacent the first layer comprises a pharmaceutically active agent that can be the same or different from the pharmaceutically active agent in the microparticles in the first layer. The composition further comprises a superabsorbent material (for example, polycarbophil) disposed within the first layer, the second layer, or both the first layer and the second layer. When intact, the pharmaceutically active agent is released from the second layer faster than the pharmaceutically active agent in the first layer.

Abstract: A pharmaceutical composition contains tolterodine L-tartrate stabilized against degradation with an acid. Acid-stabilized tolterodine L-tartrate may be used to make various types of immediate release and controlled release dosage forms.

Abstract: The present invention provides processes for making and forms of solid dispersions of pharmaceutical active ingredients.

Abstract: A carotenoid substance called zeaxanthin, when ingested orally at suitable dosages such as 30 to 100 mg/day for a span of 1 to 2 weeks, can provide effective protection against sunburns, and can give skin a darker tint that emulates a healthy suntan. In tests involving adults, it was found that zeaxanthin dosages of 30 to about 80 mg per day were sufficient to induce: (i) a mild but noticeable tinting, shading, or darkening of skin color, comparable to a mild suntan; (ii) a substantial increase in the person's ability to withstand elevated levels of sun or UV exposure; and, (iii) an increased ability of reddened and sunburned skin to convert into intact skin that looks browned and healthily tanned. Oral ingestion of dosages of zeaxanthin after a noticeable darkening of the skin has been achieved further enhances a tanned appearance and/or protects against sun damage.

Abstract: The invention provides stable, solid dosage forms and pharmaceutical compositions in particulate form comprising a fibrate, for example fenofibrate, dissolved in an non-aqueous vehicle in order to ensure improved bioavailability of the active ingredient upon oral administration relative to known fibrate formulations.

Abstract: Monolayer, bilayer and trilayer solid dosage forms of a combination of valsartan, amlodipine and hydrochlorothiazide are made.

Abstract: A rapidly-dissolving oral dosage pharmaceutical composition for inhibiting ovulation in a mammal, said composition comprising drospirenone or a pharmaceutically acceptable salt or ester thereof, optionally ethinyl estradiol or a pharmaceutically acceptable salt, ester or ether thereof, a surfactant and at least one pharmaceutically acceptable excipient, wherein the drospirenone has a surface area of less than 10,000 cm2/g.

Abstract: The sustained release formulation for oral administration of an HMG-CoA reductase inhibitor of the present invention can be easily and economically prepared and is capable of maintaining a constant drug level in blood by slowly releasing the HMG-CoA reductase inhibitor at a uniform rate for 24 hrs. Accordingly, the sustained release formulation of the present invention can be effectively used for lowering blood cholesterol and triglyceride levels.

Abstract: There is provided pharmaceutical compositions for the treatment of pain comprising a pharmacologically-effective amount of an opioid analgesic, or a pharmaceutically-acceptable salt thereof, presented in particulate form upon the surfaces of carrier particles comprising a pharmacologically-effective amount of an opioid antagonist, or a pharmaceutically-acceptable salt thereof, which carrier particles are larger in size than the particles of the opioid analgesic. The compositions are also useful in prevention of opioid abuse by addicts.

Abstract: An oral drug delivery system comprising a coated tablet having one or more surfaces. The coated tablet further comprises a core and a coating surrounding the core. The core comprises an active ingredient composition comprising at least one active ingredient and a pharmaceutically acceptable excipient and a composition selected from a swellable composition and a reactive composition located in an immediate vicinity of one or more preselected surfaces. The coating comprising water insoluble polymer(s) and leachable component(s) is operable to be reliably removed fully from the one or more of the preselected surfaces of the tablet upon contact with an aqueous environment, but not removed from at least one of the surfaces.

Abstract: This invention relates to a process for preparing a pharmaceutical composition comprising four antitubercular drugs: rifampin or a pharmaceutically acceptable salt thereof, isoniazid or a pharmaceutically acceptable salt thereof, pyrazinamide or a pharmaceutically acceptable salt thereof and ethambutol or a pharmaceutically acceptable salt thereof, wherein rifampin and isoniazid are in separate layers. The invention also provides a pharmaceutical composition prepared therefrom having advantageous stability and bioavailability.

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: Low dose pharmaceuticals can be delivered for a prolonged period using a tablet-in-tablet design wherein the drug is contained in a controlled release matrix in the outer compression coating layer but not in the inner tablet core.

Abstract: The present invention relates to granules comprising oxycodone, as well as to orally disintegrating tablets including same and optionally acetaminophen.

Abstract: The present invention is directed to solid stable pharmaceutical fixed dose compositions comprising ramipril, amlodipine besilate and pharmaceutically acceptable excipients, and to their preparation.

Abstract: An oral dosage form comprising a pharmaceutical tablet of one or more layers, one of which carries a biologically active substance; the formulation of said tablet includes different percentages of hydrophilic and lipophilic polymeric materials, and adjuvant substances. The tablets of the present invention show a release rate which is independent from the amounts of active substance present in the tablet.

Abstract: The invention relates to an extended release pharmaceutical composition comprising nevirapine.

Abstract: Unit comprising neramexane, a pharmaceutically acceptable salt, solvate, conjugate, prodrug, polymorphic form, isomer, or derivative thereof; and a release-controlling excipient; wherein said unit has a diameter of from 0.1 to less than 6 mm.

Abstract: A controlled release pharmaceutical composition which comprises therapeutically effective amount of pregabalin or salts thereof as active ingredient, a hydrophobic release controlling agent(s) and optionally other pharmaceutically acceptable excipients thereof.

Abstract: A pharmaceutical composition for the treatment of acute disorders is described. The composition comprises an essentially water-free, ordered mixture of at least one pharmaceutically active agent in the form of microparticles which are adhered to the surfaces of carrier particles which are substantially larger than the particles of the active agent or agents, and are essentially water-soluble, in combination with the bioadhesion and/or mucoadhesion promoting agent. The invention also relates to a method for preparing the composition and to the use of the composition for the treatment of acute disorders.

Abstract: To provide a peroral tablet for bowel cleansing which leaves no remains in the intestinal tract after bowel cleansing, which exhibits a dissolution property equivalent to that of conventional sodium phosphate-containing tablets including crystalline cellulose, and which is a small-size agent readily taken by a subject. The peroral tablet for bowel cleansing containing the following ingredients (A) and (B): (A) 80 to 95 mass % of sodium phosphate, and (B) (B1) 7 to 11 mass % of hydroxypropyl cellulose which has such a particle size that ?99% of the particles thereof pass through a mesh having an opening of 350 ?m and whose 2-mass % aqueous solution has a viscosity of 2.0 to 10.0 mPa.s, (B2) 5 to 13 mass % of hydroxypropyl cellulose which has such a particle size that ?99% of the particles thereof pass through a mesh having an opening of 150 ?m and whose 2-mass % aqueous solution has a viscosity of 3.0 to 5.9 mPa.

Abstract: Disclosed is a method for the preparation of easily-swallowed, reliably-dosed, aesthetically-improved tablets of sodium ibuprofen dihydrate, the method comprising the formation of the tablets with punches or presses comprising contact surfaces which are chrome or chrome-plated.

Abstract: Described herein are compositions comprising one or more embolics attached to an inert, dissolvable matrix as well as kits comprising these novel embolic formulations. Also described are methods of making and using these embolic formulations.

Abstract: A sustained release dosage form comprising Quetiapine or a pharmaceutically acceptable salt, polymorphs, solvates, hydrates thereof and one or more non-gellable release controlling polymer and one or more pharmaceutically acceptable excipient(s). A sustained release dosage form comprising first granulation comprising Quetiapine or its pharmaceutically acceptable salts, polymorphs, solvates, hydrates thereof and one or more release controlling material; and second granulation comprising one or more release controlling material which is the same or different than the one or more release controlling material of the first granulation and optionally quetiapine or its pharmaceutically acceptable salts, polymorphs, solvates, hydrates thereof. A method of preparing the sustained release dosage form by first and second granulation followed by milling; blending the said milled granules after second granulation with lubricant followed by compression to form a sustained release dosage form.

Abstract: Disclosed is an orally disintegrating tablet which masks bitterness, dissolves well, and which permanently retains good oral disintegration properties immediately following manufacture. The disclosed orally disintegrating tablet is formed by compression-molding an organic acid together with particles comprising active ingredient-containing nuclear particles covered by a layer containing water-insoluble polymers and/or enteric polymers.

Abstract: Pharmaceutical and/or dietary compositions based on short chain fatty acids or salts, esters and/or amides thereof in combination with one or more dietary soluble or water-dispersible fibre and at least one flavouring agent are disclosed.