Abstract: A sustained release oral pharmaceutical form suitable for single daily dose administration has a neutral microgranule coated with a mounting layer of active ingredient and pharmaceutically acceptable binder; and a coating layer of a hydrophobic coating polymer of a non-water soluble cellulose derivative, and at least 20% of inert load in relation to dry weight of hydrophobic coating polymer. The pharmaceutical form has improved resistance to rapid release of active ingredient, particularly in the presence of alcohol.

Abstract: A controlled-release pharmaceutical composition including first and second groups of microparticles, each of the microparticles including a core including tamsulosin or pharmaceutically acceptable salts thereof, a controlled-release polymer coating layer formed on the core, and an enteric polymer outer layer formed on the controlled-release polymer coating layer, wherein the average thickness of the controlled-release polymer coating layer is different in each of the first and second groups of microparticles, and an oral formulation including the same, are provided. This pharmaceutical composition can easily control the extent of release of an active ingredient depending on changes in pH in the intestinal tract and the release pattern of the active ingredient in the small intestine, thus preventing the active ingredient from being rapidly transferred into the blood to thereby minimize side-effects, and maintaining the effective blood concentration of the active ingredient for a predetermined period of time.

Abstract: The invention relates to a formulation for the delayed and controlled delivery of an adsorbent into the lower intestine of mammals. The formulation includes a carrageenan and an adsorbent, such as activated charcoal. The invention further relates to uses of this formulation, in particular to pharmaceutical uses. In one embodiment, the formulation is used to eliminate or reduce the side effects in the intestine, in particular in the colon, of pharmaceutical agents that are administered as a treatment for a disorder, but that have side effects when they reach the late ileum, the caecum or the colon.

Abstract: An oral pharmaceutical composition of the present invention comprising fenofibric acid or a pharmaceutically acceptable salt thereof, and 0.22 to 1 part by weight of an alkalifying agent based on 1 part by weight of fenofibric acid has improved bioavailability and a minimized absorption deviation in the gastrointestinal tract, which is useful in treating hyperlipidemia and hypertriglyceridemia.

Abstract: It is desired to provide a pharmaceutical composition containing a compound represented by formula (I) or a pharmaceutically acceptable salt thereof, or a solvate thereof, which exhibits an inhibitory effect on activated blood coagulation factor X, and is useful as an agent for preventing and/or treating thrombosis, wherein the pharmaceutical composition exhibits favorable dissolution properties. The present invention provides a method for producing a pharmaceutical composition containing a compound represented by formula (I), comprising the step of mixing a compound represented by formula (I) or a pharmaceutically acceptable salt thereof, or a solvate thereof, one or more excipients selected from the group consisting of a sugar alcohol and a water-swelling additive, a disintegrant, and a binder under conditions for keeping the maximum water content of the granules during granulation at 10% or less.

Abstract: An intrabuccally rapidly disintegrating tablet which is manufactured by a simple method, has an enough practical hardness and is rapidly disintegrated in the buccal cavity and its production method. The intrabuccally rapidly disintegrating tablet is produced by growing a powder material into a granulated material with a fixed particle diameter, the powder material including a sugar alcohol or a saccharide as main ingredient, each of which is first particle having an average particle diameter of not more than 30 ?m, by mixing thus obtained granulated material with an active ingredient and a disintegrant, and by compressing the mixture into a predetermined shape.

Abstract: Pharmaceutical compositions and dosage forms comprising an adsorbent, and an adverse agent, such as an opioid antagonist. In one embodiment, at least a portion of the adverse agent is on the surface or within the micropore structure of an adsorbent material. The pharmaceutical compositions and dosage forms comprising the adsorbent and the adverse agent are useful for preventing or discouraging tampering, abuse, misuse or diversion of a dosage form containing an active pharmaceutical agent, such as an opioid. The present invention also relates to methods for treating a patient with such a dosage form, as well as kits containing such a dosage form with instructions for using the dosage form to treat a patient. The present invention further relates to process for preparing such pharmaceutical compositions and dosage forms.

Abstract: The present invention provides immediate release and modified release oral dosage forms. Specifically, the invention provides modified and immediate release pharmaceutical dosage forms containing memantine that exhibit an enhanced release profile and provide reliable absorption. The dosage forms may be used to treat mild, moderate or severe Alzheimer's disease or neuropathic pain.

Abstract: Multiparticulate compositions having S-adenosylmethionine an active ingredient are disclosed. The multiparticulates have spheroidal core comprising S-adenosylmethionine, microcrystalline cellulose, and hydroxypropyl methylcellulose; a sub-coat comprising hydroxypropyl methyl cellulose on the spheroidal core; and an enteric coat on the sub-coated spheroidal core. The average diameter of the particulates is about 0.1-3 mm. Other aspects of the invention include methods of making and methods of using the multiparticulate compositions.

Abstract: The present invention relates to the preparation of therapeutic compositions including drug-containing nanoparticles for coating a body implant to provide for drug delivery in a locally applied and extended release manner and their methods of use to treat physiological conditions.

Abstract: The present invention is directed to a solid dose form comprising a film coating composition encapsulating a core, wherein: (i) the core comprises an active ingredient comprising at least one of a pharmaceutical, veterinary, or nutraceutical active ingredient; (ii) the film coating composition comprises ethylcellulose and guar gum, wherein the guar gum has an apparent viscosity ?151.0 cps at a shear rate of 50 s?1 in a 1% aqueous guar gum solution measured rotationally at 20° C. after 1 minute equilibration using a 6 cm acrylic cone (1°) on a cone-plate viscometer wherein the shear is ramped up linearly from 1 to 50 s?1 in 25 steps over 29 seconds; (iii) the dose form provides controlled release of the active ingredient; (iv) the guar gum is present in an amount greater than 5 wt % based on the weight of the guar gum and ethylcellulose; and (v) the dose form is ethanol resistant.

Abstract: The invention refers to a method for the production of cellulose sulfate which is completely water-soluble and has an adjustable solution viscosity in aqueous solution, which qualifies the produced sodium cellulose sulfate (SCS) as auxiliary material with ideal biological compatibility for biological and medical applications, in particular it is suitable for the encapsulation and immobilization of biological objects, e.g. tissue, cells, microorganisms, enzymes or viruses in microcapsule.

Abstract: The invention relates to pharmaceutical compositions containing rosuvastatin calcium of formula (I) and processes for their manufacture.

Abstract: Pharmaceutical compositions of topiramate for once-a-day oral administration are provided. The formulations comprise a sustained-release component and an optional immediate-release component, the compositions of which can be selectively adjusted, respectively, to release the active ingredient along a pre-determined release profile. Method of treating or preventing pathological disorders in mammalian subjects comprising the administration of the novel formulations disclosed herein is also provided.

Abstract: The invention refers to an oral solid pharmaceutical composition comprising a mixture of: (a) pellets comprising lansoprazole or a pharmaceutically acceptable salt thereof being free of alkaline-reacting compounds and (b) pellets comprising lansoprazole or a pharmaceutically acceptable salt thereof together with alkaline-reacting compounds.

Abstract: Described are injectable formulations of particulate olanzapine that produce a prolonged duration of action upon administration, and methods of making and using such formulations. The injectable formulations comprise particulate olanzapine.

Abstract: Enteric coated multiparticulate compositions that use a L-carnitine compound an active ingredient are disclosed. The multiparticulates have spheroidal core comprising a L-carnitine, microcrystalline cellulose, and hydroxypropyl methylcellulose; a sub-coat comprising hydroxypropyl methyl cellulose on the spheroidal core; and an enteric coat on the sub-coated spheroidal core. The average diameter of the particulates is about 0.1-3 mm. Other aspects of the invention include methods of making and methods of using the multiparticulate compositions.

Abstract: Enteric coated multiparticulate compositions that use 5-HTP as an active ingredient are disclosed. The multiparticulates have a spheroidal core comprising 5-HTP, microcrystalline cellulose, and hydroxypropyl methylcellulose; a sub-coat comprising hydroxypropyl methylcellulose on the spheroidal core; and an enteric coat on the sub-coated spheroidal core. The average diameter of the particulates is about 0.1-3 mm. Other aspects of the invention include methods of making and methods of using the multiparticulate compositions.

Abstract: The present invention aims to provide a particulate formulation with an effectively controlled dissolution characteristic of a drug even if the average particle diameter is small. The present invention provides a particulate formulation containing drug particles and a first coating layer coating the drug particles and characterized in that the first coating layer contains a water-insoluble polymer, inorganic particles, and/or a lipid component and the lipid component contains a C15 or higher fatty acid.

Abstract: The present invention provides various pharmaceutical compositions, in particular for oral administration, formulated for extended release of active compounds useful in the treatment of neurodegenerative diseases, in particular Parkinson's disease, and injuries to the nervous system. The active compound comprised within these compositions is preferably selected from N-propargyl-1-aminoindan, an enantiomer thereof, or a pharmaceutically acceptable salt thereof, more preferably rasagiline or a pharmaceutically acceptable salt thereof.

Abstract: A process for producing an oral preparation containing a first water-swellable gel-forming layer and a second water-swellable gel-forming layer as outermost layers, a medicine being sealed in an inner space formed by bonding the periphery of the first water-swellable gel-forming layer and the periphery of the second water-swellable gel-forming layer either directly or via an adhesive layer, the process including (a) a step of forming a first water-swellable gel-forming layer, (b) a step of forming a recess in a predetermined area of the first water-swellable gel-forming layer, (c) a step of filling the recess with a medicine to obtain a medicine-containing body, and (d) a step of forming a second water-swellable gel-forming layer over the medicine-containing body directly or via an adhesive layer so that the first water-swellable gel-forming layer and the second water-swellable gel-forming layer are bonded around the recess, and a process for continuously producing the oral preparation are disclosed.

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 3 to 8 hours, followed by an ascending release rate.

Abstract: Pharmaceutical compositions of topiramate for once-a-day oral administration are provided. The formulations comprise a sustained-release component and an optional immediate-release component, the compositions of which can be selectively adjusted, respectively, to release the active ingredient along a pre-determined release profile. Method of treating or preventing pathological disorders in mammalian subjects comprising the administration of the novel formulations disclosed herein is also provided.

Abstract: Pharmaceutical compositions of topiramate for once-a-day oral administration are provided. The formulations comprise a sustained-release component and an optional immediate-release component, the compositions of which can be selectively adjusted, respectively, to release the active ingredient along a pre-determined release profile. Method of treating or preventing pathological disorders in mammalian subjects comprising the administration of the novel formulations disclosed herein is also provided.

Abstract: The present invention provides microcapsules comprising benzoyl peroxide and topical compositions comprising them, optionally along with other active ingredients, particularly for the treatment of acne.

Abstract: In one aspect, the present invention features a method of administering an active ingredient, said method comprising chewing an oral dosage form comprising a texture masked particle, said texture masked particle comprising a) a core containing an active ingredient; b) a first coating layer comprised of a taste masking agent that substantially covers the core, wherein said taste masking agent is comprised of an insoluble film forming polymer and a non-enteric, water soluble polymer; and c) a second coating layer on the surface of the first coating layer.

Abstract: The invention relates to an oral multiparticle pharmaceutical dosage form in the form of a receptacle reducing the pH values of stomach, containing a plurality of pellets, particles, granules or agglomerates whose mean diameter ranges from 50 to 2500 ?n substentially consisting of a) an internal matrix layer containing an active agent which is neither peptide or protein, nor the derivatives or conjugates thereof, a lipophilic matrix whose melting point is greater than 37° C. and a polymer with mucoadhesive effect, b) an external film coating substentially consisting of a polymer or an anionic copolymer which is optionally formulated with conventional pharmaceutical additives, wherein the active agent has a water solubility according to DAB 10, of at least 30 volume parts of water for one part by weight of the active agent and is coated with the lipophilic matrix and said active agent-containing lipophilic matrix is coated with a matrix made of a polymer with mucoadhesive effect.

Abstract: The present invention relates to a galenic form comprising particles capable of specifically adsorbing the undesirable molecules present in the digestive tract, to the method for preparing same and to the use thereof in particular for producing a medicine intended for preventing or treating undesirable effects linked to an imbalance of the intestinal and/or colonic flora that can result for example from treatment with antibiotics.

Abstract: The present invention is directed to oral pulse-release pharmaceutical dosage form containing an immediate release component of gamma-hydroxybutyric acid, and one or more delayed/controlled release components of gamma-hydroxybutyric acid.

Abstract: The present invention provides a medicament which results in delivery of a therapeutic level of one or more cannabinoids during a clinically relevant therapeutic window. The therapeutic window is a longer window than provided by an immediate release medicament such as Marinol containing an equivalent amount of the cannabinoid. Oral administration of the present compositions provides therapeutic dosing while maintaining safe, side effect sparing, levels of a cannabinoid. The present invention also provides methods of treating cannabinoid-sensitive disorders.

Abstract: Disclosed are a solid state synthesis method of silver nanoparticles, and silver nanoparticles synthesized thereby. The method includes mixing a silver salt and a water soluble polymer acting as both a reducing agent and a protecting agent to produce a solid mixture, and milling the solid mixture by a high-speed vibration milling process to form silver nanoparticles within the water soluble polymer. According to the present invention, silver nanoparticles can be easily and simply produced in a solid state through high speed vibration milling, thereby reducing costs for industrial production and transportation of silver nanoparticles. In addition, the synthesized silver nanoparticles can be used for a long time since the silver nanoparticles are stable in a solid state for 1 year or more.

Abstract: This disclosure relates to a sustained-release oral dosage form for once-a-day administration comprising a matrix containing a viscosity modifier and coated granules containing hydromorphone. The dosage form can have a release profile such that 16 hours following administration, less than about 85 percent of the hydromorphone is released. In addition, the dosage form may have alcohol and/or crush resistance.

Abstract: A method for medical treatment was developed in which microspheres with novel properties are administered in a mammal. The microspheres are made using a novel process that results in microspheres with new combined properties of high density, low fracture, high swell capacity, rapid swell, and deformability following swell. These microspheres may be administered for void filling, tissue bulking, non-vasculature occlusion, body fluid absorption, and delivery of medications.

Abstract: A floating granule having a solid core, on which an active ingredient is supported, and a compound capable of generating a gas discharge which is constituted by an alkaline agent, characterised in that it does not comprise an acid agent that is capable of generating a gas discharge.

Abstract: Provided herein is a pharmaceutical composition 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.

Abstract: The present invention provides immediate release and modified release oral dosage forms. Specifically, the invention provides modified and immediate release pharmaceutical dosage forms containing memantine that exhibit an enhanced release profile and provide reliable absorption. The dosage forms may be used to treat mild, moderate or severe Alzheimer's disease or neuropathic pain.

Abstract: This invention relates to coated digestive enzyme preparations and enzyme delivery systems and pharmaceutical compositions comprising the preparations. This invention further relates to methods of preparation and use of the systems, pharmaceutical compositions and preparations to treat persons having ADD, ADHD, autism, cystic fibrosis and other behavioral and neurological disorders.

Abstract: The present invention relates to pharmaceutical formulations for the controlled delivery of threo-3-(3,4-dihydroxyphenyl)serine (threo-DOPS) and derivatives of it. Such formulations can contain an extended or slow release component that maintains therapeutic concentration of threo-DOPS in the blood plasma over a prolonged time period. They can be further combined with an immediate release formulation to produce a product that, when administered to a patient in need thereof, results in substantially steady levels of active drug, eliminating the sharp peaks and troughs in blood plasma drug levels experienced with the existing threo-DOPS formulations.

Abstract: Provided is a solid preparation which rapidly disintegrates in the presence of saliva or a small amount of water in the oral cavity, particularly, a rapidly disintegrating solid preparation useful as an orally-disintegrating solid preparation. Specifically provided is a rapidly disintegrating solid preparation containing coated granules wherein saccharide or sugar alcohol having an average particle size of not less than 75 ?m and a high dissolution rate is coated with cellulose, and a rapidly disintegrating solid preparation containing a) an active ingredient, b) saccharide or sugar alcohol having an average particle size of not less than 400 ?m, c) cellulose and d) a disintegrant.

Abstract: The present invention relates to a pulsatile-release pharmaceutical formulation of dexlansoprazole composed of a single type of enteric coated pellets and the process for the preparation thereof.

Abstract: The invention provides a composition comprising microparticles of a water-insoluble or poorly soluble compound, at least one phospholipid, and at least one surfactant, produced by applying an energy to a mixture comprising particles of the compound, the at least one phospholipid, and the at least one surfactant so as to obtain the microparticles. The invention also provides a process for preparing microparticles of a water-insoluble or poorly soluble compound. The process includes mixing particles of a water-insoluble or poorly soluble compound with at least one phospholipid and at least surfactant to form a mixture and applying energy to the mixture sufficient to produce microparticles of the compound. The methods of the invention allow for the production of microparticles smaller than particles produced through previously known methods and the microparticles exhibit advantageous properties including remarkable resistance to particle size growth during storage.

Abstract: The invention relates to superfine microparticles and nanoparticles and a process for their gentle preparation with exclusion of water or minimization of water and/or exclusion of plasticizers and/or reduced temperature load, in which a matrix material is subjected to a high-pressure homogenization process in an anhydrous or water-poor medium and/or at low temperatures, preferably room temperature (20° C.) and in particular below the freezing point of water, which leads to a gentle particle reduction with minimization of the impairment of the chemical stability of the homogenized material.

Abstract: The invention concerns an oral galenic form for prolonged release of anti-hyperglycaemic (metformin) active principles. Said medicine enables to obtain an efficient therapeutic protection over 24 hours by overcoming the problems of bypass of the absorption window and the massive localised release of active principles. Therefor, said medicine comprises several thousand anti-hyperglycaemic (metformin) microcapsules each consisting of a core comprising at least an anti-hyperglycaemic agent and of a coating film applied on the core and enabling the prolonged release in vivo of the anti-hyperglycaemic agent. Said microcapsules have a grain size distribution ranging between 50 and 100 microns. The reproducibility of the transit kinetics and hence of bioavailability are very high. There results for the patient a lesser risk of hyperglycaemic or hypoglycaemic. The invention also concerns the preparation of said medicine and the use of a plurality of said microcapsules for making an anti-hyperglycaemic medicine.

Abstract: The present invention refers to controlled release granular compositions of mesalazine and their use in the treatment of inflammatory pathologies of the intestinal tract. The aforesaid granular compositions comprise: a) a central core comprising an inert substrate; b) an intermediate layer comprising mesalazine and one or more physiologically acceptable excipients; c) a gastro-resistant coating. The present invention then refers to a process for obtaining the aforesaid granular compositions.

Abstract: The present invention relates to an extended release composition comprising as active compound Venlafaxine Hydrochloride, in which Venlafaxine Hydrochloride is coated on a non pareil inert core, which coated core is then coated with polymeric layer which enables the controlled release of the Venlafaxine Hydrochloride.

Abstract: Improved oil-in-water emulsions are provided and a method for their manufacture. In particular, the emulsions comprise a means to control delivery of oil-soluble or water-soluble actives in a core comprising a liquid oil or gel oil continuous phase, which actives can be delivered with improved deposition to surfaces such as, in particular, the skin, gastro-intestinal tract and that defined by the oral cavity. The emulsions are also noted for their improved stability.

Abstract: The present invention relates to pharmaceutical compositions, and methods of preparing such compositions, comprising one or more populations of controlled-release particles comprising one or more proton pump inhibitors. The present invention also relates to pharmaceutical dosage forms, including orally disintegrating tablets, tablets, capsules, and methods for their preparation.

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: Nanoparticulate bisphosphonate compositions, having an effective average particle size of less than 2000 nm, are described. The compositions are useful in treating bone resorption in a mammal.

Abstract: The present invention relates to novel nanoparticles based on cellulose and a process for producing them and their use.