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 4 to 6 hours or longer, followed by an ascending release rate.

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

Abstract: Provided are a drug-containing particle capable of suppressing dissolution of a drug in the oral cavity to suppress an unpleasant taste thereof and having excellent dissolution of the drug in the digestive tract after passing through the oral cavity; a method for preparing the drug-containing particle; a coating composition used for preparing the drug-containing particle; and a solid preparation having the drug-containing particle. More specifically, provided are a coating composition having 100 parts by weight of a cellulose-based enteric base and 50 parts by weight or less of a water-soluble cellulose ether; a drug-containing particle having a drug-containing core and a coat portion obtained by coating the core with the coating composition; a solid preparation having the drug-containing particle; and a method for preparing a drug-containing particle having a step of coating the drug-containing core with the coating composition.

Abstract: A porous cellulose aggregate characterized by having a secondary aggregate structure resulting from aggregation of primary cellulose particles, having a pore volume within a particle of 0.265 to 2.625 cm3/g, containing I-type crystals and having an average particle size of over 30 to 250 ?m, a specific surface area of 0.1 to less than 20 m2/g, a repose angle of 25° to less than 44° and a swelling degree of 5% or more, and characterized by having the property of disintegrating in water.

Abstract: A controlled release preparation wherein the release of active ingredient is controlled, which releases an active ingredient for an extended period of time by staying or slowly migrating in the gastrointestinal tract, is provided by means such as capsulating a tablet, granule or fine granule wherein the release of active ingredient is controlled and a gel-forming polymer. Said tablet, granule or fine granule has a release-controlled coating-layer formed on a core particle containing an active ingredient.

Abstract: A controlled release preparation wherein the release of active ingredient is controlled, which releases an active ingredient for an extended period of time by staying or slowly migrating in the gastrointestinal tract, is provided by means such as capsulating a tablet, granule or fine granule wherein the release of active ingredient is controlled and a gel-forming polymer. Said tablet, granule or fine granule has a release-controlled coating-layer formed on a core particle containing an active ingredient.

Abstract: The present invention relates to a method for preparing solid pharmaceutical compositions comprising fine particles of at least one active substance, dispersed on and (or) within a divided solid. This method is characterized in that a solution is formed which comprises at least one active substance in a fluid at supercritical pressure, said solution then being expanded in a chamber under temperature and pressure conditions for which a part of said fluid is in the liquid state at the time of the expansion, said fluid thus expanded being brought into contact with a divided solid in said chamber.

Abstract: Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing.

Abstract: The invention relates to an oral pharmaceutical composition comprising coated particles of a complex of at least one active agent with an ion-exchange resin, wherein said particles are coated with a bioadhesive coating layer comprising at least one bioadhesive material. The invention also relates to a process for preparing the oral pharmaceutical composition.

Abstract: A nicotine-containing particulate material for release of nicotine, the material comprising a combination of nicotine or a pharmaceutically acceptable salt, complex or solvate thereof and a microcrystalline cellulose. The particulate material is stable upon storage and releases nicotine relatively fast. The particulate material can be used in the manufacture of nicotine containing pharmaceutical composition, wherein the release of nicotine can be designed to be relatively fast so as to obtain a fast onset of action.

Abstract: A particle is disclosed. The particle comprising: (i) at least one inner core which comprises a solid matrix of nutrients for microorganism growth; (ii) an inner membrane being fabricated from a water-soluble polymer, the inner membrane surrounding the inner core and a population of dried microorganisms; and (iii) an outer porous membrane surrounding the inner membrane, the outer porous membrane being insoluble in water. Methods of generating same, propagating microorganisms within and uses of same are also disclosed.

Abstract: The present invention relates to stable oral compositions of one or more benzimidazole compounds and processes for their preparation. Also provided are methods for treating various gastrointestinal disorders.

Abstract: Various fenofibrate compositions include a plurality of first granules having a high bioavailability in vivo, and a plurality of second granules having a low bioavailability in vivo. The first granules may comprise fenofibrate, from 0.3% to 10% by weight of the first granules of a first surfactant, and a first water soluble or water dispersible cellulose derivative, and the second granules may comprise fenofibrate, from 0% to 0.25% by weight of the second granules of a second surfactant, and a second water soluble or water dispersible cellulose derivative.

Abstract: Lipoic acid pellets are described, obtained from inert cores externally coated with lipoic acid. The so obtained active cores are coated with a first layer of insulating polymeric material and then with a polymeric coat that is insoluble at the gastric pH. Pellet are then formulated pharmaceutically, for instance in jelly capsules or controlled release capsules or as oral suspensions, dispersible powders, sachets, etc.

Abstract: The present invention relates to pharmaceutical compositions, food supplement compositions and cosmetic compositions comprising diaminooxidase, and to the use thereof.

Abstract: An extended release pellet comprising an active ingredient selected from pramipexole and the pharmaceutically acceptable salts thereof, and at least one release-modifying excipient.

Abstract: A solid oral controlled-release oral dosage form of hydrocodone is disclosed. The dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and a sufficient amount of a controlled release material to render the dosage form suitable for twice-a-day administration to a human patient, the dosage form providing a C12/Cmax ratio of 0.55 to 0.85, said dosage form providing a therapeutic effect for at least about 12 hours.

Abstract: Disclosed is a pharmaceutically acceptable oral dosage form comprising fenofibrate, phospholipid, a buffer salt, a water-soluble bulking agent selected from maltodextrin, mannitol, and combinations thereof, a cellulosic additive, beads or crystals of a pharmaceutically acceptable water-soluble excipient support material, a polyvinylpyrrolidone or crospovidone, croscarmellose sodium, granular mannitol, sodium dodecyl sulfate, silicon dioxide, and a stearate, wherein the fenofibrate is in the form of microparticles, and wherein at least a portion of the phospholipid is coated on the surfaces of the fenofibrate microparticles, the phospholipid coated microparticles are embedded in a matrix comprising the water-soluble bulking agent, phospholipid that is not coated on the microparticles, the buffer salt and the cellulosic additive, and the matrix is coated on up to 100% of the surfaces of the beads or crystals of the excipient support material.

Abstract: The present invention is a solventless method of producing polymer coated active pharmaceutical ingredient that is taste-masked and may be released in relatively short time. It employs high energy vibrations or acoustic mixing of API particles, water soluble coating material particles and hydrophobic polymer particles, with or without use of other pharmaceutically relevant powders as media. Additionally the method is capable of producing individually coated drug particles without agglomeration or the long drying times associated with solvent based coating methods.

Abstract: The present invention relates to novel microparticles formed of amphiphilic polyamino acids which transport active principle(s), AP(s), in particular protein and peptide active principle(s), and to novel modified-release pharmaceutical formulations comprising said AP microparticles. Microparticles of amphiphilic polyamino acid (PO) may include at least one AP (associated noncovalently) which spontaneously form a colloidal suspension of nanoparticles in water, at pH 7.0, under isotonic conditions. The microparticles may be obtained by atomization of a solution or colloidal suspension of PO comprising at least one AP, may have a size of between 0.5 and 100 microns, and may be dispersible in colloidal suspension.

Abstract: The invention relates to a microencapsulated amino acid composition and methods of manufacturing this composition. Amino acids, such as branched-chain amino acids, have low water solubility, poor hydrophilicity, and poor stability. Amino acids are thus difficult to be digested and absorbed. Consequently amino acids can hardly meet human needs of consuming. This microencapsulated amino acid composition that can quickly disperse and dissolve in cold water, resulting clear solution. The method includes (1) adding coating agents, wetting agents, or other excipients to the amino acid mixture, (2) modifying the surface of microencapsulated particles to considerably accelerate the wetting speed. In this composition, the weight ratio of amino acids and excipients is from 100/0.1 to 100/10.0.

Abstract: Modified or extended release formulations containing mesalamine compounds and associated methods are disclosed and described. In some aspects, such formulations may be substantially bioequivalent to known FDA approved mesalamine formulations such as PENTASA®.

Abstract: The invention is directed to oral modified/controlled release drug formulations which provide a rapid initial onset of effect and a prolonged duration of effect. Preferably, the peak concentration is lower than that provided by the reference standard for immediate release formulations of the drug, and the duration of effect falls rapidly at the end of the dosing interval.

Abstract: The present invention relates to a pharmaceutical composition in a solid unit dosage form for oral administration in a human or lower animal comprising: a. a safe and effective amount of a therapeutically active agent; b. an inner coating layer selected from the group consisting of poly(methacrylic acid, methyl methacrylate) 1:2, poly(methacrylic acid, methyl methacrylate) 1:1, and mixtures thereof; and c. an outer coating layer comprising an enteric polymer or film coating material; wherein the inner coating layer is not the same as the outer coating layer; wherein if the inner coating layer is poly(methacrylic acid, methyl methacrylate) 1:1 then the outer coating layer is not poly(methacrylic acid, methyl methacrylate) 1:2 or is not a mixture of poly(methacrylic acid, methyl methacrylate) 1:1 and poly(methacrylic acid, methyl methacrylate) 1:2; and wherein the inner coating layer and the outer coating layer do not contain any therapeutically active agent.

Abstract: The present invention includes compositions and methods for the controlled release of active agents in a shelf-stable liquid formulation by blending one or more controlled release microbeads comprising one or more active agents, preparing a dense, thixotropic solution having a density that is at, or about, the density of the one or more microbeads comprising a thixotropic agent, water and one or more preservatives under conditions that reduce bubble formation and mixing the microbeads and the thixotropic solutions in a mixer that lacks scraping paddles.

Abstract: The invention relates to microencapsulated colorant granules consisting of a core (A) and a shell (B), whereby the core (A) has a diameter of between 1 and 1000 micrometer and comprises a) a colorant (I), b) microcrystalline cellulose, c) a polyol; and whereby the shell (B) has a thickness of between 1 to 500 micrometer and comprises d) a polymer selected from the group consisting of polycarboxylic acids, vinyl polymers, styrene-(meth)acrylic copolymers, cellulose and cellulose derivatives. The invention further relates to cleansing compositions, such as hand soaps, containing said microencapsulated colorant granules.

Abstract: An orally deliverable pharmaceutical composition comprises a therapeutically effective amount of pramipexole or a pharmaceutically acceptable salt thereof and at least one pharmaceutically acceptable excipient, said composition exhibiting at least one of (a) an in vitro release profile wherein on average no more than about 20% of the pramipexole is dissolved within 2 hours after placement of the composition in a standard dissolution test; and (b) an in vivo pramipexole absorption profile following single dose administration to healthy adult humans wherein the time to reach a mean of 20% absorption is greater than about 2 hours and/or the time to reach a mean of 40% absorption is greater than about 4 hours. The composition is useful for oral administration, not more than once daily, to a subject having a condition or disorder for which a dopamine receptor agonist is indicated.

Abstract: A microsphere and methods for forming the same are disclosed. The microsphere includes modified cellulose and at least one of precursors for is-situ polymerization or endothermic/exothermic reactions.

Abstract: The present invention relates to solid microparticulate oral pharmaceutical forms whose composition and structure make it possible to avoid misuse of the pharmaceutical active principle (AP) they contain. The object of the present invention is to prevent solid oral drugs from being misappropriated for any use other than the therapeutic use(s) officially approved by the competent public health authorities. In other words, the object is to avoid the voluntary or involuntary misuse of solid oral drugs. The invention relates to a solid oral pharmaceutical form which is characterized in that it contains anti-misuse means, in that at least part of the AP it comprises is contained in coated microparticles for modified release of the AP, and in that the coated microparticles of AP have a coating layer (Ra) which assures the modified release of the AP and simultaneously imparts crushing resistance to the coated microparticles of AP so as to avoid misuse.

Abstract: The invention relates to dosage forms that provide prolonged therapy. In particular, the invention relates to dosage forms including various pluralities of drug-containing resin particles. The invention also relates to methods of making these dosage forms and methods of treating using these dosage forms.

Abstract: An enteric-coated oral dosage form comprising an acid labile active pharmaceutical ingredient where the composition is substantially free of monomeric phthalic acid esters and synthetic oils is described herein. Also provided are methods for making and using the enteric-coated oral dosage form. The disclosed pharmaceutical compositions comprise an enteric coating which includes at least one plasticizer, at least one film-forming agent and optionally at least one anti-sticking agent.

Abstract: Provided are microparticles of active pharmaceutical ingredients, which are prepared by removing a sublimable carrier from a solid solution of the a active pharmaceutical ingredients in the sublimable carrier. Also provided are drug delivery vehicles comprising a carrier particle bearing the microparticles on its surface.

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: Methods and compositions are provided for generating and applying long-lasting therapeutic nitric oxide (NO) gas from the reaction of water-soluble chemical reactants microencapsulated in polymer matrices. In some applications the microencapsulated reactants are introduced in an aqueous gel, and in other applications they are introduced to the area of therapy either directly or in a medical device such as a therapeutic pad or dressing. In some applications, the microencapsulated chemical precursors are maintained in close physical proximity to one another in a limited volume, and using a limited amount of solvent residing within that same volume to extract and process the chemical precursors to form NO.

Abstract: The present invention relates to stable oral compositions of one or more benzimidazole compounds and processes for their preparation. Also provided are methods for treating various gastrointestinal disorders.

Abstract: The present invention is directed to pharmaceutical compositions and dosage forms comprising TPR beads, wherein said TPR beads comprise a solid dispersion of at least one active pharmaceutical ingredient in at least one solubility-enhancing polymer, and a TPR coating comprising a water insoluble polymer and an enteric polymer, wherein the active pharmaceutical ingredient comprises a weakly basic active pharmaceutical ingredient having a solubility of not more than 100 ?g/mL at pH 6.8.

Abstract: The invention relates to dosage forms that provide prolonged therapy. In particular, the invention relates to dosage forms including various pluralities of drug-containing resin particles. In a particular embodiment, the drug dosage form comprises a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles. The invention also relates to methods of making these dosage forms and methods of treating using these dosage forms.

Abstract: The invention concerns microcapsules with prolonged release of active principles with low solubility, consisting of a core containing the active principle and coated with a polymer layer which controls the release of the active principle. The aim is that said oral microcapsules containing hardly soluble active principles, should have a coating film of sufficient thickness to ensure controlled permeability and should be adapted to industrial reproduction. This is achieved by the inventive microcapsules of mean diameter less than 1000 microns, and whereof the coating film contains a film-forming polymer (P1) insoluble in gastrointestinal tract fluids, a water-soluble polymer (P2), a plasticizer (PL), and optionally a lubricating surfactant (TA).

Abstract: Described herein is a pharmaceutical composition comprising levetiracetam as an active ingredient to provide prolonged release characteristic to allow once a day dosage regime. The innovative formulation comprises levetiracetam and a hydrophobic polymer with or without additional release rate modifier(s). The formulation may comprise other pharmaceutically acceptable excipients. This invention also describes the processes of preparing such dosage forms.

Abstract: A composition comprising a core material, having a taste value and a polymeric coating. The polymeric coating substantially surrounds the core material and comprises a cationic polymer and optionally an anionic polymer. The polymeric coating has a uniform thickness ranging from 2 ?m to 20 ?m. The composition provides release of a portion of the core material which is taste masked over a time period ranging from 0.5 minute to 2 minutes in the oral cavity and provides a modified-release of the remaining core material in a gastrointestinal tract.

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: A formulation which comprises coated granules and a water-soluble gel, wherein the coated granules comprise an oil absorbent which comprises cashew nut shell liquid, anacardic acid, cardanol, or cardol, and wherein the coated granules are suspended in the water-soluble gel.

Abstract: The present invention provides a controlled-release composition which provides a therapeutically effective plasma concentration of N-acetylcysteine over prolonged period of time. The present invention also includes the use of the controlled-release composition, either alone or in combination with at least one additional active agent, for reduction of vascular inflammation marker and treatment of diseases, conditions, and/or symptoms associated with systemic and/or vascular inflammation in a patient. Furthermore, the present invention provides a process of making granules comprising N-acetylcysteine, or a salt, solvate, prodrug, and/or analog thereof.

Abstract: The invention relates to a bilayer pharmaceutical tablet comprising a first layer containing 3 to 50 wt. % of telmisartan dispersed in a dissolving tablet matrix and a second layer containing a diuretic in a disintegrating tablet matrix as well as a processes for producing same.

Abstract: The invention relates to dosage forms that provide prolonged therapy. In particular, the invention relates to dosage forms including various pluralities of drug-containing resin particles. The invention also relates to methods of making these dosage forms and methods of treating using these dosage forms.

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

Abstract: A multiparticulate composition is formed from a plurality of individual cores including a hydrophobic phase containing peppermint oil dispersed in a microcrystalline cellulose-based gel and a hydrophilic phase containing a hydrogel. An enteric coating is over the individual cores. The multiparticulate composition can be used to treat gastrointestinal disorders.

Abstract: The present invention provides an oral pharmaceutical formulation comprising coated spheroids of a kinase inhibitor such as neratinib, which formulation is designed to reduce or eliminate side effects associated with existing oral formulations of kinase inhibitors.

Abstract: Disclosed are compositions including powdered green tea extract and a powdered preparation comprising polyunsaturated fatty acids. Also disclosed are methods of preparing the compositions and using the compositions in food products, as well as food products containing or that are prepared from the compositions.

Abstract: Various fenofibrate compositions include a plurality of first granules having a high bioavailability in vivo, and a plurality of second granules having a low bioavailability in vivo. The first granules may comprise fenofibrate, from 0.3% to 10% by weight of the first granules of a first surfactant, and a first water soluble or water dispersible cellulose derivative, and the second granules may comprise fenofibrate, from 0% to 0.25% by weight of the second granules of a second surfactant, and a second water soluble or water dispersible cellulose derivative.