Abstract: An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.

Abstract: Disclosed is a pharmaceutical nitazoxanide composition comprising: (a) an immediate release fraction comprising nitazoxanide non-coated granules or non-granulated powder, and (b) a pH-dependent release fraction comprising granules of nitazoxanide coated with one or more polymers having a pH-dependent solubility.

Abstract: An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.

Abstract: The present invention provides oral formulations of poorly bioavailable and/or poorly absorbable, and/or poorly water soluble therapeutic agents. The invention features pharmaceutical composition including a biopolymer, a therapeutic agent, for example an antimicrobial agent such as ceftriaxone, and an absorption enhancer, for example a polyoxyethylene alkyl ether absorption enhancer. Methods of making and using the pharmaceutical compositions is also described.

Abstract: Milled nanoparticles comprising a biologically active agent, at least one biopolymer and a coating containing at least one coating which is a polymer or ligand are produced using milling and coating techniques which have not previously been used for these applications.

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: A pharmaceutical granule whose shape is spherical or sphere-like shape with a bulk density of 0.6-1.3 g/ml and a dissolution time of 0.5-5 minutes, which is prepared as follows: mother granules are filled into a fluidized-bed as bed charge; active pharmaceutical ingredients are prepared into a suspension or solution whose viscosity is adjusted to 6.0-9.8 Mpa·S with viscosity adjusting agent; then it is sprayed onto surface of said mother granule to obtain final granule.

Abstract: A microcapsule, a structure including a microcapsule, an article including a microcapsule and a method of preparing microcapsules provided, the microcapsule includes at least one material selected from the group consisting of a magnetic substance, a dielectric substance and a combination thereof. The microcapsule also includes a volatile material.

Abstract: The present invention provides an orally-disintegrating solid preparation such as a tablet produced by tabletting fine granules showing controlled release of a pharmaceutically active ingredient and an additive, and the like, and the orally-disintegrating solid preparation containing fine granules coated with a coating layer containing a polymer affording a casting film having an elongation at break of about 100-about 700%. With the preparation, breakage of fine granules during tabletting can be suppressed in the production of an orally-disintegrating solid preparation containing fine granules showing controlled release of a pharmaceutically active ingredient.

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: This disclosure relates to an extended release oral dosage form comprising a matrix containing a viscosity modifier (but no lipid) and coated granules containing metoprolol or a pharmaceutically acceptable salt or solvate thereof. The dosage form has alcohol resistance and may also have crush resistance.

Abstract: A method for preparing a gabapentin granulate comprising melt granulating gabapentin with polyethylene glycol having a melting point comprised between 50 and 80° C.

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: Provided is an aqueous hair cleansing composition, including the following components (A) to (D) and water, in which the aqueous hair cleansing composition has a pH of from 2 to 5 when diluted 20-fold: (A) an anionic surfactant; (B) a cationized hydroxypropyl cellulose having a main chain derived from an anhydroglucose, and having a degree of substitution with cationized ethyleneoxy groups of from 0.01 to 2.9 and a degree of substitution with propyleneoxy groups of from 0.1 to 4.0; (C) an organic solvent selected from (C1) and (C2): (Cl) an aromatic alcohol; and (C2) a polypropylene glycol having a molecular weight of from 200 to 1,000; and (D) a hydroxy monocarboxylic acid or a dicarboxylic acid.

Abstract: The present invention relates to a controlled-release oral dosage form for administration of oxycodone once a day and a method of preparing a controlled-release oral dosage form for administration of oxycodone once a day.

Abstract: Provided herein are methods and compositions for producing formulations systemic delivery of dopamine agonists via the oral inhalation route. Specifically, provided herein are methods and compositions for a formulation of rotigotine that is suitable for administration via oral inhalation. Such methods and compositions are useful in the treatment or amelioration of one or more Parkinson's disease symptom(s).

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: 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 relates to a floating granule comprising a solid core, on which an active ingredient is supported and also comprising a compound which is capable of generating a gas discharge which is constituted by an alkaline agent, characterized in that it does not comprise an acid agent which is capable of generating a gas discharge.

Abstract: An oral controlled-release multiparticulate dosage form comprises a plurality of individually enteric coated particulates containing an L-carnitine that independently disperse in a patient's stomach after oral ingestion and travel through the stomach and past the pyloric sphincter without substantially releasing the L-carnitine in the stomach. The individual particulates contain (a) a solid core containing the L-carnitine, (b) a subcoating containing a cellulosic water soluble polymer over the core, and (c) an enteric coating over the subcoating. The dosage form may be used to treat conditions associated with a reduction of the amount of L-carnitine in the body.

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: A stable taste masked, pharmaceutical composition comprising a plurality of coated, non-disintegrating discrete dosage units, said units comprising of a core comprising one or more cephalosporins such as cefuroxime axetil and cefpodoxime proxetil and one or more coating layers. Cefuroxime axetil is in ?-crystalline and amorphous forms, where at least 30% of the Cefuroxime axetil is in the ?-crystalline form, wherein the particle size distribution of the ?-crystalline form being such that 100% of the particles have a particle size below 250?. The ratio of the crystalline fraction to the amorphous fraction ranges from 0.3:0.7 to 0.99:0.01. The particle size of cefpodoxime proxetil is such that 90% of the particles are below 15?.

Abstract: The present invention relates to coated dehydrated microorganisms comprising a dehydrated microorganism surrounded by at least one coating, said coating comprising by dry weight at least 25% of hygroscopic salt(s) and wherein the pH of the coating is compatible with viability of the coated dehydrated microorganism. The coating can be partially crystalline, the salt(s) in the coating having preferably a crystallinity degree of up to 60% once applied onto the dehydrated microorganism. The present invention also relates to liquid coating compositions, methods for coating and protecting a dehydrated microorganism. Finally, the present invention relates to a method for the preparation of food products, feed products, consumer healthcare products or agri-products as well as to a food product, feed product, a consumer healthcare product or an agri-product containing such coated dehydrated microorganisms.

Abstract: Disclosed in certain embodiments is an oral dosage form comprising a plurality of particles, each particle comprising a compressed core comprising: (i) an active agent susceptible to abuse and (ii) a gelling agent; wherein the plurality of particles contains a therapeutically or prophylactically effective amount of the active agent; and wherein the viscosity of the dosage form mixed with from about 0.5 to about 10 ml of an aqueous liquid is unsuitable for parenteral or nasal administration.

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: A dosage form for controlled release is produced from a composition comprising a granular material having a mean particle diameter of 150 to 350 micrometers and a compactibility resulting in a compact with a tensile strength of at least 1.7 MPa when the granular material is subjected to a compaction pressure of 266 MPa, at least 80 percent of the granular material being a water-soluble cellulose ether, water-soluble cellulose ester, an alkylene oxide homo- or copolymer, or a blend thereof; and an active ingredient.

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 deals with extended release pharmaceutical compositions comprising tolterodine, wherein the composition comprises: a) a drug layer comprising tolterodine tartrate, monosaccharide and/or disaccharide on an inert core; or a drug core comprising tolterodine tartrate, monosaccharide and/or disaccharide; and b) a polymer layer comprising extended release polymer(s). The invention also provides a process for the preparation of the above mentioned composition.

Abstract: Sustained-released beads providing active ingredients over an extended period of time to an individual orally ingesting the sustained release beads. The sustained-release beads can be part of a suspension wherein the sustained-release beads are suspended and evenly dispersed in the suspension. Binding agents are used to form the structural framework of the sustained released beads and retain the active ingredients without chemical or electrical bonding. The components of the dispersion medium are GRAS designated, making the suspension suitable for use as a food product.

Abstract: Sustained-released beads providing active ingredients over an extended period of time to an individual orally ingesting the sustained release beads. The sustained-release beads can be part of a suspension wherein the sustained-release beads are suspended and evenly dispersed in the suspension. Binding agents are used to form the structural framework of the sustained released beads and retain the active ingredients without chemical or electrical bonding. The components of the dispersion medium are GRAS designated, making the suspension suitable for use as a food product.

Abstract: Sustained-released beads providing active ingredients over an extended period of time to an individual orally ingesting the sustained release beads. The sustained-release beads can be part of a suspension wherein the sustained-release beads are suspended and evenly dispersed in the suspension. Binding agents are used to form the structural framework of the sustained released beads and retain the active ingredients without chemical or electrical bonding. The components of the dispersion medium are GRAS designated, making the suspension suitable for use as a food product.

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

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 disclosure relates to the treatment of adrenal insufficiency with particular but not limiting application to paediatric treatment regimens, the treatment of the elderly and non-human animals.

Abstract: Phenylephrine particles suitable for solid, semi solid or liquid dosage forms are disclosed.

Abstract: Phenylephrine particles suitable for solid, semi solid or liquid dosage forms are disclosed.

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: The present invention relates to a controlled-release pharmaceutical composition which, when administered in the evening, promotes rapid sleep onset and makes it easy to wake up in the morning in a refreshing way. The composition comprises: a first portion having sleep-inducing activity, which is able to be degraded and absorbed in vivo within 5 minutes to 1 hour after administration; and a second portion having cognition-enhancing activity, which is able to be released in vivo after 4 to 8 hours from the start of absorption of the first portion. The composition, when administered in the evening, promotes rapid sleep onset and makes it easy to wake up in the morning in a refreshing way.

Abstract: The invention relates to a pharmaceutical formulation of nanonised fenofibrate, to a method for preparing same, and to the uses thereof.

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: The present invention relates to a stable tablet comprising a 4,5-epoxymorphinan derivative or a pharmacologically acceptable acid addition salt thereof as an effective ingredient. That is, the tablet according to the present invention comprises: (1) as the effective ingredient, a specific 4,5-epoxymorphinan derivative or a pharmacologically acceptable acid addition salt; (2) sodium thiosulfate; (3) at least one selected from the group consisting of saccharides and sugar alcohols; and (4) crospovidone, sodium carboxymethyl starch or a mixture thereof, in which tablet the content of the aforementioned (4) is 1 to 20% by weight per unit weight containing the aforementioned effective ingredient.

Abstract: Pharmaceutical formulations that resist ethanol-induced dose dumping and methods of use thereof.

Abstract: The present invention is directed to microcapsules for reliably modified release and adapted to industrial reproduction of an active principle hardly water-soluble, other than anti-hyperglycemia agents. Each of said microcapsules comprises a core of hardly soluble active principle and a coating film applied on the core. Their mean diameter is less than 1000 microns. The coating film contains a film-forming polymer (PI) insoluble in gastrointestinal tract fluids, a water-soluble polymer (P2), a plasticizer (PL), and optionally a lubricating surfactant (TA). Said coating film represents at least 4% p/p of dry matter of their total weight, and its components P1, P2, PL satisfy the following characteristics: dry weight mass fraction of PI relative to the total coating weight ranging between 40 and 90%; dry matter weight fraction of PL/P1+P2 ranging between 15 and 60%; dry matter weight fraction of PL/P1+P2 ranging between 1 and 30%.

Abstract: The present invention relates to a granular pharmaceutical composition obtained by coating a nucleus with: (1) a layer containing a material having a damp-proofing function, and (2) a drug layer containing linaclotide, a pharmaceutically acceptable salt, or a hydrate thereof, and (3) a layer containing a material having a damp-proofing function. Also, the present invention relates to a method for manufacturing the granular pharmaceutical composition obtained by coating the nucleus with (1) the layer containing the material having a damp-proofing function, (2) the drug layer containing the linaclotide, the pharmaceutically acceptable salt, or the hydrate thereof, and (3) the layer containing the material having a damp-proofing function.

Abstract: The invention relates to extended release pharmaceutical formulations in form of multiparticulates comprising 40-O-(2-hydroxy)ethyl-rapamycin, to dosage forms which comprise said pharmaceutical formulations, to methods of preparing said pharmaceutical formulations and said dosage forms, to uses of said pharmaceutical formulations and said dosage for the manufacture of a medicament for the treatment or prevention of diseases or conditions responsive to inhibition of mTOR signaling pathway, such as for instance proliferative diseases or immunosuppression.

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 5 to 8 hours or longer, followed by a prolonged release.

Abstract: Taste masked multi-layered particles include an inert core, one or more coating layer(s) comprising a pharmaceutically active ingredient and a binder, an intermediate coating layer (seal coating) free from a low molecular weight water-soluble ionic compound and including a water-soluble pharmaceutical film-forming compound selected from (i) HPMC and PEG or (ii) PVP, and an outer coating layer (final or taste masking coating) free from a low molecular weight water-soluble ionic compound and comprising (i) a poly(meth)acrylate or (ii) a mixture including 60-90% (w/w) EC and 10-40% (w/w) HPMC, where the pharmaceutically active ingredient is water-soluble and includes either at least one basic group and/or a bitter taste. Further disclosed are methods for the production of such particles and pharmaceutical compositions including such particles.

Abstract: The present invention provides various pharmaceutical compositions comprising an S1P receptor modulator, e.g. an S1P receptor agonist. In one aspect, there is provided a pharmaceutical composition having a coating. In other aspects, rapid disintegrating compositions are provided. In a further aspect, a pharmaceutical composition which is free of sugar alcohols is provided. In another aspect, the invention provides a pharmaceutical composition comprising a coating comprising an S1P receptor modulator.

Abstract: A method of treatment for epilepsy and other disease states is described, which comprises delivery of gabapentin in a gastric retained dosage form.

Abstract: A drug in a solubility-improved form is combined with a concentration-enhancing polymer in a sufficient amount so that the combination provides substantially enhanced drug concentration in a use environment relative to a control comprising the same amount of the same solubility-improved form of drug without the concentration-enhancing polymer.