Abstract: An injectable depot formulation includes a biocompatible polymer, an organic solvent combined with the biocompatible polymer to form a viscous gel, and a small molecule drug incorporated in the viscous gel such that the formulation exhibits an in vivo release profile having a Cmax to Cmin ratio of less than 200 and a lag time less than 0.2.

Abstract: The present invention relates to a concentrated melatonin solution, wherein melatonin is present in a quantity of 10.0% or higher in a substantially water-free carrier mixture of ethanol and a polyethoxylated derivative. The concentrated solution, free of preserving agents, is suitable to prepare injectable sterile compositions for parenteral administration, or formulations for topical or oral administration. The invention also encompasses a method for the preparation of the concentrated solution, as well as the possible benefits of the intravenous infusion of high levels of melatonin as adjuvant therapy in Ebola or Dengue hemorrhagic fever (DHF) or as an anti-oxidant/anti-aging treatment.

Abstract: Methods and compositions for increasing red blood cell survival and/or inhibiting hemolysis using indole-comprising compounds are described. Such methods and compositions may be useful for blood and blood product storage and preservation applications.

Abstract: Compositions and methods for combination therapy are provided. The compositions comprise a multiple unit dosage form having both a therapeutic agent and a nutritional supplement. The combination therapy is useful for restoring a nutrient depletion associated with a particular disease state. Additionally, the combination therapy can prevent or attenuate the depletion of a nutrient caused, in whole or in part, by the co-administrated therapeutic drug. Methods of manufacturing the formulations are likewise described.

Abstract: A polymeric matrix for oral administration with modified release and taste masking properties is disclosed, obtained without using inert supports such as sugar spheres, comprising particles of active substance directly and individually covered with a release regulating membrane. Use of such a matrix to prepare various administration forms for oral use as well as the method of its preparation are also disclosed.

Abstract: Chewable sustained release compositions and their methods of production are provided. The sustained release compositions contain amphipathic lipids, which are used to encapsulate various drugs and active ingredients.

Abstract: Enteric compositions comprising one or more tight junction agonists and/or one or more tight junction antagonists are provided. Compositions of the invention may comprise a delayed-release coating disposed over a tight junction agonist and/or tight junction antagonist layer which may be disposed over an inert core. Delayed-release coatings may be substantially stable in gastric fluid and substantially unstable in intestinal fluid, thus providing for substantial release of the tight junction agonist and/or antagonist from the composition in the duodenum or jejunum of the small intestine.

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: 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: A disinfectant comprising the following (a), (b), (c) and (d), but no other microbicidal disinfecting agents intended for microbicidal disinfection: (a) 40 to 90% (w/w) of ethanol, isopropyl alcohol or a mixture thereof; (b) 0.1 to 2% (w/w) of lactic acid; (c) 0.01 to 2% (w/w) of citric acid; and (d) 0.001 to 0.1% (w/w) of a zinc-containing compound which releases zinc ion in solution, relative to the whole disinfectant.

Abstract: The invention provides an apparatus for producing soft gel capsules having encapsulated therein microparticles, nanoparticles and fluids, said apparatus comprising: (a) two spreader boxes; (b) two casting drums; (c) a pair of rotary dies; (d) a liquid fill system (medicine pump system); (e) a wedge for heating gelatine ribbons and feeding said fill; and (f) one or more microgranule or nanogranule feeders located on each side of the rotary dies, said feeders being synchronized to rotate at the same tangential speed as the rotary dies.

Abstract: An oral methylphenidate powder which is reconstitutable into a final oral aqueous sustained release formulation containing at least about 50%, or at least about 80% by weight water based on the total weight of the suspension, is provided. The powder is a blend containing a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and a water soluble buffering agent such that upon formed into an aqueous liquid formulation, the formulation has a pH in the range of about 3.5 to about 5, or about 4 to about 4.5. Following administration of a single dose of the oral aqueous methylphenidate suspension, a therapeutically effective amount of methylphenidate is reached in less than one hour and the composition provides a twelve-hour extended release profile.

Abstract: Disclosed are a sustained release solid formulation comprising a drug, for example, oxycodone or its pharmaceutically acceptable salt, in a water-insoluble matrix, which comprises a wax type excipient and copovidone, and thus, has increased compressibility and fluidity and reduced adhesiveness, and a method of preparing the same.

Abstract: The invention relates to a method for the preparation of a silicic acid comprising extrudate, comprising the steps of: i) forming of stabilized silicic acid, by hydrolyzing a silicon compound into orthosilicic acid and/or oligomers thereof in the presence of a stabilizing agent, which is a quaternary ammonium compound, or an amino-acid, or an amino acid source or combinations thereof; ii) mixing of the stabilized silicic acid with a carrier in an amount up to the loading capacity of the carrier for silicic acid; and iii) extruding the resulting mixture thereby forming the extrudate, to extrudates obtainable with the method, to an extrudate for use in the production of animal feed, feed supplement, human food and/or food supplement and of a pharmaceutical or cosmetic preparation, and for the treatment of infections, nails, hair, skin, teeth, collagen, connective tissue, bones, osteopenia, cell generation and degenerative (ageing) processes, and to a pharmaceutical composition comprising an extrudate.

Abstract: Disclosed are compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of amantadine. Methods of administering the same are also provided.

Abstract: An extended-release topiramate capsule that includes a capsule shell containing a single population of coated particles; wherein each coated particle includes a core and a coating thereon; wherein each particle core includes a homogeneous mixture comprising topiramate throughout its core; and wherein the coating includes one or more release controlling agent(s).

Abstract: Provided is an electric bus battery exchange station. The electric bus battery exchange station according to the present invention includes: an exchange station body having a battery exchange, wherein said battery exchange unit is projected out to be connected with a hole of; an imaging unit taking images of the electric bus moving toward said exchange station body; an entry process storing unit storing entry process information needed in order that the electric bus is positioned exactly below the battery exchange unit; an entry information output unit comparing an entry state of the electric bus obtained from images taken by said imaging unit with the entry information stored, and outputting entry information for modifying the entry state of the electric bus to make equal to said entry process information; and an entry information providing unit providing information outputted by said entry information output unit to the electric bus.

Abstract: Disclosed herein are controlled-release oral pharmaceutical dosage forms comprising MGBG, and their application for the improved treatment of diseases with reduced side effects and/or longer time at maximum concentration.

Abstract: An oral methylphenidate powder which is reconstitutable into a final oral aqueous sustained release formulation containing at least about 50%, or at least about 80% by weight water based on the total weight of the suspension, is provided. The powder is a blend containing a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and a water soluble buffering agent such that upon formed into an aqueous liquid formulation, the formulation has a pH in the range of about 3.5 to about 5, or about 4 to about 4.5. Following administration of a single dose of the oral aqueous methylphenidate suspension, a therapeutically effective amount of methylphenidate is reached in less than one hour and the composition provides a twelve-hour extended release profile.

Abstract: The present invention relates to a controlled release capsule preparation for oral administration, which contains (i) a granule containing a physiologically active substance which is a compound represented by the formula: wherein n is an integer of 1 to 3, and Ar is an aromatic ring optionally having substituent(s), or a salt thereof, and a hydrophilic polymer, and coated with an enteric coating agent and the like, and (ii) a fluidizer. According to the present invention, a controlled release composition for oral administration of an imidazole derivative, which has steroid C17,20-lyase inhibiting activity and which has remarkably improved sustainability of the blood concentration, is provided.

Abstract: The invention relates to a capsule for the prevention of cardiovascular diseases which comprises coated tablets of acetylsalicylic acid, coated tablets of simvastatin or pravastatin, and coated tablets of lisinopril, ramiphl or perindopril. The capsules are used for the prevention of cardiovascular diseases in high-risk populations.

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 sequestering subunit comprising an aversive agent and a blocking agent, wherein the blocking agent substantially prevents release of the aversive agent from the sequestering subunit in the gastrointestinal tract for a time period that is greater than 24 hours; a composition comprising a sequestering subunit in releasable form, wherein, optionally, the mechanical fragility of the sequestering subunit is the same as the mechanical fragility of the therapeutic agent in releasable form; a capsule or tablet comprising a sequestering subunit and a therapeutic agent; and a method of preventing abuse of a therapeutic agent.

Abstract: A controlled release dosage form of venlafaxine that comprises an immediate release pellet and an extended release pellet.

Abstract: The invention concerns a pharmaceutical composition containing micronized fenofibrate, a surfactant and a binding cellulose derivative, as solubilizing adjuvant, preferably hydroxypropylmethylcellulose. The cellulose derivative represents less than 20 wt. % of the composition. The association of micronized fenofibrate with a binding cellulose derivative, as solubilizing adjuvant and a surfactant enables to enhance the bioavailability of the active principle. The invention also concerns a method for preparing said composition without using any organic solvent.

Abstract: An extended-release topiramate capsule that includes a capsule shell containing a single population of coated particles; wherein each coated particle includes a core and a coating thereon; wherein each particle core includes a homogeneous mixture comprising topiramate throughout its core; and wherein the coating includes one or more release controlling agent(s).

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

Abstract: Emulsions of lipophiles such as glycerol monostearate which are compatible with acrylic copolymer emulsions are made stable by using an emulsion stabilizer such as polysorbate 80 in an amount by weight between 1% and 5% of the lipophile and homogenizing the emulsion wherein the emulsion micelles are less than 50 microns. The ability to make a stable emulsion of a lipophile is important in the coating process as it enables preparation and shipment of the lipophilic emulsion to the coater rather than the preparation of a lipophilic emulsion at the time of the coating process which involves a heating and cooling process.

Abstract: The present invention is directed to a psychostimulant containing pharmaceutical composition comprising an enteric coating and showing a sustained release of said psychostimulant in vivo. The invention is further directed to the use of said pharmaceutical composition in the treatment of the Attention Deficit Hyperactivity Disorder (ADHD) and comorbidities, narcolepsy, fatigue and/or cognitive decline associated with systemic diseases such as acquired immunodeficiency syndrome or oncological diseases. Additionally, the present invention provides a method for the manufacture of said pharmaceutical composition.

Abstract: The invention concerns a pharmaceutical composition containing micronized fenofibrate, a surfactant and a binding cellulose derivative, as solubilizing adjuvant, preferably hydroxypropylmethylcellulose. The cellulose derivative represents less than 20 wt. % of the composition. The association of micronized fenofibrate with a binding cellulose derivative, as solubilizing adjuvant and a surfactant enables enhanced bioavailability of the active principle. The invention also concerns a method for preparing said composition without using any organic solvent.

Abstract: A sustained-release formulation is provided comprising a solid dispersion composition comprising a tricyclic compound or a pharmaceutically acceptable salt thereof in a mixture comprising a water-soluble polymer and a water-insoluble polymer, and an excipient.

Abstract: Pharmaceutical compositions comprising micronized fenofibrate, a surfactant and a binding cellulose derivative as a solubilization adjuvant, wherein said compositions contain an amount of fenofibrate greater than or equal to 60% by weight and methods of producing fenofibrate compositions.

Abstract: Sustained release compositions comprising plurality of sustained release beads are disclosed. Particularly the sustained release beads comprise coated drug-resin complexes comprising drug-resin complexes of at least one active agent and at least one ion-exchange resin; coated with at least one release modifier.

Abstract: The invention involves methods and products related to the micronization of hydrophobic drugs. A method of micronizing hydrophobic drugs using a set of solutions including an aqueous solution is provided. The invention also relates to products of micronized hydrophobic drugs and related methods of use.

Abstract: A formulation of octreotide or pharmaceutically acceptable salts thereof, which provides controlled release of a therapeutically effective amount of octreotide for a period of at least about two months. Methods of treating acromegaly, decreasing growth hormone, decreasing IGF-1, and treating conditions associated with carcinoid tumors and VIPomas by administering a controlled release formulation of octreotide are provided herein.

Abstract: The invention concerns a pH-dependent gradual sustained release composition for increasing the pH in the upper part of the small intestines. Particles of the composition are provided with a multilayer polymer coating of specific structure which ensures the gradual release of the active agent in the range of pH 4.5 to 5.5. A process for preparing said composition is also claimed.

Abstract: The invention relates to an oral administration form for pyridin-2-ylmethylsulfinyl-1H-benzimidazoles and their salts, which comprises the active compound together with tablet disintegrants and is provided with a film coating customary per se for sustained-release compositions.

Abstract: Disclosed is a pharmaceutical composition for release control comprising a plurality of particles for release control. The plurality of particles for release control comprise a core material containing methylphenidate and a polymer coating layer for release control formed on the core material. The plurality of particles for release control are divided into two or more groups based on the average thickness of the polymer coating layer for release control. The particle groups are identical in terms of the composition of the polymer in the polymer coating layer, but are different in terms of the average thickness of the coated layer. The pharmaceutical composition for release control according to the present invention may control the release pattern of methylphenidate contained in the core material as desired, and can be used as an oral formulation in a variety of forms such as orally disintegrating tablets, etc.

Abstract: A composition for the adhesive bonding and/or fixing of biological and/or synthetic tissues includes the components: a) a nitrogen-functionalized polysaccharide; and b) a terminally functionalized oligolactone.

Abstract: Capsule shells for use in multi-part dosage forms have generally cylindrical shell members with a snap fit component on an interior surface adjacent an open end, for connection to a linker part of the dosage form. The shell member also has a plurality of spaced apart integrally formed thin (relative to circumferentially adjacent shell member portions) panels located adjacent a closed shell member end, for preferential dissolution and release of pharmaceutical compositions from the shell member interior. The ratio of the thickness of the panels to the thickness of the shell member ranges from about 0.2 to about 0.6. The panels can be integrally formed together with the shell member as reliefs or depressions on the inner surface of the shell member by injection molding, and panel thicknesses as thin as about 0.1 mm can be achieved.

Abstract: The present application discloses methods for repairing hyaline cartilage defects. The methods comprise a combination of introducing autologous bone mesenchymal stem cells to a joint, and applying to the joint a membrane comprising a polyester entangled with a polysaccharide. In some aspects, the bone mesenchymal stem cells are mesenchymal stem cells originating in bone underlying the joint. In these aspects, contact between the joint and the mesenchymal stem cells can be effected by introducing apertures through the bone using standard surgical techniques such as microfracture, abrasion, or drilling. Cartilage which forms in response to application of these methods is hyaline cartilage rather than fibrocartilage.

Abstract: The present invention is directed to pharmaceutically acceptable polymeric compositions suitable for injection molding of single or multi-component pharmaceutical dosage forms comprising a plurality of drug substance containing sub-units, being capsule compartments and/or solid sub-units comprising a solid matrix of a polymer which contains a drug substance, the sub-units being connected together in the assembled dosage form by a weld between parts of the assembled dosage form.

Abstract: The invention provides dosage forms and methods utilizing nicotine to treat symptoms of a neurologic disorder. In some embodiments, the invention provides compositions for treatment of gait and balance problems associated with Parkinson's Disease.

Abstract: Disclosed herein are compositions and methods for the treatment of otic diseases or conditions with cytotoxic agent compositions and formulations administered locally to an individual afflicted with an otic disease or condition, through direct application of these compositions and formulations onto or via perfusion into the targeted auris structure(s).

Abstract: The present invention relates to a preparation method for a biodegradable polymer microparticle and a microparticle prepared by the method. More particularly, the present invention relates to a method for preparing a polymer microparticle, wherein the method includes the steps of: dissolving a biodegradable polyester-based polymer in DMSO (Dimethyl Sulfoxide); spraying the solution in a low temperature hydrocarbon solution to provide a frozen DMSO microparticle; adding the microparticle in a low temperature salt aqueous solution to dissolve DMSO; and removing salt. The present invention provides a method for preparing a novel polymer microsphere which can be injected through a syringe due to excellent physical properties (such as biocompatibility, biodegradability, porosity, mechanical strength) and the microcarrier's size-adjustability, and can be easily mass-produced.

Abstract: The present invention concerns a new method of preparing granules comprising 5-aminosalicylic acid and a new method of preparing a pharmaceutical composition for the treatment of ulcerative colitis or Crohn's disease by oral administration comprising as active ingredient 5-aminosalicylic acid.

Abstract: The present invention relates to pharmaceutical formulations for the release of an active principle (AP) over a sustained period of time. The invention relates to a liquid formulation comprising at least one active principle (AP) and an aqueous suspension based on colloidal particles of a polymer (PO), wherein said formulation satisfies the following four conditions: (a) the PO is a polyamino acid comprising glutamic residues, wherein some glutamic residues each carry a pendant cationic group (CG), said CG being identical or different from one another, and other glutamic residues each carry a pendent hydrophobic group (GH), said GH being identical or different from one another, (b) the pHf value of the pH of said formulation is between 3.0 and 6.5; (c) at the pHf value, the PO forms a colloidal solution which associates spontaneously and noncovalently with the AP; (d) 1 ml of said formulation precipitates during mixing with a volume of 1 ml of a test buffer solution Tp.

Abstract: A bilayer solid composition comprising (a) an immediate release first layer comprising an anti-allergic effective amount of desloratadine and at least one pharmaceutically acceptable excipient and (b) a sustained release second layer comprising an effective amount of a nasal decongestant, e.g. pseudoephedrine sulfate and a pharmaceutically acceptable sustained release agent wherein the composition contains less than about 2% of desloratadine decomposition products is disclosed. A solid composition comprising an anti-allergic effective amount of desloratadine and at least one, and preferably two pharmaceutically acceptable antioxidants is also disclosed.

Abstract: The present invention relates to a modified release composition of at least one form of tramadol which is a delayed and extended release composition for oral administration suitable for once daily dosing. That composition comprises a core comprising at least one form of tramadol selected from the group consisting of tramadol, racemic mixtures thereof, enantiomers thereof, pharmaceutically acceptable salts thereof, and combinations thereof in combination with a pharmaceutically acceptable excipient. That composition further comprises a modified release coating which substantially surrounds said core. The compositions of the invention provide delayed and extended release of said at least one form of tramadol such that the mean plasma concentration of the at least one form of tramadol reaches a therapeutically effective level at a time which is after at least about 3 hours after first administration.

Abstract: The present invention is directed to novel pharmaceutically acceptable polymeric compositions suitable for melt extrusion and injection molding of single or multi-component pharmaceutical dosage forms comprising a plurality of drug substance containing sub-units, being capsule compartments and/or solid sub-units comprising a solid matrix of a polymer which contains a drug substance, the sub-units being connected together in the assembled dosage form.