Abstract: A unitary intervertebral device, having no moving components is provided for non-fusion articulation and fusion applications. The interbody articulating device allows for limited flexion and rotation between the implant and an adjacent vertebrae, helping to preserve or restore near-normal motion between adjacent vertebrae. Rotational motion is achieved through one or more protrusions incorporated into the spinal interbody device. In one articulating form, a first protrusion extends perpendicularly from one bearing surface of the interbody device to form a rotational protrusion, while at least a second protrusion extends from the opposite bearing surface of the interbody device to form a non-rotational protrusion. In another form, a single protrusion extends axially from one bearing surface of the interbody device to form a spike or anchoring, rotating protrusion, while the opposite bearing surface may be slightly rounded and/or comprising a bone-ingrowth promoting surface.

Abstract: A consumer care composition or a food composition comprising a mesoporous microparticulate material wherein at least some of the pores of the material are loaded with at least one ingredient and the loaded mesoporous microparticulate material is encapsulated by a capping layer is described.

Abstract: The present invention relates to a method for preparing a granule or a pill containing a plant, medicinal herb or traditional oriental medicine decoction extract, comprising the steps of: (a) injecting a powdered plant, medicinal herb or traditional oriental medicine decoction extract into a fluidized-bed device and spraying purified water or a solution of the same type of extract as the extract powder at the extract powder while fluidizing the same, thereby generating microgranules of the extract powder; and (b) injecting the microgranules generated at step (a) as seeds into the fluidized-bed device and spraying a solution of the extract while fluidizing the same, thereby growing the microgranules to a predetermined size of granule or pill. According to the present invention, it is possible to prepare a granule or a pill containing an extract in a high concentration.

Abstract: A taste masked particulate pharmaceutical formulation include a core that comprises an active pharmaceutical ingredient; at least a partial nanoparticle material layer on the core that comprises a nanoparticle material with a median particle size not greater than 100 nm; a first polymer layer that is at least partially water soluble and a second polymer layer that is water insoluble. The active pharmaceutical ingredient is completely released in 30 minutes in the USP Dissolution Test. A process of making the particulate pharmaceutical formulation using sequential fluidized bed coating steps under controlled conditions is also described.

Abstract: In a production process of granules containing a biologically active substance, variation in the elation profile of the biologically active substance is reduced by heating the temperature of granules to about 50° C. or higher and maintaining the temperature for about 1 minute or longer. By setting the spray speed to about 90 mg/min or more per 1 g of cores when a spray agent fox a primary agent containing the biologically active substance is sprayed while spraying a binding liquid to the cores and setting the total feeding weight per unit area for a centrifugal fluidized bed coating granulation machine to about 1.5 g/cm2 more, the variation in the elution profile of the biologically active substance from the granules is reduced.

Abstract: Formulations of sparingly water-soluble active ingredients, consisting of carrier particles provided with active ingredient-containing coatings, the sparingly soluble active ingredients being embedded in coatings composed of amphiphilic copolymers.

Abstract: A continuous dosage form coating apparatus uses vibrational impulses to maintain a dosage forms in a fluid state to expose them to a coating material atomized by spraying.

Abstract: A microlead includes a conductive cable formed by a strand of microcables, each microcable being formed of a strand of individual metallic wires. The microlead also includes an insulation layer sheathing the cable. The microlead further includes at least one exposed area formed in the insulation layer so as to form a corresponding electrode of the microlead. The microlead further includes a pharmacologically active agent (e.g., an anti-inflammatory agent) configured to gradually be released into the environment of the microlead after implantation of the microlead. The pharmacologically active agent may be a soluble material. An interstitial space, delimited by the inner wall of the insulation layer and existing in the remainder between the wires of each microcable, is filled with the pharmacologically active agent.

Abstract: A continuous dosage form coating apparatus uses vibrational impulses to maintain a dosage forms in a fluid state to expose them to a coating material atomized by spraying.

Abstract: Processes for coating a carrier with microparticles of a drug are described. For example, a coated carrier can be obtained in a one-stage process that entails evaporating a solvent from microdroplets of a solution containing an API to obtain dry microparticles, which are then coated on the carrier.

Abstract: Various lipid nanoparticles are disclosed, including nanoparticles comprising a lipid bilayer comprising a phospholipid, a sterol, a polyethylene glycol-lipid surrounding an aqueous core which comprises a therapeutic and/or diagnostic agent and nanoparticles comprising a lipid monolayer surrounding a hydrophobic core. Of particular interest are limit size lipid nanoparticles with a diameter from 10-100 nm. Such lipid nanoparticles are the smallest particles possible for a specific particle composition. Methods and apparatus for preparing such limit size lipid nanoparticles are disclosed.

Abstract: Processes for coating a carrier with microparticles of a drug are described. For example, a coated carrier can be obtained in a one-stage process that entails evaporating a solvent from microdroplets of a solution containing an API to obtain dry microparticles, which are then coated on the carrier.

Abstract: In the process of coating pharmaceutical tablets in a moving bed, the temperature of the tablets is measured by incorporating a temperature transducer in the form of tablet into the bed of tablets, and transmitting temperature data to an external receiver by wireless telemetry.

Abstract: The present invention provides improved formulations of 6-mercaptopurine that exhibit better bioavailability and faster dissolution than previous formulations.

Abstract: The invention relates to a method for producing particles with a length-width ratio of less than about 1.4 from a pharmaceutical substance, which method includes the following stages, that is: (a) provision of a melt of the pharmaceutical substance; (b) production of droplets of the melt by spraying into a processing chamber; (c) repeated guiding of solid particles past sprayed droplets in the processing chamber with the aid of a process gas jet which is guided in a defined way and whose temperature is fixed, depending on the solidification point of the melt, so that at least some of the droplets come into contact with particles and solidify thereon; (d) removal of particles from the processing chamber as a function of the particle size. The invention further relates to particles of pharmaceutical substances and the use thereof.

Abstract: The invention pertains to a co-processed excipient composition suitable for tableting, said composition comprising at least one filler-binder, at least one disintegrant, and at least one lubricant which have been subjected to granulation together, and said composition partially or completely coated with lactose, preferably in crystalline form. The inventors have overcome the prejudice against the use of lubricants in tableting excipient compositions early in the tableting process. It was found that the alleged detrimental affects of the lubricant in terms of binding and disintegration could readily be controlled in a excipient composition wherein the lubricant is co-processed in the matrix, and the composition is provided with a lactose coat.

Abstract: This application relates to taste masked multi-layered particles 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 comprising 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 comprising 60-90% (w/w) EC and 10-40% (w/w) HPMC, wherein the pharmaceutically active ingredient is water-soluble and comprises either at least one basic group and/or a bitter taste. Further disclosed are methods for the production of such particles and pharmaceutical compositions comprising them.

Abstract: The invention relates to life's necessities and in particular those relating to health, more particularly a method for dissolving and improving the intestinal absorption of active ingredients which are poorly-water-soluble or water-insoluble or which cannot be turned into salts in gastric juice, containing one or more active ingredients dispersed in a polyoxyethylene 32 fatty acid ester then hot spraying said dispersion onto a granular excipient in a fluid bed. The powder mixture thus formed is distributed in pharmaceutical compositions after optional dilution in a pharmaceutically-acceptable non-toxic inert excipient. The above is of use in the production of pharmaceutical compositions containing one or more pharmaceutically-acceptable non-toxic inert excipients.

Abstract: This invention relates to the field of chemical-pharmaceutical industry, specifically a new tuberculosis treatment that contains, as an active ingredient, 4-thioureido-iminomethylpyridinium perchlorate at a therapeutically effective and safe level and pharmaceutically acceptable excipients. In addition, this treatment relates to a method of the preparation of the new drug, providing a high yield of the new treatment. The new treatment has a higher tuberculostatic activity (200 times as high) and lower toxicity (2.4 times as low), as compared to a prototype drug, and is stable during long-term storage. This medicament may be used for treating and preventing all forms of pulmonary and extrapulmonary TB by using the new treatment in combination with other TB drugs.

Abstract: Medical articles with porous polymeric structures and methods of forming thereof are disclosed. The porous structure can have pores sizes that are nanoporous or greater than nanoporous. The porous structure can be a coating or layer of a medical device such as a stent, stent graft, catheter, or lead for pacemakers or implantable cardioverter defibrillators. Additionally, the body of the medical device can be a porous polymeric structure. The porous structure can be made from bioabsorbable polymers. The porous structures can be formed by contacting a polymer with a supercritical fluid.

Abstract: A method of producing a pharmaceutical preformulation in the form of a solid, free-flowing dry extract of a natural mixture of conjugated equine estrogens, which is particularly suitable use in for solid galenic forms, e.g. tabletting. The conjugated estrogens are available for further galenic processing in a form which assures the chemical stability of the hormones and permits advantageous processing into solid galenic forms, for example a tablet.

Abstract: The present invention broadly relates to a process for preparing products comprising active components, and in particular biological materials, wherein the active components are stabilised. The invention further relates to compositions comprising the products, and in particular compositions comprising therapeutic biological materials.

Abstract: Formulations of sparingly water-soluble active ingredients, consisting of carrier particles provided with active ingredient-containing coatings, the sparingly soluble active ingredients being embedded in coatings composed of amphiphilic copolymers.

Abstract: The present invention is directed to a method of preparing an extended release pharmaceutical composition comprising cyclobenzaprine, comprising coating inert particles with a cyclobenzaprine-containing a drug layering composition to form IR beads, then coating the IR beads with an extended-release coating to form ER beads.

Abstract: A composite stent and a method for making the same are provided.

Abstract: A novel composition comprising a tablet, comprising a highly soluble active pharmaceutical ingredient, which is then coated with a coating. The core is preferably a tablet. The coating preferably comprises any type of suitable extended release polymer, with the proviso that the polymer does not comprise an enteric polymer.

Abstract: A method of forming an ocular delivery device includes exposing a solid, shaped cellulose polymer to a solution including an active pharmaceutical ingredient (API) and a solvent capable of solubilizing the API, wherein the polymer absorbs at least a portion of the solution, including the API and solvent. The method may further include removing at least a portion of the absorbed solvent from the polymer by allowing the absorbed solvent to evaporate from the polymer or by drying the polymer. A variety of cellulose polymers may be used, including hydroxypropyl cellulose. A variety of APIs may be used, including Cyclosporine, Tobramycin and Vancomycin. Ocular delivery devices prepared by the methods may be used to treat a variety of eye disorders.

Abstract: The invention relates to an improved process for preparing a new medicament formulation of the active substance dabigatran etexilate of formula I in the form of the methanesulphonic acid salt thereof, and this new medicament formulation as such.

Abstract: A method and system for modifying a drug delivery polymeric substrate for an implantable device, such as a stent, is disclosed.

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: The present invention is directed to pharmaceutical compositions comprising a plurality of taste-masked non-opioid analgesic/opioid analgesic drug-containing microparticles, dosage forms comprising such pharmaceutical compositions (such as an orally disintegrating tablet), and methods of making the pharmaceutical compositions and dosage forms of the present invention. Dosage forms comprising the pharmaceutical compositions of the present invention are improved homogeneous blends of non-opioid and opioid analgesics which provide for more convenient and palatable administration of drug combinations, for example for treating pain.

Abstract: Water soluble, gelatin-free dip coatings for pharmaceutical solid dosage forms such as tablets comprising HPMC and xanthan gum, carrageenan, and mixtures thereof, or HPMC and castor oil or maltodextrin.

Abstract: The invention provides solid dispersions of at least one insoluble active pharmaceutical ingredient, pharmaceutical dosage forms comprising the solid dispersions, and methods of manufacturing same. In an embodiment, a solid dispersion of the present invention includes a plurality of coated particles comprising inert particles with a coating, wherein the coating comprises an insoluble active pharmaceutical ingredient dispersed in a hydrophilic polymer, and wherein the inert particles comprise nonpareils; and a plurality of granules comprising an insoluble active pharmaceutical ingredient with at least one pharmaceutically acceptable excipient. In an embodiment, the insoluble active pharmaceutical ingredient in the coating and the insoluble active pharmaceutical ingredient of the granules are the same type. A solid dispersion of the present invention may optionally be encapsulated in capsules or compressed into a tablet.

Abstract: A subject of the present invention is a novel formulation of levetiracetam making it possible to obtain a solid pharmaceutical composition, particularly intended for oral administration, for the sustained release of levetiracetam. A subject of the invention is also a process for the preparation of such a pharmaceutical composition.

Abstract: Disclosed are methods and devices for producing very fine particles which are then coated with protective polymers in another step of the process. The particles are produced using a method in which a liquid flow comprising a particle-free liquid 1 that contains the active substance in a dissolved form is combined with a second liquid flow comprising a liquid 2 in a high-energy zone or no sooner than two seconds before reaching the high-energy zone. Said two liquids can be mixed with each other while the active substance dissolved in liquid 1 is insoluble or more difficult to dissolve in liquid 2 than in liquid 1 and settles in the form of particles in the high-energy zone or within a maximum of 2 seconds before reaching the high-energy zone when the two liquids are mixed. The obtained particles are introduced into an aqueous outer phase which contains the coating materials in a dissolved form and are then subjected to a drying step such that said materials settle on the particles as a closed coating.

Abstract: In a production process of granules containing a biologically active substance, variation in the elution profile of the biologically active substance is reduced by heating the temperature of granules to about 50° C. or higher and maintaining the temperature for about 1 minute or longer. By setting the spray speed to about 90 mg/min or more per 1 g of cores when a spray agent for a primary agent containing the biologically active substance is sprayed while spraying a binding liquid to the cores and setting the total feeding weight per unit area for a centrifugal fluidized bed coating granulation machine to about 1.5 g/cm2 or more, the variation in the elution profile of the biologically active substance from the granules is reduced.

Abstract: The present invention relates to a method for coating of a pharmaceutical product. The method comprises the step of producing discrete droplets (7) of controlled size, shape and composition with at least one micro dispenser (1) and distributing droplets (7) with controlled velocity, time of flight. Also, the method comprises the step of controlling the production frequency and modulation of the droplets (7). Further, the method comprises the step of controlling the flow rate, temperature and composition of the carrier gas and directing droplets (7) towards particles (10) subjected to coating. The present invention also relates to a device for coating of a pharmaceutical product. The device comprises a droplet producing unit (1) and a droplet-directing unit (8). The droplet producing unit (1) is a piezo-actuated micro dispenser (1) for producing discrete droplets (7) and controlling the size, shape and composition of said droplets (7).

Abstract: A fluidized bed apparatus has a rotary rotor 4 arranged at the bottom center thereof, a disintegrator mechanism 5 arranged above the rotary rotor 4, and a cylindrical draft tube 6 installed above the disintegrator mechanism 5. A fluidizing gas jetted from a gas dispersion plate 3 causes powder particles P in a processing container 1 to form a fluidized bed in which they circulate so as to ascend through the gap between the outer periphery of the rotary rotor 4 and the bottom inner wall of the processing container 1, the space between the disintegrator mechanism 5 and the inner wall of the processing container 1, and the space between the outer periphery of the draft tube 6 and the inner wall of the processing container 1, and descend through the inner portion of the draft tube 6.

Abstract: In a method of monitoring the formation of a coating on a single particle (P), an apparatus is used which comprises means (2,5,6,9) for arranging said particle (P) at a given spatial location, and a fluid supply unit (3) adapted to apply a coating fluid to the particle (P) such that the coating is formed. Further, the apparatus has a measurement unit (4) which is adapted to perform a spectrometric measurement on the coating during formation thereof, and to derive a measurement value of at least one principle parameter related to the coating. This, such principle parameters, for example the thickness, thickness growth rate and physical and/or chemical properties related to the quality of the coating, as well as heat, mass and momentum transfer, can be continuously and non-invasively monitored during the coating process on the single particle (P).

Abstract: Among the conventional processes for producing solid dispersion, the solid dispersion obtained by a solvent method is excellent in terms of solubility and bioavailability of a poorly soluble drug. However, due to frequent uses of organic solvents in the solvent method, problems have arisen such as organic solvent residue in products, environmental pollution and operational safety as well as corporate problems such as capital investment and the like required to avoid such events. The present invention provides a process for preparing pharmaceutical solid preparations without use of organic solvents frequently used in conventional solvent methods.

Abstract: A process for the production of encased, spherical granular grains comprising spraying grains which consist of a prostane derivative and a cyclodextrin vehicle, forming together a prostane-cyclodextrine-clathrate, with an aqueous polymer dispersion of ethyl cellulose and/or poly(methyl)acrylic acid ester in a fluidized or boiling bed is disclosed. The polymer dispersion is applied in a thickness equivalent to 1-5% (w/w) of the total mass of the encased grains. The coated grains are cured for at least 24 hours. Grains produced according to this method have a pharmaceutical active ingredient release profile which remains unchanged over the storage time.

Abstract: An oral composition which is adapted to be dispersed in an aqueous carrier substantially immediately prior to administration comprises a multiplicity of particles comprising an active substance, the particles being combined with one or more gelling or swelling agents capable of forming a viscous medium around the particles in an aqueous carrier as well as being provided with a masking surface layer when dispersed in the aqueous carrier. This serves to mask uneven surfaces on the particles and prevent them from adhering to oral mucosa when the composition is ingested and thus makes it easier to administer large dosages of an active substance. The masking surface layer is preferably provided by an increased viscosity of the viscous medium in the immediate vicinity of the particles relative to the viscosity of the surrounding aqueous carrier. A ready-to-use composition is prepared by mixing the composition with an aqueous carrier substantially immediately prior to administration of the composition.

Abstract: A method for metering active ingredient in powder form onto a predetermined area is characterized in that the active ingredient is transferred as electrically charged powder to a roll with the opposite charge, the active ingredient transferred to the roll is transferred to a two-dimensional substrate with an electric charge opposite to the active ingredient, the active ingredient transferred to the substrate is fixed by means of a heat treatment.

Abstract: The invention provides a process for the production of drug carrier pellets comprising spay-drying a solution of a physiologically tolerable cellulosic binder containing a physiologically tolerable inert particulate carrier having a particle size D(v, 0.5) of less than 50 &mgr;m.

Abstract: The invention concerns a method for coating solid particles with a thermofusible agent which consists in: fluidizing the solid particles in an ascending air movement in spiral rotation to obtain a homogeneous individualised distribution of the particles in the air fluidized bed, the temperature of the air fluidized bed being lower than the melting point of the thermofusible agent; spraying on the particles the melted thermofusible agent in the form of atomised droplets, said droplets being distributed in a spraying cone included in an air zone, whereof the temperature enables to maintain, throughout said spraying process, a temperature of the thermofusible agent substantially equal its melting point, the spraying being carried out in the same direction and tangentially to the movement followed by the solid particles; finally, after the coating process, cooling the resulting coated particles so as to solidify the thermofusible agent around the particles.

Abstract: The present invention has several plausible embodiments. In one embodiment an apparatus for coating a medical device is provided. This apparatus includes a coating chamber, a vibrating structure within the coating chamber the vibrating structure capable of suspending a medical device positioned in the coating chamber, and a coating source, the coating source positioned to introduce coating into the coating chamber. In another embodiment a method of coating a medical device is provided. This method includes moving a medical device into a predetermined coating area, vibrating a structure below the medical device, the vibration of the structure forcing the medical device away from the vibrating structure, and coating at least a portion of the medical device that has moved away from the vibrating structure.

Abstract: Pyrolytic carbon of extremely uniform crystalline characteristics and essentially free of discontinuities is obtained in a fluidized bed coater by creating an asymmetric recirculation of the fluidized bed within the high temperature coating chamber. Through the use of any of a variety of gas injection schemes, fluidizing/coating gas mixtures are injected through the three-dimensionally curved concave bottom surface of the coater to create a pattern where the fluidized bed ascends within about one-half of the volume of the coater and then spills over to become a descending bed in the other half.

Abstract: Methods and apparatuses for coating medical devices and the devices thereby produced are disclosed. In one embodiment, the invention includes a method comprising the steps of suspending the medical device in an air stream and introducing a coating material into the air stream such that the coating material is dispersed therein and coats at least a portion of the medical device. In another embodiment, the medical devices are suspended in an air stream and a coating apparatus coats at least a portion of the medical device with a coating material. The coating apparatus may include a device that utilizes any number of alternative coating techniques for coating the medical devices. This process is used to apply one or more coating materials, simultaneously or in sequence. In certain embodiments of the invention, the coating materials include therapeutic agents, polymers, sugars, waxes, or fats.

Abstract: Chewable tablets and particulate food and pharmaceutical products are disclosed which are made from agglomerates comprising an alcohol sugar such as mannitol and a high intensity sweetener such as Aspartame from which agglomerate tablets may be directly compressed, and processes for making the agglomerates and tablets. The tablets or particulate product containing the agglomerate may contain active ingredients blended with the agglomerate or as part of the agglomerate structure. Tablets and particulate products according to the invention can contain active ingredients such as pharmaceuticals (e.g., antacids, analgesics, cough medicine, drugs, etc.) breath sweeteners, vitamins and dietary supplements, to name a few. The high intensity sweetener containing agglomerates can also be used to make solid food mix type products such as sugar free ice tea mixes.

Abstract: An apparatus for coating seeds and particulate material includes an elongated tray operably mounted on a support frame with a motor for oscillating the tray to move particulate material from a rearward end to a forward end therealong. The tray includes a perforated support surface with a saw-toothed cross-sectional shape such that the particulate climbs the inclined tread of each sawtooth and drops from the forward end of one tread to the rearward end of an adjacent tread to form a “curtain”. A plurality of spray nozzles are located over the tray to direct coating solution onto the seeds as they move along the tray. Preferably, the nozzles direct spray towards the curtain of falling seeds between the treads. An upper housing on the support frame includes an air plenum which directs air downwardly onto the seeds on the support surface and through the perforated support surface to a second air plenum formed under the support surface.