Abstract: Particles containing dehydrated living micro-organisms are coated with a homogeneous layer of hydrophobic substance selected to reduce the risks of degradation of the micro-organisms by physico-chemical stresses such as heat, humidity, gastric acid, or compression. A method for producing such particles includes injecting a melting hydrophobic substance into the mass of the dehydrated micro-organisms placed in a chamber swept by an air stream at controlled temperature, where the base is rotating.

Abstract: A method of coating a pharmaceutical substrate includes the steps of applying an active coating material to a surface of the substrate to form an active coating layer and applying a cover coating material onto the active coating layer to form a cover coating layer. The active coating layer is substantially completely covered by the cover coating layer.

Abstract: An apparatus for electrostatically applying a powder material to a solid dosage from includes a source (1) of charged powder material, a support assembly (2) for supporting the solid dosage form (3) with a front face in the vicinity of the source of powder material and facing the source of powder material, the support assembly (2) including an electrically conducting member (5) in the vicinity of the rear face of the solid dosage form and an electrically conducting shield (8) disposed closely around the solid dosage from (3) between the front face and the rear face of the solid dosage form, and means (4) for creating a potential difference between the source of powder material and the electrically conducting member and for maintaining the electrically conducting shield at a potential more similar to that of the source of powder material than to that of the electrically conducting member.

Abstract: This invention provides novel methods for creation of patterned lipid bilayer membranes as well as methods for refunctionalization of such patterned membranes with selected components. Such components optionally comprise, e.g., lipid bilayer membranes (which optionally comprise specific proteins), proteins, non-biologic moieties, etc.

Abstract: A method of making an ophthalmological implant by applying a layer of pharmaceutical agent and an overlying layer of a bioerodible material, a biodegradable material, a bloavailable material or a mixture thereof, the overlying layer having variable thickness and being dimensioned for prolonged release of the pharmaceutical agent from the implant as the overlying layer degrades.

Abstract: A composition containing polydisperse aminodextran polymer molecules is soluble in an aqueous solution at a concentration of 10 mg/ml. The molecules therein have a narrow size distribution characterized by an average molecule mean hydrodynamic diameter of greater than 115 nm, a polydispersity index of between 0.10 and 0.47, an average molecular weight (MW) greater than 3 million daltons, and an amine content of greater than 50 amines per molecule. Similar soluble compositions contain the polymer molecules with an average MW of greater than 7 million daltons. These compositions are useful in forming reagents by conjugation with proteins for labeling cells. Methods of making these compositions and reagents from conventional mixtures of aminodextran polymers involve fractionation on column chromatography.

Abstract: A process for coating solid particles which comprises the steps of a) contacting a gas with a fluid composition comprising i) a polymer and ii) a liquid diluent to produce a foam, and b) contacting the produced foam with solid particles and agitating the particles to provide a coating on the solid particles.

Abstract: A stable solid controlled release formulation having a coating derived from an aqueous dispersion of a hydrophobic acrylic polymer includes a substrate including an active agent selected from the group consisting of a systemically active therapeutic agent, a locally active therapeutic agent, a disinfecting and sanitizing agent, a cleansing agent, a fragrance agent and a fertilizing agent, overcoated with an aqueous dispersion of the plasticized water-insoluble acrylic polymer. The formulation provides a stable dissolution of the active agent which is unchanged after exposure to accelerated storage conditions.

Abstract: An aqueous air foam comprising a non-crosslinked cellulose ether selected from C1–C3-alkyl celluloses, C1–C3-alkylhydroxy-C1–3-alkyl celluloses, hydroxy-C1–3-alkyl celluloses, or mixed hydroxy-C1–C3-alkyl celluloses, the foam having quality FQ of from 60 to 97 percent and the foam quality being defined as FQ (%)=(air volume+fluid volume)×100).

Abstract: An apparatus and method for locking a gun. The apparatus includes a dummy round configured for insertion into a firing chamber of a gun, a locking component configured for coupling with the dummy round, and an elongated sleeve rotatably coupled with the locking component. The locking component includes a keyed head positioned within a longitudinal channel of the elongated sleeve. The locking component and elongated sleeve are insertable through the discharge end of a gun's barrel. An actuating mechanism, such as a key is insertable through the channel of the elongated sleeve to engage with the keyed head and rotate the locking mechanism relative to the elongated sleeve. Rotation of the locking mechanism effects a friction lock between the locking mechanism and the dummy round.

Abstract: A split-pan for a panning apparatus, a panning apparatus incorporating a split-pan, and a method of coating two distinct masses of centers simultaneously with the split-pan are described. The split-pan is formed as a hollow drum, having first and second ends, an interior volume, and at least one partition, positioned between the first and second ends. The partition divides the interior volume into a plurality of coating vessels that allow the simultaneous coating of a plurality of masses of centers in the respective coating vessels.

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: A process for enrobing a core, such as a tablet core, uses a coating that is made of a patterned film having portions that are visually distinct (e.g, differently colored) from one another and having a transition line segment between these visually distinct portions. At least a portion of an outer surface of the core is covered with the film, such that the transition line segment forms a substantially continuous transition line on the coating and such that a film seam is formed which is different from the transition line. Alternatively, the coating is formed from two such patterned films, in which case the outer surface of the core is covered with the two films such that the two transition line segments cooperate to form a substantially continuous transition line on the coating and a film seam is formed which is different from the transition line.

Abstract: The following description refers to a process for the impregnation of cross-linked polymers with an active ingredient. The process is based on the used of compressed fluids, in particular CO2, with antisolvent effect, and involves the steps of impregnating the polymer with an active ingredient solution, adding a compressed fluid until precipitation of the active ingredient caused by the compressed fluid antisolvent effect, removing the solvent and the compressed fluid. The process allows to obtain accelerated release pharmaceutical formulations that, compared with the formulations already known, contain larger quantities of amorphous or nanocrystalline active ingredient.

Abstract: This invention provides novel methods for the formation of biocompatible membranes around biological materials using photopolymerization of water soluble molecules. The membranes can be used as a covering to encapsulate biological materials or biomedical devices, as a “glue” to cause more than one biological substance to adhere together, or as carriers for biologically active species. Several methods for forming these membranes are provided. Each of these methods utilizes a polymerization system containing water-soluble macromers, species, which are at once polymers and macromolecules capable of further polymerization. The macromers are polymerized using a photoinitiator (such as a dye), optionally a cocatalyst, optionally an accelerator, and radiation in the form of visible or long wavelength UV light. The reaction occurs either by suspension polymerization or by interfacial polymerization.

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 nutritional tablet or caplet has a film coating that contains folic acid available for rapid release upon contact with gastric fluid. The film coating also includes a film forming polymer such as hydroxypropyl methylcellulose.

Abstract: Provided is, among other things, a conductive inlay film comprising: a layer of dielectric film having a pattern of holes suitable to define selected regions to which particles will be deposited by electrostatic deposition; and a conductive element comprising polymer, which element comprises (a) a conductive film laminated against the dielectric film or (b) a conductive film embedded within the holes, the portion of the conductive element appearing within the holes comprising conductive inlays, wherein the conductive element is adapted to contact one or more electrode pads and provide electrical potentials at the selected regions, and wherein the dielectric film electrically isolates the selected regions.

Abstract: A process for coating solid particles which comprises the steps of a) contacting a gas with a fluid composition comprising i) a polymer and ii) a liquid diluent to produce a foam, and b) contacting the produced foam with solid particles and agitating the particles to provide a coating on the solid particles.

Abstract: A process for applying a coating having a therapeutic agent such as an antibiotic or a bone morphogenic protein to an implant uses the high surface area of a calcium phosphate coated metal implant as a repository for the therapeutic agent. The implant is coated with one or more layers of calcium phosphate minerals such as hydroxyapatite. After the crystalline layer is applied, which is usually done within an aqueous solution, the implant is dried and packaged. Immediately prior to implantation, the implant is removed from the package and the crystalline layer of calcium phosphate is wetted with an aqueous solution containing the therapeutic agent.

Abstract: In a method of electrostatically applying a powder material to a solid dosage form, charged powder material is applied to a photoconductive drum (3), is transferred to an intermediate belt (4) and then to a solid dosage form (5). The belt (4) makes contact with the solid dosage form (5).

Abstract: A method for coating drug-containing particles is provided comprising the steps of volatilizing a coating material and condensing the volatilized coating material onto a plurality of drug-containing particles. The method can be carried out without the use of solvents. Coated drug-containing particles as well as formulations and dosage forms containing coated particles are also described. A method for treating patients using drug-containing particles is provided as well.

Abstract: This invention provides a method of modifying the surface of a medical device, such as an ophthalmic lens. The method involves contacting a surface of the medical device with a solution containing a surface modifying agent; and subjecting the device surface and surface modifying agent to microwave radiation while the surface modifying agent is in contact with the device surface. The device may be constructed of materials such as hydrogel copolymers and silicone materials.

Abstract: The invention relates to a hard sugar coating method comprising a step in which a sugar coating syrup is applied, said syrup consisting of maltitol or isomalt and at least one binder, characterized in that all or part of the dry matter of said binder is substituted by a sorbitol syrup or power in order to reduce the fragility of said sugar-coated products.

Abstract: An ingestible tablet (10), e.g. of a medicament, is enrobed to produce a tamper-evident coating by vacuum forming a film (40, 46) of material, preferably hydroxypropyl methyl cellulose, onto the surface of the tablet.

Abstract: The invention concerns a device for producing granules, in particular pharmaceutical granules, comprising a drum (4) with peripheral apertures (25) and a member (30) feeding the drum with coating or fixing substance. The drum (4) comprises mutually parallel sections (22) defining between them the apertures (25).

Abstract: Spraying apparatus and methods that employ multiple nozzle structures for producing multiple sprays of particles, e.g., nanoparticles, for various applications, e.g., pharmaceuticals, are provided. For example, an electrospray dispensing device may include a plurality of nozzle structures, wherein each nozzle structure is separated from adjacent nozzle structures by an internozzle distance. Sprays of particles are established from the nozzle structures by creating a nonuniform electrical field between the nozzle structures and an electrode electrically isolated therefrom.

Abstract: Compare core LPS (lacking O-polysaccharide side chains) from Gram-negative bacteria are incorporated into a vaccine typically in liposomes. The complete core of E. coli K 12 is particularly useful. Upon administration to a mammal the vaccine stimulates synthesis of antibodies which are cross-protective against smooth and rough forms of LPS from at least two different Gram-negative bacterial strains having different core structures.

Abstract: An improved coating apparatus and an improved method of coating a mass of centers are disclosed. The improved coating apparatus comprises a temperature sensor for measuring the temperature of the surface of the coated centers and/or a moisture sensor for measuring the moisture content of the surface of the coated centers. The improved method comprises drying coated centers by measuring the temperature of the surface of the coated centers in the mass using the temperature sensor and adjusting the temperature of the drying gas to maintain the surface temperature of the coated centers at a predetermined temperature and drying the coated centers until the moisture content of the surface of the coated centers is about 0 to about 30 percent water, by weight. Advantageously, the surface temperature and/or surface moisture measurements are conducted during the coating processing of the centers, while the centers are in the coating apparatus.

Abstract: Spray-coated pharmaceutical powder compositions for transdermal administration using a needleless syringe comprise seed particles coated with a pharmaceutical composition, the said coated seed particles having an average size of about 10 to 100 &mgr;m and having an envelope density ranging from about 0.1 to about 25 g/cm3.

Abstract: An oral formulation containing an active pharmaceutical ingredient, for instance a peptide pharmaceutical, such as insulin, coated onto a suitable particulate substrate, such as dibasic calcium phosphate. The oral formulation may be a modified release formulation, for instance a controlled release formulation or a sustained release formulation, or may be an immediate release formulation. Also, the formulation may be encapsulated in gelatin capsules or may be compressed into tablets.

Abstract: The present invention relates to water soluble tablet coatings prepared from water soluble, partially and completely neutralized acrylic polymers and at least one film modifying agent.

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: A sprayable liquid coating composition, particularly for application to foodstuffs and pharmaceuticals, utilizes gaseous carbon dioxide to reduce the viscosity of a concentrated solution comprising an edible polymer and a solvent, such as ethyl alcohol or isopropyl alcohol. The addition of the gaseous carbon dioxide in the concentrated solution permits a sprayable composition to be produced using a significantly reduced level of solvent in the edible polymer/solvent solution. By reducing the amount of solvent used in the solution, the level of VOCs emission during the coating process also is reduced. Either supercritical carbon dioxide or subcritical carbon dioxide can be used as the gaseous carbon dioxide in the present invention.

Abstract: Provided is, among other things, a dry deposition apparatus for depositing grains on a substrate comprising: an electrostatic chuck having one or more collection zones, wherein the substrate is layered on the chuck for processing; a charged grain delivery apparatus for directing charged grains for electrostatic deposition on the substrate at the locations of the collection zones; and an optical detection device for quantifying the amount of grains deposited.

Abstract: The present invention is directed to an active agent dosage form and methods of its fabrication which is useful for the prolonged delivery of an active agent formulation to a fluid environment of use. The active agent dosage form is a matrix that has on its surface one or more insoluble bands located in complementary grooves. The invention is also directed to articles of manufacture, methods and systems for fabricating the active agent dosage form.

Abstract: A composition comprising particles which comprise a core material within a polymeric shell, wherein the core material comprises a hydrophobic substance, characterized in that the polymeric shell comprises a copolymer formed from a monomer blend which comprises, A) 30 to 90% by weight methacrylic acid B) 10 to 70% by weight alkyl ester of (meth)acrylic acid which is capable of forming a homopolymer of glass transition temperature in excess of 60° C. and C) 0 to 40% by weight other ethylenically unsaturated monomer. The core material can comprise an active ingredient selected from the group consisting of UV absorbers, UV reflectors, pigments, dyes, colorants, scale inhibitors, corrosion inhibitors, antioxidants, pour point depressants, wax deposition inhibitors, dispersants, flame retardants, biocides, active dye tracer materials and phase change materials. The composition has the advantage that the polymeric shell is highly impermeable to the core material even at elevated temperatures.

Abstract: An edible, hardenable coating composition is disclosed which comprises high levels of low viscosity propylene glycol alginate and a surfactant, which may additionally contain a filler, a pigment, and optionally a small amount of a secondary film former and/or a strengthening polymer. The coating composition of the present invention may be applied to pharmaceutical and veterinary solid dosage forms, confectionery, seeds, animal feed, fertilizers, pesticide tablets, and foods and provides an elegant prompt release coating which does not retard the release of active ingredients from the coated substrate.

Abstract: The present invention relates to a process using ultrasonic cutting for the preparation of an oral delivery device comprising a core which includes a pharmaceutically active agent covered by an outer coating which includes one or more openings communicating from the exterior of the device toward the core.

Abstract: Methods are provided for preparation of a coating on one or more microprojections of a microprojection array using wetting agents either as a pretreatment of the microprojection surfaces or incorporated in the coating formulation along with the active agent.

Abstract: A coating for a prosthesis, for example a stent, and a composition for forming the coating is disclosed. The coating can serve as a primer, allowing substances, such as polymers, to be effectively secured by the prosthesis. Alternatively, the coating can serve as a reservoir, allowing for the local and sustained release of a therapeutic substance to biological tissues. The composition can be formed from an ethylene vinyl alcohol copolymer and a dimethylsulfoxide solvent, with or without a therapeutic substance. Alternatively, the composition can be formed from an ethylene vinyl alcohol copolymer, a dimethylsulfoxide solvent, and a wetting fluid, with or without a therapeutic substance. The composition is applied to a surface of the prosthesis and essentially all of the dimethylsulfoxide solvent or dimethylsulfoxide solvent/wetting fluid is removed or allowed to evaporate to form the coating.

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 of making an oral dosage form of a water insoluble drug such as Saquinavir or Cyclosporine or Paclitaxel is carried out by: (a) providing a single phase working Solution comprising or consisting essentially of an active agent, water, a water-soluble polymer, and a solvent, said solvent selected from the group consisting of alcohol, acetone, and mixtures thereof; and may or may not contain a surfactant and pH of the said working solution may or may not be adjusted (b) providing particles formed from a pharmaceutically acceptable core material; (c) combining, preferably by spraying, said working solution with said particles to produce active agent-coated particles; such drug loaded particles may contain an external coat (d) drying said active agent-coated particles; and (e) forming said dried particles into an oral dosage form. Dried particles produced by the process, oral dosage forms containing such particles, and methods of treatment therewith are also described.

Abstract: A film-forming composition comprising a hydrocolloid, a plasticizer, and water is described. A process and apparatus for producing a non-gelatin film comprising a hydrocolloid, a plasticizer, and water is also disclosed. The process includes combining at least one non-gelatin hydrocolloid, water, and at least one plasticizer into a substantially homogeneous film-forming composition comprising at least about 40 percent water by weight. A substantial portion of the water is then extracted from the film-forming composition to form a dried portion having a water content of less than or equal to about 25 percent by weight. The dried portion of the film-forming composition is formed into a film. A film produced according to the process preferably has a tensile strength at rupture of at least about 5 N, and a percent elongation of at least about 50 percent at rupture at room temperature. An apparatus for performing the process is also described, as well oral dosage forms encapsulated or enrobed in the produced film.

Abstract: Microparticles with a uniform spherical shape and a very narrow size distribution are described. They consist wholly or partly of a linear water-insoluble polysaccharide, preferably of 1,4-&agr;-D-polyglucan, and may contain other, in particular biodegradable, polymers and/or active substances. They are suitable inter alia for the controlled delivery of active substances. They are prepared by dissolving 1,4-&agr;-D-polyglucan or the polysaccharide in a solvent, introducing the solution into a precipitant, cooling the mixture and removing the particles formed.

Abstract: A method of coating a pharmaceutical substrate which is not a hot-melt coating by fluid bed method comprises applying a molten coating material to the pharmaceutical substrate wherein the substrate is coated with the coating material; optionally applying to the coated substrate the same or different molten coating material, and optionally repeating the second applying step; wherein the coated substrate contains an antigen or a pharmaceutical agent or drug; and wherein the molten coating contains less than 10% solvent. Coated substrates include those made by this process.

Abstract: Coated and agglomerated products of materials containing phytochemicals, for example phytoestrogens such as isoflavones, and a method for the production of such coated and agglomerated products, are provided. The coating and agglomeration are accomplished using organic polymers in appropriate solvents, applied to the phytochemical-containing materials in a fluid bed system.

Abstract: Compositions and methods for use with substrates which are useful in the sustained delivery of bioeffecting agents are described. The compositions of the invention include a multicomponent complex which attaches a bioeffecting agent to a substrate with an anchor provided by a linker compound which also forms a cleavable linkage so that the bioeffecting agent's release into the area surrounding the substrate occurs in a sustained manner over an extended period of time. The methods of the invention involve providing a bioeffecting composition on the surface of a substrate so that a bioeffecting agent may be released in a sustained manner over time.

Abstract: This invention relates to radioactively coated devices, preferably radioctively coated medical devices. These coated devices are characterized as having a low rate of leaching of the radioisotope from the surface of the coated device and a uniform radioactive coating, and are therefore suitable for use within biological systems. Methods for coating a device with a radioisotope comprising are also disclosed. One method comprises immersing the device within a solution containing a &ggr;, &bgr;+, &agr;, &bgr;− or &egr; (electron capture) emitting radioisotope, then exposing the immersed substrate to tuned vibrational cavitation to produce a coated substrate. A second method involves coating a substrate using electroless plating, and yet a third method involves the use of electroplating a radioisotope onto a substate of interest. With these methods, the coating procedures are followed by baking the coated substrate at a temperature below the recrystallization temperature of the substrate.

Abstract: The present invention relates to a method of producing a pharmaceutical composition directly in a packaging material, a moulded packaging material comprising the pharmaceutical composition, a cassette comprising the packaging material, as well as a method of administering a dosage of the pharmaceutical composition for example directly from the packaging material.