Abstract: The present invention provides a method and composition for loading one or more drugs in a solution onto one or more ion exchange resin particles to form a drug-loaded resin particle. The drug-loaded resin particle is separated from the solution and dried before recombining the drug-loaded resin particle with the solution to load more drugs onto the drug-loaded resin particle from the solution.

Abstract: Medical devices comprising a balloon and a therapeutic agent disposed over the balloon. In one embodiment, an expandable sheath covers the balloon, and the expandable sheath is coated with the therapeutic agent. As the balloon is inflated, the sheath expands and causes the coating of therapeutic agent to break apart. In another embodiment, the balloon has a balloon wall comprising an outermost layer and one or more inner layers. The outermost layer is less compliant than the inner layer(s) such that cracks will form in the outermost layer as the balloon is inflated. The coating of therapeutic agent breaks apart when the relatively less compliant outermost layer cracks with the inflation of the balloon. Also disclosed are methods for making a medical device having a balloon.

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

Abstract: A coating composition for the enteric coating of capsule halves made of water-soluble or water-swellable polymer material in a dipping process is provided. The composition is an aqueous dispersion or solution, containing a polymer mixture of at least one first (meth)acrylate copolymer, which is enteric, and at least one further (meth)acrylate copolymer, which is enteric or water-insoluble, and also auxiliaries which influence the viscosity of the dispersion and the elasticity of the dried polymer film. The solids content of the dispersion or solution is more than 25% by weight and the viscosity is 150 to 1500 mPa·s and a dried film produced from the dispersion or solution has an elongation at break of at least 200%. Also provided is a capsule composed of two capsule halves coated with the dispersion or solution in a dipping process does. The enteric capsule does not dissolve in 0.1 N HCl at pH 1.2 after two hours, but completely dissolves in buffer at pH 6.8 in less than 30 minutes.

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 delayed release dosage form comprising core comprising duloxetine or its pharmaceutically acceptable salts or derivatives thereof, optionally, other pharmaceutically acceptable excipient(s) thereof; intermediate layer; and enteric layer; wherein the dosage form comprises one/more dissolution enhancer(s), wherein the enteric layer comprises one/more enteric polymers other than hydroxypropylmethyl acetate succinate. A process of preparing a delayed release dosage comprising mixing pharmaceutically acceptable excipients with duloxetine or its pharmaceutically acceptable derivatives thereof; granulating the product of previous step compressing the granulate formed in previous step to form core, coating said core with intermediate layer followed by coating with one/more enteric polymers and optional finishing coating.

Abstract: A laminin-modified polymeric hollow conduit is provided for promoting nerve regeneration across the gap between severed ends of a nerve. The conduit is manufactured by a method involving gas plasma treatment. Utilizing the laminin-modified conduit, functional recovery has been achieved in mammals with a severed spinal cord.

Abstract: Methods for increasing the fracture resistance of a polymer stent's drug-polymer coating and scaffolding including applying a coating and crimping using techniques that increase the resistance to fracture in the coating layer and scaffolding and scaffolding.

Abstract: The invention concerns multiparticulate galenic formulations for oral administration and designed for colon targeted delivery of active principles selected from the group comprising enzymes capable of inactivating macrolides and the like, enzymes capable of inactivating quinolones and ?-lactamases.

Abstract: A stent made from an ultra high molecular weight bioabsorbable polymer is disclosed herein. The bioabsorbable polymer can have a Mw greater than 1 million g/mole or greater than 2 million g/mole. Methods of making the ultra high molecular weight polymer stent without degrading the molecular weight are further disclosed.

Abstract: The present invention relates to drug delivery compositions, drug delivery units, drug delivery devices and methods of making the same using nanofabrication processes. The nanofabrication processes are used to make pores in a matrix. Exemplary nanofabrication processes include nanoimprinting, reverse imprinting, nanolithography, and photolithography.

Abstract: Disclosed in certain embodiments is a coating comprising a pharmaceutically acceptable mixture of gelatin and hydrophobic polymer.

Abstract: This invention relates to a method for coating a medical device comprising the steps of applying to at least a portion of the surface of said medical device, an antimicrobial coating layer and a non-pathogenic bacterial coating layer, wherein the antimicrobial and non-pathogenic bacterial coating layers inhibit the growth of pathogenic bacterial and fungal organisms. The non-pathogenic bacterium used in the bacterial coating layer is resistant to the antimicrobial agent. Furthermore, the non-pathogenic bacterium layer includes at least one of the following: viable whole cells, non-viable whole cells, or cellular structures or extracts. The antimicrobial agent and non-pathogenic bacterium are used to develop a kit comprising these compositions in one container or in separate containers. The kit is used to coat a catheter prior to implantation in a mammal.

Abstract: An implant having a coating comprising a polymer matrix is swollen in a pharmaceutical solution whereby pharmaceutically active compound is imbibed into the polymer matrix. When the product is implanted, release of the pharmaceutically active compound from the coating takes place. The polymer is preferably formed from ethylenically unsaturated monomers including a zwitterionic monomer, most preferably 2-methacryloyloxyethyl-2?-trimethylammoniumethyl-phosphate inner salt. The monomers from which the polymer is formed may further include surface binding monomers, such as hydrophobic group containing monomers, and crosslinkable monomers, the content of which may be used to control the swellability. Preferably the implant is a stent and the coating of polymer on the exterior wall surface is thicker than the coating of polymer on the interior surface. Release of the drug may be controlled by selection of comonomers. The implant is suitably a stent for use in the cardiovascular system.

Abstract: The present invention is directed to a medical device having a polymerized base coat layer for the immobilization of an anti-thrombogenic material, such as heparin, thereon. The binding coat layer is comprised of various chemically functional groups which are stable and allow for the immobilization of the anti-thrombogenic material thereto. Methods for immobilizing the anti-thrombogenic material within the base coat layer posited on a surface of the medical device are also provided.

Abstract: A method for producing an oral medication includes dispensing a structural material, the structural material including one of a polymer or a gelatin, curing the structural material, and dispensing a jettable pharmaceutical solution onto the cured structural material.

Abstract: An implantable enzyme-based monitoring system suitable for long term in vivo use to measure the concentration of prescribed substances such as glucose is provided. In one embodiment, the implantable enzyme-based monitoring system includes at least one sensor assembly, an outer membrane surrounding the sensor assembly and having a window therein, and a polymeric window cover affixed to the outer membrane and covering the window. Preferably, the outer membrane of the monitoring system is silicone and the window cover is a polymer of 2-hydroxyethyl methacrylate (HEMA), N,N,-dimethylaminoethyl methacrylate (DMAEMA) and methacrylic acid (MA). Also provided herein is an implantable enzyme-based monitoring system having at least one sensor assembly, an outer membrane surrounding the sensor assembly and a coating affixed to the exterior surface of the outer membrane, wherein the coating resists blood coagulation and protein binding to the exterior surface of the outer membrane.

Abstract: A method and device for treating a mammalian organism to obtain a desired local or systemic physiological or pharmacological effect is provided. The method includes administering a sustained release drug delivery system to a mammalian organism in need of such treatment at an area wherein release of an effective agent is desired and allowing the effective agent to pass through the device in a controlled. manner. The device includes an inner core or reservoir including the effective agent, an impermeable tube which encloses portions of the reservoir, and a permeable member at an end of the tube.

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 delayed extended release pharmaceutical composition includes a compressed core containing an effective amount of bupropion or its pharmaceutically acceptable salt, a water-attractant polymer. The core is preferably devoid of a stabilizer. The core is surrounded by an extended release layer, which is free of plasticizer and pore-forming agent. The extended release layer is surrounded by a delayed release layer. Alternating coats of extended release layer and delayed release layer may follow. A preferred extended release layer includes ethylcellulose and hydroxypropyl cellulose or hydroxypropyl methylcellulose and a preferred delayed release layer includes methacrylic acid copolymer and hydroxypropyl methylcellulose phthalate, lactose and a combination of triethyl citrate and polyethylene glycol and talc. A method of preparing the delayed extended release bupropion hydrochloride containing pharmaceutical composition is also disclosed.

Abstract: The present invention relates to methods of applying a drug—polymer coating layer onto an implantable medical device or another substrate, and the use of a choice of solvents to adjust the release of the drug from the coating. The drug to polymer ratio is about 1:1 to 1:3 on a mass basis. The polymer and the drug are hydrophobic.

Abstract: The present invention features a tablet including particles containing a pharmaceutically active agent, wherein the particles are coated with (a) a first film layer containing a modified release polymer; and (b) a second film layer containing (i) a first polymer, wherein the first polymer is a polymer of ethyl acrylate and methyl methacrylate and (ii) a second polymer, wherein the second polymer is a polymer of methyl acrylate, methyl methacrylate and methacrylic acid.

Abstract: An object of the present invention is to provide a dry coating process that can produce a dry-coated preparation in a large amount. A large amount of dry-coated preparation can be produced more efficiently, than by prior-art processes, by a process in which a material containing core particles and a dry binder (lauric acid, myristic acid, or the like) is kneaded in a twin-screw kneader to produce dry binder particles in which the surfaces of the core particles are dry-coated with the dry binder. Further, a dry coating particle production process in which a material containing core particles, a dry binder, and a coating powder is kneaded in a twin-screw kneader can also produce a large amount of dry-coated preparation more efficiently than prior-art processes.

Abstract: A method for electrostatic coating of medical devices such as stents and balloons is described. The method includes applying a composition to a polymeric component of a medical device which has little or no conductivity. The polymeric component could be a material from which the body or a strut of the stent is made or could be a polymeric coating pre-applied on the stent. The polymeric component could be the balloon wall. A charge can then be applied to the polymeric component or the polymeric component can be grounded. Charged particles of drugs, polymers, biobeneficial agents, or any combination of these can then be electrostatically deposited on the medical device or the coating on the medical device. One example of the composition is iodine, iodine, iodide, iodate, a complex or salt thereof which can also impart imaging capabilities to the medical device.

Abstract: Described are coating systems for the controlled delivery of hydrophilic bioactive agents, for example, from implantable medical devices. The coating systems of the invention comprise (a) a polymeric basecoat layer containing one or more hydrophilic bioactive agents; and (b) an elution-controlling topcoat layer that comprises a poly(ethylene-co-vinyl acetate) copolymer. The elution rate of the hydrophilic bioactive agent can be controlled by varying the vinyl acetate concentration in the elution-controlling topcoat layer.

Abstract: The present invention relates to solid oral pharmaceutical compositions of duloxetine, process for preparing such compositions and method of using such compositions. Preferably, the invention relates to a delayed release composition of duloxetine comprising a core comprising duloxetine, optional separating coat and an enteric coat, wherein the enteric coat comprises methacrylic acid copolymer.

Abstract: An apparatus for coating implantable medical devices, such as stents, and a method of coating stents using the apparatus is also disclosed. The apparatus includes a barrier or barriers for isolating an area of the stent on which a composition for coating a stent is applied. Two coating compositions can be applied simultaneously to a stent by separate nozzles on different sides of a barrier. Cross-contamination of the compositions is prevented by the barrier.

Abstract: The present invention relates to controlled release compositions comprising an anti-depressant compound. More particularly, the present invention relates to controlled release compositions comprising paroxetine hydrochloride.

Abstract: An implantable medical device for releasing therapeutic agent having a medical device body and a plurality of reservoir-defining structures disposed on a surface of the body. A reservoir can be defined by the reservoir-defining structures and therapeutic agent may be located in the reservoir. A cover may extend over the reservoir so that the therapeutic agent is released from the reservoir when the medical device implanted. Methods for making the medical device may also include providing a medical device body, positioning a plurality of reservoir-defining structures on a surface of the body to form a reservoir, loading therapeutic agent into the reservoir, and covering the reservoir so that the therapeutic agent may release when the medical device is implanted. Alternatively, the reservoir may be covered with a cover and an opening formed in the cover so that the therapeutic agent may release when the medical device is implanted.

Abstract: A dry suspendible enteric coating composition for suspension in water and then encasing orally ingestible articles. The dry suspendible enteric coating composition comprises a pH-dependent polymer selected from a group containing alginates and alginic acids, a pH-independent water insoluble polymer selected from the group comprising ethylcellulose and ethylcellulose-containing compositions, and a plasticizer selected from the group containing triethyl citrate, glycerin, propylene glycol, triacetin, acetylated monoglycerides, dibutyl sebacate, polyethylene glycols, sorbitals, middle chain triglycerides and combinations thereof.

Abstract: The present invention provides extended release pharmaceutical compositions of a beta blocker such as, but not limited to, metoprolol succinate as the active ingredient, optionally also comprising a diuretic such as but not limited to hydrochlorothiazide, and methods of preparing such extended release pharmaceutical compositions.

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

Abstract: Method of electrostatically applying powder material to a substrate, wherein the substrate is a pharmaceutical substrate and the powder material is pharmaceutically acceptable. At least some of the particles of the material comprise a core and a shell surrounding the core, and the material of the core and the shell have different physical and/or chemical properties.

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: 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 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: Pharmaceutical compositions useful for treating autoimmune diseases in a mammal comprising as an active ingredient a therapeutically effective amount of Copolymer 1, and microcrystalline cellulose are disclosed. Processes for the manufacture of such compositions are also disclosed.

Abstract: A method of controlling a dissolution rate of a bioactive agent includes selecting a desired dot topography corresponding to a target dissolution rate and applying a bioactive agent to a delivery substrate to form dots having the desired dot topography on the delivery substrate.

Abstract: A method of controlling a dissolution rate of a bioactive agent includes applying a first drop of solution carrying the bioactive agent at a first selected location on a delivery substrate, and positioning a second drop of solution carrying the bioactive agent at a second selected location on the delivery substrate, wherein the location of the first drop and the location of the second drop are selected based on a target dissolution rate.

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: This invention relates to a method for coating a medical device comprising the steps of applying to at least a portion of the surface of said medical device, an antimicrobial coating layer and a non-pathogenic bacterial coating layer, wherein the antimicrobial and non-pathogenic bacterial coating layers inhibit the growth of pathogenic bacterial and fungal organisms. The non-pathogenic bacterium used in the bacterial coating layer is resistant to the antimicrobial agent. Furthermore, the non-pathogenic bacterium layer includes at least one of the following: viable whole cells, non-viable whole cells, or cellular structures or extracts. The antimicrobial agent and non-pathogenic bacterium are used to develop a kit comprising these compositions in one container or in separate containers. The kit is used to coat a catheter prior to implantation in a mammal.

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 apparatus and method for manufacturing a pharmaceutical dose which dispenses a variable selectable quantity of at least one pharmaceutical onto a pharmaceutical receiving medium. The quantity of the dispensed pharmaceutical(s) are controllably dispensed to customize each pharmaceutical dose to suit the needs of a particular user. The apparatus is coupled by an external telecommunication network to a remote signal source for receiving pharmaceutical quantity and type data for custom manufacturing a pharmaceutical dose. In one aspect, a replaceable cartridge contains a reservoir carrying at least one pharmaceutical component and a fluid drop generator which is mountable in the fluid dispenser. The reservoir may contain a number of separate compartments, each carrying different pharmaceutical component.

Abstract: A stent having a polymeric coating for controllably releasing an included active agent. The polymeric coating includes a blend of a first polymeric material, which if alone, would release the agent at a first, higher rate, and a second polymeric material, which if alone would release the agent at a second, lower rate over a longer time period. One stent coating utilizes a faster releasing hydrophilic polymeric material and a slower releasing hydrophobic material. One stent coating includes a blend of a faster releasing PLA-PEO copolymer and a slower releasing PLA-PCL copolymer. One active agent is Taxol. One use of the Taxol delivering stent is to inhibit restenosis following angioplasty.

Abstract: A medical device including a surface, at least one depression in the surface, a nitric oxide releasing compound being deposited in the at least one depression, and at least one coating to cover the at least one depression. The coating forms a barrier inhibiting release of the nitric oxide releasing compound and being permeable to nitric oxide when the device is inserted in bodily fluid.

Abstract: The invention pertains to a process for making encased bound microparticles by nebulizing a dispersion of the bound microparticles into a solution of an encasing polymer and into a liquid, non-solvent of said encasing polymer.

Abstract: A dosage form comprising a gelatin capsule formed with a composite wall and containing a liquid, active agent formulation where the wall comprises a barrier layer formed over the external surface of the gelatin capsule, an expandable layer formed over the barrier layer and a semipermeable layer formed over the expandable layer is described. The dosage forms and methods provide for the conversion of standard gelatin, liquid formulation capsules into controlled, release dosage forms that permit the controlled release of the active agent into the environment of use over time.

Abstract: A medical device, such as a stent or balloon of a balloon catheter which includes a body portion which has an exterior surface which contacts, at least in part, a vessel wall during treatment. The body portion is expandable from a first position, wherein the body portion is sized for insertion into the vessel lumen, to a second position, wherein at least a portion of the exterior surface is in contact with the lumen wall. The medical device includes a first coating disposed over at least a portion of the exterior surface of the body portion with the first coating including a drug or therapeutic substance which is intended for controlled release from the surface. The medical device further includes a second coating overlying at least a substantial portion of the first coating. The second coating includes a material that is generally impervious to elution of the drug or therapeutic substance therethrough when the body portion is in a first position when inserted into the vessel lumen.

Abstract: The invention relates to a process for producing coated solid dosage forms by forming a plastic mixture from at least one thermoplastic physiologically tolerated polymeric binder and at least one active ingredient and extruding the plastic mixture, wherein the extrudate is subsequently treated with at least one liquid or vaporized coating agent, and the coated extrudate is shaped to the required dosage form.

Abstract: A non-toxic, edible, enteric film coating, dry powder composition for use in making an aqueous enteric suspension which may be used in coating pharmaceutical tablets comprises a) an acrylic resin, said resin comprising i) from 20 to 85 percent by weight of at least one alkyl acrylate or alkyl methacrylate moiety, ii) from 80 to 15 percent by weight of at least one vinyl or vinylidene moiety having a carboxylic acid group capable of salt formation, and iii) from 0 to 30 percent by weight of at least one other vinyl or vinylidene moiety copolymerizable with i) and ii), b) an alkalizing agent capable of reacting with the acrylic resin such that, after reaction, 0.1 to 10 mole percent of the acidic groups in 1a-ii) are present in the salt form, and c) a detacktifier.