Abstract: The current disclosure relates to a precursor capsule for holding a precursor for a vapor deposition process. The precursor capsule comprises a vapor-permeable shell configured to define a precursor space, and to allow precursor in vapor form to leave the precursor capsule under vaporization conditions. The disclosure further relates to a precursor vessel comprising capsules according to the current disclosure, to a vapor deposition apparatus and a method.

Abstract: Compressible adjuncts for use with a staple cartridge are provided. In one exemplary embodiment, a compressible adjunct includes a non-fibrous adjunct material formed of at least one fused bioabsorbable polymer and configured to be releasably retained on a cartridge and configured to be delivered to tissue by deployment of staples in the cartridge. The adjunct material includes a lattice macrostructure having a plurality of drug delivery microstructures formed in the lattice macrostructure, in which each drug delivery microstructure has drug disposed therein. The plurality of drug delivery microstructures are configured to encapsulate the drug to thereby prevent drug release until the plurality of drug delivery microstructures are at least one of thermally ruptured while the adjunct material is stapled to tissue and mechanically ruptured in response to at least one of clamping, stapling, and cutting of the adjunct material. Stapling assemblies for use with a surgical stapler are also provided.

Abstract: The method is for producing porous calcium deficient hydroxyapatite granules and comprises the following steps: (a) subjecting granules of calcium sulfate anhydrous (CSA), calcium sulfate dihydrate (CSD) or calcium sulfate hemihydrate (CSH), the granules comprising interconnected pores with a minimum mean diameter of 3 microns, to a first incubation in an alkaline aqueous solution having a pH-value of less than 10 and containing PO43? ions; (b) subjecting the granules to a second incubation in an alkaline aqueous solution having a pH-value of more than 10 and optionally PO43? ions; (c) filtering and drying the obtained porous granules of calcium deficient hydroxyapatite; and wherein (d) the sum of the amounts of PO43? ions present in the first and second incubation is at least as large as the amount of SO42? ions of the granules used for step (a).

Abstract: A method for manufacturing a nerve regeneration-inducing tube with excellent pressure resistance, shape recovery property, anti-kink property, film exfoliation resistance, resistance to invasion of outer tissues, and leakage resistance. The tubular body is formed by weaving together fibers made up of biodegradable polymer. The outer surface of the tubular body is coated multiple times with a collagen solution. The lumen of the tubular body is filled with collagen. Viscosity of the collagen solution that is first applied to the outer surface of the tubular body is between 2 to 800 cps. Viscosity of the collagen solution that is subsequently applied is higher than viscosity of the first applied collagen solution.

Abstract: Medical device coatings are provided that simultaneously release a therapeutic agent at different rates from different portions of the medical device coating. In a first embodiment, medical device coatings are provided that include particles comprising a therapeutic agent with two or more different particles sizes within a single layer on a surface of the implantable device. In a second embodiment, medical device coatings are provided having a higher concentration of the therapeutic agent in a first region of the coating than in a second region of the coating. In a third embodiment, medical device coatings are provided that are formed by certain coating processes wherein the droplet size of a spray coating solution is changed during the coating process. These coating processes preferably include applying a solution comprising a therapeutic agent and a suitable solvent to a surface of an implantable medical device.

Abstract: Coating methods and related devices are provided. Such devices can include stents. For example, the device can comprise a sidewall and a plurality of pores in the sidewall that are sized to inhibit flow of blood through the sidewall into an aneurysm to a degree sufficient to lead to thrombosis and healing of the aneurysm when the tubular member is positioned in a blood vessel and adjacent to the aneurysm. The device can also comprise an anti-thrombogenic coating distributed over at least a portion of the device such that the pores are substantially free of webs formed by the coating.

Abstract: The present disclosure provides oral dosage forms comprising an antiplatelet agent and an enterically coated acid inhibitor, as well as methods of treating subjects with an antiplatelet agent and an enterically coated acid inhibitor.

Abstract: A method of manufacturing a capsule 12 for holding a substance 14 includes providing a capsule body 2 having a closed end 5 and an opposed open end 6; providing a diaphragm 4 having a closed end 7 and an opposed open end 8; partially filling the body 2 with substance 14; providing a gas-tight chamber; providing a nitrogen gas environment within the chamber; applying a partial vacuum to the chamber; supporting an outer side 43 of the body 2; supporting an inner side 102 of the diaphragm 4; while supporting the body 2 and the diaphragm 4, inserting the closed end 7 of the diaphragm 4 into the open end 6 of the body 2 until regions of the body 2 and the diaphragm 4 overlap one another, thereby closing off the open end 6 of the body 2 and forming a chamber 104 within which the substance 14 is held; and heat welding the overlapping regions of the capsule body 2 and the diaphragm 4 to one another to hermetically seal the chamber 104.

Abstract: The present disclosure relates to acid resistant banding solutions for two piece hard capsules, and methods of making the same. The present disclosure also relates, in part, to a method for banding such capsules which provides an acid resistant seal between the capsule parts and achieves an increased acid resistance in vitro. The instant disclosure further relates to a capsule sealing solution formula that comprises shellac ink or shellac ink vehicle component.

Abstract: Delayed release of a drug to the colon is achieved from a delayed release formulation comprising a core and a coating for the core. The core comprises a drug and the coating comprises an inner layer and an outer layer. The outer layer comprises a mixture of a first polymeric material which is susceptible to attack by colonic bacteria, and a second polymeric material which has a pH threshold at about pH 5 or above. The inner layer comprises a third polymeric material which is soluble in intestinal fluid or gastrointestinal fluid, said third polymeric material being selected from an at least partially neutralised polycarboxylic acid and a non-ionic polymer. In embodiments in which the third polymeric material is a non-ionic polymer, the inner layer comprises at least one of a buffer agent and a base.

Abstract: The present invention relates to the pharmaceutical formulations comprising imatinib in solid dosage form reconstituted with a diluent just before use; preparation processes and use thereof.

Abstract: The present invention relates to solid orally administrable pharmaceutical administration forms comprising 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}-methyl)-2-thiophenecarboxamide (rivaroxaban, active compound (I)), characterized in that a partial amount of the active compound (I) is released rapidly and a partial amount is released in a controlled manner (modified, retarded, delayed), and to processes for their preparation, their use as medicaments and their use for the prophylaxis, secondary prophylaxis or treatment of disorders.

Abstract: The present invention provides a rapidly disintegrating pharmaceutical formulation in the form of a coated tablet having increased mechanical strength, or hardness. The invention furthermore relates to a process for the production of the coated tablet and to the use of these formulations.

Abstract: A bone implantable medical device made from a biocompatible material, preferably comprising titania or zirconia, has at least a portion of its surface modified to facilitate improved integration with bone. The implantable device may incorporate a surface infused with osteoinductive agent and/or may incorporate holes loaded with a therapeutic agent. The infused surface and/or the holes may be patterned to determine the distribution of and amount of osteoinductive agent and/or therapeutic agent incorporated. The rate of release or elution profile of the therapeutic agent may be controlled. Methods for producing such a bone implantable medical device are also disclosed and employ the use of ion beam irradiation, preferably gas cluster ion beam irradiation for improving bone integration.

Abstract: The present disclosure provides hollow nanostructures, methods of forming thereof, and methods of delivery of further nanomaterials utilizing the hollow nanostructures. The hollow nanostructures can be formed by illuminating particles, such as spherical particles, to create a scattering pattern that can be captured on, for example, a photoresist. Thus formed nanoparticles can have a substantially frusto-conical shape that can be tailored based on a variety of factors, including, for example, particle size, particle shape, light exposure characteristics, and light polarization.

Abstract: Provided is a composite formulation comprising multi-unit spheroidal tablets (MUSTs) encapsulated in a hard capsule and a method for preparing same. The inventive hard capsule composite formulation can effectively charge the MUSTs in the limited space of the capsule, which allows charging a high dose of different pharmaceutically active ingredients in a capsule with a relatively small size, to thereby increase the productivity and render it readily administered to patients. Also, the capsule has a good dissolution rate because the pharmaceutically active ingredients contained in the capsule are separated from one another; therefore, the dissolution rates of the ingredients are less affected by one another. It may also be possible to maximize the therapeutic effects of the pharmaceutically active ingredients since the composite formulation has good stability.

Abstract: A substantially monodisperse assemblage of particles 10 having interconnected pores 20 and a core 30 with at least one shell 40, 60 disposed about the core 30 as well as a method for their synthesis is disclosed.

Abstract: Method for producing enteric microcapsules without coating, containing diclofenac or one of the salts thereof with satisfactory anti-inflammatory activity and low gastric aggressiveness; and a pharmaceutical composition containing them. The method comprises a) preparing a mixture in water-ethanol with an alginate salt, adding diclofenac or one of the salts thereof previously diluted with a surfactant and sodium bicarbonate; b) adding the previous solution to a solution with a calcium salt; c) resuspending the microcapsules obtained and isolated in an aqueous solution of the alginate salt; and d) isolating, drying and sieving through 1000 and 250 micron meshes the microcapsules obtained; and selecting the fraction comprised between both meshes. The pharmaceutical composition can be an oral composition, tablets, chewable tablets, or a powder for suspension in water.

Abstract: The present invention provides a joint product comprising synephrine and topiramate, in which the synephrine or salt thereof is administered in form of rapid-release preparation, preferably rapid-release pellet, having daily dose of 2 mg to 25 mg, preferably 5 mg to 20 mg; the topiramate is administered in form of sustained-release or controlled-release preparation, preferably sustained-release pellet, having daily dose of 20 mg to 100 mg, preferably 23 mg to 92 mg. The composition is used for treatment of obesity or other diseases associated with obesity.

Abstract: The present invention relates to pharmaceutical compositions for the controlled and sustained release of active substance comprising a biodegradable polymer or copolymer. Furthermore, the invention relates to pharmaceutical compositions for the controlled and sustained release of at least one active substance such as peptides or hormones and analogs thereof and the manufacturing process of such pharmaceutical compositions.

Abstract: The present invention relates to modified release pharmaceutical compositions comprising salsalate. The invention also relates to processes for the preparation of such compositions.

Abstract: The present invention relates to pharmaceutical compositions of levodopa and carbidopa. In particular, the invention relates to modified release pharmaceutical compositions of levodopa and carbidopa with at least one organic acidic excipient. The invention also relates to processes for the preparation of such compositions and use thereof for treatment of Parkinson's disease.

Abstract: This invention relates to an oral stabilized modified release pharmaceutical dosage form containing L-methylfolate calcium, which is primarily absorbed from proximal small intestine via a saturable human proton-coupled folate transporter (h-PCFT) mediated transport intended as monotherapy for the treatment of patients with MDDs and/or diagnosed with dysthymia, schizophrenia, or degenerative dementia of the Alzheimer type.

Abstract: Provided herein is a coated coronary stent, comprising: a. stent; b. a plurality of layers deposited on said stent to form said coronary stent; wherein at least one of said layers comprises a bioabsorbable polymer and at least one of said layers comprises one or more active agents; wherein at least part of the active agent is in crystalline form.

Abstract: An apparatus and method provides a drug layer formed on a surface region of a medical device, the drug layer comprised of a drug deposition and a carbonized or densified layer formed from the drug deposition by irradiation on an outer surface of the drug deposition, wherein the carbonized or densified layer does not penetrate through the drug deposition and is adapted to release drug from the drug deposition at a predetermined rate.

Abstract: A paliperidone double-layered osmotic pump controlled release tablet and the preparation method thereof are disclosed. The double-layered osmotic pump controlled release tablet comprises a rigid membrane, a push layer, a drug layer, an isolation layer and an aesthetic coating, wherein the rigid membrane contains a semi-permeable polymer, a porogen and/or a plasticizer and has one or more drug release orifices on one end, the push layer comprises an expanding material, an osmotic agent, a binder, a colorant and a lubricant, the drug layer contains a pharmaceutically active ingredient, a hydrophilic polymer, an osmotic agent, a colorant, a lubricant and an antistatic agent, the isolation layer is located between the inner surface of the rigid membrane and the push layer, and contains a hydrophilic polymer. The paliperidone double-layered osmotic pump controlled release tablet shows an increasing drug release rate at early stage and keeps a constant drug release rate at later stage.

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

Abstract: An enteric preparation having a film-forming property and acid resistance is provided by using a simple and efficient method without using a special cooling apparatus. More specifically, provided is a method for producing an aqueous enteric coating liquid including the steps of: partially neutralizing an aqueous suspension including a cellulosic enteric material with an aqueous alkali solution, and mixing the partially-neutralized aqueous suspension with a plasticizer. Also provided is a solid preparation including a core including a drug and a coating portion obtained by coating the core with the produced aqueous enteric coating liquid. Further, provided is a method for producing a solid preparation, including respective steps in the method for producing an aqueous enteric coating liquid and a step of coating a core including a drug with the produced aqueous enteric coating liquid.

Abstract: An enteric-coated bead dosage form of cysteamine, and related methods of manufacture and use, are disclosed.

Abstract: The present invention relates to a sustained release pharmaceutical formulation comprising topiramate and one or more pharmaceutically acceptable excipients, wherein the formulation comprises two extended release (XR) components or a combination of an extended release (XR) component and immediate release (IR) component, wherein at least one component is in a matrix form. It also relates to method of preparing such formulations and using those formulations in the treatment of neurological and/or psychiatric condition.

Abstract: Controlled release oral dosage formulations containing calcium channel blocker and processes for preparation thereof, are provided for once a day treatment. The active agent is preferably a dihydropyridine calcium channel blocker, such as nisoldipine. In one embodiment, the formulation provides controlled release of micronized nisoldipine with one or more pH independent release controlling polymers. The controlled release matrix formulation is advantageous and can be prepared by a simple, economically viable process as compared to complex core-coat prior-art versions.

Abstract: Pharmaceutical compositions of topiramate for once-a-day oral administration are provided. The formulations comprise a sustained-release component and an optional immediate-release component, the compositions of which can be selectively adjusted, respectively, to release the active ingredient along a pre-determined release profile. Method of treating or preventing pathological disorders in mammalian subjects comprising the administration of the novel formulations disclosed herein is also provided.

Abstract: The invention relates to a controlled-release injectable microparticle comprising a polyvinyl alcohol polymer and one or more hormones, in particular progesterone. Said microparticle induces estrus in female mammals after a single application. The invention also relates to a method for obtaining the microparticle.

Abstract: The present invention relates to novel release capsules, particularly for protecting moisture-sensitive materials, particularly compositions for production of chlorine dioxide. The invention also relates to methods of manufacture of such release capsules, uses of such release capsules, and products comprising them.

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: Pharmaceutical compositions of topiramate for once-a-day oral administration are provided. The formulations comprise a sustained-release component and an optional immediate-release component, the compositions of which can be selectively adjusted, respectively, to release the active ingredient along a pre-determined release profile. Method of treating or preventing pathological disorders in mammalian subjects comprising the administration of the novel formulations disclosed herein is also provided.

Abstract: A drug delivery system for sustained delivery of bioactive agents, the system includes a matrix including nanofibrillated cellulose derived from plant based material and at least one bioactive agent, and at least one support selected from synthetic polymers, bio compounds and natural polymers. Also, methods for the manufacture of the system and methods of using it.

Abstract: A multiparticulate composition includes a plurality of individual enteric coated cores containing one or more terpene-based active ingredients and having a continuous proteinaceous subcoating layer covering the individual cores and separating the individual cores from their respective enteric coatings. The continuous proteinaceous subcoating layer prevents volatile terpene-based active ingredients from leaving the core, even when the core is heated during processing or stored for long periods above room temperature. The multiparticulate composition may be used to treat gastrointestinal disorders.

Abstract: A microencapsulated enteric matrix composition and method for manufacture are provided. The microencapsulated enteric composition includes enteric material, such as sodium caseinate and soy protein, and a functional ingredient contained therein in a core. Further, the composition includes a first coating including zein and the second, outer coating including ethylcellulose. The microencapsulated enteric composition may be suitable for use in hot comestibles.

Abstract: Hydrophobic liquids are microencapsulated by an enteric matrix in an environment substantially free of organic solvents. The process includes forming an emulsion of the enteric material and hydrophobic liquid in water, titrating the emulsion with an acid to form a particulate precipitate and optionally coating the particulate with a combination of enteric material and plasticizer.

Abstract: The present invention relates to a formulation for the controlled release of active ingredients after the passage of the ileo-cecal-valve, comprising one or more active ingredients or one or more active ingredient containing cores (W), enveloped by one or more envelopments (C), which are dissoluble or permeable above an individual defined pH value and are dissoluble or permeable below another individual defined pH value, again enveloped by an envelopment (E), which is dissoluble or permeable above still another individual defined pH value.

Abstract: A stent has first and second members. The stent is supported by a mandrel in a first position such that the mandrel is in contact with the first member and the second member is spaced from the mandrel. A method for coating the stent includes spraying or drying the stent, placing the stent in a second position such that the first member is spaced from the mandrel and the second member is placed in contact with the mandrel, and spraying or drying the stent while the stent is supported by the mandrel in the second position.

Abstract: The present invention relates to a method for the preparation of a controlled release system and especially to a method for entrapment of compounds in polymer carriers for controlled release of active ingredients, preferably bioactive ingredients, such as drugs. This method results in a system for controlled release of active ingredients and especially for controlled drug delivery. In accordance with the present invention, the tem controlled release” encompasses all kinds of controlled release, including slow release, sustained and delayed release. Particularly, the present invention results in active ingredients, entrapped in or otherwise incorporated in or coupled to polymer carriers or polymeric devices, such as micelles, nanoparticles, microspheres and other types of polymer devices for controlled release; the active ingredients are covalently bonded to the polymer carriers or polymeric devices.

Abstract: Devices and methods for using and manufacturing microstructure arrays are described.

Abstract: Microstructure arrays and methods for using and manufacturing the arrays are described.

Abstract: The present invention is a bioactive, nanofibrous material construct which is manufactured using a unique electrospinning perfusion methodology. One embodiment provides a nanofibrous biocomposite material formed as a discrete textile fabric from a prepared liquid admixture of (i) a non-biodegradable durable synthetic polymer; (ii) a biologically active agent; and (iii) a liquid organic carrier. These biologically-active agents are chemical compounds which retain their recognized biological activity both before and after becoming non-permanently bound to the formed textile material; and will become subsequently released in-situ as discrete freely mobile agents from the fabric upon uptake of water from the ambient environment.

Abstract: Modified release oral pharmaceutical compositions of dexlansoprazole or pharmaceutically acceptable salts or hydrated forms thereof in the form of a bilayer tablet and processes for the manufacture of the tablet composition and its use in the treatment of gastrointestinal disorders.

Abstract: The present invention relates to carriers for the controlled release of active agents, comprising a core, comprising surface reacted natural or synthetic calcium carbonate, and at least one active agent, wherein said at least one active agent is associated with said natural or synthetic surface-reacted calcium carbonate, and wherein said surface-reacted natural or synthetic calcium carbonate is a reaction product of natural or synthetic calcium carbonate with carbon dioxide and one or more acids, wherein the carbon dioxide is formed in situ by the acid treatment and/or is supplied from an external source, and a coating encapsulating the core. It furthermore relates to the preparation of loaded carriers, as well as their use in different applications.

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: Provided is a process for producing spherical base granules comprising a easily water-soluble drug and suited for film coating by spraying a layering liquid over pharmaceutically inert spherical core particles, thereby coating the particles with a layer comprising the easily water-soluble drug, wherein (1) the spherical core particles have a microcrystalline cellulose content of 30 mass % or greater and a water absorbing capacity of 0.5 cm3/g or greater; and (2) the layering liquid is an aqueous solution comprising at least the easily water-soluble drug and a low water-soluble saccharide.