Abstract: The present invention provides: a pitavastatin-containing preparation containing pitavastatin or a pharmacologically acceptable salt thereof and at least one kind of a basic additive selected from the group consisting of basic magnesium compounds and basic calcium compounds, and an aqueous solution or an aqueous dispersion of the pitavastatin-containing preparation having a pH of more than 8 and 10 or less; and a method for producing a pitavastatin-containing preparation, including blending at least one kind of a basic additive selected from the group consisting of basic magnesium compounds and basic calcium compounds with pitavastatin or a pharmacologically acceptable salt thereof, to make an aqueous solution or an aqueous dispersion of the pitavastatin-containing preparation have a pH of more than 8 and 10 or less.

Abstract: Compositions and methods for modulating injection site pain associated with rapid acting injectable insulin formulations have been developed for subcutaneous injection. The formulations contain insulin in combination with a zinc chelator such as ethylenediaminetetraacetic acid (“EDTA”), a dissolution/stabilization agent such as citric acid, a magnesium salt, and, optionally, additional excipients. New presentations include rapid acting concentrated insulin formulations and a way to enhance the absorption of commercially available rapid acting analog formulations by mixing them with a vial containing dry powder excipients that accelerate their absorption. Devices for mixing excipient and insulin together at the time of administration, while minimizing residence time of the mixture, are also described.

Abstract: The present invention relates to stable compositions comprising a sphingosine 1 phosphate (S1P) receptor modulator, suitable for use as a dosage form. The S1P receptor modulators are typically sphingosine analogues, such as 2-substituted 2-amino-propane-1,3-diol or 2-amino-propanol derivatives, e.g. a compound comprising a group of formula Y.

Abstract: The present invention is directed to pharmaceutical compositions comprising prasugrel and a cyclodextrin derivative, and methods of making and using the same.

Abstract: A viscoelastic hydrogel based on a protein hetero-assembled with a polymer is provided. The protein cannot self-assemble with itself and the polymer cannot self-assemble with itself. The protein has a first association sequence (1stA) and a first spacer (1stSp). The polymer has a second association sequence (2ndA) and a second spacer (2ndSp). The first association sequence and the second association sequence are physically cross-linked to interact with each other with a 1:1 known and specific stoichiometry to form a three dimensional scaffold. The protein is represented by {1stA(1stSp)}x1stA, where x is ?2, and the polymer is represented by {2ndA(2ndSp)}y2ndA, where y?2.

Abstract: The present invention provides for bioavailable oral dosage forms containing esters of 17-hydroxyprogesterone as well as related methods. The oral dosage forms can be formulated for pregnancy support and can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. In another embodiment, a pharmaceutically acceptable oral dosage form for pregnancy support is provided. The pharmaceutically acceptable oral dosage can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. The oral dosage form can, when measured using a USP Type-II dissolution apparatus in 900 mL of deionized water with 0.5 (w/v) of sodium lauryl sulfate at 50 RPM at 37° C., release at least 20 wt % of the dose of the ester of 17-hydroxyprogesterone after 60 minutes, or in the alternative release at least 20 wt % more after 60 minutes than an equivalently dosed oral dosage form without the carrier.

Abstract: Pharmaceutical compositions of conjugates are provided. The conjugates can be prepared by (among other ways) conjugating a pharmacologically active agent with a polymeric reagent that has a particular arrangement of atoms. Related methods, preparations, and so forth are also provided.

Abstract: The present invention provides methods and compositions for treating pancreatic cancer in an individual who has been previously treated for pancreatic cancer (e.g., gemcitabine-based therapy) by administering a composition comprising nanoparticles that comprise a taxane and an albumin. The invention also provides combination therapy methods of treating pancreatic cancer (for example, in an individual who has been previously treated for pancreatic cancer) comprising administering to an individual an effective amount of a composition comprising nanoparticles that comprise a taxane and an albumin and another agent.

Abstract: The present invention provides methods and compositions for treating pancreatic cancer in an individual who has been previously treated for pancreatic cancer (e.g., gemcitabine-based therapy) by administering a composition comprising nanoparticles that comprise a taxane and an albumin. The invention also provides combination therapy methods of treating pancreatic cancer (for example, in an individual who has been previously treated for pancreatic cancer) comprising administering to an individual an effective amount of a composition comprising nanoparticles that comprise a taxane and an albumin and another agent.

Abstract: A compound with the formula (I), wherein: R2 is of formula (II), where X is selected from the group comprising: OH, SH, CO2H, COH, N?C?O, NHNH2, CONHNH2, formula (A), formula (B), NHRN, wherein RN is selected from the group comprising H and C1-4 alkyl; RC1, RC2 and RC3 are independently selected from H and unsubstituted C1-2 alkyl; and either: R12 is selected from the group consisting of: (ia) C5-10 aryl group, optionally substituted by one or more substituents selected from the group comprising: halo, nitro, cyano, ether, C1-7 alkyl, C3-7 heterocyclyl and bis-oxy-C1-3 alkylene; (ib) C1-5 saturated aliphatic alkyl; (ic) C3-6 saturated cycloalkyl; (id) formula (C), wherein each of R21, R22 and R23 are independently selected from H, C1-3 saturated alkyl, C2-3 alkenyl, C2-3 alkynyl and cyclopropyl, where the total number of carbon atoms in the R12 group is no more than 5; (ie) formula (D), wherein one of R25a and R25b is H and the other is selected from: phenyl, which phenyl is optionally substituted by a group

Abstract: The present invention provides antibodies that specifically bind to trophoblast cell-surface antigen-2 (Trop-2). The invention further provides antibody conjugates comprising such antibodies, antibody encoding nucleic acids, and methods of obtaining such antibodies. The invention further relates to therapeutic methods for use of these antibodies and Trop-2 antibody conjugates for the treatment of a condition associated with Trop-2 expression (e.g., cancer), such as colon, esophageal, gastric, head and neck, lung, ovarian, or pancreatic cancer.

Abstract: Compositions of nanoparticles functionalized with at least one zwitterionic moiety, methods for making a plurality of nanoparticles, and methods of their use as diagnostic agents are provided. The nanoparticles have characteristics that result in minimal retention of the particles in the body compared to other nanoparticles. The nanoparticle comprising a nanoparticulate transition metal oxide covalently functionalized with a silane-functionalized non-targeting zwitterionic moiety.

Abstract: A sensor for the in vivo detection of glucose comprises: components of an assay for glucose, a readout of which is a detectable optical signal which can be interrogated transcutaneously by external optical means when the sensor is implanted in vivo; and a shell of biodegradable material encapsulating the assay components while allowing analyte to contact the assay components, wherein the biodegradable material comprises a co-polymer having hydrophobic and hydrophilic units. A method of preparing such a sensor preferably comprises coacervation, solvent evaporation and/or extraction, spray drying, spray coating, spray chilling, rotary disk atomisation, fluid bed coating, coextrusion and/or pan coating. A method of detecting glucose using such a sensor suitably comprises implantation of the sensor into the skin of a mammal, transdermal detection or measurement of glucose using external optical means and degradation of the biodegradable material.

Abstract: The present invention concerns compounds and methods of labeling peptides or other molecules with 18F or 19F or any other suitable radionuclide of use, for example, in PET or NMR in vivo imaging. A targeting molecule such as a protein or a peptide is linked to a substituted metallocene complex which is reacted with the 1gF or 19F shortly before performing the PET or NMR in vivo imaging on the patient. The labeled molecule is then used for targeting a cell, tissue, organ or pathogen to be imaged or detected.

Abstract: Unscented and low scented malodor control compositions are provided. The malodor control compositions are suitable for a variety of applications, including use on plastic films or in fabric and air freshening products.

Abstract: An apparatus for producing a fragrance includes a heating element, a barrier that at least partially surrounds the heating element and a shell that at least partially surrounds the barrier. At least a portion of the volume between the barrier and the shell is configured to hold one or more solid fragrance carriers. A heat induced airflow through the apparatus causes the solid fragrance carriers to emit a fragrance.

Abstract: An air freshener is configured to be carried by a power outlet of an automobile. The air freshener includes a scent capsule disposed in a housing. A heat source is disposed in the housing adjacent and opposing a permeable membrane of the scent capsule. The heat source is configured to heat the fragrant material in the scent capsule and accelerate permeation of the fragrant material through the permeable membrane of the sent capsule. A hatch is pivotally coupled to the housing and substantially contained within a hatch cavity with an outer surface that is substantially flush with an exterior of the housing in a closed position. The hatch can include a capsule cavity therein, carrying the scent capsule, and facing an interior of the housing in the closed position.

Abstract: A fragrance sampler is provided which is made from two plies, a bottom ply and a top ply, of material. A cosmetic, such as a wet fragrance, sample is deposited on the bottom ply. A well is formed in at least one of the plies and is sized and shaped to surround the sample. The two plies are then adhered together to form a liquid tight seal between the two plies and around the well.

Abstract: The invention generally relates to dextran fibers which are preferably electrospun and devices formed from such fibers. In particular, such devices may include substances of interest (such as therapeutic substances) associated with the electrospun fibers. Upon exposure to a liquid the electrospun fibers dissolve immediately and the substances of interest are released into the liquid. Exemplary devices include bandages formed from electrospun dextran fibers and associated agents that promote hemostasis, such as thrombin and fibrinogen.

Abstract: An absorbent core suitable for use in an absorbent article comprising: a first absorbent layer, the first absorbent layer comprising a first substrate, and a layer of cross-linked cellulose fibers deposited on said first substrate, a second absorbent layer, the second absorbent layer comprising a second substrate, a layer of superabsorbent polymer particles deposited on said second substrate and a fibrous layer of thermoplastic adhesive material covering the layer of superabsorbent polymer particles. The first and second absorbent layers being combined together such that at least a portion of said fibrous layer of thermoplastic adhesive material contacts at least a portion of the layer of cross-linked cellulose fibers of said first absorbent layer.

Abstract: Degradable bioprostheses made of collagen-based material having amine-based and ester-based crosslinks are provided, as are methods for their formation and use. Some embodiments of the present invention are directed towards a method of controlling the ratio of amine-based crosslinks to ester-based crosslinks within a collagen-based material to provide a tailorably crosslinked collagen-based material. Some embodiments provide a method of making a degradable bioprosthesis involving controlling crosslinking to afford a degradable bioprosthesis that is partially crosslinked. By controlling the ratio of amine-based to ester-based crosslinks, by controlling the level of crosslinking, or by controlling both of these features, degradable bioprostheses with tailored degradation rates can be synthesized. Some embodiments of degradable bioprostheses have degradation rates that are tailored to allow their use in particular medical applications.

Abstract: The present invention is directed to immobilized biologically active entities that retain significant biological activity following mechanical manipulation of a substrate material to which the entities are immobilized.

Abstract: Implantable medical devices are provided. In one embodiment, a device includes a body having an external surface defining an outer profile of the device. The body includes a porous matrix including a series of interconnected macropores defined by a plurality of interconnected struts each including a hollow interior. A filler material substantially fills at least a portion of the series of interconnected macropores. The external surface of the body includes a plurality of openings communicating with the hollow interior of at least a portion of the plurality of interconnected struts. In a further aspect of this embodiment, the external surface includes exposed areas of the filler material and porous matrix in addition to the exposed openings. In another aspect, the porous matrix is formed from a bioresorbable ceramic and the filler material is a biologically stable polymeric material. Still, other aspects related to this and other embodiments are also disclosed.

Abstract: Implantable materials having defined patterns of affinity regions for binding endothelial cells and providing for directed endothelial cell migration across the surface of the material. The affinity regions include photochemically altered regions of a material surface and physical members patterned on the material surface that exhibit a greater affinity for endothelial cell binding and migration than the remaining regions of the material surface.

Abstract: A foldable, intravascularly insertable blood pump (10) comprises a foldable, radially delivering impeller (20) accommodated in a foldable housing or envelope (24). Axially before and behind the impeller a clearance (60) is provided between the impeller (20) and the front and back walls (32, 62) of the housing (24), the clearance being at least 0.2 mm. Preferably, the space defined between adjacent blades (54) of the impeller (20) is open towards the front wall (32) of the housing (24).

Abstract: The invention relates to the balancing of fluid streams in a dialysis system. In particular the invention relates to a cassette for conveying a first and a second fluid stream in a dialysis system, wherein the first and the second fluid streams can be medical fluid streams such as for example dialysate streams or blood streams, wherein the cassette has a sensor as a device for balancing the first and the second fluid stream, and wherein the sensor has a first channel for the first fluid stream and a second channel for the second fluid stream. The invention further relates to a dialysis system, which is configured to accommodate at least one cassette which is configured as described above. Furthermore, the present invention relates to an arrangement by which two channels for the first and the second fluid streams are formed. In addition, the invention relates to a method for construction of the two channels or the arrangement.

Abstract: Systems and methods for managing the potassium concentration of a dialysate fluid during hemodialysis therapy using cation exchange materials that do not release sodium ions.

Abstract: A medical device system including a physiological sensor and ultrafiltration unit senses a physiological signal in a patient and computes a fluid status measurement of the patient using the physiological signal. Ultrafiltration therapy is delivered to the patient according to a therapy delivery control parameter established in response to the fluid status measurement.

Abstract: The invention relates to an apparatus for the elimination of substances from liquids, in particular from blood, comprising a primary circuit for the liquid to be treated, a filter which is integrated therein and at whose secondary side a secondary circuit is connected in which at least one adsorber is arranged, wherein respective pumps are provided in the primary and secondary circuits. In accordance with the invention, an expansion vessel in which liquid of the secondary circuit is discontinuously taken up and output again is integrated in the secondary circuit.

Abstract: Systems and methods for performing online extracorporeal photopheresis of mononuclear cells are disclosed. Whole blood is removed from a patient and introduced through a processing set into a separation chamber to separate the desired cell population from the blood. The separated cell population is processed through the set which is associated with a treatment chamber where the cells are treated. Once treated, the cells are returned to the patient. The processing set remains connected to the patient during the entire ECP treatment procedure and provides an online, sterile closed pathway between the separation chamber and the treatment chamber.

Abstract: The present invention provides an assembly comprising a skin-mountable device with a mounting surface, the device being arranged in a packaging releasably attached to the device and having an opening through which the device can be moved when detached from the packaging. The device and the packaging comprises cooperating attachment structure, whereby the attachment structure allows the packaging to be moved in parallel with a skin surface for a predetermined distance when a force in parallel with the skin is applied to the packaging in the first direction, yet prevents movement of the packaging away from the general plane. The attachment structure between the packaging and the skin-mountable device, allows the packaging to be used as a handling tool to place the device on a skin surface, the attachment structure preventing that the device inadvertently falls out during handling, yet allows for easy and safe removal.

Abstract: An assembly is provided which includes an infusion device coupled to a standard medication syringe. The medication syringe may be coupled to a stopcock valve having multiple ports and to which syringes, vial adapters, infusion tubing, and multiple other items may be coupled. The infusion device includes a source of power based on a resistance force such as vacuum, spring or gas power. The infusion device converts the resistance based force to usable work in the form of a force applicator. The force applicator includes a driver section on one section of a reciprocating arm and an attachment to the power source on another section of the arm. The driver is pulled outward (excursion) to increase the size of the chamber, creating a force that tends to return the driver back inward, causing incursion. The driver can be attached removably to the syringe plunger to induce the infusion process.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device capable of delivering fluid to a user involves identifying a condition of the user that is likely to influence a response to the fluid in the body of the user and classifying the condition as a first type of a plurality of types of conditions. After classifying the condition as the first type, the method continues by adjusting control information for operating the infusion device based on the first type and operating the infusion device to deliver the fluid to the user in accordance with the adjusted control information.

Abstract: A medicated module (4) for an injection system to co-deliver at least two medicaments is disclosed where a primary delivery device containing a primary medicament accepts a medicated module (4) containing a single dose of a secondary medicament (2) and where both medicaments are delivered through a single hollow needle (5). The medicated module (4) is user selectable so that it will deliver both the primary (1) and secondary medicaments (2), or only the primary medicament (1). The module (4) also contains a guard (42) that locks after dose delivery.

Abstract: Syringes and flushing medical devices are generally discussed herein for withdrawing, injecting, or instilling fluids. More particularly, syringe tips and flushing tip adaptors with multiple flow channels are discussed for flushing vascular access devices. The tips have cut-outs that are located and sized to produce a relatively wider flow profile than a typical syringe tip with a single central lumen to facilitate flushing the vascular access devices.

Abstract: A dose setting mechanism of a drug delivery device and a respective method of assembling said dose setting mechanism. The dose setting mechanism includes an inner housing having a helical groove along an external surface of the housing. The inner housing includes a rotational stop member near one end of the helical groove. The dose setting mechanism also includes a dial sleeve rotatably engaged with the helical groove of the inner housing. When a user rotates the dial sleeve to select a dose, the rotational stop member prevents the user from selecting a dose greater than a pre-defined maximum selectable dose.

Abstract: A medical device comprising an outer housing (400) having a first wall (401) defining a first passage (402) with proximal and distal ends. A retraction housing (412) is slidably received in the first passage (402), the retraction housing (412) having proximal and distal ends and a wall with an interior surface wall defining a helical path (421). Part of the device includes a carriage (422) for releasably receiving a medical sharp (423), the carriage (422) slidably received in the distal end of the retraction housing (412). A latch means (428) is present for retaining the carriage (422) in a first position in the retraction housing (412). A follower (432) is connected to the carriage (422) and engaged with the helical path (421). A stored energy device (434) is connected to the follower (432) and the carriage (422).

Abstract: A perfusion needle system for the direct simultaneous injection of a therapeutic substance fluid within a target tissue during cryothermal ablation of the tissue includes at least one cryogenic probe for insertion in the tissue, the probe having a cooling tip for selective cooling and thawing of the tissue. An injection syringe contains a fluid substance and an injection needle is fluidly communicative with the injection syringe. The injection needle includes a port at a proximal end of the needle for connecting to the injection syringe and a tubular needle body having a wall forming said tubular body, which includes an internal insulative layer, which defines a central lumen extending through the body. An injection tip devoid of the insulative layer is affixed to a distal end of the injection needle and defines at least one opening through a side the tip and is fluidly communicative with the lumen.

Abstract: The present disclosure is directed to an injector device for delivering an ophthalmic solution to a cornea of an eye. The device may include a base configured to contact part of the eye, and a needle connected to the base, wherein needle may deliver the ophthalmic solution to the cornea.

Abstract: A device for dispensing individual doses of powder from respective pockets of a disc-shaped carrier by outwardly rupturing a lidding foil by means of pressure on an opposite side surface, the device providing individual respective deaggregation flow paths for each pocket, split airstreams allowing improved entrainment of powder, a cam mechanism for outwardly rupturing the pockets, an indexing mechanism linked to the cam mechanism and a dose counter.

Abstract: A respiration system includes a patient connection (1), an inspiratory branch (3), an expiratory branch (13), a rebreathing line (99), a reservoir (25), a CO2 absorber (29), a radial compressor respiration drive (33), a fresh gas supply unit (51), an oxygen flushing device (55), connected to the rebreathing line, a pressure sensor (31) and an actuatable control valve (21), arranged in the rebreathing line between a second end (17) of the expiratory branch and the CO2 absorber. The compressor, oxygen flushing device and fresh gas supply unit are arranged in the rebreathing line between the CO2 absorber and a second end (7) of the inspiration branch. The compressor inlet points towards the CO2 absorber and the outlet points towards the second end of the inspiratory branch. The pressure sensor is arranged in the rebreathing line between the compressor and the second end of the inspiratory branch.

Abstract: A nasal mask system includes an interface (80) adapted to form an air interface with a patient's nose, and a mouth seal (10) adapted to form a seal (20) with the patient's mouth. The mouth seal (20) is communicated with the interface (80) via a one-way air path (40) that allows exhausted air from the mouth seal to pass into the interface (80) but prevents air from the interface (80) from passing into the mouth seal (10).

Abstract: A face mask (10) for a patient undergoing a sedated endoscopic procedure. The face mask (10) includes at least one of a duct or an aperture (16, 17) to provide positive airway pressure to the nose, a bite block (18) with an opening therein (20) and a one-way valve (22). The one-way valve (22) has an open position, allowing passage of an endoscopic device therethrough and into the opening (20), and a closed position substantially sealing the opening (20).

Abstract: A seal for a respiratory mask that includes a first end portion adapted to be coupled to a mask shell, a second end portion for sealing engagement with a face of a patient, and a sidewall extending between the first end portion and the second end portion. At least a portion of the second end portion includes a textured area having a predetermined pattern. The area of increased surface roughness provides the patient contacting portion of the seal with a silky feeling to maximize patient comfort and the effectiveness of the seal without impairing the sealing ability.

Abstract: Various embodiments may provide a breathing and/or anesthetic unit that is portable, compact, inexpensive, and convenient, and which may expedite medical procedures by allowing a health care provider to quickly sedate a patient. Such a unit may be ideal for minor medical procedures needing mild or moderate analgesia/sedation (e.g., <30 minutes) in various fields. Such a unit may include (i) a handheld gas supply container including a therapeutic amount of anesthetic gas; (ii) a mask; (iii) a single-use, uninterruptable flow coupler to couple the mask to the supply container; and (iv) a handheld, self-contained, recovery gas container, including a negative pressure, coupled to the mask.

Abstract: A respiratory assistance device is disclosed. There is a variable speed blower with an output, and a patient ventilation interface configured for fitment on a patient respiratory passageway. A gas passage conduit couples the output of the blower to the patient ventilation interface. A pilot line from the gas passage conduit is coupled to a piloted exhalation valve of the patient ventilation interface. A pressure sensor measures a mask pressure in the patient ventilation interface, and a blower speed sensor measures a speed of the blower. A pressure controller in communication with the pressure sensor and the blower speed sensor detects a patient inspiratory phase and a patient expiratory phase from at least one of the measured speed of the blower and a set speed of the blower. The pressure controller adjusts an operating speed of the blower and actuates the piloted exhalation valve based upon the measured mask pressure.

Abstract: An improved medicant delivery system 100 is disclosed wherein the carrier for the medicant is a fluid that can be atomized or vaporized by exposure to heat. The system provides for repeatable dose of medicant, can be stored in any orientation, and/or has an ability to maximize energy efficiency.

Abstract: A system and method for encouraging emotional behavior therapy. The method includes the steps of identifying a particular emotional behavior therapy prescription regimen to performed by a user, determining one or more procedures for administering such emotional behavior therapy prescription regimen and identifying one or more video activity sequences associated with such procedures. On a display one or more instruction prompts associated with the emotional behavior therapy administration are provided, and video activity sequences of actual administration following the one or more instruction prompts are captured by a video capture device. The captured video activity sequences are stored to a non-transitory computer readable storage medium and are compared the identified video activity sequences by a computer processor to determine differences therebetween.

Abstract: A catheter having a catheter body with a lumen and a distal lumen opening. The catheter's lumen extends through the catheter body along a longitudinal axis of the catheter body. A hole is formed through a wall of a distal portion of the catheter body. A portion of the proximal surface of the hole is inclined at an acute angle with respect to the longitudinal axis of the catheter body. The acute angle of the proximal hole surface opens proximally with respect to the catheter body.

Abstract: A method is provided for making a tubing, which includes forming a generally tubular inner layer by flowing a first material through an extrusion assembly. At least one non-tubular segment is formed along the length of the tubing by flowing a second material through the extrusion assembly. A generally tubular outer layer coaxial with the inner layer is formed by flowing a third material through the extrusion assembly. The segment is positioned between the inner and outer layers and oriented non-tangentially with an interface between the inner and outer layers. The resulting tubing, which may be suitable for medical applications, may have kink-resistant properties.