Abstract: Methods of making components for a medicinal delivery device are described, in which a base composition comprising a polysulphone is applied to the surface of a component to create a base layer, a primer composition comprising a silane having two or more reactive silane groups separated by an organic linker group is applied to the base layer to create primed surface, and a coating composition comprising an at least partially fluorinated compound is applied to the primed surface. Corresponding coated components and a medicinal delivery device are disclosed.

Abstract: Microarray applicator (10000), a method of using the same and a kit. The microarray applicator comprising a housing (2000), a microarray holder (8100) and a plunger (7000). The plunger comprising a first ridge (7310) and a second ridge (7320), both engagable to a notch (2320). Microarray applicator does not uses springs or pre-biased mechanisms to reduce costs.

Abstract: A microneedle injection and infusion apparatus, and a method of using same. The apparatus can include a housing, a microneedle array holder for holding a microneedle array, and a shuttle that holds a cartridge (e.g., that contains an active agent). The microneedle array holder can be movable between a retracted position and an extended position. The shuttle can be movable between a first position in which the cartridge is not in fluid communication with a fluid path and a second position in which the cartridge is in fluid communication with the fluid path. The apparatus can further include an actuator movable between a first position and a second position. The method can include moving the actuator to its second position to allow the shuttle to move toward its second position, wherein movement of the shuttle toward its second position allows the microneedle array holder to move to its extended position.

Abstract: Disclosed are PTHrP analogue formulations for transdermal delivery of a therapeutically effective amount of a PTHrP analogue, as well as transdermal patches prepared using these formulations, methods of preparing the disclosed formulations and patches, and methods of using these formulations and patches to treat osteoporosis, osteopenia, osteoarthritis, and/or bone fracture, improve bone mineral density (BMD), improve trabecular bone score (TBS), and treat, prevent, and/or reduce bone fractures.

Abstract: Various embodiments of a metered dose inhaler that includes a metering valve are disclosed. The inhaler includes a reservoir containing a pressurized formulation of medicament and carbon dioxide. The metering valve includes a metering chamber, a metering valve stem, and a metering valve stem seal having an opening through which the metering valve stem passes to form a dynamic seal between the metering valve stem and outside atmosphere. The metering valve stem seal has a Shore D hardness of 45 to 80 and its opening is adapted to be stretched wider by the metering valve stem passing through it than it would be absent the valve stem.

Abstract: An inhaler (60) has a breath actuated trigger mechanism (100) reactive to an inhalation flow to trigger the release of a substance to be inhaled. The inhaler (60) has an inspiration flow which is subject to a higher degree of flow governing post-triggering than pre-triggering. This allows the triggering flow rate to be closer to, or even higher than, the governing flow rate of the inhaler.

Abstract: Various embodiments of a drug delivery device and a method of using such device are disclosed. The drug delivery device includes a backing layer having a first major surface and a second major surface, and an array of patch segments defined by segment separation lines disposed in the backing layer. Each segment separation line is adapted to enhance separation of one or more patch segments from the array of patch segments. Further, a patch segment of the array of patch segments includes a polygonal shape.

Abstract: An actuator (100) for an inhaler includes a sleeve (106) having a first end (102) and a second end (104). The sleeve is substantially hollow and defines a longitudinal axis (110) along its length. A base (108) is formed at the first end of the sleeve. A mouthpiece (112) is joined to the sleeve and the base. The mouthpiece is substantially hollow and defines a delivery opening (114). The actuator includes a cover (116) removably attached to the mouthpiece for covering the delivery opening. The actuator further includes a retaining member for retaining the cover to the sleeve upon removal of the cover from the mouthpiece. The retaining member includes a ring (120) disposed around the sleeve. The ring is at least selectively rotatable about the longitudinal axis and slidable along the longitudinal axis relative to the sleeve. The retaining member further includes a strap (122) extending from the ring and attached to the cover.

Abstract: Various embodiments of an adhesive article and a method of forming such article are disclosed. The adhesive article includes an active pharmaceutical ingredient; a substrate having a first surface and a second surface including a first area and a second area; and a first adhesive layer disposed on the first area of the second surface of the substrate. The active pharmaceutical ingredient is present in the first adhesive layer at a first concentration. The adhesive article also includes a second adhesive layer having a first portion that is in contact with the first adhesive layer and a second portion that is disposed in the second area of the substrate. The active pharmaceutical ingredient is present in the second adhesive layer at a second concentration. The second concentration is less than the first concentration.

Abstract: An inhaler comprising a valve having a valve volume of no more than 40 micro liters and a valve having a first layer comprising a silane and a second layer comprising a polyfluoropolyether silane—and albuterol.

Abstract: A refill assembly configured to be removably coupled to a reusable assembly of a medicinal inhaler is disclosed and includes a patient port, a canister actuable by the reusable assembly to deliver a dose of medicament to the patient port, and a sleeve which is selectively actuable by a user independently of the reusable assembly so as to act on the canister to deliver a dose of medicament. The refill assembly further includes an override element which engages the sleeve, the override element being moveable from a first position in which the sleeve is retained in a first position by the override element and a second position in which the sleeve is permitted to move to a second position upon depression of the sleeve by a user to cause a dose of medicament to be delivered to the patient port.

Abstract: A packaging system for microarrays, such as microarrays of microneedles, comprising inner and outer pouches (500, 5000).

Abstract: Pressurized canisters coated with poly(fluoroalkylene) polymer or a copolymer of poly(fluoralkylenes) and containing a formulation comprising one or more active pharmaceutical ingredients comprising umeclidinium or a salt thereof, vilanterol or a salt thereof, or a combination of two or more of the foregoing, poly(ethylene glycol), and a propellant, inhalers comprising the pressurized canister, as well as methods of using the pressurized canisters and inhalers.

Abstract: The present disclosure provides a method of preparing a pharmaceutical composition. The method includes transferring a predetermined quantity of an excipient mixture from a second vessel to a first vessel. The excipient mixture transferred from the second vessel includes a liquid-state second quantity of a hydrofluoroalkane propellant and a first solubilized excipient comprising a low-molecular weight poly(ethylene oxide) polymer. The method further includes contacting at least one pharmaceutically-active compound with the excipient mixture under conditions that facilitate forming an intermixture comprising the propellant, the polymer, and the compound. Before transferring the excipient mixture, the first vessel contains a vapor-phase first quantity of the hydrofluoroalkane propellant and an effective amount of the at least one pharmaceutically-active compound.

Abstract: A breath-responsive metered dose inhaler having a trigger mechanism for triggering delivery of a medicament and a trigger mechanism chassis for locating the trigger mechanism within the inhaler, the trigger mechanism including a breath responsive member moveable upon inhalation of the user from a primed position in which the inhaler is prevented from delivering medicament, to a triggered position in which the medicament is delivered to the user, a spring which is flexible along its longitudinal axis, wherein the spring is configured to bias the breath responsive member from its triggered position to its primed position by flexure along its longitudinal axis.

Abstract: An applicator and method for applying a microneedle array to skin. The applicator can include a body having a first portion and a second portion defining a cavity, the second portion having a slot presented on an outside surface for insertion of the microneedle array into the cavity. The first portion and the second portion are slidable relative to one other along an axis enabling the body to be in an unprimed configuration and a primed configuration. The applicator further includes a door operable with the second portion, the door being movable from a first door position to a second door position, wherein when the device is in the unprimed configuration, the door at least partially obstructs the slot and access into the cavity. When the device is in the primed configuration, the door does not obstruct the slots and enables access into the cavity.

Abstract: A process of making a microneedle array comprising providing a microneedle array having a plurality of microneedles of a desired shape, illuminating at least a portion of said microneedle array that comprises at least one microneedle, capturing an observed image of said at least one microneedle using an optical device, electronically processing said observed image and determining at least one shape parameter for said at least one microneedle, accepting said microneedle array if said at least one shape parameter is within an acceptable range, thereby providing a microneedle array that comprises a known shape of the plurality of microneedles.

Abstract: A pressurized canister coated with poly(fluoroalkylene) polymer or a copolymer of poly(fluoralkylenes) and containing a formulation comprising one or more active pharmaceutical ingredients, PVP, and a propellant, as well as methods of using the same.

Abstract: A microarray carrier (200) for use with a microarray applicator (100) is provided. The microarray carrier (200) includes a body (202) defining a cavity (210). The microarray carrier (200) also includes a plurality of tabs (220, 222, 224, 226) disposed on the body (202) and extending into the cavity (210). Each of the plurality of tabs (220, 222, 224, 226) defines a contour line along a length thereof extending from a proximal end of the tab adjacent the body to a support surface (228, 230, 232, 234) spaced apart from the body. The support surface (228, 230, 232, 234) is inclined with respect to the contour line where the contour line intersects the support surface (228, 230, 232, 234). A projected area of each of the plurality of tabs (220, 222, 224, 226) onto a horizontal plane (HP) of the cavity (210) is greater than an area of the support surface (228, 230, 232, 234). The support surface (228, 230, 232, 234) is aligned non-perpendicular to the horizontal plane (HP).

Abstract: Film-forming gel compositions, useful in creating conformable and flexible gel bandages, can be formulate from a film-forming polymer, an amine-rich adhesion promoter, and a volatile solvent. The gel compositions form relatively thick films when dried on tissue, and can exhibit enhanced breathability to promote wound healing. In some cases, the film-forming gel composition can include lidocaine.