Abstract: Oral dosage forms that contain hydrogel-forming polymers useful for achieving sustained release of API. The formulations disclosed herein may include a hydrogel-forming polymer and a water-insoluble hydrophilic polymer, which acts as a wicking agent to draw water into the formulation. Through that wicking, water combines with the hydrogel-forming polymer to form a hydrogel, thus permitting efficient and sustained release of the API from the hydrogel-forming polymer which may act as a matrix for the API. The formulations disclosed herein are particularly useful for sustained-release of a relatively water-insoluble API, such as tamsulosin, budesonide, and pharmaceutically acceptable salts thereof.

Abstract: A method allows for rapid manufacture of relatively thick adhesive coatings using a continuous process, where a single thin coating is continuously converted into a single thicker adhesive laminate. An exemplary process includes the steps of: (1) producing a web having a first surface with an adhesive layer and a second surface with a release liner; (2) slitting the web longitudinally into a first section and a second section; (3) laminating a backing film to the adhesive layer of the first section; (4) removing the release liner of the laminate of step (3) exposing the adhesive layer of the first section; and (5) laminating the second section to the laminate of step (4), wherein the adhesive layer of the laminate of step (4) is combined with the adhesive layer of the second section.

Abstract: Features for assessing patient compliance with therapeutic usage of an inhaler, such as a nebulizer, are disclosed. Nebulizer therapy accessories include mouthpiece, mask and adaptor (i.e. an attachment to a mouthpiece or mask) that may be coupled with the nebulizer. The nebulizer therapy accessory includes at least one sensor that detects a physical parameter generated by a user's body and generates a signal. The signal is used to determine therapy compliance, which may be communicated to the patient and/or the patient's physician.

Abstract: Method for preparing granules of rivaroxaban together with pharmaceutically acceptable excipients using high-shear mixing. The granules produced by the methods disclosed herein may be incorporated into dosage forms for oral administration having enhanced oral bioavailability of rivaroxaban.

Abstract: An inventory control system includes an inventory control hub and a medicament container in communication with the inventory control hub and configured to exchange medicament information with the inventory control hub, the medicament container including a body defining a container cavity; a plurality of medicament receptacles, each medicament receptacle configured to accommodate removable storage of an unused auto-injector within the medicament receptacle and prevent storage of a used auto-injector within the medicament receptacle; and a presence sensor for each medicament receptacle, each presence sensor configured to detect a presence or absence of the unused auto-injector from the corresponding medicament receptacle.

Abstract: Sugar alcohol-free formulations of fingolimod. Compositions of fingolimod, salts thereof, or esters thereof that lack sugar alcohols are disclosed. The composition may include a water-soluble filler and a water-insoluble filler, in addition to other common excipients. In some examples, the water-soluble filler is glycine and the water-insoluble filler is dibasic calcium phosphate dihydrate as fillers. In some examples, the water-soluble filler and water-insoluble filler are present in equal concentrations. The compositions disclosed here may be used to make immediate release dosage forms containing fingolimod hydrochloride.

Abstract: Medication packaging includes a body defining a cavity for disposal of medication. A closure member is disposed with the body. The closure member includes an advancement mechanism and a window that displays indicia of a medication dosage regimen. The closure member is rotatable between a medication accessible configuration and a closed configuration that includes a sealing position and an advance position to incrementally advance the indicia. Systems and methods of use are disclosed.

Abstract: The invention relates to the field of medicine. The invention provides methods for generating glatiramer-acetate-specific human T-cell lines, and assays that use these T-cell lines for demonstrating immunological identity between glatiramer acetate preparations. These assays allow sensitive and accurate comparison of glatiramer acetate preparations, and find utility as lot-release assays.

Abstract: The hand-held device detects the distance between a muscle and an outer skin layer in a body by impacting the outer surface of the skin and detecting the distance to the muscle from that point of engagement. The device includes a first end including a force sensor configured to detect the force of an impact of the first end to an associated body part. The device further includes a distance sensor provided at the first end configured to detect the distance between a skin outer layer and a muscle; and a main body configured to receive a hand. The detection device includes a controller and processor to detect the impact force and distance between the skin outer layer and muscle at engagement. The device may be used in a method of determining muscle depth and/or location in connection with the prescription and/or administration of anaphylaxis medications by auto injector.

Abstract: Various fenofibrate dosage forms contain a plurality of beads or particles, where the beads or particles include a pharmaceutical composition comprising fenofibrate; from 0.3% to 10% by weight of the beads or particles of a surfactant; and from about 5% to about 15% by weight of the beads or particles of a water soluble or water dispersible cellulosic binder. The mass ratio of the drug to the binder in the dosage form is between about 3.5:1 and 4.5:1; and the dosage form produces a first Cmax in vivo that is between about 10% and about 50% higher than a comparative Cmax produced by a comparative dosage form. The comparative dosage form comprises the drug and the binder in a ratio of between about 5:1 and 15:1. The dosage form may contain a plurality of beads or particles, each of the beads or particles including a pharmaceutical composition containing from about 20% to about 55% by weight of fenofibrate; from 0.

Abstract: A medication delivery system includes a medical server configured to send and receive and process data, a medication device configured to administer a preselected medication, a sensor circuit configured to detect selected parameters relating to medication delivery and transmit information, a transmission hub configured to communicate with the medical server and the sensor circuit. The transmission hub is configured to receive a signal from the sensor circuit and exchange the information. An application is configured to facilitate exchange of information between the sensor circuit and the medical server. The application has a preselected set of protocols. The application monitors usage of the medication device and location of the medication device by connecting to the medication device via the transmission hub.

Abstract: A double disk dermal device for administration of one or more active agents to the skin or mucosa of a host, in particular a patch is described including: a) active reservoir film layer; b) a backing overlay adjacent to the active reservoir film layer extending beyond the perimeter of the reservoir layer in all directions; c) second overlay backing layer with a coating of pressure sensitive adhesive which is adjacent to the first backing overlay extending beyond the perimeter of the first backing overlay in all directions; and d) a removable release liner. A method of making the device is also provided.

Abstract: Various exemplary embodiments relate to a method, device, and storage medium including one or more of the following: receiving location information and expiration information; determining a current location of the mobile device; determining that the medicament device is within a predetermined distance from the mobile device; determining that the medicament device is currently associated with an expiration event; outputting an expiration alarm indicating the expiration event in response to determining that the medicament device is within a predetermined distance from the mobile device and that the medicament device is currently associated with an expiration event; receiving, from the user, a request to display a map of a geographic area; displaying, by the mobile device and via a non-operating system application, the map of the geographic area; and displaying an alert icon on the map, wherein the location of the icon on the map is based on the received location information.

Abstract: A method allows for rapid manufacture of relatively thick adhesive coatings using a continuous process, where a single thin coating is continuously converted into a single thicker adhesive laminate. An exemplary process includes the steps of: (1) producing a web having a first surface with an adhesive layer and a second surface with a release liner; (2) slitting the web longitudinally into a first section and a second section; (3) laminating a backing film to the adhesive layer of the first section; (4) removing the release liner of the laminate of step (3) exposing the adhesive layer of the first section; and (5) laminating the second section to the laminate of step (4), wherein the adhesive layer of the laminate of step (4) is combined with the adhesive layer of the second section.

Abstract: A medication delivery system includes a medical server configured to send and receive and process data, a medication device configured to administer a preselected medication, a sensor circuit configured to detect selected parameters relating to medication delivery and transmit information, a transmission hub configured to communicate with the medical server and the sensor circuit. The transmission hub is configured to receive a signal from the sensor circuit and exchange the information. An application is configured to facilitate exchange of information between the sensor circuit and the medical server. The application has a preselected set of protocols. The application monitors usage of the medication device and location of the medication device by connecting to the medication device via the transmission hub.

Abstract: Various embodiments are described for a container for storage of a medicament, the container comprising a surface having at least a cavity configured to store at least one dose of the medicament; and a covering disposed over at least the cavity of the surface and comprising at least two adjacent edges and a set of perforations disposed on the covering and spaced apart from the at least two adjacent edges of the covering. A container comprising a sheet of separable units and methods for use are described.

Abstract: Various exemplary embodiments relate to a medicament storage case including: a case body securable to a wall; a door connected to the body; a sleeve to contain an epinephrine injector; a medicament lock including a hook, wherein the hook is positioned to engage the sleeve when in a first position and is positioned to disengage the sleeve when in a second position; an actuator including a solenoid, wherein the solenoid, upon activation, moves the hook from the first position to the second position; a microphone configured to receive first audio as input; a speaker configured to output second audio; a communication unit configured to provide Internet connectivity; a button; and a processor configured to: in response to pressing the button: establish communication between the local user and a remote site, receive an unlock message, and in response to receiving the unlock message, activate the solenoid to release of the sleeve.

Abstract: This disclosure relates to a transdermal therapeutic system (TTS) containing pramipexole or related compounds and methods of making the system as well as its use in administering such compounds as a single dose over an extended period, for example, one week. The system comprises an acrylic-based or silicone-based matrix layer containing pramipexole at concentrations of at least about 5 wt. % of the matrix, which is resistant to crystallizing and discoloration of the active ingredient even when stored over long periods.

Abstract: Disclosed herein are stable pharmaceutical dosage forms containing carbidopa, levodopa, and entacapone. The dosage forms are prepared by mixing carbidopa, levodopa, and entacapone and forming granules. In some embodiments the granules also include starch. Microcrystalline cellulose can be added as an extragranular excipient. The stable pharmaceutical dosage forms have a bioavailability that is substantially similar to a dosage form prepared by adding a substantial portion of carbidopa separately from levodopa and entacapone.

Abstract: Various exemplary embodiments relate to a method, device, and non-transitory machine-readable storage medium encoded with instructions for execution by a user device, the medium comprising: instructions for displaying an indication of an incoming request to establish a communication session with a patient operating a medication dispenser; instructions for establishing a two-way communication session with the patient via the medication dispenser based on a physician user of the user device approving the incoming request; instructions for displaying a dispense user interface (UI) element during the two-way communication session; instructions for receiving a selection of the dispense UI element from the physician user; and instructions for transmitting, based on the selection, a command for the medication dispenser to dispense a medication to the patient.