Abstract: The present invention is directed to a process for manufacturing a transdermal delivery device comprising a backing layer, a release liner, and an adhesive layer between the backing layer and release liner. More specifically, the invention is directed to a process of preparing an adhesive layer, wherein the adhesive layer is comprised of polyisobutylene and an active pharmaceutical ingredient.

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: A medication reminder system comprises a controller device operable to transmit and receive data representing a dosage regimen for the medication for use with a medication indicia. The medication indicia is configured to contact a container having the medication disposed within the container. The medication indicia includes a transmitter operable to send data to the controller device to provide or generate input data representing confirmation of adherence to the dosage regimen to the controller device, wherein the controller device is operable to display an indicator representing the dosage regimen or a parameter associated with the dosage regimen. Additional systems, a computer readable storage medium and methods are disclosed.

Abstract: Extended-release formulations can be prepared that comprise a core and an optional coating layer formed over the core. The core comprises a therapeutically effective amount an active pharmaceutical ingredient (API), a non-swelling matrix forming agent comprising a water-soluble agent and a water-insoluble polymer; one or more extended-release agents; an optional, wicking agent; and one or more optional excipients. Such formulations may be useful for preparing extended-release formulations of pregabalin that are suitable for once-daily dosing for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN).

Abstract: A medicament dispensing container comprises a first wall and a second wall defining a cavity therebetween. At least one member is connected to at least one of the walls and is disposable in the cavity. The at least one member defines at least one dose receptacle configured for disposal of at least one dose of at least one medication. The at least one member includes indicia relating to a medication regimen comprising the at least one medication. The walls are movable between a medication accessible configuration and a tamper resistant configuration. Systems and methods of use are disclosed.

Abstract: The present invention is directed to a process for manufacturing a transdermal delivery device comprising a backing layer, a release liner, and an adhesive layer between the backing layer and release liner. More specifically, the invention is directed to a process of preparing an adhesive layer, wherein the adhesive layer is comprised of polyisobutylene and an active pharmaceutical ingredient.

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: 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 present invention is directed to a process for manufacturing a transdermal delivery device comprising a backing layer, a release liner, and an adhesive layer between the backing layer and release liner. More specifically, the invention is directed to a process of preparing an adhesive layer, wherein the adhesive layer is comprised of polyisobutylene and an active pharmaceutical ingredient.

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: 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: Various exemplary embodiments relate to a method of using an emergency medicament device. The method includes reading an ID tag from the medicament device using a mobile device; automatically requesting instructions for using the medicament device based on the ID tag; and displaying a video to a user of the mobile device, the video providing instructions for using the medicament device in accordance with approved labeling of the medicament device. Various exemplary embodiments relate to an electronic medicament device including: a reservoir configured to store an amount of medication for treating anaphylaxis; an administration component for administering the medication to a patient; a processor communicatively connected to a memory storing medicament device information; and an identification tag configured to be read by another device, the identification tag providing the medicament device information including identification of instructions for using the medicament device.

Abstract: Various exemplary embodiments relate to an electronic device for dispensing a medicament. The electronic device may include a medicament storage case or an electronic medicament device. The medicament storage case includes: a door moveable between an open position and a closed position; a lock moveable between a locked position where the lock maintains the door in the closed position and an unlocked position where the lock allows the door to move to the open position; a medicament dispensing device containing medication; an input device located on an external surface of the storage case activatable by a user; a communication unit configured to initiate a two-way communication between the user and a remote access control center upon activation of the input device and configured to receive an access signal from the remote access control center; and an actuator responsive to the access signal to move the lock to the open position upon receipt of the communication from the remote access control center.

Abstract: The invention describes assays for determining the potency of a test lot of glatiramer acetate (GA) by quantitating and comparing the levels of mRNA response biomarkers produced in mouse T-cells in response to stimulation with the test lot or a reference standard lot of GA, wherein the T-cells are obtained from mice immunized with the test lot or the reference standard lot of GA. Methods for identifying mRNA response biomarkers useful in the assays of the invention also are described.

Abstract: Medication packaging includes a housing. A medication container is attached with the housing by a tether. The medication container is engageable with the housing between a child resistant configuration and a medication accessible configuration. Systems and methods of use are disclosed.

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.