Abstract: A surface modifying coating for an article that includes a first component having a surface in frictional engagement with a surface of a second component. At least a portion of a surface of one of the components is coated with a coating including a mixture of at least two silicones: (i) a hydrolyzable organopolysiloxane with a viscosity of less than or equal to 1,000 centistokes and that is capable of crosslinking reaction upon exposure to moisture at ambient temperature; and (ii) a second organopolysiloxane copolymerizable with the first hydrolyzable organopolysiloxane and having viscosity of greater than or equal to 5,000 centistoke; wherein the coating provides a maximum break loose force equal to or less than three times a kinetic extrusion force such that stiction is reduced between engaged surfaces.

Abstract: The present disclosure provides an improved process for the synthesis of suganmmadex acid and suganmmadex sodium.

Abstract: A safety vial system has a vial adapter subsystem irreversibly mountable to the top of a vial containing a hazardous medicament and a vial base subsystem sealingly engaging a lower portion of the vial adapter subsystem and telescopically movable therein from a first position providing a path for gas sterilization around the vial to a second position wherein the path is closed to form a sterilized expandable, neutral pressure bellows chamber around and below the vial. The device has a removable top cap, a pierceable barrier film, a normally closed needleless valve in fluid communication with a dual lumen spike initially disposed above the film and a frangible product integrity ring holding the activation housing in place for sealed telescopic movement on a main body that surrounds the vial.

Abstract: A composition having clevidipine as an active ingredient is described. The composition includes clevidipine as an active ingredient and an amount of the impurity H168/79 that is no greater than about 1.5%, or where the ratio between clevidipine and H168/79 is equal or above 60 to 1.

Abstract: The presently disclosed subject matter relates to methods of administering an effective amount of dexmedetomidine to a pediatric patient in order to reduce the incidence of neurological damage. More particularly, the presently disclosed subject matter relates to methods of providing sedation or analgesia to a pediatric patient by administering a dexmedetomidine infusion and optionally a loading dose. The dexmedetomidine can be administered before, during, or after surgery.

Abstract: A packaged iron sucrose formulation including a container with an interior glass surface that is coated with layer of material containing silicon, such as a silicone polymer or silicon dioxide. The iron sucrose formulation is packaged inside the glass vessel and in contact with the layer of material containing silicon. The packaged formulation can be stored for extended periods without glass delamination.

Abstract: Methods and systems for a cartridge assembly for use with an injection system are provided. An example cartridge assembly may include an ampule containing a pharmaceutical product that is sealed at a distal end with a pierceable diaphragm. The cartridge assembly may also include a hub comprising a proximal portion defining a cavity that is configured to engage the distal end of the ampule and a piercing member positioned within the cavity. The piercing member may include a fluid pathway between a proximal end portion comprising an opening and a distal end in fluid communication with a distal opening of the hub. The proximal end portion may engage the pierceable diaphragm, and the piercing member may apply a force to the pierceable diaphragm in the inactivated position without penetrating the pierceable diaphragm.

Abstract: A safety vial system has a vial adapter subsystem irreversibly mountable to the top of a vial containing a hazardous medicament and a vial base subsystem sealingly engaging a lower portion of the vial adapter subsystem and telescopically movable therein from a first position providing a path for gas sterilization around the vial to a second position wherein the path is closed to form a sterilized expandable, neutral pressure bellows chamber around and below the vial. The device has a removable top cap, a pierceable barrier film, a normally closed needleless valve in fluid communication with a dual lumen spike initially disposed above the film and a frangible product integrity ring holding the activation housing in place for sealed telescopic movement on a main body that surrounds the vial.

Abstract: The presently disclosed subject matter relates to methods of administering an effective amount of dexmedetomidine to a pediatric patient in order to reduce the incidence of neurological damage. More particularly, the presently disclosed subject matter relates to methods of providing sedation or analgesia to a pediatric patient by administering a dexmedetomidine infusion and optionally a loading dose. The dexmedetomidine can be administered before, during, or after surgery.

Abstract: Methods and systems for an injection system are provided. An example injection system includes a container for a pharmaceutical that is sealed at a proximal end with a plunger having a pushing surface for engaging an inner surface of the hollow body. A plunger rod extends axially from the proximal end of the container and is covered with a plunger rod cover. Removal of the cover activates the system and allows for delivery of the pharmaceutical product from the container by advancing the plunger within the container towards the seal.

Abstract: The presently disclosed subject matter relates to pharmaceutical compositions comprising dexmedetomidine or a pharmaceutically acceptable salt thereof wherein the composition is formulated as a liquid for parenteral administration to a subject, and wherein the composition is disposed within a sealed container as a premixture. The pharmaceutical compositions can be used, for example, in perioperative care of a patient or for sedation.

Abstract: The presently disclosed subject matter relates to pharmaceutical compositions comprising dexmedetomidine or a pharmaceutically acceptable salt thereof wherein the composition is formulated as a liquid for parenteral administration to a subject, and wherein the composition is disposed within a sealed container as a premixture. The pharmaceutical compositions can be used, for example, in perioperative care of a patient or for sedation.

Abstract: Methods and systems for an injection system are provided. An example injection system includes a container for a pharmaceutical that is sealed at a proximal end with a plunger having a pushing surface for engaging an inner surface of the hollow body. A plunger rod extends axially from the proximal end of the container and is covered with a plunger rod cover. Removal of the cover activates the system and allows for delivery of the pharmaceutical product from the container by advancing the plunger within the container towards the seal.

Abstract: The presently disclosed subject matter relates to pharmaceutical compositions comprising dexmedetomidine or a pharmaceutically acceptable salt thereof wherein the composition is formulated as a liquid for parenteral administration to a subject, and wherein the composition is disposed within a sealed container as a premixture. The pharmaceutical compositions can be used, for example, in perioperative care of a patient or for sedation.

Abstract: Methods and systems for a cartridge assembly for use with an injection system are provided. An example cartridge assembly may include an ampule containing a pharmaceutical product that is sealed at a distal end with a pierceable diaphragm. The cartridge assembly may also include a hub comprising a proximal portion defining a cavity that is configured to engage the distal end of the ampule and a piercing member positioned within the cavity. The piercing member may include a fluid pathway between a proximal end portion comprising an opening and a distal end in fluid communication with a distal opening of the hub. The proximal end portion may engage the pierceable diaphragm, and the piercing member may apply a force to the pierceable diaphragm in the inactivated position without penetrating the pierceable diaphragm.

Abstract: A method and formulation for preparing spray dried vancomycin. In various embodiment, the formulation includes vancomycin HCl (10-20%) and one or more of the following PEG (0-5%), mannitol (0-5%), ethanol (0-10%), and a citrate buffer. Spray dried vancomycin has favorable reconstitution times and water content.

Abstract: The presently disclosed subject matter relates to pharmaceutical compositions comprising dexmedetomidine or a pharmaceutically acceptable salt thereof wherein the composition is formulated as a liquid for parenteral administration to a subject, and wherein the composition is disposed within a sealed container as a premixture. The pharmaceutical compositions can be used, for example, in perioperative care of a patient or for sedation.

Abstract: The presently disclosed subject matter relates to pharmaceutical compositions comprising dexmedetomidine or a pharmaceutically acceptable salt thereof wherein the composition is formulated as a liquid for parenteral administration to a subject, and wherein the composition is disposed within a sealed container as a premixture. The pharmaceutical compositions can be used, for example, in perioperative care of a patient or for sedation.

Abstract: A system and method for intermixing the contents of two containers. The system includes a first container, a second container, and a connector for providing fluid communication between the first and second containers. The connector includes at least one resilient retention member for securing the first container to the connector. In addition, the connector accommodates standard vials containing, for example, medicaments, and prevents the unwanted discharge of the contents of the vial into the environment.

Abstract: A system and method for providing updates to medical devices is disclosed. In one example, the medical devices are configured to pull update files in response to the reception of an update message from a server. Once the update files are downloaded by a medical device, the update files can be installed. While the medical device pulls the update files, the medical device can continue with its normal operation. If desired, a user can select which medical devices should be updated, based on any desired factors, such as the physical location of the device, the model of the device, the type of device, and the way the device is being used.