Abstract: Provided herein are devices, systems, and methods for the removal of preservatives/excipients/stabilizers from pharmaceutical preparations/medicaments. The devices and systems include a resin for the filtering of preservatives from pharmaceutical preparations. The methods allow for a period of time of incubation of the pharmaceutical preparation in the resin that effectively removes preservatives, while at the same time maintaining the required amount or concentration of active compound in the preparation. Also provided herein are devices, systems, and methods for the controlled release of anti-inflammatory agents in an insulin infusion set.

Abstract: A needle-bearing hub for a pen needle is provided with a distal patient-facing side having an enlarged surface for contact with the subject's skin. The enlarged surface is provided with a radius of curvature that increases the likelihood that the needle reaches full injection depth when an injection is performed at an inclined angle with respect to the surface of the skin and with to the desired depth less discomfort to the patient.

Abstract: Aspects of the present disclosure include methods of producing a cellular suspension from a tissue sample by applying resonant acoustic energy to a container comprising the tissue sample in a manner sufficient to produce a cellular suspension from the tissue sample. Resonant acoustic mixers and kits for use in producing a cellular suspension from a tissue sample are also provided.

Abstract: Aspects of the present disclosure include methods of producing a cellular suspension from a tissue sample by applying resonant acoustic energy to a container comprising the tissue sample in a manner sufficient to produce a cellular suspension from the tissue sample. Resonant acoustic mixers and kits for use in producing a cellular suspension from a tissue sample are also provided.

Abstract: A system and method is provided for an injectable substance delivery pen comprising a microneedle hub assembly removably engaged with a pen device body which includes a cartridge, a plunger, and a drive mechanism. The hub assembly includes at least one microneedle for intradermal or shallow subcutaneous injection of the contents of the cartridge. The cartridge, plunger and drive mechanism components of the pen body are fabricated of non-compliant and non-compressible materials to allow effective communication of the cartridge contents via the microneedle patient interface.

Abstract: Provided herein are devices, systems, and methods for the removal of preservatives/excipients/stabilizers from pharmaceutical preparations/medicaments. The devices and systems include a resin for the filtering of preservatives from pharmaceutical preparations. The methods allow for a period of time of incubation of the pharmaceutical preparation in the resin that effectively removes preservatives, while at the same time maintaining the required amount or concentration of active compound in the preparation. Also provided herein are devices, systems, and methods for the controlled release of anti-inflammatory agents in an insulin infusion set.

Abstract: A needle-bearing hub for a pen needle is provided with a distal patient-facing side having an enlarged surface for contact with the subject's skin. The enlarged surface is provided with a radius of curvature that increases the likelihood that the needle reaches full injection depth when an injection is performed at an inclined angle with respect to the surface of the skin and with to the desired depth less discomfort to the patient.

Abstract: A needle-bearing hub for a pen needle is provided with a distal patient-facing side having an enlarged surface for contact with the subject's skin. The enlarged surface is provided with a radius of curvature that increases the likelihood that the needle reaches full injection depth when an injection is performed at an inclined angle with respect to the surface of the skin and with to the desired depth less discomfort to the patient.

Abstract: Methods and devices for administration of substances into at least two compartments of skin for systemic absorption and improved pharmacokinetics, based on biphasic or bimodel kinetic profiling.

Abstract: Aspects of the present disclosure include methods of producing a cellular suspension from a tissue sample by applying resonant acoustic energy to a container comprising the tissue sample in a manner sufficient to produce a cellular suspension from the tissue sample. Resonant acoustic mixers and kits for use in producing a cellular suspension from a tissue sample are also provided.

Abstract: A needle-bearing hub for a pen needle is provided with a distal patient-facing side having an enlarged surface for contact with the subject's skin. The enlarged surface is provided with a radius of curvature that increases the likelihood that the needle reaches full injection depth when an injection is performed at an inclined angle with respect to the surface of the skin and with to the desired depth less discomfort to the patient.

Abstract: A medical fluid communication system is disclosed comprising a pump controller and a fluid detector. The fluid detector detects characteristics of the fluid and provides fluid measurements to the pump controller, which detects if the fluid is flowing in the medication delivery system. In the event fluid is not flowing due to an occlusion, the pump controller may attempt to resolve the occlusion or may provide a warning to a user that an occlusion is occurring.

Abstract: A device includes a plurality of skin penetrating devices for delivering or withdrawing a substance through the skin of a patient. The device has a support formed with a top and bottom end and a plurality of channels extending axially through the support. A plurality of the skin penetrating members is positioned in the channels with a tip extending from the bottom end of the support. A coupling member is attached to the support for coupling with a fluid supply and directing the fluid to the skin penetrating members. The skin penetrating members have a length of about 100 microns to about 2000 microns and are about 30 to 50 gauge.

Abstract: A medical fluid communication system is disclosed comprising a pump controller and a fluid detector. The fluid detector detects characteristics of the fluid and provides fluid measurements to the pump controller, which detects if the fluid is flowing in the medication delivery system. In the event fluid is not flowing due to an occlusion, the pump controller may attempt to resolve the occlusion or may provide a warning to a user that an occlusion is occurring.

Abstract: Methods for ID delivery of drugs and other substances to humans or animals are provided. The methods employ small gauge needles, especially microneedles, placed in the intradermal space to deliver the substance to the intradermal space as a bolus or by infusion. It has been discovered that the placement of the needle outlet within the skin and the exposed height of the needle outlet are critical for efficacious delivery of active substances via small gauge needles to prevent leakage of the substance out of the skin and to improve absorption within the intradermal space. Delivery devices which place the needle outlet at an appropriate depth in the intradermal space and control the volume and rate of fluid delivery to provide accurate delivery of the substance to the desired location without leakage are also provided herein.

Abstract: A medical fluid communication system is disclosed comprising a pump controller and a fluid detector. The fluid detector detects characteristics of the fluid and provides fluid measurements to the pump controller, which detects if the fluid is flowing in the medication delivery system. In the event fluid is not flowing due to an occlusion, the pump controller may attempt to resolve the occlusion or may provide a warning to a user that an occlusion is occurring.

Abstract: A device includes a plurality of skin penetrating devices for delivering or withdrawing a substance through the skin of a patient. The device has a support formed with a top and bottom end and a plurality of channels extending axially through the support. A plurality of the skin penetrating members is positioned in the channels with a tip extending from the bottom end of the support. A coupling member is attached to the support for coupling with a fluid supply and directing the fluid to the skin penetrating members. The skin penetrating members have a length of about 100 microns to about 2000 microns and are about 30 to 50 gauge.

Abstract: The present invention provides improved methods for ID delivery of drugs and other substances to humans or animals. The methods employ small gauge needles, especially microneedles, placed in the intradermal space to deliver the substance to the intradermal space as a bolus or by infusion. It has been discovered that the placement of the needle outlet within the skin and the exposed height of the needle outlet are critical for efficacious delivery of active substances via small gauge needles to prevent leakage of the substance out of the skin and to improve absorption within the intradermal space. The pharmacokinetics of hormone drugs delivered according to the methods of the invention have been found to be very similar to the pharmacokinetics of conventional SC delivery, indicating that ID administration according to the methods of the invention is likely to produce a similar clinical result (i.e., similar efficacy) with the advantage of reduction or elimination of pain for the patient.

Abstract: Methods and devices for administration of substances into at least two compartments of skin for systemic absorption and improved pharmacokinetics, based on biphasic or bimodel kinetic profiling.

Abstract: A method for directly delivering whereby a substance is introduced into an intradermal space within mammalian skin which involves administering the substance through at least one small gauge hollow needle having an outlet with an exposed height between 0 and 1 mm. The outlet is inserted into the skin to a depth of between 0.3 mm and 2 mm such that the delivery of the substance occurs at a depth between 0.3 mm and 2 mm.