A cryo formulation-based microneedle device for ocular delivery of bioactive therapeutic agents. The microneedle device includes: one or more microneedle patches each including an array of miniaturized needles, wherein each miniaturized needle defining a base end and a tip; and a substrate to which the base end of the array of miniaturized needles is attached or integrated thereto; wherein the microneedle patch is in a cryo status; wherein each of the one or more microneedle patch is adapted to be applied on cornea of an eye, in which the miniaturized needles penetrates into the eye; and wherein the miniaturized needles is further arranged to melt so as to release one or more bioactive therapeutic agents into the eye to achieve a targeted therapeutic effect.

A cryo formulation-based microneedle device for transdermal delivery of bioactive therapeutic agents. The microneedle device includes: one or more microneedle patches each including an array of miniaturized needles, wherein each miniaturized needle defining a base end and a tip; and a substrate to which the base end of the array of miniaturized needles is attached or integrated thereto; wherein the microneedle patch is in a cryo status; wherein each of the one or more microneedle patch is adapted to be applied on a skin surface, in which the miniaturized needles penetrates into skin; wherein the miniaturized needles is further arranged to melt so as to release one or more bioactive therapeutic agents into the skin to achieve a targeted therapeutic effect; and wherein the bioactive therapeutic agents includes protein and/or antigens.

A fluid delivery manifold system assembled and configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient. The delivery assembly generally includes a modular manifold design consisting of separately constructed components cooperatively arranged and coupled to one another. The modular manifold construction allows for rapid manufacturing reconfigurations of one or more components with minimal costs to create new delivery manifold configurations that meet specific needs (i.e., different modes of delivery depending on agent to be delivered, such as subcutaneous, intramuscular, intradermal, intravenous injection, spray, or droplet delivery).

Disclosed are applicators and methods injecting of a liquid anesthetic into a dental patient with no or minimal pain. In accordance with one embodiment the applicator is for intraligamentary injection and includes an elongated, thin member having an open distal free formed of a resilient and somewhat conformable material suitable for producing a substantially fluid-tight interface with the anatomic structures at the gingival sulcus to inject the anesthetic therein. In another embodiment the applicator includes a flexible skirt surrounding a sharpened cannula, with the cannula being movable with respect to the skirt. The skirt is arranged to receive the anesthetic to anesthetize the gum, whereupon the cannula can then pierce the gum to inject the anesthetic into the underlying anatomic structure.

Disclosed herein are methods for overfilling primary packaging components, and drug products prepared according to those methods. The methods may include introducing a volume of a formulated drug substance into a primary packaging component having a nominal volume, where the volume of the formulated drug substance is greater than the nominal volume of the primary packaging component. In some cases, the primary packaging component may be a prefillable syringe.

Described herein is a drug product delivery device and method of delivering a drug on a swab. The drug product delivery device may include an applicator platform housed within a rigid housing. The applicator platform may be in the form of a plunger. The foil drug reservoir cap creates a fluid storage chamber disposed between the foil drug reservoir cap and the plunger. A series of fluidic channels carry fluid from the fluid storage chamber to an applicator. A frangible seal is attached to the plunger between the fluid storage chamber and the applicator. The frangible seal blocks a fluid from moving from the fluid storage chamber into the series of fluidic channels. Actuation of the plunger causes the frangible seal to be ruptured, which causes the fluid to exit the fluid storage chamber and enter into the fluidic channels. The fluidic channels carry the fluid to the applicator.

Provided is a microneedle patch comprising a substrate part and multiple needle parts protruding from the substrate part. The substrate part consists of a diffusion-proof layer and a base, and each needle part consists of a needle tip, a diffusion-proof layer and a base. The diffusion-proof layer of each needle part is formed between the needle tip and the base of the corresponding needle part. The diffusion-proof layer of the substrate part and the diffusion-proof layer of needle part are one-piece structures, and so are the base of the substrate part and the base of the needle part. The diffusion-proof layer of the microneedle patch can prevent the active ingredients from diffusing to the base, limit the active ingredients to the needle tip and control the carrying quantity thereof.

A fluid sampling device and a method is provided for collecting body fluid samples such as blood without the intervention of medically trained personnel. The body fluid sampling device having a sample containment chamber made of a material having a thermal inertia permitting the maintenance of sample temperature over a known period of time. Optionally an isolating cover or sleeve may slide in place by a mechanism triggered by thermal contraction of an element after the device has reached a sufficiently low temperature in a patients refrigerator. Associated methods are provided to ensure hermetic transport of the collected body fluid sample to an analysis lab. Also disclosed is a device and app combination for drug or vaccine injection, the app including means to allow for verification of the patient's ID and/or the particular device used. The device my be equipped with geo-localization and long-range communication capabilities.

Systems and methods are provided for aerosolizing and delivering therapeutic substances in an electronic aerosol delivery device with airflow regulation. Calibrated airflow resistance settings enable adjustment and control of flow velocity and or flow volume of air, aerosolized air, and or entrained aerosol particles, through the device, for optimal aerosol delivery among diverse conditions and applications.

A method of assembling a nozzle assembly is disclosed. The method includes: providing a nozzle member having a central passage defined by at least an inner side surface and an inner distal surface; inserting a fluid atomizer into the central passage of the nozzle member; and, with a distal surface of the fluid atomizer arranged adjacent the inner distal surface of the nozzle member, flexing legs of the fluid atomizer in a radially-outward direction for engaging each leg of the legs with the inner side surface of the nozzle member. A fluid atomizer is also disclosed. A nozzle assembly is also disclosed. A method of utilizing a nozzle assembly is also disclosed.