Methods, devices, and kits for microjet drug delivery

#The methods, devices, and kits described herein are in the field of needleless drug delivery. More particularly, the methods, devices, and kits described herein are in the field of microjet drug delivery across a skin surface.

#In an effort to minimize the fear, risk, and pain associated with needle injections, several types of needleless methods of drug delivery have been developed. These methods focus on delivering drug through the skin in a variety of different ways (e.g., passive or active diffusion utilizing patches, thermoporation, ultrasound or other energy sources, etc.). However, not all of these methods are effective for delivering all types of drug across and/or through the skin, given its significant and protective barrier function. To be sure, penetrating the skin barrier has proven challenging at times because of its low permeability to foreign molecules, especially large molecules. The main barrier to entry of these molecules is the outermost layer of skin, or the stratum corneum, which consists of densely packed keratinocytes (flat dead cells filled with keratin fibers) surrounded by lipid bilayers, which are highly ordered.

#To overcome the barrier function of skin, the present Applicants have developed several microjet injectors that are capable of delivering drugs across the skin surface in a non-invasive fashion, see, e.g., U.S. patent application Ser. Nos. 10/829,888 and 11/367,202 each of which are incorporated herein by reference in their entirety. Other microjet devices have also been described.

#FIG. 1A provides an illustrative variation of a modular drug delivery device described herein.

#FIG. 1B shows an illustrative variation of a second module used with the modular drug delivery devices described herein.

#FIG. 1C shows an illustrative variation of a first module used with the modular drug delivery devices described herein.

#I. Devices

#In general, the devices described here are needleless microjet drug delivery devices. That is, they are configured to be worn on the skin of a user and to deliver an amount of drug through the skin by way of a high-speed microjet. Accordingly, the devices described here typically comprise a reservoir for housing a drug (e.g., in liquid form), a dispensing mechanism, to dispense the drug via a nozzle, and an actuator, which when actuated, causes the dispensing mechanism to dispense the drug.

#The devices may be configured for any type of attachment to the skin, and in some instances it may be desirable that the device be configured for relatively inconspicuous wear. For example, the devices described here may be configured as a patch for attachment to the skin, a watch, an armband, or the like. In some variations, which will be described in detail below, the devices described here are configured for use in a patch-like fashion. The devices may further comprise a user interface button or switch to allow for partial or total user operation and control. Similarly, the devices may further comprise one or more displays (e.g., to display device or dosing information or the like), one or more alarms (e.g., audible, tactile, vibratory, or the like, to warn the user of a potential problem), one or more LEDs (e.g., which may illuminate under various circumstances to provide some sort of system indication), or the like. Each of these components will be discussed in more detail below. The devices may also comprise two electrodes to measure capacitance of the skin, in order to help ensure proper contact of the device with the skin.