Patent Application
20220241526
The disclosure is directed to inhalation drug delivery systems and in particular to controlling plume characteristics of fluid jet drug delivery systems for inhalation applications.
Nasal spray devices have become important methods for delivering drugs to patients. Such nasal spray devices are more convenient to use than the administration of drugs through IV or injection. Nasal spray devices also provide higher bioavailability of drugs compared to oral administration of drugs. The absorption of drugs through nasal spray devices is more rapid compared to the absorption of drugs administered orally since drugs delivered by nasal spray devices directly enter the blood stream making their effect more immediate.
It is believed that smaller, lower velocity fluid droplets are best for deposition of drugs in the nasal cavity. Fluid droplets with high inertia will tend to move in a straight line and land at the point only where they are aimed. Fluid droplets with low inertia will be affected by air resistance and air currents and are more likely to float throughout the nasal cavity for more even drug delivery coverage.
Another aspect of nasal delivery of drugs that may increase deposition coverage is the plume angle of the fluid droplets. A wider plume angle is believed to provide greater mist formation and thus better coverage of drug delivery in the nasal cavity. Conventional methods for delivering drugs via the nasal cavity include medicine droppers, multi-spray bottles with spray tips, single-dose syringes with spray tips, and dry powder systems. Accordingly, conventional drug delivery devices are typically designed to deliver a specific drug to a nasal cavity and each device cannot be adapted for delivering a wide range of drugs via a nasal cavity route. Many of the conventional methods for nasal drug delivery rely on pressurized containers to inject a mist of fluid into the nasal cavity. Accordingly, the drug delivery devices are typically designed for a specific drug and cannot be adapted to administer a different drug.
Despite the availability of a variety of devices for delivering drugs via a nasal cavity route, there remains a need for a single nasal drug delivery device that can be tuned to deliver a variety of drugs over a range of velocities, fluid ejection times, and plume angles.
In view of the foregoing an embodiments of the disclosure provide a pharmaceutical drug delivery device and method of using the pharmaceutical drug delivery device.
In one embodiment, the pharmaceutical drug delivery device includes a cartridge body; a fluid outlet nozzle attached to the cartridge body; a fluid jet ejection cartridge containing a liquid pharmaceutical drug disposed in the cartridge body. A fluid ejection head is attached to the fluid jet ejection cartridge and the fluid ejection head is in fluid flow communication with the fluid outlet nozzle. A processor is disposed on a logic board or on the fluid ejection head for executing a control algorithm to control the ejection head to modify plume characteristics of fluid ejected from the ejection head by controlling one or more of an operating parameter selected from (a) a number of fluid ejectors fired per ejection burst, (b) a position of fluid ejectors fired per ejection burst, and (c) both (a) and (b).
In another embodiment, there is provided a method of controlling a fluid plume from a fluid ejection device for delivery of pharmaceutical drugs. The method includes providing a cartridge body for the fluid ejection device, a fluid outlet nozzle attached to the cartridge body and a fluid jet ejection cartridge containing a pharmaceutical drug disposed in the cartridge body. A fluid ejection head is attached to the fluid jet ejection cartridge and the fluid ejection head is in fluid flow communication with the fluid outlet nozzle. A processor is provided in electrical communication with the fluid ejection head. The processor is configured to execute a control algorithm to select one or more operating parameters selected from (a) a number of fluid ejectors fired per ejection burst, (b) a position of fluid ejectors fired per ejection burst, and (c) both (a) and (b) in order to modify fluid plume characteristics of fluid ejected from the ejection head through the fluid jet nozzles. The fluid ejection device is activated to deliver the pharmaceutical drug to a patient.
In another embodiment, there is provided a method for nasal cavity injection of pharmaceutical drugs. The method includes providing a fluid ejection device containing a cartridge body, a fluid outlet nozzle attached to the cartridge body and a fluid jet ejection cartridge containing a pharmaceutical drug disposed in the cartridge body. A fluid ejection head is attached to the fluid jet ejection cartridge and the fluid ejection head is in fluid flow communication with the fluid outlet nozzle. A processor is provided in electrical communication with the fluid ejection head. The processor is configured to execute a control algorithm to select one or more operating parameters selected from (a) a number of fluid ejectors fired per ejection burst, (b) a position of fluid ejectors fired per ejection burst, and (c) both (a) and (b) in order to modify fluid plume characteristics of fluid ejected from the ejection head through the fluid jet nozzles. The fluid ejection device is activated to deliver the pharmaceutical drug in the nasal cavity of a person.
In some embodiments, each fluid droplet ejected from the ejection head has volume ranging from about 2 to about 24 pL.
In some embodiments, the ejection head has a firing frequency ranging from about 10 KHz to about 20 KHz.
In some embodiments, the number of fluid ejectors fired per ejection burst ranges from about 40 to about 200 nozzles fired per burst.
In some embodiments, the pharmaceutical drug is delivered to the patient with a fluid plume angle ranging from about 25 to about 60 degrees.
In some embodiments, the pharmaceutical drug is delivered to the patient with a fluid plume height ranging from about 15 to about 25 centimeters.
In some embodiments, the pharmaceutical drug is delivered to the patient with a fluid jet length ranging from about 2 to about 10 centimeters from the fluid ejection head.
In some embodiments, the pharmaceutical drug is ejected with a plume characteristic that delivers the drug to a mucosa area of a nasal cavity of the patient.
In some embodiments, the pharmaceutical drug is ejected with a plume characteristic that evenly distributes the drug throughout a nasal cavity of the patient.
In some embodiments, the pharmaceutical drug is ejected with a plume characteristic that increases a drug dose delivery rate to the patient.
An advantage of the pharmaceutical drug delivery device described herein is that the device may be used for a wide variety of drugs having different fluid characteristics. The device is tunable by modifying certain fluid ejector operating parameters in order to modify a plume angle, fluid jet length, and/or plume height of fluid mist for nasal injection applications. Other features and advantage of the disclosed embodiments may be evident from the following drawings and detailed description.
For the purposes of this disclosure, the following terms are defined:
An illustration of a pharmaceutical drug delivery device 100 is illustrated in a cross-sectional view, not to scale, in
A wide variety of ejection heads 112 may be used with the device 100 described above. Accordingly, the ejection head 112 may be selected from a thermal jet ejection head, a bubble jet ejection head, or a piezoelectric jet ejection head. Each of the foregoing ejection heads can produce a spray of fluid on demand and may be programmed to provide a variety of fluid plume characteristics as described below. By contrast, conventional spray pumps are mechanically fixed for a particular drug delivery application and generally cannot be modified to provide a variety of fluid plume characteristics.
Unlike conventional inkjet ejection heads which are designed to eject fluid droplets in a straight line for 2 to 3 mm to reach a substrate such as paper, the device 100 described herein is designed to eject fluid droplets as a mist further into an air stream so that the droplets eventually land in the mucosa area of the nasal cavity.
A portion of the ejection head 202 is illustrated in plan view in
Accordingly, in one embodiment, a “position” of fluid ejectors and associated nozzles 208 may be referred to as adjacent to one another or may be spaced-apart or non-adjacent to one another. Non-adjacent nozzles 208, such as fluid ejectors 220 and 222 with respect to fluid ejector 214, may be activated at the same time to eject fluid from the associated nozzles 208, rather than activating adjacent fluid ejectors 216 and 218 with respect to fluid ejector 214. Thus, for ejection head 202, adjacent fluid ejectors 216 and 218 with respect to fluid ejector 214 may be skipped during an ejection burst. For example, an ejection head having 96 fluid ejectors and associated nozzles 208, may be programmed to activate only 48 fluid ejectors out of 96 fluid ejectors (48 per side of the fluid via 212) per ejection burst at a frequency of 18 KHz to provide a fluid plume 224 and fluid jet 226 as shown in
Thus, a single fluid ejection head 202 having 96 fluid ejectors can be operated in multiple fashions to obtain different plume characteristics allowing the same ejection head to be used for multiple applications. For example, adjacent fluid ejectors can be activated for applications that require a maximum flow rate of fluid to be ejected. The same ejection head 202 can be programmed to activate non-adjacent fluid ejectors for alternate applications, such as nose to brain drug delivery requiring a minimum flow rate of fluid to be ejected. When non-adjacent fluid ejectors are activated, the dose delivery rate is reduced and the time to deliver a predetermined dose of pharmaceutical drug is increased.
In another embodiment, a larger ejection head 250 (
It is noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the,” include plural referents unless expressly and unequivocally limited to one referent. As used herein, the term “include” and its grammatical variants are intended to be non-limiting, such that recitation of items in a list is not to the exclusion of other like items that can be substituted or added to the listed items.
For the purposes of this specification and appended claims, unless otherwise indicated, all numbers expressing quantities, percentages or proportions, and other numerical values used in the specification and claims, are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by the present disclosure. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.
While particular embodiments have been described, alternatives, modifications, variations, improvements, and substantial equivalents that are or can be presently unforeseen can arise to applicants or others skilled in the art. Accordingly, the appended claims as filed and as they can be amended are intended to embrace all such alternatives, modifications variations, improvements, and substantial equivalents.
