PRESSURE BARRIER DRUG DELIVERY DEVICE
A beneficial agent dispensing device comprises a dispenser body comprising a pressure chamber and at least one dispensing port. A flexible primary container stores the beneficial agent contained within the body. The arrangement is such that pressure in the pressure chamber depress the flexible primary container to expel the beneficial agent through the dispensing port. The beneficial agent dispenser can be configured to deliver the beneficial agent intranasally.
This application claims the benefit of U.S. Provisional Pat. Application No. 62/749,296 filed Oct. 23, 2018 and is incorporated herein by reference in its entirety.
TECHNICAL FIELDThe present disclosure generally relates to dispensing packages. More specifically, the disclosure relates to intranasal drug delivery devices.
BACKGROUNDIntranasal dispensers, such as those used to administer Narcan®, utilize manual force to create a spray or jet of beneficial agent contained in the device. This results in potential variation in the dispensed flow characteristics depending on how strong and/or how fast the dispenser is operated. This irregularity in the flow characteristics may also result in varying drug absorbance and effectiveness.
Previously known intranasal dispensers use a syringe style form factor (i.e., barrel and piston arrangement). One drawback of such dispensers is that the exposure of the beneficial agent with materials associated with syringes such as silicone and rubber may compromise the beneficial agent’s stability and effectiveness. Glass syringes can also compromise the device’s tolerance to impact.
Accordingly, a need exists for improved intranasal dispensers that address some or all of the issued discussed above.
Described herein are various embodiments of a beneficial agent dispenser comprising a body and at least one dispensing port. A pressure chamber is located in the body. Beneficial agent is stored in a flexible primary container located within the body. In some embodiments, the primary container may be a blister pack made from at least one of a film and a foil. Pressure in the pressure chamber depresses the primary container causing the beneficial agent to expel through the dispensing port. A pressure source causes the pressure chamber to pressurize. In some embodiments, the pressure source is a relatively small CO2 cartridge having a rupturable membrane. A rupturable pin may be located in front of the rupturable membrane. The rupturing pin ruptures the rupturable membrane when the two are moved toward each other in a relative motion. A handle associated with an activation mechanism may be used to initiate the relative motion to rupture the CO2 cartridge and pressurize the pressure chamber.
The primary container may be a flexible or semi-flexible package including, e.g., molded containers, blow molded containers, a sachet, a pouch, a tube, or any combination thereof.
The dispensing port may be configured for a variety of applications including, topical, oral, sub-lingual, ocular, oraticular, and for inhalation. The dispensing port may be of a variety of forms, including, e.g., a jet nozzle, a spray nozzle, or a topical applicator such as a brush or sponge.
Pressure sources other than CO2 cartridges may be used, including pressure sources wherein pressure results from a chemical reaction.
In some embodiments, the disclosed dispenser includes multiple primary containers containing the same or different beneficial agents. In other embodiments, the primary container comprises multiple compartments that can be manually or automatically merged prior to administration. In some embodiments, a first compartment comprises an active ingredient in dry format and a second compartment comprises a diluent, and the two compartments are merged prior to administration to allow the two substances to reconstitute and form the beneficial agent. The disclosed dispenser may comprise multiple primary containers, with the contents of each being dispensed through a common dispensing port. In some configurations, the disclosed dispenser includes multiple primary containers, the content of each is dispensed from a different dispensing port
In
In some embodiments, a bleed hole opens when the seal 128 reaches the activated position, allowing the gas from the pressure chamber 110 to deplete and reduce the pressure. In some embodiments, a piston return spring (not shown) is disposed in vented chamber 130 (
From the foregoing, it will be appreciated that specific embodiments of the invention have been described herein for purposes of illustration, but that various modifications may be made without deviating from the scope of the invention. Accordingly, the invention is not limited except as by the appended claims.
Although the technology has been described in language that is specific to certain structures and materials, it is to be understood that the invention defined in the appended claims is not necessarily limited to the specific structures and materials described. Rather, the specific aspects are described as forms of implementing the claimed invention. Because many embodiments of the invention can be practiced without departing from the spirit and scope of the invention, the invention resides in the claims hereinafter appended.
Unless otherwise indicated, all number or expressions, such as those expressing dimensions, physical characteristics, etc., used in the specification (other than the claims) are understood as modified in all instances by the term “approximately”. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the claims, each numerical parameter recited in the specification or claims which is modified by the term “approximately” should at least be construed in light of the number of recited significant digits and by applying rounding techniques. Moreover, all ranges disclosed herein are to be understood to encompass and provide support for claims that recite any and all sub-ranges or any and all individual values subsumed therein. For example, a stated range of 1 to 10 should be considered to include and provide support for claims that recite any and all sub-ranges or individual values that are between and/or inclusive of the minimum value of 1 and the maximum value of 10; that is, all sub-ranges beginning with a minimum value of 1 or more and ending with a maximum value of 10 or less (e.g., 5.5 to 10, 2.34 to 3.56, and so forth) or any values from 1 to 10 (e.g., 3, 5.8, 9.9994, and so forth).
Claims
1-21. (canceled)
22. A dispensing device for dispensing a beneficial agent comprising:
- a pressurized fluid source configured to contain a pressurized fluid,
- a pressure chamber with an internal volume and comprising a primary container adapted to store a beneficial agent, and
- a fluid barrier between the internal volume and an ambient environment;
- wherein a fluid pathway from the primary container is provided responsive to providing a pressurized fluid into the pressure chamber from the pressurized fluid source, and
- wherein the pressurized fluid source is disposed through the fluid barrier such that an internal end of the pressurized fluid source is exposed to the internal volume and an external end of the pressurized fluid source is exposed to the ambient environment.
23. The dispensing device of claim 22, wherein the pressurized fluid source comprises a canister configured to contain a pressurized fluid.
24. The dispensing device of claim 23, wherein the pressurized fluid includes any of liquified carbon dioxide, carbon dioxide gas, nitrogen gas, and argon gas.
25. The dispensing device of claim 22, wherein the internal end of the pressurized fluid source is configured to open to provide the pressurized fluid to the internal volume upon opening.
26. The dispensing device of claim 25, wherein the internal end of the pressurized fluid source is configured to rupture to open.
27. The dispensing device of claim 22, further comprising the primary container comprising a beneficial agent, and wherein the fluid pathway from the primary container is adapted to expel the beneficial agent through a dispensing port.
28. The dispensing device of claim 22, wherein the pressurized fluid source is configured to move relative to the fluid barrier from a first position where the internal end is unopened to a second position where the internal end is opened to provide the pressurized fluid to the internal volume.
29. The dispensing device of claim 22, wherein the ambient environment includes an activation mechanism confronting the external end and configured to actuate the pressurized fluid source upon actuation.
30. The dispensing device of claim 29, wherein the actuation of the pressurized fluid source brings the internal end into an interaction with a fluid source opening element such that the internal end opens to provide the pressurized fluid to the internal volume.
31. The dispensing device of claim 30, wherein the internal end includes a rupturable membrane, and the fluid source opening element comprises a rupturing pin configured to rupture the rupturable membrane.
32. The dispensing device of claim 29, wherein the activation mechanism is configured to prevent movement of the pressurized fluid source away from the internal volume of the pressure chamber.
33. The dispensing device of claim 22, wherein the pressurized fluid source comprises an abutment feature configured to prevent movement of the pressurized fluid source away from the internal volume of the pressure chamber.
34. The dispensing device of claim 22, wherein the fluid barrier comprises any of a seal, an o-ring, or a tight fit between the fluid barrier and at least a section of the pressurized fluid source.
35. The dispensing device of claim 22, further comprising a connecting section of the pressurized fluid source connecting the internal end to the external end, wherein the fluid barrier is configured to seal against the connecting section.
36. The dispensing device of claim 22, wherein the internal volume contains a dispensing assembly.
37. The dispensing device of claim 36, wherein the dispensing assembly includes piston configured to move when a pressurized fluid is provided to the internal volume.
38. The dispensing device of claim 22, wherein the pressurized fluid source is configured to move in an axial direction relative to the fluid barrier.
39. The dispensing device of claim 22, further comprising a bleed path configured to controllably release the pressurized fluid from the internal volume of the pressure chamber.
40. The dispensing device of claim 39, wherein the fluid barrier is configured to provide the bleed path responsive to the pressurized fluid source providing a pressurized fluid to the internal volume of the pressure chamber.
Type: Application
Filed: Mar 23, 2023
Publication Date: Oct 26, 2023
Inventor: Amir Genosar (Broomfield, CO)
Application Number: 18/189,129