Drug delivery system and method

Abstract

To provide a drug delivery system including a medicine administration device, medicines in the medicine administration device, a container defining a cavity for receiving the medicine administration device, and a cap attached to the container and sealing the medicine administration device within the cavity.SOLUTION: A medicine administration device includes an actuator extending from a body and being operable to eject medicines by depressing the actuator into the body. A cap includes a pressing member disposed to come into contact with the body of the medicine administration device so as to prevent movement of the medicine administration device toward the cap beyond a prescribed distance. This configuration prevents the medicine administration device in particular from prematurely ejecting medicine during storage and transport.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure provides a drug delivery device and a drug contained therein that maintains its operational state. The present disclosure further relates to a drug delivery system in which the drug administration device is configured to receive a container assembly for use. The present invention relates to a drug delivery system that can be quickly and easily removed from an assembly. [Background technology]

[0002] A medication system including a medication delivery device containing a medication is provided. It must be maintained in good condition from the time it is placed in the device until its final use by the patient. There are transportation methods that increase the viability of pre-filled medication delivery devices during storage and transport. There is a particular need for a delivery system. This type of drug delivery device is available in a variety of quality For example, the U.S. Food and Drug Administration (FDA) recently Published draft guidance on quality considerations for delivery systems. www.fda.go v / downloads / Drugs / GuidanceComplianceRegu latoryInformation / Guidances / UCM070573.pd See http: / / www.aerosolresearch.org / reports / 2018 / 04 / 18 / guidelines / for-the-development-and-manufacturing-of-aerosols-and-products ... The guidance covers a range of topics including stability, dosage form, aerodynamic performance, and delivery systems. All of these aspects correspond to a quality profile that includes the following elements: This affects the utility of

[0003] In certain embodiments, the disclosed drug delivery systems are used in connection with the delivery of glucagon. Normally, glucagon is produced in the pancreas and works in conjunction with insulin to regulate blood glucose levels in the body. Glucagon is released by the body when blood glucose levels are low and transports blood to the liver. People with diabetes no longer produce insulin. (Type 1) or the body's ability to respond to insulin is reduced (Type 2) It's either one or the other.

[0004] Both the medication delivery device and the medication significantly enhance the safety and efficacy of the medication dispensed The drug must be delivered in a manner that allows for the appropriate moisture content, aerodynamic particle size distribution, and The drug administration device may be provided in a stable environment to maintain activity and / or function. The drug delivery device is kept in a hermetically sealed enclosure prior to use and can be maintained under appropriate conditions. This can be achieved by reducing moisture, foreign particulate matter, impurities, degradants, and drug delivery devices. This can limit contact with other harmful substances that may impair the proper functioning of the device. The drug delivery device should also be protected from physical damage and premature activation.

[0005] Insulin and insulin pumps are highly technologically and effectively used to treat diabetes. has evolved into a valuable tool, but is urgently needed to save the lives of people with diabetes who experience hypoglycemia. Methods for delivering glucagon to the body have not progressed as much as desired. Reconstituting and injecting it can be difficult, and often people with diabetes need help. A simple nasal spray provides fast and easy delivery of glucagon in emergency situations. It becomes possible to administer

[0006] For people with type 1 diabetes (T1D), excess insulin can cause blood glucose levels to drop. This can limit the body's ability to release glucagon, thus contributing to the progression of T1D. To restore balance to blood glucose levels when a person is unable to eat or drink sugar Treatment with glucagon is necessary. Severe hypoglycemia can result in hospitalization and, in extreme cases, death. Therefore, maintaining the integrity of both the glucagon and its delivery device is essential. It is understood that this is extremely important. Summary of the Invention

[0007] According to one aspect of the present disclosure, there is provided a drug delivery device, a drug received within the drug delivery device, and a drug A container defining a cavity for receiving the administration device; and a cap for sealing the medication within the container. The drug delivery system includes a drug injection device having an actuator attached to a main body. and is movable from the extended position to the depressed position to eject the medicine. The container defines an access opening to a cavity in which the medication delivery device is disposed. The cap is secured to the container in a closed position to form an airtight seal of the drug delivery device within the cavity. The cap is positioned to prevent the medication delivery device from moving against the cap. The support includes one or more retaining members.

[0008] In another aspect, the training system is configured to simulate a drug delivery device. Training modules that involve, but do not involve, pharmaceutical products, and / or product container operations The present invention also includes a training vessel configured to simulate the

[0009] The drug delivery device further includes a component for preventing premature expulsion of the drug. and providing a cap and container assembly that provides a secure and sealed enclosure for The purpose is to

[0010] Another object is to provide a drug delivery device that can be easily and quickly removed from the container for use. The present invention provides a drug delivery system that houses a drug administration device so that the drug administration device is

[0011] The drug delivery device is designed to maintain operability and viability of the enclosed drug. A method of encapsulating the device is also disclosed.

[0012] Other objects and advantages of the disclosed drug delivery system will be apparent to those skilled in the art.

[0013] The features and advantages of the present disclosure will become more readily apparent to those skilled in the art when considered in conjunction with the following detailed description taken in conjunction with the accompanying drawings. It will become clearer to those who [Brief explanation of the drawings]

[0014] [Figure 1] 1 is a perspective view of components useful in conjunction with a drug delivery system, depicting a drug administration device and a container in side-by-side relationship; [Figure 2] FIG. 1 is a perspective view of one embodiment of a drug delivery system depicting the device inserted into a container with the cap in an open position. [Figure 3] 3 is a side cross-sectional view of the container of the drug delivery system of FIG. 2 with the device inserted. [Figure 4] 3 is a side elevational view of the drug delivery system of FIG. 2 showing the hinged connection between the cap and the container. [Figure 5] FIG. 10 is a side elevational view of the container with the cap in the closed position, showing further details of the living hinge. [Figure 6] FIG. 3 is a partial perspective view of the medication delivery system shown in FIG. 2, showing details of the latching mechanism of the container and cap. [Figure 7]1 is a side partial cross-sectional view of a container of a drug delivery system showing the cap in a closed position sealed with the container having a device inserted therein. [Figure 8] FIG. 1 is a partial cross-sectional view of the container showing the interior of the container with a desiccant plug. [Figure 8A] FIG. 9 is a detailed view of the desiccant plug retention mechanism of FIG. 8. [Figure 9] FIG. 1 is a perspective view of a training container with the cap in the open position. [Figure 10] FIG. 10 is a side cross-sectional view of the training container shown in FIG. 9 with the cap in the closed position. DETAILED DESCRIPTION OF THE INVENTION

[0015] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, in which: Certain language will be used to describe this, however, and should not be construed as limiting the scope of the invention. It will be understood that this is not intended to define

[0016] In one aspect, an intranasal delivery system is disclosed that includes a drug administration device for dispensing a drug. Such drug delivery devices typically include a drug reservoir in communication with the drug reservoir through an ejection port. and an actuator mechanism for expelling the medication through the expulsion port. The discharge port is sealed prior to use. The actuator opens the seal on the discharge port and releases the medication. A typical configuration of such a drug administration device is The actuator extends from the body prior to delivery of the drug. When the syringe is moved from the depressed position to the depressed position, the discharge port is unsealed and the medication is discharged.

[0017] In one embodiment, a drug administration device, a drug contained within the drug administration device, and a drug delivery system and a cap for sealing the drug delivery system within the container. In another embodiment, a drug delivery system is disclosed that provides a sealed, protected drug delivery system. In yet another embodiment, a method for containing a drug delivery device is provided. a container having an internal cavity for sealing the internal cavity in a closed position; A container assembly for a medication delivery device is provided that includes a cap for attaching the container to the medication delivery device.

[0018] Referring to FIG. 1, a drug delivery device 12 containing a drug (not shown) and a device for receiving the drug delivery device 12 are shown. An exemplary pharmaceutical composition includes a container 14 for containing the pharmaceutical composition, and a cap 16 for sealing the container 14. A drug delivery system 10 is shown. The drug dispenser 12 has a discharge end 20 and an opposing actuator. a body 18 generally longitudinally disposed along a device axis DA having a control end 22; The drug delivery device is defined by a body 18, which contains a drug to be dispensed from the drug delivery device. The drug is delivered through a drug delivery port having an opening in communication with the drug reservoir. It will be distributed through 24.

[0019] The drug delivery device 12 further includes a valve for discharging the drug from the reservoir through a discharge port 24. The actuator 26 extends from the actuator end of the body 18. The actuator 26 is further movable from the extended position shown in FIG. When the actuator 26 is in the extended position, the drug ejection The outlet port 24 is sealed from communication with the drug reservoir to keep the contained drug sealed. The actuator 26 displaces the fluid from the reservoir during axial movement from the extended position to the depressed position. During such movement, the ejection port and the reservoir are operable to eject the medication from the ejection port. Communication between the two is provided to allow for the delivery of the drug.

[0020] Also shown in Figure 1 is a container 14 and a cap 16. The container 14 is aligned along a container axis CA. The side wall 28 is bounded at one end by a bottom wall 30. The container 14 is closed by an end wall portion 36, which defines a cavity 32 within the container 14. The cavity 32 is adjacent to the bottom wall 30 and provides an access opening 34 defined by sized and configured to receive a medication delivery device 12 with a discharge end 20 The sidewall 28 may define a generally cylindrical shape.

[0021] The cap 16 mates with the container 14 in the closed position and is received within the cavity 32. sized and configured to provide an airtight seal for the medication delivery device 12 when The cap 16 is adapted to abut the non-actuator portion of the body 18 of the medication delivery device 12. 2. The method includes: positioning and configuring one or more retaining members (described below with reference to FIG. 2) such that The one or more retaining members may be attached to the actuator 26 while the cap 16 is in the closed position. The drug delivery device is held in the cavity 32 without any pressure being applied. The retaining member includes a protrusion extending from the cap 16 toward the bottom wall 30. In one example, each retaining member The cap is integrally formed from the same material as the cap using a molding process. In some examples, the retainer member is formed separately and glued or otherwise secured to the cap. The retainer member may be made from a material that provides a rigid structure. , the rigid retention members to the cap (and to each other if there are more than one), and their relative orientation to the non-actuator portions of the body 18 of the medication delivery device 12 and and maintain positioning to prevent the end of the hold-down member from causing premature actuation of the device. The rigid retaining member is configured to prevent the cartridge from moving to an undesired position. Maintaining the relative axial and radial positions of the member ends relative to the cap and device It is possible.

[0022] The drug delivery device 12 is shown received within a container 14 in Figures 2-3. 6 is shown extending axially from the body 18 of the medication delivery device 12. At least one end portion 38 of the cap 16 extends beyond the plane of the end wall portion 36. has a cap sidewall 41 defining a recess 40 that receives the end portion 38 of the actuator 26. The cap 16 may include a cup-shaped body 39 having a may include a radially outward rim portion 66 .

[0023] In FIG. 2, the body 18 of the medication administration device 12 is configured to move around the device axis DA and the actuator 2. 6 and includes a peripheral surface 42 that is coaxial with the bottom wall 30 and faces away from the bottom wall 30. The material 44 is adapted to extend axially along the axis CA of the container when the cap is in the closed position. 2-3. In one embodiment, two retainers extend from the cap 16. The retainer member has an end contact surface 46 disposed to abut the peripheral surface 42. and the non-actuator portion is configured to separate the medication delivery device 12 from the bottom wall 30. When urged to move axially, the actuator is radially outward and The rigid retaining member allows the end contact surface 46 to contact the periphery of the cap and device. maintains its relative axial and radial position with respect to surface 42. Movement of the end contact surface 46 from the structure in which it is positioned may result in the end contact surface unintentionally causing premature actuation of the device. In one embodiment shown in FIG. The surface 41a and the inner surface 44a of the retainer member 44 define a continuous surface, and in some instances, The retainer member 44 defines a smooth surface that is continuous with the support ribs along the radially outer surface of the retainer member. Other parts of the device may include non-actuator parts that are contacted by the hold-down member. It may also be used as

[0024] The relative arrangement of the components is apparent from Figure 3. One or more hold-down members may include: The drug delivery device engages the end portion 38 of the actuator 26 with the inner axial surface 48 of the cap 16 . The bottom wall 30 is provided to prevent the bottom wall 30 from moving away from the bottom wall 30 by a distance that allows the bottom wall 30 to abut against the bottom wall 30. If contact is possible, the medication delivery device may be damaged or may dispense medication prematurely. There is a possibility.

[0025] The one or more retaining members interfere with the movement of the medication administration device and are arranged to prevent the medication administration device from moving from the bottom wall 30 of the medication administration device. to allow movement of at most a predetermined amount in the direction away from and toward the cap 16. The end contact surface 46 does not need to be in constant engagement with the peripheral surface 42. Rather, when the components of the drug delivery system are in a rest position, the end contact surfaces 46 A small gap may be provided between the bottom wall 30 and the peripheral surface 42. When an external force is applied to separate the pressing member 44, the contact surface 46 of the pressing member 44 is resistant to such movement. It acts as an end stop for the

[0026] In this regard, a small gap is formed between the contact surface 46 and the surface 42 of the body 18, as shown in FIG. A gap is provided between the end surface 47 of the end portion 38 and the inner surface 48 of the cap 16. The relative sizes of the two gaps are such that the inner surface 48 faces the actuator. 26. Smaller gaps are, for example, 0.1 mm to 1.865 mm. It may be between m.

[0027] 4-5, the cap 16 is joined to the container 14 by a hinge connection 50. The connector 50 is a continuous bridge of material that connects the cap 16 and the container 14 together. The hinge may be in the form of a "living hinge" including a hinge 52. FIG. The enlarged axially extending portion 54 of the side wall 28 extends to the end wall portion 36. , providing a living hinge 52. Portion 54 is flat instead of conforming to the radius of wall 28. If the hinge is not straight, high stress is applied to both ends of the hinge. The design aims to minimize changes to the exterior shape of the container to improve appearance. Other common hinges result in a portion of the hinge protruding from the wall 28. In this embodiment, the cap and container are formed as one integral part, such as by injection molding. It is formed by

[0028] Various embodiments of suitable hinges are known. For example, in another embodiment, the hinge may include: The container includes a shaft-like member extending horizontally along the exterior of the container. The shaft is supported by a pair of outwardly extending flanges. The container is held in a spaced position from the outside of the wall of the container by a syringe or the like. The cap includes a partially cylindrical member that is received over and pivots about the shaft. Alternatively, these structures may include a cap and a cylindrical component that includes a pivot. In these alternative embodiments, the cap and container may be inverted. are formed separately and assembled together.

[0029] The two presser members are disposed circumferentially apart from each other, and the hinge connection 50 connects the two presser members. In the exemplary embodiment, the cap 16 is hinged. Two holding parts positioned at opposite orthogonal positions, i.e., at approximately 90 degrees, relative to the continuation 50 The presser member 44 includes a presser foot 46. This provides two points of contact between the presser foot 46 and the body 18. An even member extends from the cup-shaped body of the cap on a radially opposite side of the cap. In some instances, this may be the exact opposite. In other instances, the radial They do not have to be exactly opposite, but can be offset by, for example, 150 degrees. The relative positioning of the members is such that, as the cap 16 moves between the open and closed positions, The retainer makes it easier to "clear" the sidewall 28 and actuator 26. However, it should be understood that any number and positioning of retaining members 44 may be used. It will also be appreciated that the cap 16 need not be hinged to the container 14, but may be self-contained. It is understood that a body may require or allow for one or more hold-down members of different configurations. Let's solve it.

[0030] In another exemplary embodiment, the cap includes a hinge that connects the cap to the container. In some embodiments, the cap can be positioned along any location from the interior of the cap. In one embodiment, the single retainer member is located inside the hinge. and radially aligned with the hinge to provide good containment of the drug delivery device within the container. In another embodiment, the single presser member may be, for example, any of the presser members shown in FIG. It may be located in any one of the locations shown in FIG. It may be attached.

[0031] Alternatively, the cap 16 may be completely removable from the container 14. The advantage of the hinged connection is that it facilitates the installation and removal of the cap 16. The retainer is then oriented in the desired position relative to the container 14.

[0032] Regardless of how the cap 16 is attached to the container 14 in the closed position, a portion of the cap The provision of the retainer member 44 as a medication delivery device provides a distinct advantage. Holds the medication delivery device while attached to a cap that is removed when needed Therefore, by removing the cap 16, as pressed without requiring a separate action to unlock the medication delivery device from the container. This allows the medication delivery device to be quickly and easily removed from the container. Although not required, the retainer member may be provided as an integral part of the cap 16. This allows for easier manufacturing of the presser member and prevents it from being provided as a separate part. In this case, additional manufacturing steps and costs are avoided.

[0033] Referring to Figure 6, the drug delivery system is designed with two components purposefully separated. a locking mechanism 5 for holding the cap 16 in a closed position with the container 14 when the cap is not in use; 6. A locking mechanism is provided that is sufficiently secure to hold the components in a locked position. Any other suitable locking mechanism that provides the necessary security while also allowing for the intelligent release of the locking mechanism when required. In one embodiment, the locking mechanism 56 is The latch 58 is attached to the cap 16 and includes a latch member or latch mechanism. When latch 16 is in the closed position, it extends axially along the axis of the container. 58 is positioned to be received adjacent an outer surface 60 of the side wall 28. , includes a pair of apertures 62. A pair of complementary nubs 64 are formed in the outer surface 60. 1. The nozzle 16 is positioned to be received within the aperture 62 when the nozzle 16 is in its closed position. The latch components and support members are configured to open and close the latch as needed. It is sufficiently flexible and elastic.

[0034] Alternative locking and sealing mechanisms may also be used. For example, in one embodiment, In another embodiment, the cap is press-fit. Thus, it is fixed to the container.

[0035] The latch 58 is attached to the cap 16 just below the underside of the rim portion 66, as shown in FIG. 58 may be attached to and depend from the outer surface 60 of the side wall 28. The outer surface of the cup-shaped body of the cap can be fitted to receive the cap. The radial extent of the rim portion 66 away from the rim portion 66 may be constant. The radial extent of the rim portion 66 adjacent to the latch 58 is, for example, such that the portion 67 of the rim portion 66 adjacent to the latch 58 is It may vary, such as being radially more extended than a portion of the outer rim portion 66. 67 to facilitate removal of the cap 16 from the access opening 34 of the container 14. The underside of extension portion 67 defines a thumb contact tab that can be extended outward. 14. The cap is then pressed up against the container 14 to provide a surface that extends upward and away from the container 14, facilitating removal of the cap from the container. The user can apply an axial force to portion 67 to allow the flexibility of the material to force portion 67 to release. 7, thereby clearing the latch aperture 62 from the nub 64 and releasing the latch 5 8 clears nub 64 and moves the cap to the open position.

[0036] The drug delivery systems are sealed in the cap and container assembly. The medication delivery device and The cap and container are configured to maintain the integrity of the drug. It has complementary sealing components to ensure sealing. See Figures 6 and 7 The container 14 then includes an end wall portion 36 that defines the access opening 34. The cap 16 and the end wall portion 36 are fitted closely together and extend along the inner surface of the end wall portion 36 to secure the medication delivery device to the cap 16 and the end wall portion 36. and is sized and configured to provide a hermetic seal enclosing the assembly of the container 14. The cap includes a peripheral sealing member having a peripheral axially extending flange 68. Lunge 68 extends axially along container axis CA and extends radially inward away from latch 58. The circumferentially spaced apart end wall portions 36 define a gap for receiving the radial thickness of the end wall portions 36. A facing sealing flange 68 may depend axially from the underside of the rim portion 66. , as shown in FIG. 7, are disposed radially inwardly and spaced apart from the flange 68. The support member 44 is sized to extend axially beyond the bottom wall facing the end wall of the flange 68. The flange 68 is shown extending axially beyond the latch 58 of the latching mechanism. If the latch is short compared to the flange wall, the force required to open the cap may be reduced. The latch 58 is shown circumferentially disposed between the two retaining members 44, but the recess and is radially opposite the hinge connection 50. The presser member 44 is rotated approximately 180 degrees. Alternatively, the latch 58 and hinge connection 50 may be approximately 180 degrees apart.

[0037] The materials used for the cap and container are of a type well known in the art. The material must provide the desired sealing function. No living hinges, latches, or other When functionalities are involved, the material must have sufficient strength, stretch, and elasticity to meet the functional requirements. A wide variety of materials are suitable for use in the container 14 and cap 16. It is known in the art and is typically made of plastics, particularly polypropylene and polyethylene. and other thermoplastics.

[0038] Many drugs are adversely affected by contact with harmful levels of moisture. The drug delivery system includes a drug that is moisture sensitive, and the container 14 and / or cap 16 8, a desiccant plug 70 is shown received within the container 14. The desiccant plug is configured to fit within the container 14 adjacent the bottom wall 30 and A central cavity 71 is provided for receiving the drug delivery port 24 of the drug delivery device 12. It has an annular shaped body.

[0039] The desiccant plug, for example, contains a well-known desiccant to absorb moisture that might otherwise degrade the drug. The material may be used to form a molecular sieve type injection molded plug. The ventilator is sized to have sufficient material to provide adequate absorption of moisture. For this purpose, a desiccant plug is provided between the medication delivery device 12 and the interior of the side wall 28 of the container 14. The cavity 32 may be configured to substantially fill the cavity 32.

[0040] The desiccant plug 70 is secured within the cavity 32 by various means, such as an interference fit. The container 14 may also include snap-fit retention features, which may be attached to the interior of the container sidewalls. A continuous radially inwardly projecting ring or continuous internal shoulder 72 extending from the cavity surface When tilted a sufficient distance into the tee 32, it engages the axial end face of the desiccant plug 70. The desiccant plug 70 has an annular notch 73 defined along the radially outer surface 75 of the desiccant body. This may include a cap facing the axial plane 77 of the desiccant body and a radial plane of the desiccant body. Annular notch 73 is shown formed at the intersection with the outer surface as shown in FIG. sized and configured to receive shoulder 72 when the desiccant is placed within the container. Alternatively, the shoulder 72 may be axially aligned with the desiccant body without the desiccant having the notch 73. Engaging the cap facing the facing surface 77 operates to retain the annular desiccant. It may be possible.

[0041] The disclosed drug delivery system includes, among other things, a pre-filled drug delivery system that provides a dosage form of drug. In particular, a drug administration device, as used herein, is a device for administering a metered amount of Dispersion devices that are considered to be devices that deliver drugs in a dispersed form, such as aerosol or spray devices These drug delivery devices may be pre-filled with a finished dosage form of the drug. Embodiments are described in Federal Register Nos. 36,675, 36,676, and 36,680 (2000). 68) issued Jun. 18, 2003. includes intranasal aerosol and spray devices.

[0042] The drug delivery system may include a wide range of drug administration devices and drugs. It is particularly well suited for use in drug administration devices used to administer powdered drugs, such as intranasal delivery powders. The drug can be anything that can be delivered by a dispersion device. one or more other It may be associated with the component.

[0043] In an exemplary embodiment, the drug is glucagon. A drug delivery device has been developed that delivers a nasal powder containing a liquid and powder mixture. This offers a significant advantage over more complex systems that involve mixing the solution and then injecting it. The use of a drug delivery device has been shown to increase blood glucose levels to near normal within 30 minutes of taking powdered glucagon. It is believed that this will be possible.

[0044] In one embodiment, the drug contains 2 mg of glucan in 20 mg of dry powder depending on the dose. intranasal AMG504- containing 3 mg of glucagon in a 30 mg dry powder The nasal powder is a single-use product (Locemia Solutions). It is administered with a step-dispensing device. The tip of the device is inserted into one nostril and the powder is dispensed into that nostril. The dose is delivered by simply pressing the actuator connected to the piston that ejects the Absorption occurs through the nasal mucosa, so patient cooperation is not required. The glucagon formulation is provided in a drug delivery system as disclosed herein, This provides highly effective protection against the viability of both the device and its delivery system.

[0045] Allowing potential users the opportunity to become familiar with how to use the drug delivery system in its commercially available form In one aspect, it may be desirable to provide a training device that is compatible with commercially available devices. Modified versions of the described drug delivery systems having the same basic structure and function are provided. However, training equipment does not need to be equipped with the same level of refinement. It is also important that the training device cannot be confused with commercially available devices. The device is designed to provide a tight seal when the lid is closed on the container, is not required for training equipment.

[0046] Therefore, the training equipment is designed to not involve interchangeable parts with commercially available equipment. For example, the training drug delivery device may be packaged in a commercially available container and / or cap. Conversely, the training container and / or cap are designed to prevent The pump is configured not to include reception of a commercially available drug delivery device.

[0047] In one example, the training device may be configured such that its container and / or cap is a commercially available medication dispensing device. sized to define a cavity that is too short and / or too narrow to accommodate the Similarly, the training drug delivery device may be attached to a commercially available container and / or cap. The tray may be designed to have dimensions that cannot be received within the cavity defined thereby. The containers, caps, and / or drug delivery devices for the cleaning and commercial devices are It will be appreciated that incompatibility may be achieved in various other ways.

[0048] 9 and 10, an exemplary training container and cap assembly is shown. The container 74 simulates the space occupied by the desiccant plug 70 of the previous embodiment. A pair of arms 78 extend from the top of the container 74 to the cylindrical body containing the grid 76 that supports the container. The cap 82 extends outward and supports the hinge pin 80. The cap 82 is a cap in which the hinge pin 80 is received. The cup-shaped portion 84 defines a channel through which the hinge pin is inserted. 80. The hinge is formed from a material that is flexible enough to allow it to be pressed onto the hinge. The combination of the upper received cup-shaped portion 84 of the pin 80 forms the cap 82 and the container 74. A hinge 86 is provided to connect the

[0049] The container 74 further includes a ridge 88 along the top edge of the container 74 opposite the hinge 86. The ridge 88 extends across the container 74 and has a slightly convex shape when viewed in cross section. See Figure 10. The cap 82 has a raised portion when the cap 82 is in the closed position. 88 includes a flange 90 positioned to be engaged by the flange 90.

[0050] The cap 82 further includes a single retainer member 92 aligned with the hinge 86 . The retaining member 92 is configured to prevent the simulated administration device received in the container 74 from being displaced upward. The end face 94 of the T-shape is disposed thereon.

[0051] This allows the container 74 and cap 82 to be modified from the design of the previously described embodiment. For example, the cap 82 has a pair of pressing members 44. The hinge 86 and flange 90 are similar to those of the previous embodiment in that they have a single retaining member. 10A-10C depict alternative designs of living hinges and latches of embodiments.

[0052] In one embodiment, two different containers and a training system are provided. and a cap assembly. The training system is used to house a medication administration device containing the medication to be delivered. is used to familiarize the patient with the structure and function of the product system. The patient must use the container and kit of the training system to learn how to operate the product assembly. It serves the sole purpose of allowing the training module to operate on the cap assembly. Add.

[0053] The embodiment of Figures 2 and 9 represents the entire drug delivery system. The embodiment of FIG. 9 can function as a production system, while the embodiment of FIG. 9 functions as a training system. obtain.

[0054] For maximum effectiveness, the training system should include a simulated drug delivery device. It includes training modules on the use of pharmaceutical products, but does not include pharmaceutical products. The training module demonstrates how the medication delivery device is packaged in the product system and cap assembly. The training system is configured to work with Bri The container and cap assembly is configured to operate with the container and cap assembly.

[0055] Thus, the training module includes a discharge end defining a simulated drug discharge port; and opposing actuator ends including the simulated actuator. The actuator extends from the actuator end of the body, and the actuator moves from the extended position The training module can be moved linearly to the pressed position. It is not necessary for the system to be fully functional, e.g., to include an actuating actuator. The training container and cap assembly should also be used for the container and cap assembly of the product system. configured to simulate a cap assembly, but containing, e.g., a desiccant It does not need to be fully functional.

[0056] As previously mentioned, the components of the product and training system are Not compatible with training container and cap assembly, training module It is designed to be incompatible with various product containers and cap assemblies. This can be achieved in a variety of ways. For example, the training module can be embedded in the product system container. Alternatively, the container of the training system may have an outer diameter that does not fit into the , so that the cap cannot be closed on the medication administration device. It may be made too short. Generally, the training container is It is sufficient that the dimensions of the drug delivery device are incompatible with the device received in the vessel.

[0057] While the invention has been illustrated and described in detail in the drawings and foregoing description, these are by way of example only. The invention should be considered as illustrative and not limiting in nature, and is intended to be a preferred embodiment only. What is shown and described, and as defined by the claims that follow. All changes, equivalents and modifications that fall within the spirit of the invention are desired to be protected. It is understood that all publications, patents, and patent applications cited herein are the property of their respective owners. Each publication, patent, or patent application is incorporated herein by reference and is set forth in its entirety. All such references are incorporated herein by reference as if specifically and individually indicated to be in accordance with the present invention. can be.

[0058] Various aspects are described in this disclosure, including but not limited to the following aspects.

[0059] 1. A drug delivery system, comprising: a discharge end defining a drug discharge port; and an opposing actuator. a drug delivery device including a body having a drug delivery device and a drug delivery device; a drug reservoir, and a drug delivery device configured to release the drug from the reservoir through an outlet port. the actuator extends from the actuator end of the body. The actuator is linearly movable from an extended position to a depressed position, and the discharge port is sealed when the actuator is in the extended position, and the discharge port is The actuator is released when it is in the depressed position and the actuator is released when it is in the extended position. a drug reservoir operable to expel the drug from the reservoir upon axial movement to a depressed position; a drug delivery device; a drug received in a reservoir of the drug delivery device; and a container having an end wall portion an axially extending sidewall defining a cavity having an access opening defined therethrough; and a closed bottom wall, wherein the drug delivery device includes a discharge end adjacent the bottom wall of the container. a container having a side wall and a bottom wall, the side wall and the bottom wall being received in the cavity; a cap movable relative to the container between an open position and a closed position, a cap in position sealably engages the container to enclose the medication delivery device within the cavity. , the cap defines one or more retainer axial projections, and when the cap is in the closed position, One or more retaining axial projections extend axially from the cap toward the bottom wall. , allowing axial movement of the medication administration device in a direction away from the bottom wall by at most a predetermined amount. and one or more retaining axial protrusions are sized to engage a non-actuating portion of the medication delivery device. and a cap contactable with the drug portion.

[0060] 2. The drug delivery system of aspect 1, wherein the one or more pressure axial protrusions are rigid structures. Hmm.

[0061] 3. The body of the medication delivery device has a radius that surrounds the actuator and faces away from the bottom wall. When the cap is in the closed position, it has one or more retaining axial projections. The actuator is positioned radially outward so that the rise can contact the circumferential surface. The drug delivery system according to any one of aspects 1 and 2,

[0062] 4. The cap includes a cap sidewall and is configured to receive a portion of the actuator. a cup-shaped body defining a recess, and one or more retaining axial projections extending from the recess 4. The drug delivery system of any one of aspects 1 to 3, wherein the drug delivery system extends beyond

[0063] 5. The inner surface of the cap side wall and the inner surface of one or more retaining axial projections define a continuous surface. 5. The drug delivery system of claim 4,

[0064] 6. One or more retaining axial protrusions shall be attached to the cap on both radial sides of the cap. Any one of embodiments 1 to 5, including a pair of retaining axial protrusions extending from the cup-shaped body. The drug delivery system according to claim 1.

[0065] 7. The cap has an outer rim disposed around the cup-shaped body and a bottom wall of the outer rim. a circumferential flange depending axially from the facing surface, and one or more retaining axial projections A flange is spaced radially inward from the flange and extends axially beyond the flange. 7. The drug delivery system according to any one of aspects 1 to 6.

[0066] 8. Any one of aspects 1-7, wherein the cap is coupled to the container by a hinge connection. The drug delivery system described.

[0067] 9. The drug delivery system of aspect 8, wherein the hinge connection is a living hinge.

[0068] 10. The cap includes two pressing axial protrusions, and the two pressing axial protrusions are mutually and a hinge connection is disposed circumferentially between the two retainer axial projections. 9. The drug delivery system of embodiment 8, wherein

[0069] 11. The drug delivery system of embodiment 8, wherein the cap comprises a single retaining axial protrusion. .

[0070] 12. The cap has an outer rim extending radially from the cup-shaped body and a a peripheral flange depending axially from a surface facing the bottom wall, a latch member for securing the cap to the container in the closed position, the latch member comprising: a latch extending axially from the outer rim of the cap, the flange extending beyond the latch and extending axially from the outer rim of the cap; 12. The drug delivery system according to any one of aspects 1 to 11, stretched in the direction of

[0071] 13. One or more pressing axial protrusions of the cap include two pressing axial protrusions, and The two presser projections are arranged circumferentially apart from each other, and the hinge connection is The latch is disposed between the two axial projections in the circumferential direction, opposite to the hinge connection. 13. The drug delivery system of embodiment 12, wherein the drug delivery system is circumferentially disposed between the proximal and distal ends of the proximal end.

[0072] 14. A drug delivery system, comprising: a discharge end defining a drug discharge port; and an opposing end a body having a actuator end, a drug reservoir for containing a drug, and a discharge valve for discharging the drug from the reservoir; an actuator for releasing the agent through the port, the actuator comprising: a body; The actuator extends from the end of the actuator, and the actuator moves linearly from the extended position to the depressed position. The discharge port is sealed when the actuator is in the extended position, and the discharge port is movable in the extended position. The outlet port is open when the actuator is in the depressed position, and the actuator and operable to expel medication from the reservoir upon axial movement from the depressed position to the depressed position. The body of the drug delivery device surrounds the actuator and has a radially extending portion facing away from the bottom wall. a container having an end wall portion defining an adsorbent; an axially extending sidewall and a closed bottom defining a cavity having an access opening; a wall, the drug delivery device being received within the cavity with its discharge end adjacent the bottom wall of the container; a side wall and a bottom wall, and a cap hinged to the container, the cap comprising: a cap movable relative to the container between an open position and a closed position, the cap in the closed position comprising: The medication delivery device is placed in the cavity and the container is adapted to enclose the desiccant disposed in the cavity. a container including a cap sealably engaging the container; The cap defines a pair of retainer axial projections, and when the cap is in the closed position, the retainer The axial projection extends axially from the cap toward the bottom wall and away from the bottom wall. sized to allow at most a predetermined amount of axial movement of the medication delivery device in the and each of the pressing axial protrusions is disposed radially outward of the actuator of the medication administration device. The pressing axial projections have contact end surfaces that can come into contact with the peripheral surface of the device, and each of the contact end surfaces is and maintaining its relative axial and radial position with respect to the circumference of the device. and a drug delivery system configured to enable the drug delivery system to:

[0073] 15. The vessel has a continuous inner ring disposed radially inward from the inner surface of the vessel sidewall. an inner ring disposed axially spaced from the bottom wall, and a desiccant disposed between the inner ring and the bottom wall; 15. The drug delivery system of embodiment 14, wherein the drug delivery system firmly holds the

[0074] 16. The desiccant includes an annular notch defined along a radially outer surface of the desiccant, the latch is configured to receive the inner ring when the desiccant is disposed in the container. 16. The drug delivery system according to claim 15.

[0075] 17. The pharmaceutical composition of any one of aspects 1 to 16, wherein the pharmaceutical administration device is an air dispersion device. Drug delivery system.

[0076] 18. The drug delivery method of any one of aspects 1 to 17, wherein the drug is an intranasal delivery powder. Attainment system.

[0077] 19. The drug delivery system of aspect 18, wherein the powder is glucagon.

[0078] 20. A method for providing a drug delivery system comprising a glucagon composition, the drug positioning a drug administration device within the container, the drug administration device defining a drug delivery port; a body having a discharge end and an opposing actuator end, a drug reservoir containing the lucagon drug, and a drug delivery device for delivering the drug from the reservoir to an outlet port; and an actuator for releasing the agent through the body. The actuator extends from the end of the actuator, and the actuator moves linearly from the extended position to the depressed position. The discharge port is sealed when the actuator is in the extended position and the discharge port is The outlet port is open when the actuator is in the depressed position. When the actuator moves axially from the extended position to the depressed position, the drug is released from the reservoir. the container is operable to dispense, and the container has an access opening defined by an end wall portion. a bottom wall defining a cavity having a side wall and a closed bottom wall, the cavity being The discharge end is adjacent to the wall to receive and position the medication delivery device within the cavity. and attaching the cap to the container to provide an airtight seal enclosing the medication delivery device within the cavity. In most cases, the cap is sealed to the container in a direction away from the bottom wall. The actuator can move a predetermined amount without contacting the axial end face of the cap. one or more and sealing the retainer axial projection.

[0079] 21. A drug container and cap assembly for housing a drug administration device, comprising: The drug delivery device has a discharge end defining a drug delivery port and an opposing actuator end. the drug delivery device includes a drug reservoir containing a glucagon drug; The drug delivery device includes an actuator for releasing the Glucogan drug from the reservoir through the discharge port. the actuator extends from the actuator end of the body, The actuator is linearly movable from an extended position to a depressed position, and the discharge port is The discharge port is sealed when the actuator is in the extended position, and the discharge port is closed when the actuator is depressed. and the actuator is released when the actuator is in the extended position. and operable to expel the glucagon drug from the reservoir upon axial movement of the The assembly is a container having a cavity with an access opening defined by an end wall portion. a side wall defining a cavity and a closed bottom wall, the cavity being adapted to receive a medication delivery device; the medication delivery device is sized and configured to deliver the medication to the container by a discharge end adjacent the bottom wall of the container. a container and a cap, the container and the cap being receivable within the cavity; a connection to the container and mating with the container when in the closed position, the cap is configured to provide an airtight seal for sealing the medication delivery device inserted therein; The cap is adapted to allow movement of the medication delivery device in a direction away from the bottom wall by at most a predetermined amount. A pair of retainers positioned and configured to interfere with the movement of the medication administration device. The presser members are arranged to be spaced apart from each other in the circumferential direction, and the hinge connection is and a cap circumferentially disposed between the two presser members.

[0080] 22. The container sidewall is such that the end portion of the actuator extends beyond the container sidewall through the open end of the container. the cap is sized to allow the actuator to extend beyond the end of the actuator. a cup-shaped body defining a recess configured to receive the part, the cup-shaped body facing the recess; The inner surface of the cup-shaped body and the inner surface of each of the pressing members extending from the cup-shaped body 22. The assembly of embodiment 21, wherein the assembly defines a continuous surface.

[0081] 23. The container includes a desiccant configured to fit within the container adjacent the bottom wall; The desiccant is positioned within a central cavity configured to receive the drug delivery port of the drug delivery device. The container includes an annular-shaped body having a tee, and the container is disposed radially from the inner surface of the sidewall of the container. the desiccant is disposed on the radially outer side of the annular shaped body facing away from the bottom wall. and an annular notch defined along an edge thereof, the annular notch allowing the desiccant to be disposed within the container. and an inner ring.

[0082] 24. A training module for use with a drug delivery system, comprising: a discharge end defining a discharge port and an opposing actuator end including a simulated actuator; a training module including a body having a portion, and an actuator a training module extending from the actuator end and defined by an end wall portion; a tray having side walls and a closed bottom wall defining a cavity with an access opening; a training container, the cavity of the container being sized to receive the training module; and a training module is provided, the training module being configured to a training container received in a cavity in the training container; A training cap attached to a training container. The training cap is fitted to enclose the training module within the cavity. Allows movement of the training module in a direction away from the bottom wall by at most a predetermined amount. positioned and configured to interfere with movement of the training module so as to One or more pressure members are defined, the pressure members being disposed circumferentially spaced apart from one another. Each of the one or more holding members extends in a direction from the training cap toward the bottom wall. a training cap including a protrusion; and a training module including:

[0083] 25. A drug delivery system, comprising: a discharge end defining a drug discharge port; and an opposing abutment. a actuator end; and a body having: A drug delivery device includes a drug reservoir, and the drug delivery device releases the drug from the reservoir through an outlet port. an actuator for the actuator, the actuator extending from an actuator end of the body; The actuator is linearly movable from an extended position to a depressed position, and the discharge port The valve is sealed when the actuator is in the extended position, and the discharge port is The actuator is released when the actuator is in the depressed position, and the actuator is moved axially from the extended position to the depressed position. an actuator operable to expel a drug from a reservoir upon movement in a direction perpendicular to the axis of the actuator; a medication delivery device, further comprising a medication received in a reservoir of the medication delivery device; and a product container. a side defining a cavity having an access opening defined by a bottom wall portion; a wall and a closed bottom wall, the cavity being sized to receive a medication delivery device. and a medication delivery device configured to deliver a drug to a cavity with the delivery end adjacent the bottom wall of the container. a side wall and a bottom wall, and a product cap attached to the container, the product being received within the container; A product cap mates with the container and provides an airtight seal enclosing the medication delivery device within the cavity. and the product cap prevents movement of at most a predetermined amount of the medication delivery device in a direction away from the bottom wall. positioned and configured to interfere with movement of the medication delivery device to allow movement of the medication delivery device Each of the one or more presser members extends from the cap to the bottom wall. a product cap including a protrusion extending in a direction toward the product container; a discharge end defining a drug discharge port and an opposing actuator including a simulated actuator; a training module including a body having an end, the body including a simulated actuator; extends from the actuator end of the body of the training module. a training vessel having an access opening defined by an end wall portion; a sidewall and a closed bottom wall defining a cavity having a tray; sized and configured to receive a training module; The sidewall and bottom wall of the container are configured such that the nozzle is received within the cavity with the discharge end adjacent the bottom wall of the container. a wall and a training cap attached to the training container, The cap mates with the training container, enclosing the training module within the cavity. However, the training cap is positioned so that the training module is It interferes with the movement of the training module, allowing a certain amount of movement without and defining one or more presser members positioned and configured to Each training cap includes a protrusion extending in a direction from the training cap toward the bottom wall. and a training container having a training cap, , with the training cap closed and received in the training container The drug delivery system includes dimensions that are incompatible.

[0084] 26. The training module must be able to: 26. The drug delivery system of claim 25, comprising dimensions that are incompatible when received within the Stem.

Claims

1. 1. A drug delivery system comprising: The device has an ejection end defining a drug ejection port and an opposing actuator end. a drug delivery device comprising a drug reservoir, the drug delivery device comprising: a drug delivery device having an actuator for expelling the drug from the reservoir through the outlet port; Further containing eta, the actuator extends from the actuator end of the body; The actuator is linearly movable from an extended position to a depressed position, The port is sealed when the actuator is in the extended position, and the discharge port The actuator is released when the actuator is in the depressed position, When the actuator moves axially from the extended position to the depressed position, the reservoir a medication delivery device operable to expel medication from the dispenser; a drug received in the reservoir of the drug delivery device; A container defining a cavity having an access opening defined by an end wall portion. an axially extending side wall and a closed bottom wall, a sidewall and a nozzle received within the cavity with the discharge end adjacent the bottom wall of the container; a container having a bottom wall and a desiccant disposed within the cavity; a valve coupled to the container and movable relative to the container between an open position and a closed position; a cap, wherein the cap in the closed position is in sealable engagement with the container. and enclosing the medication delivery device within the cavity; The cap defines one or more retaining axial projections, and the cap is in the closed position. When the cap is in the cap position, the one or more retaining axial protrusions extend from the cap toward the bottom wall. The drug delivery device extends axially in a direction away from the bottom wall. the one or more pressure members are sized to allow a predetermined amount of axial movement even when the pressure members are in the axial direction. a cap having a facing projection contactable with a non-actuator portion of the medication delivery device; Equipped with a drug delivery system.

2. 10. The drug delivery system of claim 1, wherein the one or more pressure axial protrusions are rigid structures. Tem.

3. A body of the medication delivery device surrounds the actuator and faces away from the bottom wall. and a radially extending peripheral surface that, when the cap is in the closed position, The actuator is provided with a retaining axial projection that can contact the peripheral surface. The drug delivery system according to any one of claims 1 to 2, wherein the drug delivery system is positioned radially outward of the Stem.

4. The cap includes a cap sidewall and is adapted to receive a portion of the actuator. the one or more hold-down axial projections having a cup-shaped body defining a recess configured therein; The drug delivery system according to any one of claims 1 to 3, wherein the recess extends beyond the recess. 。

5. The inner surface of the cap side wall and the inner surface of the one or more retaining axial projections form a continuous surface. The drug delivery system of claim 4 .

6. The one or more axial retaining projections are arranged on both radial sides of the cap.

5. The method of claim 4, further comprising a pair of retaining axial projections extending from said cup-shaped body of said cap. The drug delivery system described.

7. The cap has an outer rim disposed around the cup-shaped body and a a circumferential flange extending axially downward from the bottom wall facing surface of the one or more pressing shafts; A directional projection is disposed radially inwardly and spaced apart from the flange, and the flange 5. The drug delivery system of claim 4, wherein the drug delivery system extends axially beyond the

8. Any of claims 1 to 7, wherein the cap is connected to the container by a hinge connection. The drug delivery system described in claim 1.

9. The drug delivery system of claim 8 , wherein the hinge connection is a living hinge.

10. The cap includes two pressing axial protrusions, and the two pressing axial protrusions are The hinge connection is formed between the two pressing axial projections. The drug delivery system of claim 8 , wherein the drug delivery system is disposed in a direction perpendicular to the axis of the drug delivery system.

11. The drug delivery system of claim 8 , wherein the cap includes a single retaining axial projection. 。

12. The cap has an outer rim extending radially from the cup-shaped body and an outer a peripheral flange depending axially from the bottom-facing surface of the rim, The cap has a latch for securing the cap to the container in the closed position. a latch member extending axially from the outer rim of the cap; 4. The method of claim 3, wherein the flange extends axially beyond the latch. Drug delivery system.

13. the one or more pressing axial protrusions of the cap include two pressing axial protrusions; The two pressing projections are arranged circumferentially apart from each other, and the hinge connection is The latch is disposed circumferentially between two pressing axial projections, and the latch is radially spaced apart from the hinge connection. The drug of claim 12, wherein the two pressure axial protrusions are circumferentially disposed between the two pressure axial protrusions in opposite directions. Drug delivery system.

14. 1. A drug delivery system comprising: A drug delivery device, comprising: a discharge end defining a drug discharge port; and an opposing actuator. a body having a tap end, a drug reservoir for containing a drug, and a discharge port for discharging the drug from the reservoir. an actuator for releasing the drug through a port, extends from the actuator end of the body, and the actuator is The discharge port is movable linearly from the depressed position to the depressed position, and the actuator is The discharge port is sealed when the actuator is in the extended position. and the actuator is released when the actuator is in the extended position and in the depressed position. and operable to expel medicament from the reservoir upon movement of the medicament delivery device. the body of the actuator surrounds the actuator and extends radially facing away from the bottom wall. a medication delivery device including an expanding periphery; A container defining a cavity having an access opening defined by an end wall portion. an axially extending side wall and a closed bottom wall, a sidewall and a nozzle received within the cavity with the discharge end adjacent the bottom wall of the container; and a bottom wall, and a cap hinged to the container, the cap being in an open position. and a closed position, the cap being movable relative to the container between the closed and closed positions, is in sealable engagement with the container to enclose the medication delivery device within the cavity. a cap and a desiccant disposed in the cavity, wherein the desiccant The drug delivery device has an annular shape that defines an opening for receiving the drug delivery port. a container comprising a desiccant; The cap defines a pair of retaining axial projections, and when the cap is in the closed position When the pressing axial protrusion is in the axial direction from the cap toward the bottom wall, and extending in the direction away from said bottom wall, and limiting axial movement of said medication delivery device in a direction away from said bottom wall by at most a predetermined amount. each of the pressure axial protrusions is sized to allow movement of the pressure axial protrusions of the medication delivery device. a contact end surface, facing radially outward of the actuator, that is capable of coming into contact with the peripheral surface of the device; The pressing axial projection has a contact end surface that contacts the cap and the device. and capable of maintaining its relative axial and radial position with respect to said peripheral surface of The drug delivery system is configured to:

15. The container has a continuous inner rib disposed radially inward from the inner surface of the side wall of the container. the inner ring is disposed axially spaced from the bottom wall, and the inner ring and The drug delivery system of claim 14, wherein the desiccant is tightly held between the bottom wall and the drug delivery system. Hmm.

16. the desiccant includes an annular notch defined along a radially outer surface of the desiccant; The annular notch is adapted to receive the inner ring when the desiccant is disposed within the container.

16. The drug delivery system of claim 15, wherein the drug delivery system is configured as follows:

17. 15. The drug delivery system of claim 14, wherein the drug administration device is an air dispersion device.

18. The medicament according to any one of claims 14 to 17, wherein the medicament is an intranasal delivery powder. Delivery system.

19. 19. The drug delivery system of claim 18, wherein the powdered agent is glucagon.

20. 1. A method for providing a drug delivery system comprising a glucagon composition, the method comprising: Positioning a medication administration device within a container, The drug delivery device has a discharge end defining a drug discharge port and an opposing actuator. and a drug delivery device having a drug reservoir containing a glucagon drug. the drug administration device dispenses the drug from the reservoir through the discharge port. and an actuator for discharging the actuator, the actuator discharging the actuator of the body. The actuator extends from the end of the actuator, and the actuator moves linearly from the extended position to the depressed position. the discharge port is sealed when the actuator is in the extended position. and the discharge port is opened when the actuator is in the depressed position. The actuator is configured to move from the extended position to the depressed position. and operable to expel the glucagon drug from the reservoir upon directional movement; The container defines a cavity having an access opening defined by an end wall portion. a cavity adjacent to the bottom wall of the container; The dispensing end receives and positions the medication delivery device within the cavity. And, The capsule is adapted to provide an airtight seal enclosing the medication delivery device within the cavity. and sealing a cap to the container, wherein the cap is oriented away from the bottom wall. The actuator is moved in the axial direction of the cap to move the medication delivery device by at most a predetermined amount. To prevent movement of the drug administration device without contacting the facing surface. and defining one or more retaining axial projections positioned and configured to seal. , a method comprising:

21. A drug container and cap assembly for housing a drug administration device, the drug The delivery device has a discharge end defining a drug delivery port and an opposing actuator end. the drug delivery device including a drug reservoir containing a glucagon drug; The drug administration device releases the Glucogan drug from the reservoir through the discharge port. the actuator further comprises an actuator for ejecting the actuator of the body. The actuator extends from the end of the actuator, and the actuator moves linearly from the extended position to the depressed position. the discharge port is sealed when the actuator is in the extended position. and the discharge port is open when the actuator is in the depressed position. The actuator is configured to move in an axial direction from the extended position to the depressed position. and operable to expel the glucagon drug from the reservoir upon forward movement. The assembly is A container defining a cavity having an access opening defined by an end wall portion. a cavity having a side wall and a closed bottom wall, the cavity receiving the medication delivery device; and wherein the medication delivery device is sized and configured to a container receivable within the cavity by the discharge end; and a cap connected to the container by a hinged connection and in a closed position; and a cavity for fitting the container thereto to seal the medication administration device inserted into the cavity. and the cap is configured to provide a hermetic seal in a direction away from the bottom wall. a movement of the medication delivery device to allow movement of the medication delivery device by at most a predetermined amount; a pair of presser members positioned and configured to interfere with the movement of the presser; The members are arranged circumferentially spaced apart from one another, and the hinge connection is a cap circumferentially disposed between the members.

22. The container sidewall is configured to allow an end portion of the actuator to extend beyond the container sidewall. the cap is sized to allow the end portion of the actuator to each of said presser members having a cup-shaped body defining a recess configured to receive said presser member; extending from the cup-shaped body, and an inner surface of the cup-shaped body facing the recess. and the inner surface of the presser member define a continuous smooth surface. assembly.

23. The container includes a desiccant configured to fit within the container adjacent the bottom wall. the desiccant is configured to receive the drug ejection port of the drug administration device therein. a container having an annular shaped body with a central cavity formed therein, the container having a side wall of the container; an inner ring disposed radially from an inner surface of the wall, the desiccant being spaced apart from the bottom wall; a facing annular notch defined along a radially outer edge of the annular-shaped body, An annular notch is configured to receive the inner ring when the desiccant is disposed within the container.

23. The assembly of claim 22, wherein

24. 1. A training module for use in a drug delivery system, comprising: A discharge end defining a simulated drug discharge port and an opposing actuator including a simulated actuator. a training module having a body with a actuator end, a training module having a motor extending from the actuator end of the body; a sidewall defining a cavity having an access opening defined by an end wall portion; and A training container having a closed bottom wall, the cavity being adapted to accommodate a training model. the training module being sized and configured to receive a training module; a nozzle received within the cavity with the discharge end adjacent the bottom wall of the container; a training container; a training cap hinged to the training container, A training cap is fitted to the training container and holds the training container in the cavity. A training module is enclosed in the training cap, and the training cap is moved away from the bottom wall. to allow at most a predetermined amount of movement of the training module in one or more devices positioned and configured to interfere with movement of the training module and defining a presser member, each of the one or more presser members being attached to the training cap. a training cap having a protrusion extending from the training cap toward the bottom wall, Training module.

25. 1. A drug delivery system comprising: The device has an ejection end defining a drug ejection port and an opposing actuator end. a drug delivery device comprising a drug reservoir, the drug delivery device comprising: a drug delivery device having an actuator for expelling the drug from the reservoir through the outlet port; the actuator extends from the actuator end of the body. The actuator is linearly movable from an extended position to a depressed position, and the discharge The port is sealed when the actuator is in the extended position, and the discharge port The valve is released when the actuator is in the depressed position, and the valve is and expelling the drug from the reservoir upon axial movement from the extended position to the depressed position. an actuator operable to: a medication delivery device further comprising a medication; A product container comprising a cavity having an access opening defined by a bottom wall portion. a side wall defining a cavity and a closed bottom wall, the cavity receiving the medication delivery device; the medication delivery device is sized and configured to accommodate the medication delivery device adjacent the bottom wall of the container. a side wall and a bottom wall received within the cavity with the discharge end abutting the side wall and the bottom wall of the container; a product cap attached to a container, said product cap mating with said container and a product cap providing an airtight seal enclosing the medication delivery device within the cavity; allows movement of the medication delivery device in a direction away from the bottom wall by at most a predetermined amount. a device positioned and configured to interfere with movement of the medication administration device so as to and each of the one or more pressing members is configured to a product cap having a protrusion extending in a direction toward the bottom wall. and, A discharge end defining a simulated drug discharge port and an opposing actuator including a simulated actuator. a training module having a body with a simulator end, An actuator is attached to the actuator end of the body of the training module. training modules that extend from A training container having an access opening defined by an end wall portion. a side wall and a closed bottom wall defining a cavity, said cavity being a training module sized and configured to receive the training module; A valve is received in the cavity with the discharge end adjacent the bottom wall of the container. a side wall and a bottom wall, and a training cap attached to the training container. The training cap is fitted to the training container, and the cavity The training module is enclosed in a training cap, and the training cap is attached to the bottom wall. and allowing movement of the training module in a direction away from the training module by at most a predetermined amount. positioned and configured to interfere with movement of the training module so that and defining one or more presser members for supporting the training object, each of the one or more presser members being a training cap having a protrusion extending in a direction from the training cap toward the bottom wall; a training container having a cup; The medication delivery device is adapted to be inserted into the training cap when the training cap is closed. Drug delivery systems including dimensions that are incompatible when received within a container Hmm.

26. The training module is configured to:

26. The pharmaceutical composition of claim 25, wherein the pharmaceutical composition includes dimensions that are incompatible when received within a product container. Drug delivery system.

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