Oral drug delivery devices

Abstract

A housing having a longitudinal axis and extending from a first end to a second end, It comprises a first mounting portion having a first distal end and a first proximal end, connected to a housing and configured to deliver an active drug component, and an actuator that engages with the first mounting portion and is configured to rotate the first mounting portion about a first rotation axis, The first axis of rotation optionally forms an angle greater than 45 degrees with the longitudinal axis. Oral drug delivery device.

Description

Technical Field

[0003]

[0001] The present disclosure relates to drug delivery devices, particularly to drug delivery devices for oral administration. The drug delivery device is advantageously configured for the delivery of an active drug substance in the gastrointestinal tract (gastrointestinal tract), including the stomach and / or intestine, such as the small intestine and / or large intestine (colon).

Background Art

[0002] Currently, many low-permeability and / or water-insoluble active drug substances are being delivered via routes such as subcutaneous, intradermal, intramuscular, rectal, vaginal or intravenous. Since oral administration is potentially the most widely accepted by patients, attempts have been made to administer low-permeability and / or water-insoluble active drug substances via the preferred oral administration route, but success has been limited, particularly due to a lack of stability and limitations in absorption from the gastrointestinal tract.

[0003] Stability is related to both the stability of the active drug substance during the manufacture and storage of the delivery device and the stability of the active drug substance during passage through the gastrointestinal tract until it becomes absorbable.

[0004] Gastrointestinal absorption is limited, for example, due to the low permeability of the active drug substance caused by pre-systemic metabolism (pre-systemic metabolism, metabolism before systemic metabolism), size, and / or charge, and / or due to the water solubility of the active drug substance, because the gastrointestinal wall barrier prevents the absorption of the active drug substance after oral administration.

[0005] ​​​​​​​​​​Therefore, there remains an unmet need for drug delivery devices that can deliver drug components for absorption within gastrointestinal tissue. More generally, there is still a need for drug products and methods that enable enhanced drug delivery when drugs are administered orally to patients. [Means for solving the problem]

[0007] Disclosed herein are oral drug delivery devices. The oral drug delivery device comprises a housing having a longitudinal axis and extending from a first end to a second end. The oral drug delivery device comprises a first attachment part having a first distal end and a first proximal end, connected to and / or connected within the housing, and configured to deliver an active drug component. The oral drug delivery device comprises an actuator engaging with the first attachment part and configured to rotate the first attachment part, for example, relative to the housing, about a first axis of rotation. The first axis of rotation optionally forms an angle greater than 45 degrees (angle greater than 45 degrees) with respect to the longitudinal axis.

[0008] An advantage of oral drug delivery devices is that they can be efficiently attached to the patient's system, for example, via a first attachment, to deliver the active drug component to the patient. Oral drug delivery devices can include a minimum number of moving components, thereby reducing the amount of components that may be damaged and / or fail during use. Furthermore, certain implementations of the disclosed oral drug delivery devices improve the ability of the oral drug delivery device to be attached to the patient, for example, to the gastrointestinal (gastrointestinal) tissue in the stomach and / or intestines, without relying on multiple attachments.

[0009] Advantageously, the present disclosure provides a large difference in inertia between the housing / body and the mounting portion(s), causing movement of the mounting portion only or primarily the mounting portion during insertion, thereby providing efficient insertion of the mounting portion(s) into the tissue.

[0010] Furthermore, improved design flexibility for oral drug delivery devices is provided by enabling, for example, greater flexibility in the insertion angle of the spike tip / distal end into the tissue, and / or a greater reach of the spike by increasing the distance from the spike tip to the center of the rotation axis.

[0011] Other advantages of this disclosure include design simplicity, large spikes, miniaturization, and a small spatial footprint, which in turn allows for increased volume and improved flexibility in high-load devices.

[0012] The above and other features and advantages of the present invention will be readily apparent to those skilled in the art by describing in detail below exemplary embodiments with reference to the accompanying drawings. [Brief explanation of the drawing]

[0013] [Figure 1] Figure 1 is an exploded view of an exemplary oral drug delivery device. [Figure 2] Figure 2 is a diagram of the exemplary oral drug delivery device shown in Figure 1 from a different perspective. [Figure 3] Figure 3 is a diagram of the exemplary oral drug delivery device shown in Figure 1 from a different perspective. [Figure 4] Figure 4 is a diagram of the exemplary oral drug delivery device shown in Figure 1 from a different perspective. [Figure 5] Figure 5 is a diagram of the exemplary oral drug delivery device shown in Figure 1 from a different perspective. [Figure 6] Figure 6 is a diagram of the exemplary oral drug delivery device shown in Figure 1 from a different perspective. [Figure 7] Figure 7 is an exploded view of an exemplary oral drug delivery device. [Figure 8] Figure 8 is a diagram of the exemplary oral drug delivery device shown in Figure 7 from a different perspective. [Figure 9]Figure 9 is a view of the exemplary oral drug delivery device of Figure 7 from a different perspective. [Figure 10] Figure 10 is a view of the exemplary oral drug delivery device of Figure 7 from a different perspective. [Figure 11] Figure 11 is a view of the exemplary oral drug delivery device of Figure 7 from a different perspective. [Figure 12] Figure 12 is a view of the exemplary oral drug delivery device of Figure 7 from a different perspective. [Figure 13] Figure 13 is an exploded view of an exemplary oral drug delivery device. [Figure 14] Figure 14 is a view of the exemplary oral drug delivery device of Figure 13 from a different perspective. [Figure 15] Figure 15 is a view of the exemplary oral drug delivery device of Figure 13 from a different perspective. [Figure 16] Figure 16 is a view of the exemplary oral drug delivery device of Figure 13 from a different perspective. [Figure 17] Figure 17 is a view of the exemplary oral drug delivery device of Figure 13 from a different perspective. [Figure 18] Figure 18 is a view of the exemplary oral drug delivery device of Figure 13 from a different perspective. [Figure 19] Figure 19 is a view of the exemplary oral drug delivery device of Figure 13 from a different perspective. [Figure 20] Figure 20 is a view of the exemplary oral drug delivery device of Figure 13 from a different perspective. [Figure 21] Figure 21 is a view of an exemplary oral drug delivery device from a different perspective. [Figure 22] Figure 22 is a view of an exemplary oral drug delivery device from a different perspective. [Figure 23] Figure 23 is a view of an exemplary oral drug delivery device from a different perspective. <00​​​​​ [Figure 26] Figure 26 shows an exemplary oral drug delivery device from different perspectives. [Figure 27] Figure 27 shows an exemplary oral drug delivery device from different perspectives. [Figure 28] Figure 28 shows an exemplary oral drug delivery device from different perspectives. [Figure 29] Figure 29 shows an exemplary oral drug delivery device from different perspectives. [Figure 30] Figure 30 shows an exemplary oral drug delivery device from different perspectives. [Figure 31] Figure 31 shows an exemplary oral drug delivery device from different perspectives. [Figure 32] Figure 32 shows an exemplary oral drug delivery device from different perspectives. [Figure 33] Figure 33 shows an exemplary oral drug delivery device from different perspectives. [Figure 34] Figure 34 shows an exemplary oral drug delivery device from different perspectives. [Modes for carrying out the invention]

[0014] Detailed explanation The following describes various exemplary embodiments and details, with reference to the figures where applicable. Note that the figures may or may not be drawn to scale, and that elements having similar structures or functions are represented by the same reference numerals throughout the figures. Also note that the figures are intended solely to facilitate the description of embodiments and their associated functions. They are not intended to be an exhaustive description of the invention, or to limit the scope or physical appearance of the invention. Furthermore, illustrated embodiments do not necessarily have all the aspects or advantages shown. Aspects or advantages described in relation to a particular embodiment are not necessarily limited to that embodiment and may be implemented in other embodiments even if not so illustrated or explicitly described.

[0015] Disclosed herein are oral drug delivery devices; that is, drug delivery devices configured for oral administration are provided. The oral drug delivery device comprises a housing or body having a longitudinal axis and extending from a first end to a second end.

[0016] The drug delivery device optionally comprises a shell or cover that encapsulates (encases) other parts of the drug delivery device. The shell may be made of a biodegradable material such as gelatin and / or hydroxypropyl methylcellulose (HPMC). Other materials suitable for the shell include compositions comprising one or more polymethacrylate copolymers, also known as Eudragit (trademark), such as Eudragit (trademark) E PO. The shell may be a multi-part shell, such as a two-part capsule. The shell or capsule may comprise multiple layers, for example, a first layer of a first material and a second layer of a second material different from the first material.

[0017] An oral drug delivery device comprises one or more, for example two, mounting parts, including a first mounting part having a first distal end and a first proximal end. The first mounting part is connected to and / or connected within the housing and configured to deliver the active drug component in, for example, an attached position.

[0018] The first mounting portion, such as the first spike described later, may be made from or comprise a biodegradable material. For example, the first mounting portion, such as the first spike, may be made from a material comprising one or more types of starch-based polymers, one or more types of cellulose-based polymers, one or more types of synthetic polymers, a mixture of starch-based polymers and synthetic polymers, or a mixture of starch-based polymers and cellulose-based polymers, or a combination thereof.

[0019] In one or more examples, the first attachment portion, such as a first spike, comprises one or more biodegradable polymers selected from polylactic acid (PLA), one or more derivatives of PLA, polycaprolactone (PCL), one or more derivatives of PCL, polyhydroxybutyrate (PHB), and one or more derivatives of PHB.

[0020] In one or more examples, the first mounting portion, such as a first spike, comprises or is composed of PLA, ethylcellulose, one or more plasticizers (such as any of the plasticizers described herein), and one or more UV stabilizers (such as any of the UV stabilizers described herein), and optionally contains an active drug component.

[0021] In one or more examples, the material of the first mounting device may comprise a metal or metal alloy, for example, a biodegradable or bioabsorbable metal or metal alloy, for example, magnesium, zinc, and / or iron, or an alloy comprising one or more of magnesium, zinc, and iron. A biodegradable or bioabsorbable metal or metal alloy can be understood as a metal or metal alloy that safely decomposes in the body, such as the human body, within a practical time related to its application. In the example, the first mounting portion of the metal may be preferred if the first mounting portion, such as a first spike, has or provides access to a first chamber, also called a drug cavity, for example, to hold or retain an active drug component.

[0022] In one or more examples, the first attachment, such as a first spike, comprises a biodegradable polymer or is made of a material that is a biodegradable polymer, and the first attachment, such as a first spike, comprises a drug cavity for comprising, holding, or housing an active drug component.

[0023] In one or more examples, a first attachment, such as a first spike, is made from a material comprising a biodegradable and / or bioabsorbable polymer, in which, for example, the active drug component is embedded in or dispersed in the polymer, such as polyethylene glycol (PEG), a PEG derivative, polyethylene oxide (PEO), a PEO derivative, or a combination thereof.

[0024] In one or more examples, a first mounting portion, such as a first spike, is made from a material comprising one or more copolymers, such as one or more poloxamers. The one or more poloxamers may include poloxamer 188 and / or poloxamer 407.

[0025] An oral drug delivery device comprises an actuator that engages with a first mounting portion and / or housing and is configured to rotate the first mounting portion relative to the housing about a first axis of rotation. In one or more exemplary oral drug delivery devices, the first axis of rotation forms an angle greater than 45 degrees with respect to the longitudinal axis. In one or more exemplary oral drug delivery devices, the first axis of rotation forms an angle greater than 75 degrees with respect to the longitudinal axis, for example, an angle in the range of 80 to 100 degrees.

[0026] In one or more examples, an oral drug delivery device is disclosed, comprising: a housing having a longitudinal axis and extending from a first end to a second end; a first mounting portion having a first distal end and a first proximal end, connected to and / or connected within the housing and configured to deliver an active drug component; and an actuator engaging with the first mounting portion and configured to rotate the first mounting portion about a first rotation axis, the first rotation axis forming an angle greater than 45 degrees (angle greater than 45 degrees) with the longitudinal axis.

[0027] An oral drug delivery device may have an initial configuration. The initial configuration may be the initial position and / or initial state when the oral drug delivery device is taken into the patient by means of swallowing, etc. The initial configuration may be the pre-operation configuration of the actuator, for example, the actuator mechanism, of the oral drug delivery device. The initial configuration may be the configuration of the mounting part(s), for example, a first mounting part and / or a second mounting part, when they are in their initial positions.

[0028] Oral drug delivery devices may have a size and geometry designed to accommodate pharmaceutical compositions for oral administration. In this specification, unless otherwise specified, "drug delivery device" refers to an oral drug delivery device.

[0029] Oral drug delivery devices may be configured to be taken into the body via an oral orifice (oral opening). For example, an oral drug delivery device may be configured to be taken into the body in its initial configuration, for example, when the first attachment and / or second attachment are in their respective initial positions. Therefore, the external dimensions of an oral drug delivery device may be small enough to be swallowed by the user. Oral drug delivery devices may be adapted to deliver drug components, such as active drug components, into the user's body via the digestive system, so that the drug delivery device can travel, for example, from the user's mouth through the esophagus to the stomach. Oral drug delivery devices may be configured to travel further from the stomach to the intestines, optionally to the large intestine, and exit the body through the rectum. Drug delivery devices, such as housings, may have lengths ranging from 10 mm to 30 mm. Housings may be single-part or multi-part.

[0030] Oral drug delivery devices may be configured to deliver a drug to any part of the user's digestive system, for example, to deliver a drug component to the user's stomach. In another example, an oral drug delivery device may be adapted to begin drug delivery when the device has passed through the stomach and entered the user's intestines. In other words, an oral drug delivery device may be configured to attach to the stomach wall or the intestinal wall, for example, depending on the desired release site of the active drug component. For example, an oral drug delivery device may be configured to transition from an initial configuration to an attached configuration so as to attach to a patient. In one or more exemplary oral drug delivery devices, the oral drug delivery device is configured to transition from an initial configuration to an attached configuration as a first attachment part and / or a second attachment part move from their respective initial positions to their attached positions.

[0031] The attachment portion(s) of the oral drug delivery device, for example, a first attachment portion and / or a second attachment portion, may be configured to interact with the inner surface lining of the gastrointestinal tract, for example, by penetrating it, so that the oral drug delivery device can be attached, for example, to the inner surface (mucosa) of the stomach, or alternatively to the mucosa of the intestine, for example, in a post-attachment position. The attachment portion(s), for example, a first attachment portion and / or a second attachment portion, may be configured to interact with the mucosa, for example, to fix or attach the oral drug delivery device in the user's body for a certain period of time, for example. By attaching the oral drug delivery device, the drug component can be delivered to a part of the digestive system in order to supply the active drug component into the user's body. The attachment portion(s) may be configured to interact with the mucosa, for example, by penetrating it, so that the active drug component can be injected into the wall of the digestive tract (gastrointestinal wall).

[0032] In one or more exemplary drug delivery devices, the oral drug delivery device may be configured to include a desorption function. For example, the oral drug delivery device may be configured in such a way that, after the dispersion of the active drug component, the oral drug delivery device or at least a part thereof may be released from its internal tissue and / or internal surface.

[0033] An oral drug delivery device may have a post-attachment configuration, such as an attached position, attachment position, attachment configuration, and attached state. The post-attachment configuration may allow the oral drug delivery device to attach to a surface within the patient, such as tissue, and enable the delivery of the active drug component. The post-attachment configuration may be a configuration for attaching the drug delivery device to the patient. The post-attachment configuration may differ from the initial configuration. In the post-attachment configuration, the oral drug delivery device may be held in a state attached to the patient. In the post-attachment configuration, the first attachment element and / or the second attachment element are in the post-attachment position. The post-attachment configuration may be a configuration after the actuator of the oral drug delivery device has been activated.

[0034] In one or more exemplary oral drug delivery devices, the oral drug delivery device may be defined by a housing. The housing includes a first end and a second end, which may be considered to be a first and second longitudinal end. The first end is opposite the second end. The housing includes a longitudinal axis. The longitudinal axis extends between the first and second ends. In one or more oral drug delivery devices, the housing may be configured to retain certain components of the oral drug delivery device in their initial positions. For example, the housing may retain one or more of a first mounting portion and an actuator. The housing may retain a second mounting portion. The housing may form a first cavity and / or a second cavity, as discussed herein. The housing may be configured to at least partially house (e.g., surround) components of the oral drug delivery device. For example, the housing may at least partially house an actuator. The housing can accommodate at least partially the first mounting portion.

[0035] In one or more oral drug delivery devices, the housing may be a one-piece or single-piece body, for example, an integrated body. In one or more oral drug delivery devices, the housing or body may consist of one or more body parts, for example, a first body part and a second body part. The housing includes an outer surface. In one or more oral drug delivery devices, the housing may be non-rotatable. For example, the internal components of the oral drug delivery device may rotate relative to the housing, while the housing remains stationary (outside the range of inertial forces). In other words, if the housing is formed from two body parts that are attached to each other, such as a first body part and a second body part, the first body part may be non-rotatable relative to the second body part. For example, the first body part may be fixed non-rotatably (not to rotate) relative to the second body part.

[0036] In one or more exemplary oral drug delivery devices, the housing may define a first cavity, such as a recess, gap, slot, hole, opening, retainer, or first housing cavity, extending to the outer surface of the housing. The first cavity may be formed by solid walls on at least two sides, excluding the open outermost surface(s). For example, the first cavity may be formed by a first wall, a second wall, and optionally a bottom. The first wall may face the second wall. The bottom may connect the first wall and the second wall. In one or more exemplary oral drug delivery devices, the first wall and / or the bottom wall and / or the second wall are flat. In one or more exemplary oral drug delivery devices, the first wall and / or the bottom wall and / or the second wall are curved. The open outermost surface may be curved to conform to the outer surface of the oral drug delivery device. The housing may include multiple cavities, such as a second cavity, a third cavity, a fourth cavity, and so on. For example, the first cavity may be located on the opposite side of the housing from the second and / or third cavities, for example, on the opposite side of the longitudinal axis. Components of an oral drug delivery device within the first cavity can be considered to be housed within the housing.

[0037] The oral drug delivery unit may include one or more attachments of the oral drug delivery device, e.g., a first attachment and / or a second attachment. One or more attachments may be considered any type of attachment(s) that can attach the oral drug delivery device to biological tissue, e.g., the stomach wall, large intestine and / or small intestine (intestine) wall of a human or animal body. The attachment(s), e.g., the first attachment and / or the second attachment, may be configured to attach the drug delivery device to a patient. The attachment(s), e.g., the first attachment and / or the second attachment, may be configured to deliver the active drug component. The oral drug delivery unit may have only a single attachment.

[0038] The first mounting portion may be connected to the housing. The first mounting portion may be translatably mounted to the housing. The first mounting portion may be configured to move relative to the housing. For example, the first mounting portion may be rotatably mounted in the housing, for example, via the first proximal end of the first mounting portion. The first mounting portion may be rotatably connected to and / or within the first cavity. The first mounting portion may be configured to move from an initial position to a post-mounting position via an actuator. In the initial position, the first mounting portion or at least part or a section thereof may be located within the first cavity. For example, the first distal end and / or distal section of the first mounting portion may be located within the first cavity in the initial position. The first distal end may exit or "clear" from the first cavity and / or housing when moving from the initial position to the post-mounting position. Clearing the first cavity may include areas outside the housing, such as the outside of the first cavity.

[0039] The first mounting portion may comprise a single component, such as being integrated. The first mounting portion may comprise multiple components. In one or more exemplary oral drug delivery devices, the first mounting portion comprises a first arm. In one or more exemplary oral drug delivery devices, the first mounting portion comprises a first spike. The first spike may be located at the first distal end. The first mounting portion, such as the first spike, may include a bend.

[0040] In other words, the first mounting portion may comprise a first arm and / or a first spike, e.g., a spike component, a needle, a spike, or a spear. The first mounting portion has a first proximal end, e.g., a proximal end, and a first distal end, e.g., a distal end. The first tip of the first spike may form the first distal end. In other words, the first distal end is the first tip of the first spike. The first arm may be positioned at the first proximal end of the first mounting portion, may form part of the first proximal end of the first mounting portion, or may constitute the first proximal end of the first mounting portion. The first arm may be connected to a housing and / or connected to the housing, for example, at the first proximal end of the first mounting portion.

[0041] The first spike may have a length in the range of 1 mm to 15 mm, for example, in the range of 3 mm to 10 mm. This may provide sufficient penetration into internal tissue while simultaneously reducing the risk of damaging the internal tissue. The first distal end of the first attachment may have a tip configured to penetrate biological tissue. The first distal end of the first attachment may be provided with a gripping portion configured to grasp biological tissue.

[0042] The first spike may be linear and / or curved. The first mounting portion may include one, two, or more linear portions formed at an angle, thereby forming a bend between them. The bend may be in the range of 30 to 120 degrees, for example, 75 to 105 degrees, for example, 90 degrees. In one or more exemplary oral drug delivery devices, the first spike comprises a proximal section. In one or more exemplary oral drug delivery devices, the first spike comprises a distal section including a distal end. The distal end is oriented distally, parallel to the distal section. In one or more exemplary oral drug delivery devices, the distal section extends at an angle between 30 and 80 degrees, or between 100 and 170 degrees, from the longitudinal axis in the post-mounted position. In other words, the distal direction may form an angle between 30 and 80 degrees from the longitudinal axis in the post-mounted position. In one or more exemplary oral drug delivery devices, the distal section extends at an angle between 30 and 80 degrees from the longitudinal axis in the post-mounted position. In one or more exemplary oral drug delivery devices, the distal section extends at an angle between 100 and 170 degrees from the longitudinal axis in the post-mounted position. In other words, the distal direction can form an angle between the longitudinal axis and the longitudinal axis in the range of 100 and 170 degrees in the post-mounted position. The angle between the distal and proximal sections may be formed by a curved section. The angle between the distal and proximal sections may be formed by a single change in angle. A bend may separate the proximal section from the distal section, for example, by connecting the proximal section to the distal section. The distal section may extend at an angle between 30 and 80 degrees, or between 100 and 170 degrees, from the longitudinal axis when the housing is cleared, such as when the distal end clears the first cavity. The angle may be formed within the rotational plane of the first mounting portion. The angle may be formed at a second angle from the rotational plane of the first mounting portion.

[0043] In one or more exemplary oral drug delivery devices, the first mounting portion may include one or more components, such as members, intermediate parts, or pieces. One or more of the components may be releasably connected to an oral drug delivery device, such as a housing.

[0044] A first mounting portion, such as a distal portion, may be held within a first cavity of the housing, for example, in an initial position. In one or more exemplary oral drug delivery devices, the first mounting portion may be translatably connected to the housing. The first mounting portion may be rotatably connected to the housing. In the initial configuration, the first mounting portion or a part thereof, such as the distal portion, may be held entirely within the first cavity. This may be known as the initial position. In the post-mounted configuration, the first mounting portion may extend at least partially from the first cavity. Thus, the distal end of the first mounting portion may translate, such as by rotation, from within the first cavity, such as in the initial position, to outside the first cavity, such as in the post-mounted position. This translation may occur during the operation of an actuator.

[0045] While rotational motion is described herein, it will be understood that other translations and / or motions may also be used, for example, as an alternative to or in combination with rotational motion. For example, linear motion, longitudinal motion, radial motion, and circumferential motion may all be used to move the first mounting part between an initial position and a post-mounting position. Furthermore, as used herein, translations may include one or more of shifting, rotation, moving, and releasing.

[0046] In one or more exemplary oral drug delivery devices, the proximal end of a first mounting portion may include a first mounting point (mounting location) within the housing (e.g., a mounting surface, mounting mechanism, mounting plane, mounting section, mounting component, mounting structure, attachment, connector, rotatable connector). For example, the first mounting portion may include a first mounting point within the housing. The first mounting point may be, for example, a hinge. The first mounting point may be a pin. The type of mounting point is not limited. The first mounting portion may include, for example, a first hinge portion located at the proximal end of the first mounting portion. The first hinge portion may include, for example, a bore such as a through bore configured to accommodate a second hinge portion or rod for forming a rotatable connection between the housing and the first mounting portion. Thus, the housing may have a second hinge portion such as a rod. Actuators such as springs may be positioned between the first hinge portion and the second hinge portion, for example, circumferentially with respect to the second hinge portion, and / or at least partially within the through bore.

[0047] In one or more exemplary oral drug delivery devices, the first mounting portion may be configured to move relative to the housing at a first mounting point. In one or more exemplary oral drug delivery devices, the first mounting portion may be configured to rotate relative to the housing at a first mounting point. The rotation of the first mounting portion may be about a first axis of rotation. For example, the first mounting portion may be rotatably connected along the first axis of rotation within a first cavity, for example, relative to the housing.

[0048] The first axis of rotation may be different from the longitudinal axis. For example, the first axis of rotation may form an angle greater than 45 degrees with respect to the longitudinal axis. The first axis of rotation may form an angle greater than 75 degrees with respect to the longitudinal axis. In the current context, the angle between two axes can be considered the smallest angle between the two axes. For example, if there is a primary angle and a quadratic angle, the smallest angle is the primary angle.

[0049] In one or more exemplary oral drug delivery devices, the first axis of rotation is perpendicular to the longitudinal axis. For example, the first axis of rotation may form a 90-degree angle with the longitudinal axis. In one or more exemplary oral drug delivery devices, the first axis of rotation may form an angle of less than 15 degrees with the longitudinal axis. In one or more exemplary oral drug delivery devices, the first mounting portion may be configured to rotate along a plane formed by the longitudinal axis. In one or more exemplary oral drug delivery devices, the first mounting portion may be configured to rotate along a single plane formed by the longitudinal axis.

[0050] In one or more exemplary oral drug delivery devices, the first axis of rotation is fixed (stationary). In particular, the first axis of rotation is fixed to the housing. Thus, although the oral drug delivery device may rotate in space, the first axis of rotation is always positioned in the same relative position to the housing. For example, the oral drug delivery device may rotate due to inertia, but the axis of rotation can remain in the same position relative to the housing.

[0051] In one or more exemplary oral drug delivery devices, the first axis of rotation is located at the center of the housing and / or the drug delivery device. In one or more exemplary oral drug delivery devices, the first axis of rotation is located at the longitudinal center of the housing. In one or more exemplary oral drug delivery devices, the first axis of rotation is located at the center of the housing defined by an axis perpendicular to the longitudinal axis. The longitudinal axis may intersect the first axis of rotation.

[0052] In one or more exemplary oral drug delivery devices, a first axis of rotation is located closer to the outer surface of the housing than to the center of the housing. The first axis of rotation may be spaced apart from the longitudinal axis. For example, a first mounting portion may be configured to rotate around the outer surface of the housing. In one or more exemplary oral drug delivery devices, a second axis of rotation is located closer to the outer surface of the housing than to the center of the housing. The second axis of rotation and the first axis of rotation may be located on the same side of the housing, such as on the same side of the longitudinal axis. The second axis of rotation and the first axis of rotation may be located on opposite sides of the housing, such as on the opposite side of the longitudinal axis.

[0053] In one or more exemplary oral drug delivery devices, the first axis of rotation is located closer to the first end than to the second end. In one or more exemplary oral drug delivery devices, the first axis of rotation is located between the first end and the center along the longitudinal axis. In one or more exemplary oral drug delivery devices, the first axis of rotation is located closer to the first end than to the center of the housing. For example, the housing may be defined as having a length L. The first axis of rotation may be located less than 0.4L, e.g., less than 0.25L, from the first end of the housing. The first axis of rotation may be located at positions of 0.1L, 0.2L, 0.3L, and 0.4L from the first end of the housing. The first axis of rotation near the first end allows for a longer first attachment, thereby increasing the opportunity for the first attachment / distal end to engage with tissue while rotating outside the housing. The first axis of rotation may be positioned at a location greater than 0.6L from the second end of the housing, for example, greater than 0.75L.

[0054] As described above, the actuator is configured to rotate the first mounting portion about a first axis of rotation, for example, in a first direction such that the distal end of the first mounting portion is parallel to the distal direction, which is parallel to the distal section, or forms an angle of less than 45 degrees with the distal direction. For example, the first mounting portion may rotate relative to the housing. In one or more exemplary oral drug delivery devices, the first mounting portion may rotate out of a first cavity. In one or more exemplary oral drug delivery devices, the first mounting portion, such as the distal end / distal section, may rotate (partially and / or completely) into the first cavity or a second cavity after rotating out of the first cavity, for example.

[0055] In one or more exemplary oral drug delivery devices, the first mounting portion is configured to rotate between an initial position and a post-mounted position between 200 and 350 degrees. In other words, the first mounting portion may rotate within a range of 200 to 350 degrees to move from the initial position to the post-mounted position. The first mounting portion may be configured to rotate at least 100 degrees, for example, at least 180 degrees, and even more than 270 degrees, from the initial position to the mounted position. In one or more exemplary oral drug delivery devices, the first mounting portion is configured to be in a non-mounted position between 30 and 350 degrees of rotation of the first mounting portion.

[0056] In one or more exemplary oral drug delivery devices, in the initial position, a first mounting portion, for example, the distal end and / or distal section of the first mounting portion, is located within a first cavity of the housing. In the post-mounted position, the first mounting portion may be located within a first or second cavity of the housing. In the post-mounted position, the first mounting portion, such as the distal end and / or distal section of the first mounting portion, may be located at least partially within a first or second cavity. For example, the first distal end may be located within a second cavity in the post-mounted position. In one or more exemplary oral drug delivery devices, the first mounting portion is located on and / or near the outer surface of the housing.

[0057] In one or more exemplary oral drug delivery devices, the oral drug delivery device may include a stopper. The stopper may be located inside a second cavity. The stopper may be located outside the housing. For example, a portion of the outer surface of the housing may form the stopper. The stopper is configured to prevent rotation of the first mounting portion. In one or more exemplary drug delivery devices, the stopper is configured to rotate, for example, about a first axis of rotation or about a stopper axis of rotation. The stopper axis of rotation may be parallel to the first axis of rotation. The stopper may be configured to rotate together with the first mounting portion. The stopper may be configured to rotate differently from the first mounting portion. The stopper may be part of the housing, such as an outer surface. For example, the stopper may be an indentation in the housing. The stopper may be separate from the housing.

[0058] In one or more exemplary oral drug delivery devices, a first attachment is configured to deliver an active drug component. The first attachment, such as a first spike, may have one or more openings providing access to the housing and / or a (first) chamber within the first attachment. In one or more exemplary oral drug delivery devices, the (first) chamber is formed as a through-bore of the first spike or comprises a through-bore. The (first) chamber may be configured to hold, for example, retain the active drug component. In one or more exemplary oral drug delivery devices, the (first) chamber may open outward from the internal volume of the housing to the external portion of the housing. In one or more examples, the (first) chamber may be located inside the first spike so that the active drug component can be released from the (first) chamber into the biological tissue via the first spike when the first distal end of the first attachment penetrates the biological tissue. This could be the case, for example, when the first spike is a tubular portion and the first distal end is in fluid communication with the (first) chamber.

[0059] In one or more exemplary oral drug delivery devices, the oral drug delivery device has only a single mounting portion (e.g., a first mounting portion). In one or more exemplary oral drug delivery devices, the oral drug delivery device comprises a second mounting portion. The second mounting portion may be connected to the side of the housing opposite to the first mounting portion. The second mounting portion may be connected to the side of the housing on the same side as the first mounting portion. The second mounting portion may be rotatably connected to the housing. The second mounting portion may be fixed, for example, non-rotatable.

[0060] In one or more exemplary oral drug delivery devices, the second mounting portion is configured to rotate about a first axis of rotation. For example, both the first and second mounting portions may be configured to rotate about a first axis of rotation. In one or more exemplary oral drug delivery devices, the second and first mounting portions are configured to rotate simultaneously about a first axis of rotation.

[0061] In one or more exemplary oral drug delivery devices, the oral drug delivery device may include a second mounting portion. The second mounting portion may have a second distal end and a second proximal end. The second mounting portion may be connected to and / or connected within the housing. An actuator may engage with the second mounting portion and may be configured to rotate the second mounting portion about a second axis of rotation relative to the housing. The second axis of rotation may be different from the first axis of rotation. The second axis of rotation may be the same as the first axis of rotation. In other words, the first and second mounting portions may share the same first hinge portion.

[0062] In one or more exemplary oral drug delivery devices, a second attachment is configured to deliver an active drug component. The second attachment, such as a second spike, may have one or more openings providing access to a first chamber and / or a second chamber within the housing and / or the first attachment. In one or more exemplary oral drug delivery devices, the second chamber is formed as a through-bore of the second spike or comprises a through-bore. The second chamber may be configured to hold, for example, retain the pharmacoactive substance. In one or more exemplary oral drug delivery devices, the second chamber may open from the internal volume of the housing toward the external portion of the housing. In one or more examples, the second chamber may be inside the second spike, and the active drug component may be released from the chamber through the second spike into the tissue when the second distal end of the second attachment penetrates the tissue. This could be the case, for example, when the second spike is a tubular component and has a second distal end that is in fluid communication with the second chamber.

[0063] In one or more exemplary oral drug delivery devices, an actuator is configured to rotate a first mounting portion and a second mounting portion. In one or more exemplary oral drug delivery devices, an actuator is configured to rotate a first mounting portion, and a second actuator is configured to rotate a second mounting portion.

[0064] In one or more exemplary oral drug delivery devices, a first mounting portion is operably coupled to a second mounting portion, such that rotation of the first mounting portion causes rotation of the second mounting portion. For example, the first mounting portion may be operably coupled to the second mounting portion via one or more gears. Other connecting and / or intermediate components may be used to operably couple the first and second mounting portions.

[0065] In one or more exemplary oral drug delivery devices, a first mounting portion comprises a first arm and a first spike. The first spike may be located at or may have a first distal end. In one or more exemplary oral drug delivery devices, a second mounting portion comprises a second arm and a second spike, the second spike may be located at or may have a second distal end. In one or more exemplary oral drug delivery devices, the first spike and the second spike overlap within the housing. In one or more exemplary oral drug delivery devices, the first spike and the second spike overlap within the housing when the first mounting portion and the second mounting portion are in their respective initial positions. The overlap may be longitudinal. The overlap may be radial.

[0066] In one or more exemplary oral drug delivery devices, a first arm extends over at least half the longitudinal length of the housing. In one or more exemplary oral drug delivery devices, a second arm extends over at least half the longitudinal length of the housing.

[0067] In one or more exemplary oral drug delivery devices, when the actuator is operated, the first and second arms are configured to intersect each other within the housing. For example, the first and second arms may have a combined length greater than the length of the oral drug delivery device. In one or more exemplary drug delivery devices, both the first and second arms may be simultaneously positioned on a plane perpendicular to the longitudinal axis. The plane perpendicular to the longitudinal axis may be at the longitudinal center of the oral drug delivery device. The plane perpendicular to the longitudinal axis may be offset from the longitudinal center of the oral drug delivery device.

[0068] In one or more exemplary oral drug delivery devices, the first axis of rotation and the second axis of rotation are coaxial. In one or more exemplary oral drug delivery devices, the first axis of rotation is spaced apart from the second axis of rotation. For example, the first axis of rotation may be spaced apart from the second axis of rotation.

[0069] In one or more exemplary oral drug delivery devices, the oral drug delivery device may include an actuator. The actuator engages with a first mounting portion. The actuator is configured to rotate the first mounting portion about a first axis of rotation. For example, the actuator is connected to the first mounting portion (e.g., directly connected). The actuator may be operably connected to the first mounting portion. In one or more exemplary oral drug delivery devices, the actuator is configured to rotate the first mounting portion about a first axis of rotation, without rotating any part of the housing. In other words, the actuator may be configured to rotate the first mounting portion relative to the housing. The actuator may be configured to rotate the first mounting portion from an initial position to a post-mounting position. The actuator may be an elastic member, or may include an elastic member. The actuator may be a spring. The actuator may be a rotary spring or a linear spring. Since the actuator can engage directly with the first mounting portion, there is no need to deploy the first mounting portion or perform any additional actions to attach it to the tissue. The first mounting portion can be attached to the tissue in a single action, namely rotation around the first axis of rotation.

[0070] An actuator, such as an elastic member, can be used to store energy, such as rotational energy or rotational force, that can be applied to the first mounting portion and which is stored in the actuator, such as an elastic member. Furthermore, when the energy is released, the force can be released against the first mounting portion. The actuator, such as an elastic member, may take the form of, for example, a helical spiral spring (main spring) and / or a spiral torsion spring. The actuator can store energy in the main spring by twisting the spiral more tightly. The stored force in the main spring can then rotate the mounting portion in the opposite direction when the main spring is unwound. Thus, the force of the main spring can move the first mounting portion, and optionally the second mounting portion, in opposite directions, so that the mounting portion(s) can clamp, and further clamp or penetrate, the biological tissue for attaching an oral drug delivery device to biological tissue.

[0071] In one or more exemplary oral drug delivery devices, the actuator may be configured to move the first mounting portion in relation to the second mounting portion, such as by moving the first distal end toward the second distal end. In one or more exemplary oral drug delivery devices, the actuator may be configured to move the first distal end toward the second distal end on the first side of the housing, and then move the first distal end toward the second distal end on the second side of the housing. For example, the actuator mechanism may be configured to move the first mounting portion in a first direction about a first axis of rotation, and move the second mounting portion in a second direction about a second axis of rotation.

[0072] In one or more exemplary oral drug delivery devices, the actuator is configured to move a first distal end toward a second distal end, such as from an initial position to a post-mounted position. Moving the first distal end toward the second distal end can be understood as reducing the distance between the first distal end and the second distal end. Moving the first distal end toward the second distal end can be understood as reducing the angle between the first mounting axis and the second mounting axis, such as reducing the angle between the first mounting portion and the second mounting portion. In one or more exemplary drug delivery devices, the actuator reduces the distance between the first distal end and the second distal end during the rotation of the first body portion relative to the second body portion about a central axis. In certain exemplary embodiments, the drug delivery device may be in a mounting configuration when the first distal end is closest to the second distal end.

[0073] Therefore, the attachment portion can be adapted to contact and / or penetrate the tissue of the digestive tract (gastrointestinal tract). Rotation of the attachment portion(s) can move the attachment portion(s) in such a manner that it can penetrate or clamp, for example, the mucosa, in order to fix the oral drug delivery device in place within the gastrointestinal tract, such as the stomach and / or gastrointestinal tissue and / or the intestines. When the first attachment portion and / or second attachment portion penetrate or clamp the biological tissue, each(s) penetration point in the biological tissue can be used to deliver the active drug component from the oral drug delivery device into the biological tissue, and the active drug component can be introduced into the biological tissue beyond the mucosa. This can make drug delivery more effective, as the active drug component can enter the bloodstream more easily than when it is released in the lumen of the stomach or intestine. For example, if the active drug component is insulin, insulin can be broken down in the gastrointestinal tract and cannot be absorbed from the gastrointestinal tract. However, if the mucosa is penetrated and insulin is released through the penetrated gastrointestinal wall, the insulin remains intact and reaches the user's bloodstream via the blood vessels in the intestinal layer beyond the mucosa (surface).

[0074] In one or more exemplary oral drug delivery devices, the drug delivery device comprises a locking mechanism. The locking mechanism may be configured, for example in an initial configuration, to prevent rotation of a first mounting portion and / or a second mounting portion relative to the housing. A shell may act as a locking mechanism. The locking mechanism may be configured to release, for example, by dissolving, to allow rotation. The locking mechanism may be configured to prevent the operation of an actuator. The locking mechanism may be a cover, shell, and / or collar around the outer surface of the drug delivery device, for example, around the outer surface of the housing. The locking mechanism may partially cover the outer surface of the drug delivery device, for example, around the outer surface of the housing. The locking mechanism may completely cover the outer surface of the drug delivery device, for example, around the outer surface of the housing. Other locking mechanisms may be used, such as a dissolvable plug, and no particular locking mechanism is limited. When the locking mechanism dissolves, the actuator is configured to rotate the first mounting portion about a first axis of rotation.

[0075] In one or more exemplary oral drug delivery devices, the locking mechanism may be a capsule, such as a soluble (e.g., degradable, biodegradable) capsule. The capsule may partially and / or completely enclose the oral drug delivery device. The capsule may partially and / or completely enclose the housing. The oral drug delivery device may include a capsule and a locking mechanism. When the capsule dissolves, the actuator is optionally configured to rotate the first mounting portion about a first axis of rotation.

[0076] In the initial configuration, the first mounting portion may be in a first initial position (e.g., initial position), and / or the second mounting portion may be in a second initial position. For example, the first initial position may be the same for the second mounting portion, where the first mounting portion is positioned within the first cavity, such as the first distal end. Furthermore, the actuator may be configured to rotate the first mounting portion and / or the second mounting portion relative to the housing, but rotation may be prevented. This may be the most compact configuration for a drug delivery device.

[0077] Next, the oral drug delivery device may transition from an initial configuration to a post-mounted configuration via the rotation of the first mounting portion from the initial position to the post-mounted position. This transition may result from the operation of an actuator, for example, from the release of a locking mechanism. The transition from the initial configuration to the post-mounted configuration may include moving the first mounting portion about a first axis of rotation relative to the housing, for example, by rotation. In other words, the first mounting portion may move, such as rotating out of the first cavity / housing. The transition from the initial configuration to the mounted configuration may also include moving the second mounting portion about a second axis of rotation relative to the housing. In other words, the second mounting portion may move out of the second cavity / housing. The mounting position may be configured for mounting the drug delivery device to a patient.

[0078] Figure 1 shows an exploded view of an exemplary oral drug delivery device according to the present disclosure, and Figures 2 to 6 show different viewpoints of the drug delivery device of Figure 1. As illustrated, the oral drug delivery device 100 includes an optional shell / capsule 101 (not shown in Figures 2 to 6) and a housing 102 housed in the shell 101. The housing 102 has a longitudinal axis 104 and extends between a first end 106 and a second end 108. Furthermore, the oral drug delivery device 100 includes a first mounting portion 110. The first mounting portion 110 has a first distal end 112 and a first proximal end 114. As illustrated, the first mounting portion 110 is connected to and / or connected within the housing 102 and configured to deliver an active drug component 154. The shell 101 acts as a locking mechanism and is configured to maintain the first mounting portion 110 in an initial position. Once the shell 101 dissolves in the stomach / intestine, the first mounting portion 110 is permitted to rotate to its post-mounted position. The oral drug delivery device 100 further includes an actuator 116 that engages with the first mounting portion 110. The actuator 116 (a spiral blade spring) is configured to rotate the first mounting portion 110 about a first rotation axis 118. The first rotation axis 118 forms an angle greater than 45 degrees with the longitudinal axis 104. In the illustrated example, the first rotation axis 118 is perpendicular to the longitudinal axis 104. In other implementations, the first rotation axis 118 forms an angle less than 15 degrees with the longitudinal axis 104.

[0079] The housing 102 forms a first cavity 120 and optionally a second cavity 122. The housing 102 / first cavity 120 is configured to at least partially house (e.g., surround, house) components of the oral drug delivery device, such as at least a portion of the first mounting device 110.

[0080] In a specific mounting configuration as shown in Figure 1, the first mounting portion 110 includes a first arm 132, a first spike 134, and a bent portion 136 between the first arm 132 and the first spike 134. The first spike 134 is positioned at the first distal end 112, and the bent portion 136 has a bend in the range of 75 to 105 degrees, for example, a 95-degree bend as shown; see also Figure 5. The first spike 134 includes a proximal section 142 and a distal section 144, the distal section extending at an angle between 30 and 80 degrees or between 100 and 170 degrees from the longitudinal axis 104 in the post-mounted position; see also Figure 5.

[0081] The first mounting portion includes a first mounting point (mounting location) at its proximal end 114, which is embodied as a first hinge portion 146 having or forming a through bore 147 that forms a hinge with a second hinge portion 148 in the form of a rod 149 of the housing 102.

[0082] The oral drug delivery device 100 is optionally equipped with a stopper 152 configured to stop the first mounting portion 110 in the mounted position; see Figure 5.

[0083] Figures 2 and 3 show the first mounting portion 110 in its initial position. Figure 2 is a perspective view of the oral drug delivery device 100 with no shell 101 and the first mounting portion 110 in its initial position, wherein the first mounting portion 110 or at least portions 132, 134, 136 are located within the first cavity 120 of the housing 102.

[0084] Figure 3 is a cross-sectional view of the oral drug delivery device 100. As is clear from Figure 3, the first rotation axis is located closer to the first end 106 than to the second end 108 of the housing, for example, less than 0.25 L from the first end 106. For example, the first rotation axis 118 is located between the first end 106 and the center C along the longitudinal axis 104. For example, the first rotation axis 118 is located closer to the first end 106 than the center C of the housing 102. As shown in Figure 3, in the initial position, the first mounting portion 110 and the stopper 152 are located within the first cavity 120 of the housing 102.

[0085] Figure 4 is a cross-sectional view of the oral drug delivery device 100 with the first mounting device 110 beginning to rotate around the first rotation axis 118. The first mounting portion 110 can rotate as indicated by the arrows in Figure 4 and end up in the post-mounted position shown in Figures 5 and 6. The first mounting portion 110 is configured to rotate from the initial position to a post-mounted position between 200 and 350 degrees. When the first distal end 112 abuts against the stopper 152, the first mounting portion 110 can stop in the post-mounted position.

[0086] Figure 5 is a cross-sectional view of the oral drug delivery device 100 in its post-mounted position after the first mounting device 110 has rotated around the first rotation axis 118. The first mounting portion 110, such as the first spike 134, optionally includes a chamber 153 for holding the active drug component 154. In one or more mounting configurations, the active drug component is embedded in the first mounting portion 110.

[0087] Figure 7 shows an exploded view of an exemplary oral drug delivery device 100A, and Figures 8 to 12 show the drug delivery device of Figure 7 from different viewpoints. The drug delivery device 100A shown in Figures 7 to 12 may include any and / or all of the components of the drug delivery device 100 shown in Figures 1 to 6, using the same reference numerals. As illustrated, the first axis of rotation 118 may be located at the center of the oral drug delivery device 100A, in particular at the center of the longitudinal axis 104. Figures 8 to 9 show the first mounting portion 110 in its initial position, Figures 10 to 11 show the first mounting portion 110 rotating about the first axis of rotation 118 as indicated by the arrows, and Figure 12 shows the first mounting portion 110 in its post-mounted position, with the stopper 152 being the outer surface 124 of the housing 102.

[0088] Figure 13 shows an exploded view of an exemplary oral drug delivery device 100B, and Figures 14 to 20 show the drug delivery device of Figure 13 from different viewpoints. The drug delivery device 100B shown in Figures 13 to 20 may include any and / or all of the components of the drug delivery device 100 shown in Figures 1 to 6 and / or the drug delivery device 100A shown in Figures 7 to 12, using the same reference numerals.

[0089] As shown in the figure, the oral drug delivery device 100B further includes a second mounting portion 210. The second mounting portion 210 has a second distal end 212 and a second proximal end 214. The second mounting portion 210 is connected within the housing 102. An actuator 116 engages with the second mounting portion 210 and is configured to rotate the second mounting portion 210 about a second axis of rotation 218 relative to the housing 102. The first mounting portion 110 is operably coupled with the second mounting portion 210, and the rotation of the first mounting portion 110 rotates the second mounting portion 210. As shown in Figure 13, the oral drug delivery device 100 may further include a second actuator 216 for rotating the second mounting portion 210.

[0090] The first mounting portion 110 includes a first arm 132 and a first spike 134, the first spike 134 being positioned at the first distal end 112. The second mounting portion 210 includes a second arm 232 and a second spike 234, the second spike 232 being positioned at the second distal end 212. As shown in Figure 16, the first spike 134 and the second spike 234 overlap within the housing 102. Furthermore, the first arm 132 extends over at least half the longitudinal length of the housing 102, and the second arm 232 extends over at least half the longitudinal length of the housing 102. When the actuator 116 is operated, the first arm 132 and the second arm 132 are configured to intersect each other within the housing 102, as shown in Figure 17. Furthermore, the first axis of rotation 118 is located at a distance from the second axis of rotation 218.

[0091] Figures 14-16 show both mounting sections 110 and 210 in their respective initial positions. As shown, a locking mechanism 208, in this case a cover, prevents the mounting sections 110 and 210 from rotating. Figure 17 shows the state where the locking mechanism 208 is released from the housing 102, thereby allowing the mounting sections 110 and 210 to rotate, followed by Figures 18-19. Figure 20 shows the mounting sections 110 and 210 in their mounted position.

[0092] Figures 21–26 are perspective views of an exemplary oral drug delivery device 100C. The drug delivery device 100C may include any and / or all of the components of drug delivery devices 100, 100A, and 100B, using the same reference numerals.

[0093] As shown in Figures 21 to 26, the first rotation axis 118 and the second rotation axis 218 are coaxial. This can occur because the first mounting portion 110 and the second mounting portion 210 can rotate in the same direction. As shown, the second mounting portion 210 can be radially inward from the first mounting portion 110. The actuator 116 can rotate both mounting portions 110 and 210. Figures 21 to 22 show the mounting portions 110 and 210 in their initial positions. The actuator 116 can rotate the mounting portions 110 and 210 through the positions shown in Figures 23 to 25 and end up in the post-mounted position in Figure 26.

[0094] Figures 27–30 are perspective views of an exemplary oral drug delivery device 100D. Drug delivery device 100D may include any and / or all of the components of drug delivery devices 100, 100A, 100B, and 100C, using the same reference numerals.

[0095] Figure 27 is a cross-sectional view of the oral drug delivery device 100D in its initial configuration, without the shell 101 and with the first mounting portion 110 in its initial position, where the first mounting portion 110 or at least a part thereof is located within the first cavity 120 of the housing 102. As is evident from Figure 27, the first pivot axis 118 is located closer to the first end 106 than to the second end 108 of the housing, and even closer to the first end than the center C, such as less than 0.25 L from the first end 106.

[0096] Figure 28 is a cross-sectional view of the oral drug delivery device 100D with the first mounting device 110 beginning to rotate around the first rotation axis 118. The first mounting portion 110 can rotate as indicated by the arrows in Figure 28 and end up in the post-mounted position shown in Figures 29 and 30. The first mounting portion 110 is configured to rotate from the initial position to a post-mounted position between 200 and 350 degrees. When the first distal end 112 abuts against the stopper 152, the first mounting portion 110 may stop in the post-mounted position.

[0097] Figures 29 and 30 are cross-sectional views of the oral drug delivery device 100D with the first mounting device 110 rotated to the post-mounted position around the first rotation axis 118. The housing 102 includes a chamber 153 that holds the active drug component 154. In the post-mounted position, the first mounting portion 110, such as the first spike 134, acts on an injector 160 (spring 161 and piston 162) located inside the housing 102, for example, by penetrating a membrane 164 covering the second chamber 163, thereby creating fluid communication from the chamber 153 to the opening 166 of the hollow spike and / or hollow bend of the first mounting device 110, allowing the active drug component to flow out of the chamber 153 through the opening 166. Figure 30 shows the oral drug delivery device 100D after the active drug component has been removed.

[0098] Figures 31 and 32 are perspective views of an exemplary oral drug delivery device 100E. The drug delivery device 100E may include any and / or all of the components of drug delivery devices 100, 100A, 100B, 100C, and 100D, using the same reference numerals.

[0099] Figure 31 is a cross-sectional view of the oral drug delivery device 100E in its initial configuration, without the shell 101 and with the first mounting portion 110 in its initial position, the first mounting portion 110 or at least a portion thereof located within the first cavity 120 of the housing 102. The housing 102 includes a chamber 153 that holds the active drug component 154. The chamber 153 is in fluid communication with the first mounting portion 110 via a tube 168. The oral drug delivery device 100E includes an injector 160 (spring 161 and piston 162) located within the housing 102.

[0100] Figure 32 is a cross-sectional view of the oral drug delivery device 100E with the first mounting device 110 rotated to the post-mounted position about a first rotation axis perpendicular to the longitudinal axis 104. In the post-mounted position, the injector 160 (spring 161 and piston 162) is activated to discharge the active drug component 154 from the chamber 153 to the distal end 112 and / or the opening 166 (optional) of the hollow spike and / or hollow bend of the first mounting device 110, allowing the active drug component 154 to flow out of the chamber 153 through the tube 168 to the distal end 112 and / or the opening 166. In one or more examples of the oral drug delivery device 100E, the injector may be triggered or activated by a soluble plug (not shown) in the distal end 112 / opening 166. This can ensure the correct sequential operation of the injector.

[0101] Figures 33-34 are perspective views of an exemplary oral drug delivery device 100F. Drug delivery device 100E may include any and / or all of the components of drug delivery devices 100, 100A, 100B, 100C, 100D, and 100E, using the same reference numerals.

[0102] Figure 33 is a cross-sectional view of the oral drug delivery device 100F in its initial configuration, without the shell 101 and with the first mounting portion 110 in its initial position, the first mounting portion 110 or at least a portion thereof located within the first cavity 120 of the housing 102. The first mounting portion 110 includes a chamber 153 for holding the active drug component 154, the chamber 153 being located on the first hinge portion 146. The oral drug delivery device 100E includes an injector 160 (piston 162 actuated / moved by actuator 116) located on the first hinge portion 46 of the first mounting portion 110.

[0103] Figure 34 is a cross-sectional view of the oral drug delivery device 100F, in which the first mounting device 110 is rotated to the post-mounted position about a first rotation axis perpendicular to the longitudinal axis 104. In the post-mounted position, the injector 160 (actuator 116 and piston 162) is operated to discharge the active drug component 154 to the distal end 112 and / or opening 166 (optional) of the hollow spike and / or hollow bend of the first mounting device 110, so that the active drug component 154 flows out from the chamber 153 to the distal end 112 and / or opening 166. In one or more examples of the oral drug delivery device 100F, the injector 160 may be triggered or operated by a soluble plug (not shown) in the distal end 112 / opening 166. This can ensure the correct sequential operation of the injector.

[0104] In addition, oral drug delivery devices based on any of the following items are also disclosed.

[0105] [Item 1] A housing having a longitudinal axis and extending from a first end to a second end, A first mounting portion having a first distal end and a second distal end, connected to and / or connected within the housing, and configured to deliver the active drug component, The system comprises an actuator that engages with the first mounting portion and is configured to rotate the first mounting portion about a first axis of rotation, The first axis of rotation described above forms an angle greater than 45 degrees with the longitudinal axis described above. Oral drug delivery device. [Item 2] The first rotation axis described above is perpendicular to the longitudinal axis, and the oral drug delivery device is as described in item 1. [Item 3] The oral drug delivery device according to item 1, wherein the first rotational axis described above forms an angle of less than 15 degrees with the longitudinal axis described above. [Item 4] The oral drug delivery device according to any one of items 1 to 3, wherein the first mounting portion described above is configured to rotate between 200 and 350 degrees from the initial position to the post-mounted position. [Item 5] An oral drug delivery device according to any one of items 1 to 4, wherein in the initial position, the first mounting portion is located within the first cavity of the housing, and in the post-mounting position, the first mounting portion is located within the second cavity of the housing. [Item 6] The first rotational axis described above is fixed, in the oral drug delivery device according to any one of items 1 to 5. [Item 7] An oral drug delivery device according to any one of items 1 to 6, wherein the first axis of rotation is located closer to the outer surface of the housing than to the center of the housing. [Item 8] An oral drug delivery device according to any one of items 1 to 7, wherein the first axis of rotation is located closer to the first end than to the second end. [Item 9] The oral drug delivery device according to item 8, wherein the first axis of rotation is located between the first end and the center along the longitudinal axis. [Item 10] The oral drug delivery device according to item 9, wherein the first axis of rotation is located closer to the first end than to the center of the housing. [Item 11] The oral drug delivery device according to any one of items 1 to 10, wherein the first mounting portion comprises a first arm and a first spike, the first spike being positioned at the first distal end, and the first spike including a bend. [Item 12] The oral drug delivery device according to item 11, wherein the first spike comprises a proximal section and a distal section, the distal section extending at an angle between 30 and 80 degrees or between 100 and 170 degrees from the longitudinal axis in the post-mounted position. [Item 13] An oral drug delivery device according to any one of items 1 to 12, further comprising a second mounting portion having a second distal end and a second proximal end, wherein the second mounting portion is connected to the housing, and the actuator is configured to engage with the second mounting portion and rotate the second mounting portion relative to the housing about a second axis of rotation. [Item 14] The oral drug delivery device according to item 13, wherein the first mounting portion is operably coupled to the second mounting portion, and rotation of the first mounting portion causes rotation of the second mounting portion. [Item 15] The oral drug delivery device according to item 13 or 14, wherein the first mounting portion comprises a first arm and a first spike, the first spike being positioned at the first distal end, and the second mounting portion comprises a second arm and a second spike, the second spike being positioned at the second distal end, and the first and second spikes overlap within the housing. [Item 16] The oral drug delivery device according to item 15, wherein the first arm extends over a length of at least half the longitudinal length of the housing, and the second arm extends over a length of at least half the longitudinal length of the housing. [Item 17] An oral drug delivery device according to item 15 or 16, wherein when the actuator is operated, the first arm and the second arm are configured to intersect each other within the housing. [Item 18] An oral drug delivery device according to any one of items 13 to 17, wherein the first axis of rotation and the second axis of rotation are coaxial. [Item 19] An oral drug delivery device according to any one of items 13 to 17, wherein the first axis of rotation is separated by a distance from the second axis of rotation.

[0106] The use of terms such as "first," "second," "third," "fourth," "primary," "secondary," and "tertiary" does not imply a specific order, but is included to identify individual elements. Furthermore, the use of terms such as "first," "second," "third," "fourth," "primary," "secondary," and "tertiary" does not indicate any order or importance; rather, these terms are used to distinguish one element from another. Please note that the terms "first," "second," "third," "fourth," "primary," "secondary," and "tertiary" are used here and elsewhere solely for labeling purposes and are not intended to indicate a specific spatial or temporal order.

[0107] Furthermore, the labeling of the first element does not imply the existence of the second element, and vice versa.

[0108] Please note that the term "prepare" does not necessarily exclude the existence of elements or steps other than those listed.

[0109] Please note that the words "a" or "an" preceding an element do not exclude the possibility of multiple such elements existing.

[0110] Furthermore, it should be noted that no reference numerals limit the scope of the claims, exemplary embodiments may be implemented at least partially by both hardware and software means, and multiple “means,” “units,” or “devices” may be represented by the same hardware components.

[0111] As used herein, terms of degree such as “approximately,” “about,” “generally,” and “substantially” refer to values, quantities, or characteristics that are close to the stated value, quantity, or characteristic that perform the desired function or achieve the desired result. For example, the terms “approximately,” “about,” “generally,” and “substantially” may refer to quantities that are within a range of 10% or less, 5% or less, 1% or less, 0.1% or less, and 0.01% or less of the stated quantity. If the stated quantity is 0 (e.g., none, having no), the stated ranges above may be specific ranges, not specific percentage ranges of the value. For example, within a range of 10% by weight / volume or less, within a range of 5% by weight / volume or less, within a range of 1% by weight / volume or less, within a range of 0.1% by weight / volume or less, and within a range of 0.01% by weight / volume or less of the stated quantity.

[0112] While the features have been described and explained, these are not intended to limit the claimed invention, and it will be obvious to those skilled in the art that various changes and modifications can be made without departing from the spirit and scope of the claimed invention. Therefore, this specification and the drawings are to be considered illustrative rather than restrictive. The claimed invention is intended to encompass all alternatives, modifications, and equivalents. [Explanation of symbols]

[0113] 100, 100A, 100B, 100C, 100D, 100E, 100F Oral drug delivery devices 102 Housing 104 Longitudinal axis 106 First end 108 Second end 110 First mounting part 112 First distal end 114 First proximal end 116 Actuators 118 First axis of rotation 120 First Cavity 122 Second Cavity 124 External surface 132 First Arm 134 First Spike 136 Bent section 142 Proximal Section 144 Distal Section 146 First hinge section 147 Penetrating Bore 148 Second hinge section 149 Rods 152 Stopper 153 Chamber 154 Active drug components 160 Injector 161 spring 162 Pistons 163 Second Chamber 164 Membrane 166 Opening 168 Tube (Pipe) 208 Locking mechanism 210 Second mounting section 212 Second distal end 214 Second proximal end 216 Second actuator 218 Second axis of rotation 232 Second Arm 234 Second Spike C Housing Center L Housing Length D_D distal direction

Claims

1. A housing having a longitudinal axis and extending from a first end to a second end, A first mounting portion having a first distal end and a second distal end, connected to and / or connected within the housing, and configured to deliver the active drug component, An actuator that engages with the first mounting portion and is configured to rotate the first mounting portion about a first rotation axis, Equipped with, The first axis of rotation forms an angle greater than 45 degrees with the longitudinal axis. Oral drug delivery device.

2. The oral drug delivery device according to claim 1, wherein the first axis of rotation is perpendicular to the longitudinal axis.

3. The oral drug delivery device according to claim 1 or 2, wherein the first mounting portion is configured to rotate between 200 and 350 degrees from an initial position to a post-mounting position.

4. An oral drug delivery device according to any one of claims 1 to 3, wherein in the initial position, the first mounting portion is located within a first cavity of the housing, and in the post-mounting position, the first mounting portion is located within a second cavity of the housing.

5. The oral drug delivery device according to any one of claims 1 to 4, wherein the first axis of rotation is fixed.

6. The oral drug delivery device according to any one of claims 1 to 5, wherein the first axis of rotation is located closer to the outer surface of the housing than to the center of the housing.

7. The oral drug delivery device according to any one of claims 1 to 6, wherein the first axis of rotation is positioned closer to the first end than to the second end.

8. The oral drug delivery device according to claim 7, wherein the first axis of rotation is located between the first end and the center of the oral drug delivery device along the longitudinal axis.

9. The oral drug delivery device according to claim 8, wherein the first axis of rotation is located closer to the first end than to the center of the oral drug delivery device.

10. The first mounting portion comprises a first arm and a first spike, the first spike being positioned at the first distal end, and the first mounting portion includes a bent portion. An oral drug delivery device according to any one of claims 1 to 9.

11. The oral drug delivery device according to claim 10, wherein the first spike comprises a proximal section and a distal section, the distal section extending at an angle between 30 and 80 degrees or between 100 and 170 degrees from the longitudinal axis in the post-mounted position.

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