Drug delivery and administration devices

Abstract

The present invention relates to a device for delivering and / or applying a therapeutic composition in a delivery form to the rectum and / or vaginal cavity, the device comprising an external wearable pad (2); a non-absorbent platform (3) for receiving the therapeutic composition in a delivery form; and a sheath (4) connecting the platform to the pad so that a user's finger can be received in the sheath.

Description

Technical Field

[0001] The present invention relates to a device for delivering and / or administering a therapeutic composition within the rectum or vaginal cavity. Background Art

[0002] The advantages of administering drugs via the vaginal or rectal cavity are that they can achieve local and systemic administration and provide an alternative to traditional routes of administration. In some cases, oral administration is not recommended due to gastrointestinal side effects or reduced bioavailability, or simply because the patient is uncooperative or unable to swallow the drug. Parenteral drugs (such as intravenous injections) may not be suitable because they usually must be used by trained practitioners.

[0003] Vaginal and rectal medications (such as ointments) can be applied while wearing gloves. However, when a finger is inserted into the vaginal or rectal cavity, a portion of the medication retained by the vaginal or rectal wall is not applied to the target area when the finger passes through the cavity. Therefore, it is difficult to administer the medication in an accurate dose in the target area.

[0004] Drugs can also be delivered by inserting a suppository or by injection using a syringe or spray. However, due to their physiological functions, both the vaginal and rectal cavities have a tendency to reject foreign bodies. The drug may reach the target area but not be retained within the cavity to achieve adequate contact and absorption. This is especially the case with suppositories that must dissolve to allow penetration and absorption of the drug into the cavity walls. Elastic vaginal rings have been developed to retain leaked medication, but these devices are often uncomfortable for the patient.

[0005] Many medicated tampons and sponges are known for use in delivering medications to the vaginal or rectal cavity. These devices are typically inserted using a therapeutic applicator or inserter, which is uncomfortable and it is often difficult to properly position the tampon.

[0006] European patent publication EP 3027155 relates to a drug delivery device comprising a medicated tampon connected to a sanitary pad by a sheath. The user can insert his / her finger into the sheath to accurately and atraumatically push the tampon into the vaginal or rectal cavity. However, there may be some drugs that require a lot of modification and cost to be incorporated into a tampon, or cannot be incorporated into a tampon at all. Summary of the invention

[0007] It is an object of the present invention to at least alleviate the above disadvantages, or to provide an alternative to existing products.

[0008] According to a first aspect of the present invention, there is provided a device for delivering and / or administering a therapeutic composition in a delivery form into the rectal and / or vaginal cavity, the device comprising an external wearable pad; a non-absorbent platform for receiving the therapeutic composition in a delivery form; and a sheath connecting the platform to the pad so that a user's finger can be received in the sheath.

[0009] In the context of the present invention, the delivery form can be any commercially available delivery form, including but not limited to suppositories, vaginal suppositories, capsules, tablets, liquids, solutions, suspensions, lotions, dispersions, creams, gels, powders and granules. The present invention does not relate to the delivery and administration of therapeutic compositions delivered in gaseous form.

[0010] Known rectal or vaginal delivery devices require absorption or combination of the drug with the delivery device. Although this helps to control the release of the drug, there is still a risk that the entire dose is retained by the release device and cannot be released to the target area. The present invention enables the entire therapeutic composition (i.e., in its delivery form) to be delivered to the target area because there is no absorption involved. It can be said that the device of the present invention acts as an applicator rather than a delivery device because there is no interaction between the device and the therapeutic composition. It can also be said that the therapeutic composition is supported by the platform.

[0011] Preferably, the sheath comprises said platform.The sheath comprises a first end connected to the pad and a second end comprising the platform, so that the platform can be pushed into the rectum or vaginal cavity by a user's finger.

[0012] In a preferred embodiment, the therapeutic composition is in a delivery form having a shape, and the platform includes a receiving portion having a shape that partially corresponds to the shape of the delivery form of the therapeutic composition.

[0013] In the context of the present invention, we will refer to the shape of the delivery form of the therapeutic composition, wherein the delivery form consists of one component, such as a suppository, a vaginal suppository, a capsule, a tablet; but not liquids, solutions, suspensions, emulsions, dispersions, creams, gels, powders and granules, which have no specific shape in their delivery form.

[0014] The shape of the delivery form can be spherical, elliptical, cylindrical, diamond or any other commercially available shape. The shape of the receiving portion preferably partially corresponds to the shape of the delivery form so that the therapeutic composition can fit snugly into the receiving portion and be released at the target area. Preferably, the shape of the receiving portion corresponds to up to half of the shape of the delivery form of the therapeutic composition to enable easy release at the target site.

[0015] If the delivery form is in the shape of a spherical or ellipsoidal capsule, the platform may include a hemispherical or egg-cup shaped receiving portion. If the delivery form is in the shape of a rhombus, the platform may include a conical shaped receiving portion.

[0016] The receiving portion may be integrally formed in the sheath. For example, the sheath may include a receiving portion (as a pocket or recess) formed in the same material as the sheath. Alternatively, the receiving portion may include additional or alternative material connected to the sheath.

[0017] The advantage of this particular configuration of the receiving portion is that it improves the delivery of the therapeutic composition. The sheath allows for the user's finger to be received therein. This can be achieved by using a sheath of sufficient diameter or a sheath material that can expand to accommodate a finger. Thus, the diameter of the sheath may be wider than the size of the delivery form, so that the tablet, capsule, suppository or other drug will become loose if not retained by the shaped receiving portion, and thus it will be difficult for the user to push the therapeutic composition into the rectal or vaginal cavity.

[0018] Preferably, the platform comprises a receiving portion adapted and configured to receive a predetermined amount of the therapeutic composition.

[0019] In a preferred embodiment, the receiving portion may be a container, such as a cup or a bowl. Preferably, the receiving portion has a rounded base to prevent the therapeutic composition from being trapped in a corner and unable to be delivered.

[0020] This is particularly advantageous when the delivery form of the therapeutic composition is uncertain, for example, when the therapeutic composition is in a delivery form that is difficult to quantify, such as if the delivery form is a liquid, solution, suspension, lotion, dispersion, cream, gel, powder, and granules. If the receiving portion is adapted and configured to receive a predetermined amount of the therapeutic composition, the user can simply fill the receiving portion with the exact amount of the therapeutic composition required for the treatment.

[0021] In another embodiment, the receiving portion may include visual scales or markings so that the user can adjust the amount of therapeutic composition required for treatment. The required amount may depend on the condition to be treated, the severity of the condition, and the patient's characteristics, such as age, weight, and sex.

[0022] Preferably, the platform includes a relatively large rigid region. The platform may include or be made of a material that is harder than the sheath material. Additional or alternative materials may be used to increase the rigidity of the platform and / or receiving portion. For example, the relatively large rigid region may have a multi-layer structure or be made of a different, more rigid material.

[0023] This will allow the platform and / or receiving portion to maintain its shape when entering the rectal or vaginal cavity. If the shape of the receiving portion collapses, the liquid therapeutic composition contained therein may overflow or diffuse into the sheath, thereby making delivery to the target site more difficult and / or resulting in an inaccurate amount of the therapeutic composition to be delivered to the target site. If the therapeutic composition is in a single solid form (e.g., a tablet, capsule, suppository, bougie, or vaginal suppository), the composition may accidentally fall off the receiving platform before reaching the target area.

[0024] The more rigid area may also be used to increase the sturdiness of the platform so as to allow a removal cord to be attached to the platform.

[0025] Preferably, the receiving portion is foldable and / or reversible. In a preferred embodiment, the receiving portion has sufficient rigidity to maintain its shape during the insertion step, i.e. when the therapeutic composition is pushed through the rectal cavity or vaginal cavity to the target area, but has sufficient flexibility to fold and release the therapeutic composition at the target area. Preferably, the device according to the present invention does not include any fully rigid parts to avoid injury and discomfort to the user during insertion and removal.

[0026] In a preferred embodiment, the platform comprises means for releasing the therapeutic composition.

[0027] In the simplest embodiment, the platform is reversible so as to push the therapeutic composition out of the receiving portion. For example, the platform comprises or is a cup-shaped or bowl-shaped container that can be poured out. Once reversed, the platform can be used to apply the therapeutic composition to the target area, such as in the case of creams, lotions, liquids, particles, etc., so that the composition penetrates the cavity wall.

[0028] The platform may be foldable, or the platform may include foldable side walls so that the therapeutic composition is released from the receiving portion. The platform may include one or more wires configured and arranged to be pulled toward the cavity hole and fold the side walls. For example, the platform wall may include a conical structure.

[0029] In a preferred embodiment, the receiving portion may be closable to contain the therapeutic composition, for example, during storage, transport, handling, and insertion of the device. The sheath may be releasably closed by ultrasonic welding, pulse heating, or thermal welding, etc. These techniques are particularly advantageous because the strength of the seal may be adjusted so that the seal is strong enough to contain the therapeutic composition before use, but may also be opened by pushing the sheath into the patient's cavity. The receiving portion is pushed to the target area, and the user further pushes the distal end of the sheath to open the seal and release the therapeutic composition from the receiving portion.

[0030] Preferably, the length of the sheath is substantially the same as the distance between the rectal or vaginal opening and the target area in the rectal or vaginal cavity. If the sheath includes a releasable closure, the length of the sheath between the pad and the closure is preferably substantially the same as the distance between the rectal or vaginal opening and the target area in the rectal or vaginal cavity.

[0031] In a preferred embodiment, the device also includes a removal cord. Preferably, the device includes a line for releasing the therapeutic composition from the receiving portion and / or for removing the device from the rectum or vaginal cavity. Preferably, the line is connected to the platform, or to the end of the sheath that includes the platform. In another embodiment, the line includes a loop or forms a loop so that the user can easily grab the line. The loop can be connected to multiple points on or near the platform to evenly manipulate and / or pull the device, platform or receiving portion.

[0032] In a preferred embodiment, the pad comprises an absorbent layer facing towards the rectal or vaginal cavity during use and an impermeable layer facing away from the rectal or vaginal cavity during use.

[0033] The external wearable pad may include an absorbent layer to absorb any excess therapeutic composition or body fluids that leak from the cavity. This is particularly advantageous when applying a delivery form (such as a liquid, cream, or gel) that is more likely to leak from the cavity. The external wearable pad may include an impermeable layer to prevent leaking liquid from contaminating the user's underwear. Preferably, the pad is positioned outside the vaginal opening as an interlabial pad or between the user's buttocks outside the rectal opening. In a preferred embodiment, the pad includes one or more weak lines to facilitate the pad to remain between the labia or the user's buttocks. The weak lines also allow for sanitary handling of the drug delivery device because the pad can be folded around the weak lines to close the sheath so that the user does not contact the dirty surface of the pad or sheath.

[0034] According to a second aspect of the present invention, there is provided a kit comprising a therapeutic composition in a delivery form and a device according to any one of claims 1 to 9 for delivering and / or applying the delivery form of the therapeutic composition to a target area in the rectum or vaginal cavity.

[0035] Preferably, the therapeutic composition comprises an antifungal agent, an antimicrobial agent, an anti-inflammatory agent, an analgesic agent, a steroidal (NSAID) compound, a non-steroidal compound and / or a hormone.

[0036] According to another aspect of the invention, the device may be used to deliver and / or administer a therapeutic composition for treating menorrhagia.

[0037] According to another aspect of the invention, the device may be used to deliver and / or administer a therapeutic composition for fertility treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] The present invention will be further described with reference to the accompanying drawings and figures, in which

[0039] Figures 1A to 1D is a schematic diagram of a first device according to the present invention;

[0040] Figures 2A to 2D is a schematic diagram of a second apparatus according to the present invention;

[0041] Figures 3A to 3D is a schematic diagram of a third device according to the present invention;

[0042] Figure 4 is a schematic diagram of a fourth apparatus according to the present invention;

[0043] Figure 5 is a schematic diagram of a fifth apparatus according to the present invention;

[0044] Figure 6 is a schematic diagram of a sixth apparatus according to the present invention;

[0045] Figures 7A to 7D is a schematic diagram of a seventh apparatus according to the present invention;

[0046] Figure 8 is a schematic diagram of an eighth apparatus according to the present invention;

[0047] Fig. 9 is a schematic diagram of a ninth apparatus according to the present invention;

[0048] Fig.10 is a schematic diagram of a tenth apparatus according to the present invention;

[0049] Figures 11A to 11C is a schematic diagram illustrating the use of a device according to the present invention to deliver a therapeutic composition into the rectal cavity of a female patient; and

[0050] Fig. 12A and 12B is a schematic diagram illustrating the use of a device according to the present invention to deliver a therapeutic composition into the rectal cavity of a male patient. DETAILED DESCRIPTION

[0051] Referring to Figure 1, a device 1 for delivering and / or applying a therapeutic composition C in a delivery form into the rectum and / or vaginal cavity is shown, the device 1 comprising an external wearable pad 2; a non-absorbent platform 3 for receiving the delivery form of the therapeutic composition C; and a sheath 4 connecting the platform 3 to the pad 2 so that a user's finger can be received in the sheath 4.

[0052] The non-absorbable platform 3 is located at the distal end of the sheath 4. In the context of the present invention, the distal end is the end closest to the target area in the vaginal or rectal cavity and the proximal end is the end of the sheath 4 closest to the cavity opening in use.

[0053] The main function of the platform 3 is to provide a support surface for the therapeutic composition C and to provide a support surface for the user to push the therapeutic composition C along the vaginal or rectal cavity. If the user is using latex gloves without the platform 3, the therapeutic composition C will be removed from the user's fingertips and it will not be possible to deliver it efficiently and accurately. The platform 3 also enables the user to keep the therapeutic composition C in the target area within the vaginal or rectal cavity and can act as an internal barrier to prevent the therapeutic composition C from shifting or leaking from the cavity.

[0054] Preferably, the platform 3 comprises a harder material than the material of the sheath 4. The platform 3 may be made of or from a single or multi-layer sheet structure. The material of the platform 3 may be the same as the material of the sheath 4, but its thickness is greater than the material thickness of the sheath 4 to provide relative rigidity. The platform 3 may comprise a multi-layer structure including a structural layer that applies relative rigidity. A relatively large structural rigidity platform 3 also facilitates the connection of the line or rope 6.

[0055] The platform 3 includes a receiving portion 5 or is capable of forming a receiving portion 5. The platform 3 can be arranged in a first configuration in which there is no receiving portion 5 (e.g., when it is in a delivery configuration at a target area in a cavity and / or flipped in a retrieval configuration), and in a second configuration in which there is a receiving portion 5 (e.g., in an insertion configuration, when the therapeutic composition C is pushed along the vaginal or rectal cavity). In a preferred embodiment, the receiving portion 5 can be arranged in a receiving configuration, in which the therapeutic composition C can be contained, and in a delivery configuration, in which the therapeutic composition C is ejected from the receiving portion 5.

[0056] The platform 3 and the receiving portion 5 may be made of the same non-absorbent material or of different absorbent materials. In a preferred embodiment, the receiving portion 5 is integrally formed in and / or with the platform 3 .

[0057] Preferably, the platform 3 and / or the receiving portion 5 are made of a material that is sufficiently rigid to allow the user to push the therapeutic composition C into the receiving portion 5 and is flexible enough to allow the user to push the therapeutic composition C out of the receiving portion 5. The platform 3 and the receiving portion 5 are preferably not so rigid as to injure the patient during insertion and / or removal. Preferably, the platform 3 and / or the receiving portion 5 are made of a semi-flexible plastic sheet.

[0058] If the therapeutic composition is in the form of a fluid, liquid, granules or powder, the shape and size of the receiving portion 5 can be adjusted to receive a desired amount / dose of the therapeutic composition C.

[0059] refer to Figures 2A to 2D The receiving portion 5 may be cup-shaped or bowl-shaped to receive the therapeutic composition in solid or liquid delivery form. A removal cord 6 may be connected to the platform 3 to pull the device 1 out of the cavity after the therapeutic composition C has been delivered.

[0060] refer to Figures 3A to 3D and Figure 5 , the receiving portion 5 may include a flat bottom 7 (eg a cylindrical receiving portion 5) to provide a surface for pushing by a user.

[0061] refer to Figure 4 , the receiving portion 5 may be a groove or a liquid storage tank 8. Figure 6 , receiving portion 5 may include a visual indication of the amount of therapeutic composition C contained therein.

[0062] The receiving portion 5 may be reversible (inside out) to release the therapeutic composition C (e.g. Figures 3A to 3D ), or the wall of the receiving portion 5 may be foldable, as Figures 7A to 7D For example, the wall of the receiving portion 5 may include an accordion mechanism 9 which is remotely foldable.

[0063] A string or wire 6 may be connected to the platform 3 to facilitate pulling the device 1 out of the cavity after use. The string 6 may also be used to fold the walls of the receiving portion 5. The string 6 may be connected to the platform 3 at a single point, or there may be multiple connection points to facilitate manipulation of the device 1 and / or the receiving portion 5.

[0064] The therapeutic composition C can be a single solid delivery form, such as a tablet, capsule, vaginal suppository, suppository, etc. This solid form will have a specific shape and a specific size. Figures 8 to 10 , the shape of the receiving portion 5 has a shape that partially corresponds to the shape of the delivery form of the therapeutic composition C.

[0065] The sheath 4 is substantially cylindrical and extends from the non-absorbent platform 3 to the pad 2. Preferably, the sheath 4 is made of or comprises a sheet of polymeric biocompatible material. The sheath 4 is arranged and configured to receive a finger. A wide sheath 4 may be provided, however, if the sheath 4 is loose around the user's finger, insertion becomes difficult. The sheath 4 is preferably extendable in at least the radial direction. An extendable sheath 4 may be provided to fit snugly and comfortably around the user's finger.

[0066] The length of the sheath 4 between the pad 2 (remaining outside the cavity) and the platform 3 can be adjusted depending on the target area to which the therapeutic composition and / or drug is to be delivered.

[0067] The pad 2 is connected to the sheath 4, in particular to the second end of the sheath 4. The pad 2 includes a hole 10 to allow the user to insert his finger into the sheath 4. The pad 2 is substantially circular, oval, rectangular or any other suitable shape. The pad 2 can be a standard rectangular sanitary napkin or a small interlabial pad. In a preferred embodiment, the pad 2 is a flat egg shape.

[0068] The pad 2 comprises a first surface 2A comprising a layer or sheet of absorbent material. In use, the first surface 2A faces the patient cavity into which the therapeutic composition C is delivered. The pad 2 comprises a second surface 2B comprising a layer or sheet of impermeable material. In use, the second surface 2B faces away from the patient cavity. The impermeable material of the pad 2 may be the same as the material of the sheath 4. The sheath 4 may extend through the aperture 10 and along the absorbent layer 2A to form an impermeable layer 2B.

[0069] The use of the device according to the invention will be explained with reference to the drawings, in particular to FIGS. 1 , 2 , 3 , 7 , 11 and 12 .

[0070] In use, the device 1 is positioned so that the absorbent surface 2A of the pad 2 faces upwards and the impermeable surface 2B faces downwards. The sheath 4 extends from the impermeable surface 2B of the pad 2 so that the platform 3 and its receiving portion 5 are located at the bottom thereof. Alternatively, the device 1 is positioned so that the absorbent surface 2A of the pad 2 faces upwards and the impermeable surface 2B faces downwards. The sheath 4 extends from the absorbent surface 2A of the pad 2 so that the platform 3 and its receiving portion 5 are located at the top thereof. In both starting configurations, the receiving portion 5 is in its delivery configuration, arranged to receive the therapeutic composition C therein.

[0071] The shape of the receiving portion 5 of the device 1 is selected based on the delivery form and shape of the therapeutic composition C. When the composition C is in a delivery form having a specific shape, the shape and size of the receiving portion 5 will correspond at least in part to the shape and size of the delivery form, such as cylindrical in the case of a suppository. The receiving portion 5 is preferably made of an extensible material so that the therapeutic composition C is fixed therein. When the composition C is an indefinite shape such as granules, creams, emulsions, dispersions, gels, etc., the receiving portion 5 forms a container, such as a cup-shaped or bowl-shaped container, to receive the composition C therein. The receiving portion 5 is preferably made of a sufficiently rigid material so that it can hold the composition and keep its shape while pushing the platform 3 through the vaginal or rectal cavity. The receiving volume of the receiving portion 5 can be adjusted to contain the desired amount of composition C for one application. The sheath 4 or the receiving portion 5 may include a visual indication of the amount of composition C in the receiving portion 5, such as one or more lines or scale lines.

[0072] The therapeutic composition C is positioned and fixed in the receiving portion 5 of the sheath 4. The user inserts his finger into the sheath 4 so that the sheath 4 extends from the absorbent side 2A of the pad 2. The user pushes the platform 3 so that the device 1 is inserted into the cavity. The platform 3 advances along the cavity until it reaches the target area where the composition C will be delivered and applied. The length of the sheath 4 can be adjusted so that when the sheath 4 is fully extended, the platform 3 is located in the target area in the cavity. Because the therapeutic composition C is nested in the receiving portion 5, the user can easily and accurately guide the composition through the cavity.

[0073] At the target area, the therapeutic composition is released from the receiving portion 5. This can be achieved, for example, by turning the receiving portion 5 inside out to allow the therapeutic composition to be expelled from the receiving portion 5. Alternatively, the receiving portion 5 (or its walls) can be folded by pushing the platform 3 to the distal end of the sheath 4 or by using an alternative means of folding the receiving portion 5 (or its walls). For example, one or more strings 6 can be connected to the receiving portion 3 to remotely fold the walls of the receiving portion 3 (e.g., by pulling the strings 6 from outside the cavity).

[0074] In the case where the device 1 includes a therapeutic composition C pre-positioned in the sealed receiving portion 5, the user inserts his finger into the sheath 4 and inserts the sheathed finger into the cavity until the distal end of the sheath 4 reaches the target area. Pressure is applied to the sealed composition C with the finger to break the seal, invert the receiving portion, and release the therapeutic composition C.

[0075] Once delivered, the therapeutic composition C can be applied to the target area. A particular advantage of the present invention is that the composition can be rubbed against the cavity wall to improve the application and absorption of the drug through the cavity wall. This can be done without the user getting his / her fingers dirty.

[0076] The device 1 may be left in place to retain the therapeutic composition C at the target area. The platform 3 acts as an anchor and / or plug, for example, until the composition dissolves and is absorbed.

[0077] Any excess liquid leaking from the cavity will be absorbed by the absorbent surface 2A of the pad 2 located at the cavity opening. Due to the impermeable surface 2B of the pad 2, the user's fingers are protected from the fluid.

[0078] The device 1 is removed by pulling the pad 2 or the string 6. By pulling the string 6, the sheath 4 is turned over so that the dirty outer surface of the sheath 4 is now inside. The user can hold the device 1 by the unstained surface of the sheath 4 or the impermeable surface 2B of the pad 2 and dispose of the device 1.

[0079] The present invention is particularly suitable for the delivery and application of therapeutic compositions for relieving the symptoms of menorrhagia. Menorrhagia is a condition in which a woman experiences excessive bleeding during her menstrual period. This may be due to heavy menstrual bleeding (80 ml or more) and / or prolonged menstrual periods (7 days or longer). The causes of menorrhagia vary, from hormonal imbalances, use of intrauterine devices to pregnancy complications. There are many treatments that can relieve the symptoms of menorrhagia, including:

[0080] Nonsteroidal and / or nonhormonal medications, such as nonsteroidal anti-inflammatory drugs and analgesics, can reduce bleeding;

[0081] Hormonal medications, such as birth control pills or hormone coils for birth control, although some women with heavy periods may still want to have children;

[0082] Surgery when non-invasive treatments have failed, such as endometrial ablation

[0083] For these patients who do not wish to use contraceptive treatment or refuse surgery, the present invention provides a non-invasive treatment that includes the delivery of non-hormonal drugs (e.g., analgesics) to treat symptoms in situ. The present invention is particularly advantageous because treatment will be performed during heavy bleeding, when intravaginal medication will be particularly difficult and messy due to the abundance of body fluids. The sheath protects the patient's fingers while delivering and applying the drug and enables the drug to be applied and rubbed against the cavity wall. During the delivery and application of the drug, the external pad can absorb any body fluids that flow out of the cavity.

[0084] The present invention is particularly applicable to fertility treatments, particularly treatments such as in vitro fertilization (IVF), which involve the administration of various drugs (such as hormones and anticoagulants), usually in the form of suppositories, tablets or injections (subcutaneous or intramuscular). The vast majority of IVF drugs are self-administered, so there is a need for a simpler, more patient-friendly method of administration that does not compromise the delivery of the therapeutic components.

[0085] During IVF treatment, women need to take progesterone three times a day. Progesterone cannot be taken orally due to bioavailability issues. In order to effectively deliver the required amount of progesterone to the uterus, the amount taken must be high enough not to cause adverse side effects. Another option is to inject progesterone in situ. However, injecting progesterone into the vagina is impractical, painful and expensive. The most common route of administration is to insert a vaginal suppository with the finger or use an applicator. To be effective, the suppository must remain in place to dissolve and be absorbed. However, in practice, most of the progesterone leaks out, making precise dosing impossible. It is also not possible to wear a tampon to prevent leakage, otherwise the progesterone will be absorbed by the tampon.

[0086] The present invention can replace the traditional rigid applicator and can deliver and apply the suppository comfortably and cleanly. The suppository can be kept in the target area until it is completely dissolved, and since the fingers are protected, the dissolved composition can be rubbed against the vaginal cavity to optimize drug delivery.

[0087] The present invention provides a device for delivering and / or applying a therapeutic composition to the rectum or vaginal cavity. As can be seen from the above description, the device is used as a drug inserter that can deliver and apply an accurate amount of a therapeutic composition to a target area painlessly and hygienically.

Claims

1. A device for delivering and / or administering a therapeutic composition in a delivery form into the rectum and / or vaginal cavity, the device comprising: External wearable pads; a non-absorbent platform for receiving the therapeutic composition in a delivery form; and A sheath connects the platform to the pad so that a user's finger can be received in the sheath, wherein the platform includes a region that is more rigid than the sheath.

2. The device according to claim 1, characterized in that The therapeutic composition is in a delivery form having a shape, and the platform includes a receiving portion having a shape that partially corresponds to the shape of the delivery form of the therapeutic composition.

3. The device according to claim 1 or 2, characterized in that: The platform includes a receiving portion adapted and configured to receive a predetermined amount of a therapeutic composition.

4. The device according to claim 2, characterized in that The receiving portion is foldable and / or reversible.

5. The device according to claim 1, characterized in that The platform includes means for releasing the therapeutic composition.

6. The device of claim 1 further comprising a removal cord.

7. The device according to claim 1, characterized in that The pad comprises an absorbent layer which faces the rectal or vaginal cavity during use and an impermeable layer which faces away from the rectal or vaginal cavity during use.

8. The device according to claim 1, characterized in that The length of the sheath is substantially equal to the distance between the rectal or vaginal opening and the target area in the rectal or vaginal cavity.

9. A kit comprising a therapeutic composition in a delivery form and a device according to any one of claims 1 to 8 for delivering and / or administering the therapeutic composition in a delivery form into the rectum or vaginal cavity.

10. The kit according to claim 9, characterized in that The therapeutic composition comprises an antifungal agent, an antimicrobial agent, an anti-inflammatory agent, an analgesic agent, a steroidal (NSAID) compound, a non-steroidal compound and / or a hormone.

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