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CN-121985977-A - Applicator for placing a mucoadhesive surface on a patient's nasal or oral mucosa and disposable component for use therewith

CN121985977ACN 121985977 ACN121985977 ACN 121985977ACN-121985977-A

Abstract

The present invention relates to an applicator (100) for arranging a mucoadhesive surface (202), in particular a mucoadhesive film (204) loaded with an active agent, such as a drug, on a nasal or oral mucosa, in particular a buccal mucosa, of a patient, to a disposable component for use with an applicator for arranging a mucoadhesive surface on a nasal or oral mucosa of a patient, and to a kit comprising a disposable component having a mucoadhesive surface and an applicator for arranging said mucoadhesive surface on a nasal or oral mucosa of a patient.

Inventors

  • BEHL WALTER
  • E. Horstcott
  • K. I. Murholtzl Odov
  • A. Schweitzer

Assignees

  • IQ医疗股份有限公司

Dates

Publication Date
20260505
Application Date
20241009
Priority Date
20231009

Claims (20)

  1. 1. An applicator (100) for arranging a mucoadhesive surface (202), in particular a mucoadhesive film (204) loaded with an active agent, on a nasal or oral mucosa (12), in particular a buccal mucosa, of a patient, the applicator (100) comprising: An insertable part (102) and an outer part (104) connected to the insertable part (102), the insertable part (102) and the outer part (104) being for insertion into a nasal cavity or an oral cavity of the patient and for placement on a skin (14) of the patient, respectively, wherein the nasal or oral mucosa (12) is arranged between the insertable part (102) and the outer part (104), wherein the insertable part (102) comprises a holding means (114), the holding means (114) being configured to receive a disposable part (200) comprising the mucoadhesive surface (202) such that the mucoadhesive surface (202) faces the nasal or oral mucosa (12) when the nasal or oral mucosa (12) is arranged between the insertable part (102) and the outer part (104), and Means for pressing the mucoadhesive surface (202) against the nasal or oral mucosa (12) when the disposable part (200) is received by the holding means (114) and the nasal or oral mucosa (12) is arranged between the insertable part (102) and the outer part (104).
  2. 2. The applicator (100) according to claim 1, wherein the means for pressing the mucoadhesive surface (202) against the nasal or oral mucosa (12) is or comprises a resilient member (102-106, 112), in particular a spring, the resilient member (102-106, 112) being configured to bias the disposable component (200) or a part of the disposable component (200) towards the external component (104) when the resilient member (102-106, 112) is received by the holding means (114).
  3. 3. The applicator (100) according to claim 2, wherein the insertable component (102) and/or the external component (104) comprises a different material than the elastic members (102-106, 112).
  4. 4. An applicator (100) according to claim 2 or 3, wherein the resilient member (102-106, 112) and one or both of the insertable part (102) and the external part (104) are formed as a single piece, in particular by injection moulding.
  5. 5. The applicator (100) according to any one of the preceding claims, wherein the means for pressing the mucoadhesive surface (202) against the nasal or oral mucosa (12) is configured to press the mucoadhesive surface (202) against the nasal or oral mucosa (12) with a force between 0.1N and 50N, preferably between 0.5N and 10N, most preferably between 2N and 4N.
  6. 6. The applicator (100) according to any one of the preceding claims, wherein the applicator (100) comprises a hinge (110), the hinge (110) pivotably connecting the insertable part (102) and the external part (104).
  7. 7. The applicator (100) according to claim 6, wherein each of the insertable member (102) and the outer member (104) comprises a proximal handle portion (102 a,104 a), a central hinge portion (102B, 104B), and a distal clamping portion (102 c,104 c), wherein the holding means (114) is arranged on and/or in the clamping portion (102 c,104 c) of the insertable member (102), wherein the hinge (110) connects the hinge portion (102B) of the insertable member (102) and the hinge portion (104B) of the outer member (104) so as to allow the clamping portions (102 c,104 c) to be moved apart from each other by pushing the handle portions (102 a,104 a) towards each other.
  8. 8. The applicator (100) according to claim 6 or 7, wherein the applicator (100) comprises the resilient member (112), and wherein the hinge (110) is formed by or comprises the resilient member (112), or the resilient member (112) extends between a handle portion (102A) of the insertable component (102) and a handle portion (104A) of the external component (104).
  9. 9. The applicator (100) according to any one of the preceding claims, wherein the retaining means (114) is or comprises a retaining structure configured to removably receive the disposable component (200), in particular via a snap fit or a press fit.
  10. 10. The applicator (100) according to any one of the preceding claims, further comprising a contact surface (106A), the contact surface (106A) being arranged between the insertable component (102) and the outer component (104), wherein when the insertable component (102) is inserted into the nasal cavity or oral cavity of the patient to a predefined insertion depth (d), the contact surface (106A) will be in contact with an edge (16) of the nostril or oral opening of the patient, in particular with a mouth corner, to prevent the insertable component (102) from being further inserted beyond the predefined insertion depth (d), in particular wherein a distance (i) between the contact surface and the holding means (114) is between 0.5 cm and 6 cm, preferably between 2 cm and 4 cm, most preferably between 2.5 cm and 3.5 cm.
  11. 11. The applicator (100) according to any one of the preceding claims, wherein the insertable component (102) comprises a disc-shaped portion (102D), the holding means (114) being arranged in and/or on the disc-shaped portion (102D), wherein preferably the lateral physical gauge (w a ) of the disc-shaped portion (102D) is in particular between 1.5 cm and 5cm, most preferably between 2.5 cm and 4 cm.
  12. 12. A disposable component (200) for use with an applicator (100) for arranging a mucoadhesive surface (202) on a nasal or oral mucosa (12) of a patient, the applicator (100) comprising an insertable component (102) and an external component (104) connected to the insertable component (102), the insertable component (102) and the external component (104) being for insertion into a nasal or oral cavity of the patient, respectively, and for placement on a skin (14) of the patient, the nasal or oral mucosa (12) being arranged between the nasal or oral cavity of the patient and the skin (14) of the patient, the disposable component (200) comprising: a carrier (206), the carrier (206) having a mucoadhesive surface (202), and Attachment means (208, 210), the attachment means (208, 210) being for attaching the disposable component (200) to an insertable component (102) of the applicator (100) such that a mucoadhesive surface (202) of the disposable component (200) faces a nasal or oral mucosa (12) of the patient when the nasal or oral mucosa (12) is arranged between the insertable component (102) and the external component (104) of the applicator (100).
  13. 13. The disposable component (200) of claim 12, wherein the mucoadhesive surface (202) is arranged on a first side of the carrier (206) and the attachment means (208, 210) is arranged on a second side of the carrier (206) opposite to the first side.
  14. 14. The disposable component (200) according to claim 12 or 13, wherein the disposable component (200) is for use with an applicator (100) according to any one of claims 1 to 11, and the attachment means (208, 210) is configured to be received by a holding means (114) of an insertable component (102) of the applicator (100).
  15. 15. Disposable component (200) according to claim 14, wherein the attachment means (210) is or comprises a mechanical connector configured to be removably received by the holding means (114), in particular via a snap fit or a press fit.
  16. 16. The disposable component (200) according to any one of claims 12 to 15, wherein the mucoadhesive surface (202) is formed by a mucoadhesive film (204) loaded with an active agent, in particular a drug, and the mucoadhesive surface (202) is arranged on the carrier (206) and/or in the carrier (206), in particular wherein the mucoadhesive film (204) comprises a mucoadhesive polymer matrix layer (204A) comprising the active agent and optionally a backing layer (204B), the mucoadhesive polymer matrix layer (204A) being attached to the backing layer (204B).
  17. 17. The disposable component (200) according to any one of claims 12 to 16, wherein the mucoadhesive surface (202) is removably attached to the carrier (206), in particular by means of an adhesive (204C), so as to allow separation of the mucoadhesive surface (202) from the carrier (206) when the mucoadhesive surface (202) is arranged on the nasal or oral mucosa (12).
  18. 18. A kit (10, 20, 30, 40, 50, 70), the kit (10, 20, 30, 40, 50, 70) comprising a disposable component (200) and an applicator (100), the disposable component (200) having a mucoadhesive surface (202), the applicator (100) being for disposing the mucoadhesive surface (202) on a nasal or oral mucosa (12) of a patient, wherein: The applicator (100) comprises an insertable part (102) and an outer part (104) connected to the insertable part (102), the insertable part (102) and the outer part (104) being for insertion into the nasal cavity or oral cavity of the patient and for placement on the skin (14) of the patient, respectively, wherein the nasal or oral mucosa (12) is arranged between the insertable part (102) and the outer part (104); the disposable part (200) is attached or attachable to an insertable part (102) of the applicator (100) such that a mucoadhesive surface (202) of the disposable part (200) faces the nasal or oral mucosa (12) when the nasal or oral mucosa (12) is arranged between the insertable part (102) and the external part (104) of the applicator (100), and The applicator (100) comprises means for pressing the mucoadhesive surface (202) of the disposable component (200) against the nasal or oral mucosa (12) when the disposable component (200) is attached to the insertable component (102) of the applicator (100) and the nasal or oral mucosa (12) is arranged between the insertable component (102) and the external component (104) of the applicator (100).
  19. 19. The kit (10, 20, 30, 40, 50, 70) according to claim 18, wherein the applicator (100) is an applicator (100) according to any one of claims 1 to 11 and/or the disposable component (200) is a disposable component (200) according to any one of claims 12 to 17 or any one of claims 22 to 24.
  20. 20. The kit (10, 20, 30, 40, 50, 70) according to claim 18 or 19, wherein the means for pressing the mucoadhesive surface (202) against the nasal or oral mucosa (12) is configured to apply a pressure between the mucoadhesive surface (202) of the disposable part (200) and the nasal or oral mucosa (12) of between 0.1 kPa and 1000 kPa, preferably between 2.5 kPa and 100 kPa, most preferably between 4 kPa and 50 kPa.

Description

Applicator for placing a mucoadhesive surface on a patient's nasal or oral mucosa and disposable component for use therewith Technical Field The present invention relates to an applicator for arranging a mucoadhesive surface, in particular a mucoadhesive film loaded with an active agent (e.g. a drug), on a nasal or oral mucosa, in particular a buccal mucosa, of a patient, to a disposable part for use with an applicator for arranging a mucoadhesive surface on a nasal or oral mucosa of a patient, and to a kit comprising a disposable part having a mucoadhesive surface and an applicator for arranging said mucoadhesive surface on a nasal or oral mucosa of a patient. Background In recent years, the oral cavity has become increasingly important as a site for local and systemic drug delivery. A drug-loaded mucoadhesive film (e.g., polymer-based) may be painlessly disposed over the patient's oral mucosa (particularly over the buccal mucosa) to release the drug (or any other active agent) directly into the oral tissue (e.g., by passive diffusion), which may allow for rapid delivery of the drug to the circulatory system. This route of administration is well accepted by patients, but additionally provides many pharmacological advantages such as fast onset of action, direct access to systemic blood and lymphatic circulation, avoidance of first pass and food effects, elimination of degradation in the gastrointestinal tract prior to access to systemic circulation, improved bioavailability, and reduced drug exposure to patients, as well as ease of self-administration with a high degree of convenience and flexibility. However, the release rate of the drug from the mucoadhesive film (e.g., the amount of drug released from the film over a period of time) may depend on (a) the location of the mucoadhesive film on the mucosa, (b) the contact pressure of the mucoadhesive film on the mucosa, and (c) the extent of adhesion of the mucoadhesive film to the mucosa and/or the surface area of the mucoadhesive film adhered to the mucosa, all of which may affect the amount of wetting of the mucoadhesive film by saliva. This naturally leads to various possible errors in the administration of the film, in particular in the case of self-administration, which may require positive cooperation and good compliance by the patient in order to achieve a controlled and reliable release of the drug from the mucoadhesive film and thus ultimately therapeutic success. Thus, there is a need for a device for disposing a mucoadhesive film loaded with an active agent (e.g., a drug) on a patient's mucosa that is easy to use and that facilitates a controlled and reliable release of the active agent to the mucosa even in self-administered situations. Disclosure of Invention Hereinafter, elements of the present application will be described. These elements are listed with particular embodiments, however, it should be understood that they may be combined in any manner and in any number to create additional embodiments. The various described examples and preferred embodiments should not be construed as limiting the application to only the explicitly described embodiments. The specification should be understood to support and cover embodiments that combine two or more of the explicitly described embodiments, or embodiments that combine one or more of the explicitly described embodiments with any number of disclosed elements and/or preferred elements. Furthermore, any arrangement and combination of all described elements in this application should be considered as disclosed by the description of the application unless the context indicates otherwise. In a first aspect, the invention relates to an applicator for arranging a mucoadhesive surface, in particular a mucoadhesive film loaded with an active agent, on a nasal or oral mucosa, in particular a buccal mucosa, of a patient. The applicator comprises an insertable part and an external part connected to the insertable part, the insertable part and the external part being for insertion into the nasal cavity or oral cavity of a patient and for placement on the skin of the patient, respectively, the nasal or oral mucosa being arranged between the insertable part and the external part. The insertable component includes a retaining device configured to receive the disposable component including a mucoadhesive surface such that the mucoadhesive surface faces the nasal or oral mucosa when disposed between the insertable component and the external component. The applicator further comprises means for pressing the mucoadhesive surface against the nasal or oral mucosa when the disposable part is received by the holding means and the nasal or oral mucosa is arranged between the insertable part and the outer part. In some embodiments, the means for pressing the mucoadhesive surface against the nasal or oral mucosa is or comprises a resilient member (in particular a spring) configured to bias the disposable part or a part ther