Oral administration device as well as preparation method and application thereof

Abstract

The invention discloses an oral administration device as well as a preparation method and application thereof. The oral administration device comprises a core assembly and a fixing device, wherein the core assembly comprises a molar anastomosis functional area and a medicine carrying functional area which are integrally formed; the molar anastomosis functional area comprises a first section close to the medicine carrying functional area and a second section far away from the medicine carrying functional area; one ends of the first section and the second section are mutually connected, and the other ends are open ends to form a U-shaped structure; the first section and the second section are used for being matched with the buccal side and the lingual side of teeth respectively; the medicine carrying functional area comprises a first ring and a second ring which are coaxially arranged; the fixing device is used for enhancing the fixing effect of the core assembly on the teeth; the fixing device is a fixer or a fixing layer. When in use, the oral administration device is high in wearing firmness, high in safety, high in comfort level and small in influence on the appearance of the face.

Description

Oral drug delivery device and its preparation method and application

[0001] This application claims priority to Chinese Patent Application No. 2023103663509 filed on April 4, 2023 and Chinese Patent Application No. 2023207303692 filed on April 4, 2023. This application incorporates the entirety of the aforementioned Chinese patent applications. Technical Field

[0002] The present invention particularly relates to an oral medication dispenser and a preparation method and application thereof. Background Art

[0003] For active pharmaceutical ingredients such as levodopa, carbidopa, baclofen, and acyclovir, whose absorption windows are limited to the upper gastrointestinal tract, conventional sustained-release preparations have low bioavailability and insufficient treatment coverage. Existing technologies for extending the gastric retention time of drugs (including expansion, swelling, floating, raft formation, sinking, mucosal adhesion) have very limited prolongation effects, particularly when administered in a fasted state. In addition, for topical administration to the oral mucosa, liquid or semisolid preparations such as conventional sprays, gargles, and ointments have short residence times in the oral cavity and cannot achieve a sustained drug administration effect. Therefore, a drug delivery system that can provide long-term drug ingredient exposure is needed, which is suitable for drugs with absorption windows in the upper gastrointestinal tract or that need oral topical administration. The drug is loaded by a drug delivery device and fixed in the oral cavity after being combined with a fixture to form a drug controlled release system, which provides long-term exposure of drugs with absorption windows limited to the upper gastrointestinal tract.

[0004] Regarding oral drug delivery devices, patent applications US10668274 and CN1997421A disclose an oral drug-containing container based on an electrically controlled drug release mechanism. The drug-containing container and electrically controlled system claimed in the patents are difficult to implement. CN105873631A discloses an oral drug delivery device that requires an electronic pump or a mechanical pump as an external power source to achieve drug delivery. In addition, CN1925823A discloses a tooth bracket for attaching fluoride pellets to teeth to improve the treatment or prevention of dental caries. This patent application does not involve drug absorption in the upper gastrointestinal tract. In addition, patent application CN109908461A discloses an oral drug delivery device for dentures, braces, or oral implants, which is suitable for oral mucosal drug delivery and does not involve drug absorption in the upper gastrointestinal tract. The above-mentioned published patent applications either require external power, or need to rely on dentures, braces, etc. to achieve delivery, or do not involve drug absorption at the absorption end in the upper gastrointestinal tract.

[0005] CN114191307A and CN212973560U disclose an oral retention device for retaining tablets in the oral cavity, providing long-term exposure of drugs with absorption windows limited to the upper gastrointestinal tract, so as to obtain long-term stable blood drug concentrations. The oral retention device takes into account that the tablet is inserted from the back to the front, close to the throat and blocked by oral tissues such as the buccal fat pad tip, so that the tablet is not easy to fall off when the device is worn. At the same time, the tooth-fitting components in the oral retention device can fit the patient's teeth according to the personalized design, making it stable to wear. However, for patients with clinically short crowns, small buccal space or special oral conditions, when the oral movement amplitude is large, the oral retention device may be poorly retained and there is a risk of tilting or falling off.

[0006] The above-mentioned intraoral drug delivery devices do not take into account the wearing firmness under special oral conditions, and the complex structure or large device volume may cause poor wearing comfort and safety for patients, and will also have a great impact on facial appearance when worn.

[0007] Summary of the Invention

[0008] In order to solve the problem in the prior art that some patients have the risk of the applicator falling off after making movements such as opening their mouths widely, the present invention provides an oral applicator and its preparation method and application. Specifically, the present invention provides an oral applicator for inserting tablets from back to front, which is composed of a core component and a fixing device, which can keep the oral applicator and tablets stably in the oral cavity and will not fall off with oral movements. The long-term release of drugs with an absorption window limited to the upper end of the gastrointestinal tract, as well as the release of drugs administered to the oral mucosa or acting locally in the oral cavity, can be achieved by patients wearing the applicator. At the same time, the oral applicator is highly comfortable to use and has little impact on facial appearance.

[0009] The present invention mainly adopts the following technical solutions to solve the above technical problems:

[0010] The present invention provides an oral medication dispenser, which comprises a core component and a fixing device, wherein the core component comprises an integrally formed molar anastomotic functional area and a drug loading functional area;

[0011] When the oral drug delivery device is fixed in the oral cavity, the drug-carrying functional area is located in the space between the teeth and the cheek, or the drug-carrying functional area is located in the space between the teeth and the tongue;

[0012] The molar anastomotic functional area includes a first section close to the drug-carrying functional area and a second section away from the drug-carrying functional area; one end of the first section and the second section are connected to each other, and the other end is open, forming a U-shaped structure; the first section and the second section are respectively used to anastomose with the buccal side and the lingual side of the tooth, so as to fix the drug-carrying functional area on the tooth;

[0013] The drug-carrying functional area includes a first ring and a second ring arranged coaxially; the axial clamping space formed between the first ring and the second ring is used to fix the drug;

[0014] The fixing device is a fixator or a fixing layer, which is used to strengthen the fixing effect of the core component on the teeth;

[0015] When the fixing device is a fixer:

[0016] When the oral applicator is in use, the lingual side, buccal side and occlusal surface of the retainer are aligned with the lingual side, buccal side and occlusal surface of the teeth and covered on the outer peripheral surface of the teeth; the retainer also covers the molar anastomotic functional area;

[0017] When the fixing device is a fixing layer:

[0018] The fixing layer is attached to outer surfaces of the first section and the second section for contacting teeth.

[0019] In the present invention, the first ring and the second ring are preferably located on the buccal side of the first or second molar.

[0020] In the present invention, the fixture and the molar anastomotic functional area are preferably connected by mechanical assembly, mechanical connection or adhesive bonding.

[0021] Among them, the mechanical assembly is preferably embedded, and a slot is provided on the fixture at the position corresponding to the drug-carrying functional area to achieve detachable fixation of the fixture and the core component. The embedding means that the molar anastomosis functional area is embedded in the space formed on both sides of the fixture.

[0022] The mechanical connection is preferably welding, riveting or bolting.

[0023] The adhesive is preferably one or more of pressure-sensitive adhesive, starch adhesive, latex, epoxy resin and polyurethane acrylate.

[0024] In the present invention, the fixing layer is preferably also attached to other outer surfaces of the first section and the second section.

[0025] In the present invention, the first ring is close to the open end of the molar anastomosis functional area, and the second ring is far away from the open end of the molar anastomosis functional area. The first ring and the second ring are preferably solid or hollow ring structures.

[0026] Wherein, the hollow ring structure is a closed loop or an open loop.

[0027] The shape of the annular structure is preferably one or more of circular, elliptical and polygonal.

[0028] The shapes of the annular structures of the first ring and the second ring are preferably circular; the hollow area of ​​the first ring is preferably smaller than the hollow area of ​​the second ring, and the tablet can be inserted from the second ring to the first ring.

[0029] In the present invention, the material of the core component is preferably titanium, stainless steel, cobalt-chromium alloy, cobalt-chromium-molybdenum alloy or one of precious metals, more preferably cobalt-chromium alloy, and the material of the core component meets the standards of materials used in dentistry.

[0030] In the present invention, the material of the fixator is preferably one or more of polyvinyl chloride, polyethylene terephthalate, polyethylene terephthalate-1,4-cyclohexanedimethanol, polyurethane, polyamide, ethylene-vinyl acetate copolymer, polycaprolactone, high-density polyethylene, polypropylene, epoxy acrylate, methacrylate, and polyurethane acrylate; more preferably, polyethylene terephthalate or ethylene-vinyl acetate copolymer. The materials of the fixator meet medical grade standards.

[0031] In the present invention, the material of the fixing layer is preferably one or more of polyvinyl chloride, polyethylene terephthalate, polyethylene terephthalate-1,4-cyclohexanedimethanol, polyurethane, polyamide, ethylene-vinyl acetate copolymer, polycaprolactone, high-density polyethylene, polypropylene, cellulose acetate, hydroxypropyl cellulose and copovidone, more preferably polyethylene terephthalate or copovidone, and the materials of the fixing layer meet medical grade standards.

[0032] In the present invention, the thickness of the fixing layer is preferably 0.01 mm to 1 mm.

[0033] In the present invention, the number of teeth covered by the retainer can be adjusted according to the tooth condition and wearing security. The length of the retainer is preferably corresponding to the length of 4 to 16 teeth in the upper or lower jaw, and more preferably corresponding to the length of 5 to 9 teeth in the upper or lower jaw.

[0034] In the present invention, the length of the molar anastomotic functional area is preferably corresponding to the length of 2 to 5 teeth in the mandibular.

[0035] Among them, those skilled in the art should understand that the length is a length that enables the fixture or the molar anastomotic functional area to cover the number of teeth, and does not exceed the number of teeth in the target range.

[0036] In a preferred embodiment, the fixture is connected to the molar anastomosis functional area in an embedded manner, and a slot is provided on the fixture at a position corresponding to the drug-loaded functional area to achieve detachable fixation of the fixture and the core component; the length of the molar anastomosis functional area corresponds to the length of the mandibular first and second premolars and the first and second molars; the first ring and the second ring are circular closed rings.

[0037] In a preferred embodiment, the fixture is connected to the molar anastomosis functional area in an embedded manner; the length of the molar anastomosis functional area corresponds to the length of the mandibular first and second premolars and the first and second molars; the first ring and the second ring are elliptical closed rings.

[0038] In a preferred embodiment, the fixture is connected to the molar anastomosis functional area in an embedded manner; the length of the molar anastomosis functional area corresponds to the length of the maxillary second premolar and the first, second and third molars, and the first ring and the second ring are circular closed rings.

[0039] In a preferred embodiment, the fixture is connected to the molar anastomosis functional area by bonding with a pressure-sensitive adhesive; the length of the molar anastomosis functional area corresponds to the length of the first, second and third molars; the first ring and the second ring are polygonal closed rings.

[0040] In a preferred embodiment, the fixing layer is attached to the entire outer surface of the first section of the U-shaped structure and the second section of the U-shaped structure; the length of the molar anastomosis functional area corresponds to the length of the mandibular first and second premolars and the first and second molars; the first ring and the second ring are circular closed rings.

[0041] In a preferred embodiment, a pair of clamping walls are symmetrically provided on the first ring along the direction of the open end of the molar anastomotic functional area.

[0042] The present invention also provides a method for preparing the above-mentioned oral applicator, which includes the following steps: when the fixing device is a fixer, combining the fixer with the integrally formed first section and second section in a covering form; when the fixing device is a fixing layer, affixing the fixing layer to the outer surface of the integrally formed first section and second section.

[0043] In the present invention, the preparation method of the core component preferably includes laser melting, injection molding or die molding.

[0044] Among them, the laser melting and casting steps are preferably: scanning the subject's oral cavity or taking an oral mold to make a plaster model and then scanning to obtain the subject's oral data; using three-dimensional design software and dental design software to respectively design the drug-loading functional area and molar anastomosis functional area of ​​the core component, and combining them in the dental design software to generate a core component design file; preparing the core component by laser melting and casting, grinding, polishing, and cleaning.

[0045] The injection molding steps are preferably as follows: taking a mouth mold of a subject to make a plaster model; using dental wax as a material to prepare a dental wax model on the plaster model, and preparing the core components by a traditional injection molding process.

[0046] In the present invention, the method for preparing the fixator preferably includes lamination, molding, cutting or 3D printing.

[0047] The laminating step is preferably as follows: the raw material of the fixture is heated and softened by a laminating machine and then vacuumed, so that the raw material of the fixture covers the dental model and the molar anastomotic functional area.

[0048] The impression making step is preferably as follows: heating and softening the raw material of the fixture, and covering the teeth of the test subject and the molar anatomical functional area.

[0049] In the present invention, the raw material of the fastener is preferably as described above.

[0050] In the present invention, the method for preparing the fixing layer preferably includes dipping, spraying or lamination.

[0051] The dipping step is preferably as follows: after dissolving the raw material of the fixing layer, immersing the molar anastomotic functional area into the raw material solution of the fixing layer, taking it out, and drying it to form a film.

[0052] The spraying step is preferably as follows: dissolving the raw material of the fixing layer and then applying it to the molar anastomotic functional area by spraying, and drying to form a film.

[0053] The lamination step is preferably as follows: heating and softening the raw material of the fixing layer, covering the molar anastomotic functional area, and then cooling.

[0054] In the present invention, the raw material of the fixing layer is preferably as described above.

[0055] In the present invention, the fixing device and the covering structure of the first section and the second section are preferably formed by mechanical assembly, mechanical connection or adhesive bonding.

[0056] The mechanical assembly is preferably in the form of embedding.

[0057] When the combination is mechanically assembled, the retainer fits with the dental mold and the core component during the molding process, naturally forming a slot-like structure. At the same time, a buckle design can be added to the molar anastomosis functional area as needed.

[0058] The mechanical connection is preferably in the form of welding, riveting or bolting.

[0059] The adhesive is preferably applied to the outer surfaces of the first and second sections that are in contact with teeth, and more preferably to the entire outer surfaces of the first and second sections.

[0060] Wherein, the coating thickness of the adhesive is preferably no more than 1.0 mm.

[0061] The present invention also provides an application of the above-mentioned oral medication device, characterized in that: when the fixing device is a retainer: the lingual side, buccal side and occlusal surface of the retainer are aligned with the lingual side, buccal side and occlusal surface of the teeth and covered on the outer peripheral surface of the teeth; the drug-carrying functional area is placed in the space between the teeth and the cheek, or the drug-carrying functional area is placed in the space between the teeth and the tongue; and the retainer covers the molar-aligning functional area;

[0062] When the fixing device is a fixing layer: the drug-carrying functional area is placed in the space between the teeth and the cheek, or the drug-carrying functional area is placed in the space between the teeth and the tongue.

[0063] On the basis of conforming to the common sense in this field, the above-mentioned preferred conditions can be arbitrarily combined to obtain the preferred embodiments of the present invention.

[0064] The reagents and raw materials used in the present invention are commercially available.

[0065] The positive progress effect of the present invention is:

[0066] The present invention provides an oral drug delivery device that conforms to the teeth of the oral cavity and has a very low risk of dislodging. By inserting a tablet from the back side forward into the drug-loading functional area of ​​the drug delivery device and securing the combined tablets to the corresponding tooth in the mouth, the oral drug delivery device can achieve sustained release of drugs, including but not limited to drugs with absorption windows limited to the upper gastrointestinal tract and drugs that act locally in the oral cavity.

[0067] The oral applicator of the present invention does not require external power or adjustment of the patient's teeth, and is easy to wear and operate. The oral applicator of the present invention is highly secure to wear, that is, highly safe, and can prevent accidental swallowing or choking caused by the applicator becoming loose and falling off. The oral applicator of the present invention has little impact on the patient's facial appearance when worn, and is highly aesthetically pleasing to wear. At the same time, the oral applicator is also highly comfortable. BRIEF DESCRIPTION OF THE DRAWINGS

[0068] Figure 1 is a schematic structural diagram of the various components of the oral applicator of Example 1 of the present invention, which consists of a core component 1 and a fixing device 2, wherein the core component 1 includes a molar anastomosis functional area 11 and a drug-carrying functional area 12, and the drug-carrying functional area 12 consists of a first ring 121 and a second ring 122.

[0069] FIG2 is a schematic structural diagram of the core components of the oral applicator according to Example 1 of the present invention.

[0070] FIG3 is a schematic diagram of the structure of the holder when the fixing device in the oral applicator according to Example 1 of the present invention is a holder.

[0071] FIG4 is a cross-sectional view along the AA plane of FIG1 .

[0072] FIG5 is a schematic structural diagram of the oral medication device of Example 2.

[0073] FIG6 is a schematic structural diagram of the oral medication device of Example 3.

[0074] FIG7 is a schematic structural diagram of the oral medication device of Example 6.

[0075] FIG8 is a cross-sectional view along the BB plane of FIG7 .

[0076] FIG9 is a schematic structural diagram of the oral medication device of Example 9.

[0077] The reference numerals are as follows: 1-core component; 2-fixing device; 201-lingual side of the fixing device; 202-buccal side of the fixing device; 203-occlusal surface of the fixing device; 11-molar anastomotic functional area; 12-drug loading functional area; 121-first ring; 122-second ring; 123-clamping wall. DETAILED DESCRIPTION

[0078] The present invention is further illustrated by way of examples below, but the present invention is not limited to the scope of the examples. Experimental methods in the following examples where specific conditions are not specified were performed according to conventional methods and conditions, or selected according to the product specifications.

[0079] Example 1

[0080] This embodiment is an oral medication dispenser that covers all mandibular teeth, as shown in Figure 1. It includes a core component 1 and a fixing device 2. The fixing device 2 is a fixture. The structural schematic diagram of the core component 1 is shown in Figure 2, the structural schematic diagram of the fixing device 2 is shown in Figure 3, and a cross-sectional view of the oral medication dispenser is shown in Figure 4. The lingual side 201 of the fixing device, the buccal side 202 of the fixing device, and the occlusal surface 203 of the fixing device are respectively aligned with the lingual side, buccal side, and occlusal surface of the teeth and cover the outer peripheral surface of the teeth; the fixing device 2 also covers the molar anastomosis functional area 11. The core component 1 consists of the molar anastomosis functional area 11 and the drug loading functional area 12. The molar anastomosis functional area 11 can be tightly fitted with the mandibular first and second premolars and the first and second molars in the subject's oral cavity. The drug loading functional area 12 is sized so that it can accommodate at least one tablet and fix the tablet in the oral cavity. The fixing device 2 is tightly fitted with all mandibular teeth of the subject and with the molar anastomosis functional area 11, so that the core component 1 and the tablet are fixed in the oral cavity. The molar anastomosis functional area 11 and the drug-carrying functional area 12 are made of cobalt-chromium alloy, and the molar anastomosis functional area 11 and the drug-carrying functional area 12 are connected at their respective sides. The drug-carrying functional area 12 includes a first ring 121 and a second ring 122, and the first ring 121 and the second ring 122 are circular closed rings. The tablet is inserted from the second ring 122 and is blocked by the first ring 121. The molar anastomosis functional area 11 and the fixing device 2 are combined in an embedded mechanical assembly manner, and a slot is provided on the fixing device 2 at a position corresponding to the drug-carrying functional area 12 to achieve detachable fixation of the fixing device 2 and the core component 1. The fixing device 2 is made of colorless and transparent polyethylene terephthalate and covers all mandibular teeth, that is, covers 14 teeth. After the core component 1 and the fixing device 2 are combined, they match the teeth in the subject's mouth.

[0081] The oral applicator of this embodiment can be worn firmly in the oral cavity after being loaded with tablets, and the tablets are fixed in the oral cavity. The retainer, core component and tablets will not fall off or shift with the movement of the oral cavity. It is very comfortable to wear and has little impact on facial appearance.

[0082] Example 2

[0083] The present embodiment is an oral applicator covering 10 mandibular teeth, as shown in Figure 5, which includes a core component 1 and a fixing device 2, the fixing device 2 is a fixer, and the core component 1 is composed of a molar anastomosis functional area 11 and a drug-carrying functional area 12, the molar anastomosis functional area 11 can be tightly fitted with the mandibular first and second premolars and the first and second molars in the subject's oral cavity, and the size of the drug-carrying functional area 12 is such that it can accommodate at least one tablet and fix the tablet in the oral cavity. The fixing device 2 is tightly fitted with part of the subject's mandibular teeth (including the teeth from the left canine to the right second molar), and is tightly fitted with the molar anastomosis functional area 11, so that the core component 1 and the tablet are fixed in the oral cavity. The molar anastomosis functional area 11 and the drug-carrying functional area 12 are made of cobalt-chromium alloy, and the molar anastomosis functional area 11 and the drug-carrying functional area 12 are connected at their respective sides. The drug-carrying functional area 12 includes a first ring 121 and a second ring 122. The first ring 121 and the second ring 122 are elliptical closed rings. A pair of clamping walls 123 are symmetrically provided on the first ring 121 along the direction of the open end of the molar anastomosis functional area, which is suitable for the insertion of non-cylindrical tablets. The tablets are inserted from the second ring 122 and are blocked by the first ring 121. The molar anastomosis functional area 11 and the fixture 2 are combined in an embedded mechanical assembly manner. Slots are provided on the fixture 2 at positions corresponding to the drug-carrying functional area 12 to achieve detachable fixation of the fixture 2 and the core component 1. The fixture 2 is made of colorless and transparent polyethylene terephthalate and covers 10 teeth in the mandible from the left canine to the right second molar. After the core component 1 and the fixture 2 are combined, they match part of the mandibular teeth in the subject's mouth.

[0084] The oral applicator of this embodiment can be worn firmly in the oral cavity after being loaded with tablets, and the tablets are fixed in the oral cavity. The retainer, core component and tablets will not fall off or shift with the movement of the oral cavity. It is very comfortable to wear and has little impact on facial appearance.

[0085] Example 3

[0086] The present embodiment is an oral applicator covering 7 mandibular teeth, as shown in Figure 6, which includes a core component 1 and a fixing device 2, the fixing device 2 is a fixer, and the core component 1 is composed of a molar anastomosis functional area 11 and a drug-carrying functional area 12, the molar anastomosis functional area 11 can be tightly fitted with the mandibular first and second premolars and the first and second molars in the subject's oral cavity, and the size of the drug-carrying functional area 12 is such that it can accommodate at least one tablet and fix the tablet in the oral cavity. The fixing device 2 is tightly fitted with part of the subject's mandibular teeth (including a total of 7 teeth from the right incisor to the right second molar), and is tightly fitted with the molar anastomosis functional area 11, so that the core component 1 and the tablet are fixed in the oral cavity. The molar anastomosis functional area 11 and the drug-carrying functional area 12 are made of cobalt-chromium alloy, and the molar anastomosis functional area 11 and the drug-carrying functional area 12 are connected at their respective sides. The drug-carrying functional area 12 includes a first ring 121 and a second ring 122. The first ring 121 and the second ring 122 are circular closed rings, which are suitable for inserting cylindrical tablets. The tablets are inserted from the second ring 122 and are blocked by the first ring 121. The molar anastomosis functional area 11 and the fixture 2 are combined in an embedded mechanical assembly manner. Slots are provided on the fixture 2 at positions corresponding to the drug-carrying functional area 12 to achieve detachable fixation of the fixture 2 and the core component 1. The fixture 2 is made of colorless and transparent ethylene-vinyl acetate copolymer and covers a total of 7 teeth on the right side of the mandible from the incisor to the second molar. The core component 1 and the fixture 2 are combined to match the teeth of the subject.

[0087] When the oral applicator of this embodiment is worn in the mouth, the tablets can be fixed in the mouth after being loaded and are not easy to fall off. The wearing firmness is not significantly different from that of Examples 1 and 2. At the same time, because the number of teeth covered is small, the wearing comfort and the impact on facial appearance are better than those of Examples 1 and 2.

[0088] Example 4

[0089] The difference between this embodiment and embodiment 1 is that the oral applicator covers all maxillary teeth, and the molar anastomosis functional area 11 can fit tightly with the maxillary second premolar and the first, second and third molars in the subject's mouth. The rest is the same as embodiment 1.

[0090] The oral applicator of this embodiment can be worn firmly in the oral cavity after being loaded with tablets, and the tablets are fixed in the oral cavity. The retainer, core component and tablets will not fall off or shift with the movement of the oral cavity. It is very comfortable to wear and has little impact on facial appearance.

[0091] Example 5

[0092] The difference between this embodiment and Example 1 is that the core component 1 is 3 teeth long and can be designed for subjects with molar defects; the first ring 121 and the second ring 122 are polygonal closed loops, and the molar anastomotic functional area 11 and the fixing device 2 are bonded together using a pressure-sensitive adhesive as an adhesive. The bonding position is the entire outer surface of the molar anastomotic functional area 11, and the adhesive thickness is 0.1 mm; the fixing device 2 is made of colorless and transparent ethylene-vinyl acetate copolymer; the rest is the same as Example 1.

[0093] The oral applicator of this embodiment can be worn firmly in the oral cavity after being loaded with tablets, and the tablets are fixed in the oral cavity. The retainer, core component and tablets will not fall off or shift with the movement of the oral cavity. It is very comfortable to wear and has little impact on facial appearance.

[0094] Example 6

[0095] The structural schematic diagram of the oral medication dispenser of this embodiment is shown in Figure 7 . It includes a core component 1 and a fixing device 2, which serves as a fixing layer. A cross-sectional view of the oral medication dispenser is shown in Figure 8 . The core component 1 comprises a molar-fitting functional area 11 and a drug-carrying functional area 12. The molar-fitting functional area 11 is designed to fit snugly against the mandibular first and second premolars and first and second molars in the subject's oral cavity. The drug-carrying functional area includes a first ring 121 and a second ring 122. The first and second rings 121 and 122 are circular closed loops suitable for inserting cylindrical tablets. Tablets are inserted through the second ring 122 and are blocked by the first ring 121. The drug-carrying functional area 12 is sized to accommodate at least one tablet and secure it in the oral cavity. The fixing device 2 is attached to the entire outer surface of the first and second segments of the U-shaped structure. The molar-fitting functional area 11 and the drug-carrying functional area 12 are made of cobalt-chromium alloy and are connected at their respective sides. Fixture 2 is made of colorless, transparent polyethylene terephthalate, which is softened by heating and then applied to the surface of the molar anastomotic functional area 11. Excess material is trimmed after cooling. Fixture 2 is 0.3-0.5 mm thick. The core assembly 1 and fixture 2 are combined to match the subject's teeth.

[0096] The oral applicator of this embodiment can be worn firmly in the oral cavity after being loaded with tablets, and the tablets are fixed in the oral cavity. The fixing layer, core component and tablets will not fall off or shift with the movement of the oral cavity. It is very comfortable to wear and has little impact on the facial appearance.

[0097] Example 7

[0098] The difference between this embodiment and embodiment 6 is that the fixing device 2 is made of light blue polycaprolactone and has a thickness of 0.8 to 1 mm. The rest is the same as embodiment 6.

[0099] The oral applicator of this embodiment can be worn more firmly in the oral cavity after being loaded with tablets, and the tablets can be fixed in the oral cavity. However, because the fixing device is thicker, the oral applicator of this embodiment is not as firmly worn and comfortable as that of Example 6. Compared with Example 6, this embodiment has a greater impact on facial appearance.

[0100] Example 8

[0101] The difference between this embodiment and Example 6 is that the core component 1 and the fixing device 2 are bonded together using pressure-sensitive adhesive, the bonding position is the part where the molar anastomotic functional area contacts the teeth, and the adhesive thickness is 0.1 mm; the fixing device 2 is a colorless and transparent polypropylene film with a thickness of 0.02 to 0.04 mm; the rest is the same as Example 6.

[0102] The oral applicator of this embodiment can be worn firmly in the mouth after being loaded with tablets, and the tablets can be fixed in the mouth. However, because the thickness of the fixing layer is thin and the surface of the fixing layer material is smooth, the oral applicator of this embodiment is not as firm and comfortable to wear as in Examples 6 and 7.

[0103] Example 9

[0104] The oral drug delivery device of this embodiment is shown in Figure 9, which includes a core component 1 and a fixing device 2 that are symmetrical on the left and right sides. The fixing device 2 is a fixer. The two core components 1 are composed of a molar anastomosis functional area 11 and a drug-carrying functional area 12. The molar anastomosis functional area 11 can be tightly fitted with the maxillary first and second premolars and the first and second molars in the subject's oral cavity. The size of the drug-carrying functional area 12 is such that it can accommodate at least one tablet and fix the tablet in the oral cavity. The fixing device 2 is tightly fitted with all the maxillary teeth of the subject and with the molar anastomosis functional area 11, so that the core component 1 and the tablet are fixed in the oral cavity. The molar anastomosis functional area 11 and the drug-carrying functional area 12 are made of cobalt-chromium alloy, and the molar anastomosis functional area 11 and the drug-carrying functional area 12 are connected at their respective sides. The drug-carrying functional area 12 includes a first ring 121 and a second ring 122. The first ring 121 and the second ring 122 are circular closed rings, which are suitable for inserting cylindrical tablets. The tablets are inserted from the second ring 122 and are blocked by the first ring 121. The molar anastomosis functional area 11 and the fixture 2 are combined in an embedded mechanical assembly manner. Slots are provided on the fixture 2 at positions corresponding to the drug-carrying functional area 12 to achieve detachable fixation of the fixture 2 and the core component 1. The fixture 2 is made of colorless and transparent polyethylene terephthalate and covers all maxillary teeth. After the core component 1 and the fixture 2 are combined, they match the teeth in the subject's mouth.

[0105] The oral applicator of this embodiment can be worn firmly in the oral cavity after being loaded with tablets, and the tablets are fixed in the oral cavity. The retainer, core component and tablets will not fall off or shift with the movement of the oral cavity. It is very comfortable to wear and has little impact on facial appearance.

[0106] Example 10

[0107] The cobalt-chromium alloy core component was prepared by laser melting and casting, and the fixator was prepared by die-casting. The specific steps are as follows:

[0108] Step 1: Obtain the subject's oral data by scanning the subject's oral cavity or taking a plaster model of the oral cavity and then scanning it.

[0109] Step 2: Use 3D design software and dental design software to respectively design the drug-loading functional area and molar anastomosis functional area of ​​the core component, and combine them in the dental design software to generate the core component design file.

[0110] Step 3: Prepare the cobalt-chromium alloy core components through laser melting, grinding, polishing and cleaning.

[0111] Step 4: Wear the core component on the subject's dental mold, heat and soften the polyethylene terephthalate through a laminator, and then vacuum it on the dental mold. Trim off excess material and polish it. Remove it from the dental mold to obtain the oral applicator, which matches the subject's teeth.

[0112] Example 11

[0113] The cobalt-chromium alloy core components were prepared by injection molding and the applicator was prepared by die-casting. The specific steps are as follows:

[0114] Step 1: Make a plaster model by taking a mouth mold of the subject.

[0115] Step 2: Use dental wax as material to prepare a dental wax model on the plaster model.

[0116] Step 3: Use cobalt-chromium ceramic alloy as the material and prepare the core components through traditional injection molding process.

[0117] Step 4: Wear the core component on the plaster dental model, heat and soften the polyurethane through a laminating machine, and then vacuum the dental model. Trim away excess material and polish it. Remove it from the dental model to obtain the oral applicator consisting of the core component and the retainer.

[0118] Example 12

[0119] The cobalt-chromium alloy core component was prepared by injection molding and the applicator was prepared by the impression method. The specific steps are as follows:

[0120] Step 1: Make a plaster model by taking a mouth mold of the subject.

[0121] Step 2: Use dental wax as material to prepare a dental wax model on the plaster model.

[0122] Step 3: Using cobalt-chromium porcelain alloy as the material, prepare the applicator through traditional injection molding process.

[0123] Step 4: Wear the core component on the corresponding teeth of the subject, heat and soften the polycaprolactone material, and cover the molar matching functional area of ​​the subject's teeth and the core component. After cooling, remove it from the teeth together with the core component to obtain the oral applicator.

[0124] Comparative Example 1

[0125] The oral medication dispenser of this comparative example only includes the core component 1 in Example 1, as shown in FIG2 .

[0126] Effect Example 1

[0127] The oral applicators of Example 1, Example 3, Example 6 and Comparative Example 1 were tested for wearing firmness, and the wearing firmness scores were as follows in Table 1: 1: not firm, and the applicator is very easy to fall off after being worn under basic oral movements such as opening the mouth and talking; 2: relatively loose, and the applicator sometimes becomes loose, tilted or falls off after being worn under basic oral movements such as opening the mouth and talking; 3: basically firm, and the applicator is easy to fall off only during large-scale oral movements; 4: firm, and the applicator tilts or loosens only during large-scale oral movements, but does not fall off; 5: very firm, and there is no looseness, tilting or falling off during basic oral movements or large-scale oral movements.

[0128] Table 1

[0129] As can be seen from Table 1, the embodiments 1, 3 and 6 of the present application adopt a combination of a fixing device and a core component, and the wearing security is better compared with the comparative example 1 which only adopts the core component, and the wearing security of the fixing device using a fixator is higher than that of the fixing layer.

[0130] Effect Example 2

[0131] The oral applicators of Example 1, Example 3, Example 6 and Comparative Example 1 were tested for wearing comfort, and the wearing comfort scores were as follows in Table 2: 1 point means extremely uncomfortable, with obvious foreign body sensation or irritation, and unacceptable; 2 points means uncomfortable, with obvious foreign body sensation or irritation, and not very acceptable; 3 points means there is a foreign body sensation or irritation, which has a slight effect on oral function, but is acceptable; 4 points means a high degree of comfort, with no obvious foreign body sensation or irritation, and basically no effect on oral function; 5 points means a high degree of comfort, with almost no foreign body sensation or irritation, and no effect on oral function.

[0132] Table 2

[0133] As can be seen from Table 2, the embodiments 1, 3 and 6 of the present application which combine the fixing device and the core component have better wearing comfort compared with the comparative embodiment 1 which only uses the core component.

[0134] Effect Example 3

[0135] The degree of influence of the oral applicators of Example 1, Example 3, Example 6 and Comparative Example 1 on facial appearance when worn was tested, and the scores were as shown in Table 3 below: 1 point means the degree of influence on facial appearance is the greatest and unacceptable; 2 points means the degree of influence on facial appearance is relatively large and not very acceptable; 3 points means the facial appearance has an influence but is acceptable; 4 points means the facial appearance has a small influence; and 5 points means there is almost no difference in facial appearance before and after wearing.

[0136] Table 3

[0137] It can be seen from the above table that the oral applicators of Examples 1, 3 and 6 of the present application, which combine the fixing device and the core component, have a similar degree of impact on the facial appearance when worn compared to the comparative example 1 which only uses the core component. That is, the oral applicators of the embodiments of the present application have similar wearing aesthetics compared to the comparative example.

[0138] Although the above describes specific embodiments of the present invention, it should be understood by those skilled in the art that these are merely illustrative and that various changes or modifications may be made to these embodiments without departing from the principles and essence of the present invention. Therefore, the scope of protection of the present invention is defined by the appended claims.

Claims

1. An oral medication device, characterized in that: It includes a core component and a fixing device, wherein the core component includes an integrally formed molar anastomotic functional area and a drug-carrying functional area; When the oral drug delivery device is fixed in the oral cavity, the drug-carrying functional area is located in the space between the teeth and the cheek, or the drug-carrying functional area is located in the space between the teeth and the tongue; The molar anastomosis functional area includes a first section close to the drug-carrying functional area and a second section away from the drug-carrying functional area; One end of the first section and the second section are connected to each other, and the other end is an open end, forming a U-shaped structure; the first section and the second section are respectively used to match the buccal side and the lingual side of the tooth, and are used to fix the drug-carrying functional area on the tooth; The drug-carrying functional area comprises a first ring and a second ring arranged coaxially; an axial clamping space formed between the first ring and the second ring is used to fix the drug; The fixing device is a fixator or a fixing layer, which is used to strengthen the fixing effect of the core component on the teeth; When the fixing device is a fixture: When the oral applicator is in use, the lingual side, buccal side and occlusal surface of the retainer are correspondingly matched with the lingual side, buccal side and occlusal surface of the teeth and covered on the outer peripheral surface of the teeth; the retainer also covers the molar matching functional area; When the fixing device is a fixing layer: The fixing layer is attached to the outer surfaces of the first section and the second section for contacting with teeth.

2. The oral medication device according to claim 1, wherein: The fixture is connected to the molar anastomotic functional area by mechanical assembly, mechanical connection or adhesive bonding; And / or, the fixing layer is also attached to other outer surfaces of the first section and the second section; And / or, the first ring is close to the open end of the molar anastomosis functional area, the second ring is far away from the open end of the molar anastomosis functional area, and the first ring and the second ring are solid or hollow ring structures.

3. The oral medication device according to claim 2, characterized in that: The mechanical assembly is embedded, and a slot is provided on the fixture at a position corresponding to the drug-carrying functional area to achieve detachable fixation between the fixture and the core component; and / or, the mechanical connection is welding, riveting or bolting; and / or, the adhesive is one or more of pressure-sensitive adhesive, starch adhesive, latex, epoxy resin and polyurethane acrylate; And / or, the hollow annular structure is a closed loop or an open loop; And / or, the shape of the annular structure is one or more of a circle, an ellipse and a polygon; And / or, the shapes of the annular structures of the first ring and the second ring are both circular; and the hollow area of ​​the first ring is smaller than the hollow area of ​​the second ring.

4. The oral medicating device according to at least one of claims 1 to 3, characterized in that The core component is made of titanium, stainless steel, cobalt-chromium alloy, cobalt-chromium-molybdenum alloy or precious metal, preferably cobalt-chromium alloy; And / or, the material of the fixer is one or more of polyvinyl chloride, polyethylene terephthalate, polyethylene terephthalate-1,4-cyclohexanedimethanol, polyurethane, polyamide, ethylene-vinyl acetate copolymer, polycaprolactone, polyethylene, polypropylene, epoxy acrylate, methacrylate, polyurethane acrylate; preferably polyethylene terephthalate or ethylene-vinyl acetate copolymer; and / or, the length of the fixture corresponds to the length of 4 to 16 teeth in the upper or lower jaw, preferably corresponds to the length of 5 to 9 teeth in the upper or lower jaw; And / or, the length of the molar anastomotic functional area corresponds to the length of 2 to 5 teeth in the mandible.

5. The oral medicating device according to at least one of claims 1 to 4, characterized in that The material of the fixing layer is one or more of polyvinyl chloride, polyethylene terephthalate, polyethylene terephthalate-1,4-cyclohexanedimethanol, polyurethane, polyamide, ethylene-vinyl acetate copolymer, polycaprolactone, high-density polyethylene, polypropylene, cellulose acetate, hydroxypropyl cellulose and copolyvidone; preferably polyethylene terephthalate or copolyvidone; And / or, the fixing layer has a thickness of 0.01 mm-1 mm.

6. The oral medicating device according to at least one of claims 1 to 5, characterized in that The fixture is connected to the molar anastomosis functional area in an embedded manner; the length of the molar anastomosis functional area corresponds to the length of the first and second premolars and the first and second molars of the mandible; the first ring and the second ring are circular closed rings; Alternatively, the fixture is connected to the molar anastomosis functional area in an embedded manner; the length of the molar anastomosis functional area corresponds to the length of the mandibular first and second premolars and the first and second molars; the first ring and the second ring are elliptical closed rings; Alternatively, the fixture is connected to the molar anastomosis functional area in an embedded manner; the length of the molar anastomosis functional area corresponds to the length of the maxillary second premolar and the first, second and third molars, and the first ring and the second ring are circular closed rings; Alternatively, the fixture is connected to the molar anastomotic functional area by bonding using a pressure-sensitive adhesive as an adhesive; the length of the molar anastomotic functional area corresponds to the length of the first, second, and third molars; the first ring and the second ring are polygonal closed rings; Alternatively, the fixing layer is attached to the entire outer surface of the first section of the U-shaped structure and the second section of the U-shaped structure; the length of the molar anastomotic functional area corresponds to the length of the mandibular first and second premolars and the first and second molars; the first ring and the second ring are circular closed rings; Alternatively, a pair of clamping walls are symmetrically provided on the first ring along the direction of the open end of the molar anastomotic functional area.

7. A method for preparing an oral drug delivery device according to at least one of claims 1 to 6, characterized in that: It includes the following steps: When the fixing device is a fixer, the fixer is combined with the first section and the second section formed integrally in a covering form; when the fixing device is a fixing layer, the fixing layer is attached to the outer surface of the first section and the second section formed integrally.

8. The method for preparing the oral drug delivery device according to claim 7, characterized in that: The preparation method of the core component includes laser melting, injection molding or die molding; and / or, the preparation method of the fixator comprises lamination, molding, cutting or 3D printing; And / or, the preparation method of the fixing layer includes dipping, spraying or lamination; And / or, the fixing device and the covering structure of the first section and the second section are formed by mechanical assembly, mechanical connection or adhesive bonding.

9. The method for preparing the oral drug delivery device according to claim 7 and / or 8, characterized in that: In the preparation method of the fixator: The laminating step comprises: heating and softening the raw material of the fixture through a laminating machine and then evacuating the raw material of the fixture so that the raw material of the fixture covers the dental model and the molar anastomotic functional area; Alternatively, the impression step is: heating and softening the raw material of the fixture, and covering the teeth of the subject and the molar anatomical functional area; And / or, in the method for preparing the fixed layer: The dipping step is: after dissolving the raw material of the fixing layer, immersing the molar anastomotic functional area into the raw material solution of the fixing layer, taking it out, and drying it to form a film; Alternatively, the spraying step is: dissolving the raw material of the fixing layer and applying it to the molar anastomotic functional area by spraying, and drying to form a film; Alternatively, the step of laminating is: heating and softening the raw material of the fixing layer, covering the molar anastomotic functional area, and then cooling; And / or, the mechanical assembly is in the form of embedding; And / or, the mechanical connection is in the form of welding, riveting or bolting; And / or, the adhesive is applied on the outer surfaces of the first section and the second section that are used for contacting teeth, preferably on the entire outer surfaces of the first section and the second section; And / or, the coating thickness of the adhesive does not exceed 1.0 mm.

10. Use of an oral medicating device according to at least one of claims 1 to 6, characterized in that: When the fixing device is a fixture: the lingual side, buccal side and occlusal surface of the fixture are matched with the lingual side, buccal side and occlusal surface of the teeth and covered on the outer peripheral surface of the teeth; the drug-carrying functional area is placed in the space between the teeth and the cheek, or the drug-carrying functional area is placed in the space between the teeth and the tongue; and covering the molar anastomotic functional area with the fixture; When the fixing device is a fixing layer: the drug-carrying functional area is placed in the space between the teeth and the cheek, or the drug-carrying functional area is placed in the space between the teeth and the tongue.

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