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WO2022057905A1 - Dispositif de retenue buccal et son procédé de préparation - Google Patents

Dispositif de retenue buccal et son procédé de préparation Download PDF

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Publication number
WO2022057905A1
WO2022057905A1 PCT/CN2021/119120 CN2021119120W WO2022057905A1 WO 2022057905 A1 WO2022057905 A1 WO 2022057905A1 CN 2021119120 W CN2021119120 W CN 2021119120W WO 2022057905 A1 WO2022057905 A1 WO 2022057905A1
Authority
WO
WIPO (PCT)
Prior art keywords
drug
retention device
dental
oral
tablet
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2021/119120
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English (en)
Chinese (zh)
Inventor
董良昶
陈溪山
吴刚
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai Wd Pharmaceutical Co Ltd
Original Assignee
Shanghai Wd Pharmaceutical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shanghai Wd Pharmaceutical Co Ltd filed Critical Shanghai Wd Pharmaceutical Co Ltd
Priority to CN202180064047.2A priority Critical patent/CN116322602A/zh
Priority to EP21868727.5A priority patent/EP4215175A4/fr
Priority to JP2023517740A priority patent/JP7500116B2/ja
Publication of WO2022057905A1 publication Critical patent/WO2022057905A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0092—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine for holding medicines in, or fixing medicines on, a tooth, e.g. holder containing medicines fixed on a tooth

Definitions

  • the invention relates to the field of medical devices, in particular to an oral retention device and a preparation method thereof.
  • Patent application US10/668,274 and patent application CN1997421A disclose an oral medicine-containing container based on the mechanism of electric control of drug release. Moreover, the drug-containing container and the electric control system claimed in the patent are difficult to implement. There is no example in the patent specification, and it does not explain how to use the electric control drug release mechanism to realize the controlled release of the osmotic pump tablet as the drug storage device, so as to achieve the above Drug absorption in the gastrointestinal tract, so as to achieve long-term stable blood drug concentration.
  • CN1925823A discloses a dental bracket for attaching fluoride pills to teeth to improve the treatment and/or prevention of dental caries.
  • the patent application does not involve drug absorption in the upper gastrointestinal tract and long-term stable blood drug concentration, nor does it involve the method of tablet insertion.
  • Chinese patent application CN105873631A discloses an oral retention device that requires an electronic pump or a mechanical pump as an external force for drug delivery, and does not involve a tablet insertion method.
  • the tablet In the way of inserting the tablet from the front to the back (from the incisor to the molar), the tablet is easy to slip out from the front of the device (the side of the incisor), and the patient is prone to suffocation due to accidentally swallowing the dropped tablet.
  • the present invention provides a novel oral retention device that allows the tablet to remain in the oral cavity and not easily fall off.
  • the present invention provides an oral retention device in which the tablet is inserted from the back to the front. Since the rear side is close to the throat, there are oral tissues such as buccal fat pad tip and pterygomandibular fold that block the tablet, so that the tablet does not remain in the oral device. It will fall off and will not cause suffocation due to accidental swallowing.
  • a first aspect of the present invention provides an oral retention device.
  • the oral retention device includes a dental engagement member and a medicated member, the dental engagement member is connected to the drug loaded member, wherein the dental engagement member is used for bridging and mating with the teeth in the mouth cavity , the drug-carrying member can accommodate at least one tablet and is used to keep the tablet in the oral cavity.
  • the dental anastomosis member and the drug-carrying member are connected at their respective sides; and/or, the drug-carrying member is a mesh structure or a non-mesh structure, and the drug-carrying member has a mesh structure or a non-mesh structure.
  • the shape of the cross section is a circle, an ellipse, a polygon, or a special-shaped closed-loop or open-loop structure, or a combination thereof.
  • the cross section is a cross section perpendicular to the long axis direction of the dental engaging member (the long axis direction of the dental engaging member is substantially equal to the horizontal plane formed after the dental engaging member is matched with the teeth in the oral cavity).
  • the drug-carrying member includes at least one ring body and at least one limiting member, or the drug-carrying member is composed of at least one limiting member; wherein, the ring body has a space for inserting a tablet
  • the structure of the limiting member is used to limit the tablet in the drug-carrying member.
  • the opening faces the molars in a horizontal direction formed by the molars and the incisors, so that the tablet is inserted from the molars to the incisors in the horizontal direction; or, the openings are perpendicular to the incisors. It is arranged in the horizontal direction, and the tablet is inserted from top to bottom in the horizontal direction perpendicular to the Insert horizontally from buccal to lingual.
  • the horizontal direction described herein is basically equivalent to the horizontal direction in which the longest axis of the dental anastomosis member is located when the oral retention device is placed horizontally, and is also basically equivalent to the horizontal direction in which the oral retention device is matched with the teeth in the oral cavity of the subject through the dental anastomotic member.
  • the form of the tablet of the present invention does not change with time, and it is an osmotic pump tablet.
  • the osmotic pump tablet contains active drugs and excipients.
  • the component of the active drug is one of levodopa or its ester, carbidopa, baclofen, acyclovir, valacyclovir, ganciclovir, metformin and gabapentin, or levodopa or one or both of its esters and carbidopa.
  • the tablet is a film-controlled tablet, the controlled release film is a water-insoluble cellulose acetate excipient, and the tablet core is supported by an insoluble excipient skeleton or a booster layer. When the tablet completely releases the drug in the oral cavity, the appearance of the tablet is The top is still a full tablet shape.
  • the ring body is an open ring body or a closed ring body.
  • the closed-loop body is a circular, elliptical, polygonal or special-shaped closed-loop body;
  • the open-loop body is a circular, elliptical, polygonal or special-shaped open-loop body with missing parts (non-closed).
  • the limiting member is an arc-shaped hollow or solid shape, or the limiting member is formed by connecting a closed-loop body and a semicircle perpendicular to the closed-loop body; and/or, the The limiting member is adjacent to the ring body, or the limiting member is spaced from the ring body.
  • the abutments are integrally formed or connected together by connecting structures.
  • the number of the stopper is one, and the stopper is located on the side of the incisor in the horizontal direction; and/or, the number of the ring body is one, and the ring body It is located on the side of the molars in the horizontal direction formed by the molars and the incisors.
  • the tooth-fitting member can fit with any one or more teeth in the oral cavity, and/or the length of the tooth-fitting member is the length of 2-5 teeth.
  • the teeth are mandibular permanent teeth.
  • Mandibular molars are preferred. Most preferably first molars and second molars, or first molars, second molars and second premolars, or first molars, second molars and third molars, or first molars, second molars, third molars Tri-molars and second premolars.
  • the dental engaging members are prepared according to the size and shape of individual teeth.
  • the dental engaging member wraps, engages, snaps into, or inserts the teeth to which it engages.
  • the material of the oral retention device is a stable material for oral cavity, and the stable material for oral cavity is selected from oral stable metal or thermoplastic elastomer.
  • the oral-stable metal is selected from one of dental titanium, stainless steel, cobalt-chromium alloy, cobalt-chromium-molybdenum alloy or precious metal;
  • the thermoplastic elastomer is selected from polycaprolactone, ethylene-vinyl acetate copolymer , HDPE, polypropylene, polyacrylate, polyurethane, silicone polymers, polyester, poly(styrene-ethylene-butylene-styrene), poly(styrene-butadiene-styrene), poly A copolymer of one or both of (styrene-isoprene-styrene).
  • the material of the dental anastomosis member and the drug-carrying member is cobalt-chromium alloy.
  • a second aspect of the present invention provides a method of manufacturing the oral retention device of the first aspect of the present invention.
  • the method is selected from any of 3D printing, injection molding or impression molding.
  • the method for preparing the oral retention device of the first aspect of the present invention is 3D printing, which includes the following steps:
  • the design software add the plan of the saved drug-carrying component, and assemble the plan of the integrated oral retention device with the plan of the dental anastomosis component, and export the 3D printable file;
  • the design software is preferably 3Shape Dental System ;
  • the 3D printing preferably uses a laser sintering process
  • the step (1) it also includes: (0) in the software, design and save the plan of the drug-carrying member according to the data of the tablet size, the software is preferably SolidWorks or Zhongwang 3D platform design software; and /or, in the design software, design the plan of the dental anastomosis member according to the data of the subject's tooth size;
  • the data of the tablet size and/or the data of the subject's teeth are obtained by scanning the tablet and/or the subject's teeth or the subject's tooth model using a scanner, and the tooth model is obtained by traditional impression taking techniques prepared, the scanner is preferably a 3Shape scanner.
  • “3Shape” The intraoral scanner scans the size data of the tablet, and then, import the data into the "SolidWorks” software, design a plan for the drug-carrying component that can load the drug part, create and save the plan as a "standard attachment”file; use “3Shape” "The intraoral scanner scans the subject's teeth, and the data is imported into the “3Shape Dental System” software, and the dental anastomotic components are designed according to the tooth data; on the "3Shape Dental System” software, "standard accessories” are added and assembled with the dental anastomotic components.
  • the 3D printing preferably uses a laser sintering process.
  • the 3D printing is basically the same as the working principle of an ordinary printer.
  • the 3D printer is equipped with different "printing materials” such as metal, ceramics, plastic, sand, etc. After the printer is connected to the computer, the "printing materials" can be superimposed layer by layer through the computer control, and finally the blueprint on the computer can be turned into a real thing.
  • 3D printing refers to the technical principles of ordinary printers, in which the process of layered processing is very similar to inkjet printing. This printing technology is called 3D stereo printing technology. Many different technologies exist for 3D printing, which differ in the way the materials are available, and build up in different layers to create parts.
  • 3D printing Common materials for 3D printing are nylon glass fiber, polylactic acid, ABS resin, durable nylon material, gypsum material, aluminum material, titanium metal, titanium alloy, stainless steel, silver-plated, gold-plated, cobalt-chromium alloy, cobalt-chromium-molybdenum alloy or rubber materials, etc.
  • the advantage of 3D printing is that the operation can be automated, the production speed is fast, the design blueprint in the computer can be directly and accurately converted into a physical model, and it is also suitable for small-scale custom manufacturing.
  • the method of making the oral retention device of the first aspect of the present invention is injection molding comprising the steps of:
  • the tooth model is prepared by traditional impression taking technology or the subject's tooth data is obtained and printed by oral scanning technology;
  • the material of the dental anastomosis component model, the drug-carrying component model and the oral retention device model is dental wax, and/or the material of the tooth model is gypsum or resin.
  • Injection molding also known as injection molding, is a molding method of injection and molding, that is, at a certain temperature, the completely molten material is stirred by a screw, injected into the mold cavity with high pressure, and cooled and solidified to obtain a molded product Methods.
  • This method is suitable for mass production of complex-shaped parts, and is one of the important processing methods.
  • the advantages of the injection molding method are that the production speed is fast, the efficiency is high, the operation can be automated, there are many varieties of colors, the shape can be from simple to complex, the size can be from large to small, and the size of the product is accurate, the product is easy to replace, and it can be formed into complex shapes. Parts, injection molding is suitable for mass production and complex shape products and other molding processing fields.
  • the method of making the oral retention device of the first aspect of the present invention is impression molding, comprising:
  • the drug-carrying component was designed according to the tablet size; the dental anastomosis component was prepared with polycaprolactone (PCL) as the material, and the drug-carrying component was prepared with cobalt-chromium alloy as the material; the dental anastomosis component and the drug-carrying component were assembled into a complete oral retention device.
  • PCL polycaprolactone
  • a traditional injection molding process is used to prepare a drug-carrying member capable of loading an osmotic pump sheet; then the thermoplastic sheet is heated and softened to prepare a dental anastomosis member, and the softened dental anastomosis member is embedded with the drug-carrying member at the same time. After cooling, an integrated oral retention device is formed and taken out from the oral cavity.
  • the reagents and raw materials used in the present invention are all commercially available.
  • the positive and progressive effect of the present invention is that: an oral retention device in which the insertion direction of the tablet is from the throat to the incisors is provided. Because the rear side of the oral retention device is close to the throat, the tablet is not easy to fall off in the oral cavity due to the blocking effect of the oral mucosal tissue. .
  • the tablet is inserted into the oral cavity retention device to form a drug-device composition, and the drug-device composition is fixed on the matching teeth in the oral cavity, so that the drug can be continuously released within a certain period of time. After holding for 0-24 hours, the drug-device composition is taken out, replaced with a new tablet, and the drug-device composition is re-fixed on the matching teeth in the oral cavity, so that the drug can be continuously and stably released.
  • FIG. 1 is a tablet post-insertion oral retention device according to an embodiment of the present invention, which is composed of a dental anastomosis member 11 and a drug-carrying member 41, wherein the drug-carrying member 41 is composed of a stopper 21 and a ring body 31, and the ring body 31 There is an opening 311 thereon.
  • FIG. 2 shows a tablet front-insertion oral retention device according to an embodiment of the present invention, which is composed of a dental anastomosis member 12 and a drug-carrying member 42 , wherein the drug-carrying member 42 is composed of a stopper 22 and a ring body 32 , and the ring body 32 There is an opening 321 thereon.
  • the tablet post-insertion oral retention device is formed by connecting the dental anastomosis member 11 and the drug-carrying member 41 .
  • the dental engagement member 11 can be in close contact with the teeth in the oral cavity of the subject, and the drug-carrying member 41 is sized to accommodate at least one tablet and retain the tablet in the oral cavity.
  • the dental anastomosis member 11 and the drug-carrying member 41 are both made of cobalt-chromium alloy, and the dental anastomosis member 11 and the drug-carrying member 41 are connected at their respective sides.
  • the drug-carrying member includes a ring body 31 and a limiter 21 at the end.
  • the ring body 31 is a circular closed-loop body and has an opening 311 for inserting a tablet.
  • the stopper and the ring body are arranged at intervals, and are respectively connected to the dental anastomosis member 11; It can also be produced in one piece with the ring body and the dental engagement member.
  • the opening 311 opens toward the molars in the horizontal direction formed by the molars and the incisors (the ring body 31 is located in the horizontal direction close to the molars.
  • the dental anastomosis member 11 is anastomosed with the mandibular first molars, second molars and/or third molars in the oral cavity of the subject, and wraps the teeth through anastomosis.
  • the oral retention device of this embodiment after the tablet is loaded in the oral cavity, even if the drug immediate-release layer is rapidly dissolved by vigorous gargling, the tablet can be fixed firmly and will not slip out of the device.
  • Example 2 Cobalt-chromium alloy front insertion oral retention device
  • the tablet front-insertion oral retention device is formed by connecting the dental anastomosis member 12 and the drug-carrying member 42 .
  • the dental engagement member 12 can be in close contact with the teeth in the oral cavity of the subject, and the medicated member 42 is sized to receive at least one tablet and retain the tablet in the oral cavity.
  • the dental anastomosis member 12 and the drug-carrying member 42 are both made of cobalt-chromium alloy, and the dental anastomosis member 12 and the drug-carrying member 42 are connected at their respective sides.
  • the drug-carrying member 42 includes a ring body 32 and a limiter 22 at the end.
  • the ring body 32 is a circular closed ring body and has an opening 321 for inserting a tablet.
  • the stopper and the ring body are arranged at intervals, and are respectively connected to the dental anastomosis member 11; It can also be produced in one piece with the ring body and the dental engagement member.
  • the opening 321 opens toward the incisors in the horizontal direction formed by the molars and the incisors (the ring body 32 is located on the side of the molars in the horizontal direction formed by the molars and the incisors, that is, the position of the ring body 32 is higher than the position of the limiting member 22 .
  • the dental anastomosis member 11 is anastomosed with the mandibular first molars, second molars and/or third molars in the oral cavity of the subject, and wraps the teeth through anastomosis.
  • the tablet may slip from the device during the rapid dissolution of the drug immediate release layer, and the tablet may also slip out of the device during wearing. Slipped, but still has a certain use value.
  • Step 1 Scan the size data of the tablet by the "3Shape Dental System” scanner. Then, through the “SolidWorks” software, a drug-carrying member capable of loading drug parts is designed, created and saved as a "Standard Attachment” file. Each time an oral retention device is designed in the "3Shape Dental System” software, a "standard accessory” is added and assembled with the dental anastomotic component to form an integrated oral retention device.
  • Step 2 Perform an intraoral or dental model scan:
  • the scanning can be performed using a conventional mouth scanner in the field, such as 3Shape Mouth scanner or conventional scanner such as Qscan type dental scanner, so scanning software such as 3Shape can be used
  • a conventional mouth scanner in the field such as 3Shape Mouth scanner or conventional scanner such as Qscan type dental scanner, so scanning software such as 3Shape can be used
  • the oral scanner or Qscan type dental scanner comes with its own system software.
  • Step 3 Device Design
  • Step 4 3D Print/Sand Polish Clean.
  • the cobalt-chromium alloy post-insertion oral retention device prepared in this embodiment includes a dental anastomosis member 11 and a drug-loading member; In close contact with the teeth in the oral cavity, the drug-carrying member can accommodate at least one tablet and keep the tablet in the oral cavity.
  • the tablet may be a controlled release formulation, preferably an osmotic pump tablet.
  • the osmotic pump tablet contains an active drug and excipients, and the active drug is composed of levodopa or its ester, carbidopa, baclofen, acyclovir, valacyclovir, ganciclovir, metformin and one of gabapentin, or one or both of levodopa or its esters and carbidopa.
  • the shape of the cross section of the drug-carrying member is a circular closed loop.
  • the drug-carrying member may be a mesh structure or a non-mesh structure.
  • the drug-carrying member includes at least one ring body 31 and at least one limiter 21 at the end, and the ring body 31 forms an opening 311 into which the tablet can be inserted.
  • the limiting piece is in the shape of a circular arc hollow.
  • the opening faces the molars in a horizontal direction formed by the molars and the incisors, and the tablet is inserted from the molars to the incisors in the horizontal direction.
  • the dental plaster model of the patient/volunteer is prepared by the traditional impression taking technique; then the dental wax model is manually prepared on the plaster model by using the dental wax as the material through the traditional manual process; The injection molding process was used to prepare the oral retention device.
  • Example 5 Cobalt-chromium alloy front insertion oral retention device prepared by 3D printing
  • the oral retention device shown in FIG. 2 is prepared by the same method as in Example 3. Only in step 3 f, the positions of the ring body of the drug-carrying member and the stopper are opposite to those in Example 3.
  • the ring body 32 of the drug-carrying member 42 forms an opening 321 into which the tablet can be inserted.
  • the opening opens toward the incisor in the horizontal direction formed by the molar and the incisor, and the tablet is inserted from the incisor to the molar in the horizontal direction.
  • the tablet may be a controlled release formulation, preferably an osmotic pump tablet.

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  • Health & Medical Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un dispositif de retenue buccal et son procédé de préparation. Le dispositif de retenue buccal comprend un composant d'ajustement de dent et un composant de chargement de médicament. Le composant d'ajustement de dent est relié au composant de chargement du médicament. Le composant d'ajustement de dent est utilisé pour le pontage d'une dent dans la cavité buccale et son ajustement à la dent. Le composant de chargement de médicament peut accueillir au moins un comprimé, et est utilisé pour retenir le comprimé dans la cavité buccale. La méthode de préparation du dispositif de retenue buccal est choisie parmi l'un quelconque des procédés suivants : impression 3D, moulage par injection ou moulage par estampage. Lorsque le comprimé est inséré dans le dispositif de retenue buccal de la présente invention, un produit de combinaison médicament-dispositif peut être formé, le produit de combinaison médicament-dispositif est fixé sur les dents correspondantes dans la cavité buccale, et le comprimé ne peut pas tomber facilement dans la cavité buccale, de telle sorte que le médicament peut être libéré en continu pendant un certain temps, le comprimé peut être remplacé, et le médicament est libéré en continu et de manière stable.
PCT/CN2021/119120 2020-09-17 2021-09-17 Dispositif de retenue buccal et son procédé de préparation Ceased WO2022057905A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CN202180064047.2A CN116322602A (zh) 2020-09-17 2021-09-17 一种口腔滞留装置及其制备方法
EP21868727.5A EP4215175A4 (fr) 2020-09-17 2021-09-17 Dispositif de retenue buccal et son procédé de préparation
JP2023517740A JP7500116B2 (ja) 2020-09-17 2021-09-17 口腔滞留装置及びその製造方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202010980311.4A CN114191307A (zh) 2020-09-17 2020-09-17 一种口腔滞留装置及其制备方法
CN202010980311.4 2020-09-17

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WO2022057905A1 true WO2022057905A1 (fr) 2022-03-24

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EP (1) EP4215175A4 (fr)
JP (1) JP7500116B2 (fr)
CN (2) CN114191307A (fr)
WO (1) WO2022057905A1 (fr)

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CN114191307A (zh) * 2020-09-17 2022-03-18 上海汉都医药科技有限公司 一种口腔滞留装置及其制备方法
WO2024208183A1 (fr) * 2023-04-04 2024-10-10 上海汉都医药科技有限公司 Distributeur de médicament oral, son procédé de fabrication et son utilisation

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