WO2017107417A1 - 微针芯片及其制备方法 - Google Patents

微针芯片及其制备方法 Download PDF

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WO2017107417A1
WO2017107417A1 PCT/CN2016/086496 CN2016086496W WO2017107417A1 WO 2017107417 A1 WO2017107417 A1 WO 2017107417A1 CN 2016086496 W CN2016086496 W CN 2016086496W WO 2017107417 A1 WO2017107417 A1 WO 2017107417A1
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Prior art keywords
female mold
air ejection
microneedle chip
liquid
breathable film
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PCT/CN2016/086496
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English (en)
French (fr)
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李革
陈航平
张敏敏
张茜
姚港涛
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广州新济药业科技有限公司
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Priority to US16/065,592 priority Critical patent/US11452853B2/en
Publication of WO2017107417A1 publication Critical patent/WO2017107417A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C33/00—Moulds or cores; Details thereof or accessories therefor
    • B29C33/10—Moulds or cores; Details thereof or accessories therefor with incorporated venting means
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C33/00—Moulds or cores; Details thereof or accessories therefor
    • B29C33/38—Moulds or cores; Details thereof or accessories therefor characterised by the material or the manufacturing process
    • B29C33/3842—Manufacturing moulds, e.g. shaping the mould surface by machining
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C33/00—Moulds or cores; Details thereof or accessories therefor
    • B29C33/42—Moulds or cores; Details thereof or accessories therefor characterised by the shape of the moulding surface, e.g. ribs or grooves
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/0053—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor combined with a final operation, e.g. shaping
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/17—Component parts, details or accessories; Auxiliary operations
    • B29C45/26—Moulds
    • B29C45/2626—Moulds provided with a multiplicity of narrow cavities connected to a common cavity, e.g. for brushes, combs
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
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    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/003—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0053—Methods for producing microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0244—Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/04—Skin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/0053—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor combined with a final operation, e.g. shaping
    • B29C2045/0079—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor combined with a final operation, e.g. shaping applying a coating or covering
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/17—Component parts, details or accessories; Auxiliary operations
    • B29C45/26—Moulds
    • B29C45/263—Moulds with mould wall parts provided with fine grooves or impressions, e.g. for record discs
    • B29C2045/2651—Moulds with mould wall parts provided with fine grooves or impressions, e.g. for record discs using a plurality of mould cavities
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2005/00—Use of polysaccharides or derivatives as moulding material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2039/00—Use of polymers with unsaturated aliphatic radicals and with a nitrogen or a heterocyclic ring containing nitrogen in a side chain or derivatives thereof as moulding material
    • B29K2039/06—Polymers of N-vinyl-pyrrolidones
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/0005—Condition, form or state of moulded material or of the material to be shaped containing compounding ingredients
    • B29K2105/0035—Medical or pharmaceutical agents
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B29K2827/00—Use of polyvinylhalogenides or derivatives thereof as mould material
    • B29K2827/12—Use of polyvinylhalogenides or derivatives thereof as mould material containing fluorine
    • B29K2827/18—PTFE, i.e. polytetrafluorethene, e.g. ePTFE, i.e. expanded polytetrafluorethene
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2867/00—Use of polyesters or derivatives thereof as mould material
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2883/00—Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as mould material
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B29K2995/00—Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
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    • B29L2031/00—Other particular articles
    • B29L2031/756—Microarticles, nanoarticles

Definitions

  • the invention relates to the technical field of transdermal drug preparation, in particular to a microneedle chip and a preparation method thereof.
  • Microneedle transdermal drug delivery technology as a new type of transdermal drug delivery method, initially using micro-needle of silicon and silicon oxide, which has a mature preparation process, but its biocompatibility is poor and the texture is brittle. And has the disadvantages of slow production speed, which limits its industrialization.
  • the other type is metal microneedles, which have good mechanical strength, but have the disadvantages of small drug loading, complicated process and high processing cost, and also limit the industrial production and clinical application of such microneedles.
  • Soluble microneedles refer to the formation of needles from soluble or degradable excipients.
  • the drug components are mixed directly with the excipients and present directly in the needles. After the needles penetrate the skin, the drugs distributed in the needles begin to be released.
  • the preparation of such micro-needles is still difficult to achieve mass production at present due to the problem of small volume (operable space within 1 mm 3 ).
  • the soluble microneedle preparation methods still in the laboratory stage reported in the literature can be divided into two types: one method is to dissolve the polymer material in water or ethanol, and the viscosity of the solution is used to pass the small liquid of the solution.
  • a drop clamp is prepared by drawing between two sheets (e.g., WO 2008/010681 A1).
  • This method has long production time, the wire drawing process must be precisely controlled, the needle body is irregular, and the formed needle body has large needle tip fine, easy to break, industrial production speed is slow, and production controllability is poor. Therefore, the pharmaceutical industry has been difficult to achieve for the precise control of drug use, but it can only be used in the cosmetics industry.
  • Another method is to prepare soluble microneedles by using micro-perfusion of the negative mold.
  • the key step is to rapidly inject the fluid needle material into the micropores, and how to achieve effective and rapid micro-infusion becomes the soluble micro-needle industry.
  • the key issue in the process It is mentioned in the U.S. Patent No. 2009/0182306 A1 and the international patent WO 2012/023044 A1 that the micro-perfusion can be carried out by means of centrifugation or vacuum, but the method of centrifugation is difficult to industrially produce.
  • the viscosity of the solution used for micro-perfusion is higher, if the viscosity is controlled at 100 centipoise (cP) Within, if the viscosity is high, the solution is easy to shape during micro-perfusion

Abstract

一种微针芯片及其制备方法，该方法包括以下步骤：将流态针体液体(600)灌注至阴模(200)中，阴模(200)上设有若干个与微针芯片的针体(610)形状相适配的型腔，形成型腔阵列，阴模(200)的一侧表面设有多个灌注入口(212)，另一侧表面设有多个排气口(211)，形成排气面；并在阴模(200)的排气面覆盖透气膜(300)，灌注时，使气体透过该透气膜(300)而将液体保留于型腔内；待所述流态针体液体(600)固化形成微针芯片后，脱模，即得。由于该排气口(211)和透气膜(300)配合后，能够在截留液体的同时排出气体，具有较好的微灌注效果。该制备方法的工艺流程中，无需进行离心等工业生产中难以实现的工序，也无需采用高压或高温等产业化成本高的技术手段，该制备方法具有简便易行、成本低的优点，适用于工业化推广使用。

Description

微针芯片及其制备方法 技术领域
本发明涉及经皮给药制剂技术领域，特别是涉及一种微针芯片及其制备方法。
背景技术
微针经皮给药技术作为一种新型的经皮给药方法，最初采用的是硅及氧化硅的微针，该类微针具有成熟的制备工艺，但其生物相容性差、质地较脆，并且具有生产速度慢等缺点，使其产业化受到限制。另一类是金属微针，该类微针的机械强度好，但存在载药量小、工艺复杂，加工成本高等缺点，也限制了该类微针的工业化生产和临床应用。
可溶性微针指的是针体由可溶解或可降解的辅料形成，药物成分通过与辅料混合，直接存在于针体中，针体刺入皮肤后，分布在针体内的药物开始释放。该类微针的制备由于本身体积小(可操作空间在1mm3以内)的问题，目前实现批量化生产仍比较困难。
现阶段文献报道的仍处于实验室阶段的可溶性微针制备方法，具体可分为两种：一种方法是高分子材料在水或乙醇中溶解，利用该溶液的粘度，通过该溶液的小液滴夹在两张板之间拉丝的方法制备(如WO2008/010681A1)。这种方法存在生产时间长，拉丝过程须精密控制、针体呈不规则状，形成的针体基部大针尖细，易断裂，产业化生产速度慢，生产可控性较差等缺点。所以对于必须精确控制药物使用药量制药行业至今还难以实现，而只能用于化妆品行业。
另一种方法是采用阴模微灌注制备可溶性微针，其关键步骤是要快速地使流动性的针体材料灌注到微孔内，而如何实现有效快速的微灌注就成为了可溶性微针产业化中的关键问题。美国专利US2009/0182306A1及国际专利WO2012/023044A1中提到了可采用离心、真空的方法实现微灌注，但是，离心的方法难以工业化生产。而真空减压、或在密闭容器中加压2-5个大气压的方法(如中国专利CN104027324A)，又对微灌注所采用的溶液粘度要求较高，如需将粘度控制在100厘泊(cP)以内，如粘度较高，微灌注时溶液则易形

Claims (1)

  1. Figure PCTCN2016086496-appb-100001
PCT/CN2016/086496 2015-12-24 2016-06-21 微针芯片及其制备方法 WO2017107417A1 (zh)

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DE102018215324A1 (de) * 2018-09-10 2020-03-12 Lts Lohmann Therapie-Systeme Ag Vorrichtung und Verfahren zur Herstellung von Mikrostrukturen
WO2023193422A1 (zh) * 2022-04-06 2023-10-12 苏州大学 硅基冰微针及其制备方法

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Publication number Priority date Publication date Assignee Title
CN105498082B (zh) 2015-12-24 2017-10-27 广州新济药业科技有限公司 微针芯片及其制备方法
TWI626954B (zh) * 2016-11-28 2018-06-21 國立成功大學 利用抽氣過濾製備可溶性或生物可降解的高分子微針貼片的製法
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