CN1145036A - 局部敷贴器、制造局部敷贴器的方法和局部敷贴器的使用 - Google Patents
局部敷贴器、制造局部敷贴器的方法和局部敷贴器的使用 Download PDFInfo
- Publication number
- CN1145036A CN1145036A CN95192432A CN95192432A CN1145036A CN 1145036 A CN1145036 A CN 1145036A CN 95192432 A CN95192432 A CN 95192432A CN 95192432 A CN95192432 A CN 95192432A CN 1145036 A CN1145036 A CN 1145036A
- Authority
- CN
- China
- Prior art keywords
- pad
- dish
- elastic layer
- applicator
- cavity
- 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.)
- Granted
Links
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 14
- 230000000699 topical effect Effects 0.000 title abstract 6
- 238000000034 method Methods 0.000 claims abstract description 20
- 239000013543 active substance Substances 0.000 claims abstract description 16
- 239000000853 adhesive Substances 0.000 claims abstract description 13
- 230000001070 adhesive effect Effects 0.000 claims abstract description 13
- 238000003860 storage Methods 0.000 claims abstract description 3
- 239000000463 material Substances 0.000 claims description 28
- 239000011230 binding agent Substances 0.000 claims description 13
- 238000007789 sealing Methods 0.000 claims description 12
- 229940019097 EMLA Drugs 0.000 claims description 2
- NNJVILVZKWQKPM-UHFFFAOYSA-N Lidocaine Chemical group CCN(CC)CC(=O)NC1=C(C)C=CC=C1C NNJVILVZKWQKPM-UHFFFAOYSA-N 0.000 claims description 2
- 239000011148 porous material Substances 0.000 claims description 2
- 238000000926 separation method Methods 0.000 claims description 2
- KXKPYJOVDUMHGS-OSRGNVMNSA-N chondroitin sulfate Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](OS(O)(=O)=O)[C@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](C(O)=O)O1 KXKPYJOVDUMHGS-OSRGNVMNSA-N 0.000 claims 2
- 230000001680 brushing effect Effects 0.000 claims 1
- 239000003589 local anesthetic agent Substances 0.000 claims 1
- 239000010409 thin film Substances 0.000 claims 1
- 230000002500 effect on skin Effects 0.000 abstract 1
- 239000000126 substance Substances 0.000 abstract 1
- 239000010410 layer Substances 0.000 description 27
- 210000003491 skin Anatomy 0.000 description 24
- 239000003814 drug Substances 0.000 description 15
- 238000003475 lamination Methods 0.000 description 12
- 239000002184 metal Substances 0.000 description 6
- 239000003795 chemical substances by application Substances 0.000 description 4
- 238000005520 cutting process Methods 0.000 description 4
- 239000013536 elastomeric material Substances 0.000 description 4
- 239000002648 laminated material Substances 0.000 description 4
- 229920000642 polymer Polymers 0.000 description 4
- 238000005452 bending Methods 0.000 description 3
- 238000010276 construction Methods 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 239000011159 matrix material Substances 0.000 description 3
- -1 polyethylene Polymers 0.000 description 3
- 239000013047 polymeric layer Substances 0.000 description 3
- 239000004698 Polyethylene Substances 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 230000001419 dependent effect Effects 0.000 description 2
- 238000009792 diffusion process Methods 0.000 description 2
- 229920000728 polyester Polymers 0.000 description 2
- 229920000573 polyethylene Polymers 0.000 description 2
- 210000000433 stratum disjunctum Anatomy 0.000 description 2
- 239000002344 surface layer Substances 0.000 description 2
- SNICXCGAKADSCV-JTQLQIEISA-N (-)-Nicotine Chemical compound CN1CCC[C@H]1C1=CC=CN=C1 SNICXCGAKADSCV-JTQLQIEISA-N 0.000 description 1
- 208000034693 Laceration Diseases 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 230000003213 activating effect Effects 0.000 description 1
- 239000012790 adhesive layer Substances 0.000 description 1
- 230000000202 analgesic effect Effects 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 210000001072 colon Anatomy 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000006261 foam material Substances 0.000 description 1
- 238000007373 indentation Methods 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 210000000629 knee joint Anatomy 0.000 description 1
- 238000011031 large-scale manufacturing process Methods 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 229960002715 nicotine Drugs 0.000 description 1
- SNICXCGAKADSCV-UHFFFAOYSA-N nicotine Natural products CN1CCCC1C1=CC=CN=C1 SNICXCGAKADSCV-UHFFFAOYSA-N 0.000 description 1
- 239000002674 ointment Substances 0.000 description 1
- 239000011505 plaster Substances 0.000 description 1
- 239000002984 plastic foam Substances 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 150000003431 steroids Chemical class 0.000 description 1
- 239000003351 stiffener Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0259—Adhesive bandages or dressings characterised by the release liner covering the skin adhering layer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0276—Apparatus or processes for manufacturing adhesive dressings or bandages
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0276—Apparatus or processes for manufacturing adhesive dressings or bandages
- A61F13/0279—Apparatus or processes for manufacturing adhesive dressings or bandages by attaching individual patches on moving webs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F15/00—Auxiliary appliances for wound dressings; Dispensing containers for dressings or bandages
- A61F15/001—Packages or dispensers for bandages, cotton balls, drapes, dressings, gauze, gowns, sheets, sponges, swabsticks or towels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7084—Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00361—Plasters
- A61F2013/00544—Plasters form or structure
- A61F2013/00604—Multilayer
- A61F2013/00608—Multilayer with reinforcing layers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00361—Plasters
- A61F2013/00902—Plasters containing means
- A61F2013/00906—Plasters containing means for transcutaneous or transdermal drugs application
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00361—Plasters
- A61F2013/00902—Plasters containing means
- A61F2013/0091—Plasters containing means with disinfecting or anaesthetics means, e.g. anti-mycrobic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0276—Apparatus or processes for manufacturing adhesive dressings or bandages
- A61F2013/0296—Apparatus or processes for manufacturing adhesive dressings or bandages for making transdermal patches (chemical processes excluded)
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Dermatology (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Manufacturing & Machinery (AREA)
- Medicinal Preparation (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Cosmetics (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Materials For Medical Uses (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Supplying Of Containers To The Packaging Station (AREA)
- Packaging Of Special Articles (AREA)
- Basic Packing Technique (AREA)
- Telephonic Communication Services (AREA)
- Communication Control (AREA)
- Closures For Containers (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
- Crystals, And After-Treatments Of Crystals (AREA)
Abstract
在皮肤上或透过皮肤施加一种物质的局部敷贴器,包括一底结构(1),它包含一盘(3),一含有活性物质的垫(9),在其一面上涂有粘合剂(5)的弹性层(4),弹性层和粘合剂有确定一空腔(8)的缺口(7),空腔中装有垫(9),底结构(1)的盘(3)装在弹性层的一面,与弹性层涂有粘合剂的面相反,并部分覆盖弹性层(4),并包括一盖结构(2),它有一分离衬和一盘(18),形成的盘在敷贴器生产和储存过程中接纳该垫(9),该盖结构(2)装到弹性层(4)的粘合剂面上,因而底结构(1)装设一个或几个条(20),它从底盘(3)的周边向外延伸到弹性层(4)的周边,并且盖结构(2)和底结构(1)在空腔(8)内密封在一起。同时也提供了生产按照本发明的局部敷贴器的方法,并建议相同的局部敷贴器的使用。
Description
发明领域
本发明涉及一种局部敷贴器,用于在皮肤上或透过皮肤施加一种物质,它包括权利要求1前序部分的各项特点。
本发明也涉及按照本发明的局部敷贴器的制造方法,该敷贴器用于在皮肤上或透过皮肤施加。
发明的背景
本发明与用于局部施加药物和其他物质的敷贴器有关。
已知在皮肤上和透过皮肤施加药物,即保持一种药物与病人的皮肤紧密接触,从而使活性成分慢慢地通到和穿过皮肤,并在一段延长的时间内吸收到病人的体内。
一般是使用粘合贴片在所需的时间内将药物保持在位置上。
EP-A-0013606描述透过皮肤施加药物的粘合贴片,它包括叠层底条,其形状含有空腔,用含有要施加药物的聚合物基体充填空腔。空腔与皮肤粘合剂联接,并由叠层盖条进行密封,由粘合剂将盖条保持就位。盖条装设分离材料的表面层,从而它可以很容易地与底条分离,将聚合物扩散基体暴露并与皮肤粘合投入使用。
EP-B-0181333描述透过皮肤施加的粘合贴片,它包括底条,底条有固定在支持片上的微孔材料的圈,支持片是聚乙烯/金属箔/聚酯的叠层片。微孔材料圈有一皮肤贴合剂的表面层,并形成包含要施加药物的中心空腔。盖条由与上述支持片相同的叠层材料组成,并通过盖条表面上分离层与皮肤粘合剂的接触,也通过在底条叠层材料和超过微孔材料圈外周边的盖条之间的热密封圈,将盖条保持在位置上并密封空腔。通过撕掉穿孔圈周围的叠层材料,使底条叠层材料的一部分与连接的微孔材料圈分离,将空腔中的药物与皮肤粘合剂暴露以便使用。
按照上述已知的结构,通过底条上皮肤粘合层和盖条上分离层之间的接触,在专利EP-B-0181333中还通过外面的热密封圈来达到空腔的密封。使用这种机构有一个问题,就是空腔中的药物至少可以部分逃逸,即扩散的周围的粘合剂和/或其他层中,尤其是当药物是游离或挥发性质,特别是当药物本身放在空腔内或者吸收在垫中,或者是以容易释放的形式而不是与象EP-A-0013606的聚合物基体那样的保持(rotentive)介质结合在一起。因为使用透过皮肤的敷贴可以精确施加预先确定量的药物,这将可以理解从空腔中逃逸某些数量的药物可以造成严重的问题。
在澳大利亚专利申请No.75975/91中也描述上述类型的局部敷贴器。这种敷贴器装设一底层,它包括仅仅部分复盖弹性层的底片,具有权利要求1前序中的各项特征。
在上述的澳大利亚文献中是以单个底的形式提供底片,在生产过程中,单个底将一个挨一个放到连续的弹性材料层预定的位置上。但是这个过程产生新的问题。因为底片是由非常薄的材料制成,约10-50微米,单个底的边缘将向上弯曲,这使在弹性层上加上盘的操作非常困难,有时几乎是不可能的。即使盘被适当地放到弹性结构上,但对盘和弹性结构之间的密封将产生不好的作用,在使用贴片时会发生泄漏。
解决这个问题最明显的办法是以连续层的形式提供底盘或底片,使其覆盖整个连续的弹性材料层。但这将生产不柔软的敷贴器,它将会很困难应用到身体的某些部分,如肘、膝、手等。也会给使用者带来很不舒服。因此底片在成品贴片中必须要小于弹性材料。
因此有必要解决这个问题,且不损害成品的柔软性。
本发明
因而本发明的一个目的是提供上述类型的一种局部敷贴器,它克服了已知的敷贴器的各项缺点,提供的敷贴器合适地贴合到使用者的皮肤而不会泄漏活性物质,它很容易使用,并且当从皮肤上撕掉时使用者不会感到不舒服。同时制造也很方便和简单,当需要贴到皮肤上时可以很容易去掉密封。
如权利要求1特征部分描述的那样,在底结构上装设从底盘的周边向外延伸到弹性层的周边的各个条以达到这个目的。
在从属的权利要求2至4中描述进一步的各优选实施方案。
本发明的另一个目的是提供制造用于透过皮肤施加的局部敷贴器的方法,如权利要求5所述,同时提供按照本发明透过皮肤施加一种活性物质的局部敷贴器的使用,如权利要求9和10所述。
在从属的权利要求5至8中描述进一步优选的各个步骤。
附图的简单描述
现在将通过例子参考附图来描述按照本发明的局部敷贴器,附图有:
图1是按照本发明的敷贴器优选实施方案的剖面图,这是沿图3中I-I线取的,
图2是图1中敷贴器盖结构的正面图,
图3是图1中敷贴器底结构的正面图,
较4是制造该敷贴器方法的示意图。
附图的详细描述
现在相对按照本发明敷贴器的优选实施方案来描述敷贴器。
如图1至3中可见,敷贴器有底结构1和盖结构2。
底结构1包括盘3,它优选是,但不必须是,圆的和由不渗透的材料制成,例如在聚合物层的相对面用金属箔覆盖制成的叠层片。叠层片的一面或这些聚合物层中的一层中心固定到弹性材料的层4,弹性材料如泡沫塑料材料。弹性泡沫材料用贴合剂层5覆盖,粘合剂粘合到使用者的皮肤。
盖结构是由不渗透的材料制成,例如在一聚合物层的一面用金属箔覆盖制成的叠层片。在本发明的优选实施方案中盖结构是由金属箔制成,它比底结构的材料厚和更硬。这种盖结构对敷贴器提供支持,以防止敷贴器的变形和在仓储和搬运期间活性物质的泄漏。
为了防止盘3边缘的弯曲,在制造过程中当将它放到弹性层上时,盘3装设几个加强条20。这些条20最好是,但不必须是,4个,从盘3的边缘向外延伸到弹性盘4的边缘,并沿着盘3的周边最好是,但并不必须是,互相成90度角装设,见图3。这些条20与盘3的材料相同并固定到弹性层4。条20的尺寸由盘3的边缘到弹性材料4的边缘之间的距离决定。试验已经显示良好的结果,当条20沿着弹性层4的各边中心定位时,如图2中所见,达到完全排除“弯曲效应”。条20必须有一定程度的向侧边伸展,例如一定的宽度以达到所希望的效果,但必须尽可能小,以避免显著地损害弹性层4的弹性。在优选的实施方案中,条20的宽度约为5至20%,最好约10%的弹性层各边的总长度。
盘3是中心固定到弹性层4的。在弹性层4的中心有个基本成圆形的缺口。弹性层的整个表面涂复粘合剂5,但在缺口处则完全没有粘合剂。
在缺口7内形成一空腔8,多孔材料的盘状垫9放在空腔8中。垫9的厚度比弹性层4略为厚一些。垫是中心定位在空腔中,其直径小于缺口7的直径。从而在它们之间确定一个环形的空间10。垫以任何合适的方法固定到盘3,例如热密封。
盖结构2包括盘12,它由不渗透材料,例如用聚合物层在两面覆盖金属箔而制成。盘12的一面固定有一片分离衬13,可用圆形的热密封将盘12固定到分离衬13。分离衬13有一中心缺口15,并与弹性层4中缺口7有相同的尺寸。
盖结构2贴合到底结构1,从而衬13与粘合剂涂复的弹性层4对齐叠合,这样两个结构1和2通过粘合剂层5结合在一起,盘3和12之间产生密封。
盘12的中心形成圆形部分16,从而提供基本环形的突起17,并确定盘18。突起17的形状是这样选择,当盖结构2和底结构1合在一起时它将位于分离衬13的缺口15和弹性层4之内。在这个位置突起17将通过两个缺口15和7突出并与盘3接合。突起17热密封盘3。
通过使用本发明的敷贴器,打算施加到皮肤上或透过皮肤施加的活性物质被吸收到垫9中。该垫由多孔物质制成,最好是纤维素材料。
通过使用本发明的局部敷贴器,可以施加到皮肤上或透过皮肤施加的活性物质,例如有局部的麻醉剂,如EMLA,止痛药,类固醇,尼古丁,抗菌素。
由于敷贴器的优选结构将活性物质完全密封在盘3和盘12之间,因而该物质不可能逃逸到的邻近的各层中。
当使用敷贴器时撕掉盖结构2,因而它在分离衬13处与粘合剂层5分离,突起17从盘3拉开,使它们之间的密封破裂。这时可将敷贴器贴到皮肤上,从而使贴合剂层5将敷贴器保持在垫9与皮肤接触的位置上。
按照本发明的局部敷贴器可很容易地充填和安全地闭合,在保持足够的卫生和安全的水平下可以达到在大规模生产的基础上方便地制造。还有,得到的敷贴器使用特别方便,在避免药物逃逸可能弄脏衣服并使病人不舒服的同时可以达到良好的药物治疗效果。
上述的敷贴器可使用参考图4所述的方法进行制造。
盖结构的不渗透叠层片是预制的,由第一滚子22上的第一连续的细长薄片21供给。在第一片21上的突起17是在冲压站23成形,因而提供盘18。
从第二滚子42上以第二连续的细长薄片41形式供给带有粘合剂5和分离衬13的弹性层4,在切割站43中产生缺口7。这种缺口形成在弹性结构中的空腔8。切割之后第二细长片41放到盖结构叠层片,如第一片21的上面,然后固定在一起,最好是热密封。
在平行的生产线中制造底结构。底结构的不渗透叠合片是预制的,由第三滚子52以连续的细长片51的形式供给。
此后,已经预制的垫9由肠形传送器(colons)91送出,放到底结构的片上,并在密封站92中与其密封。然后在充填站93将活性物质加到垫9。如上所述,优选的是在各垫已经放到底片上并与其密封之后再加活性物质,但是也可以在放置和密封各步之前加活性物质。
在垫充填之后,细长的片51通过切割站53。在这里叠层片的未构成盘3和条20部分的其他部分材料以这样的方式被切掉,使底的材料仍然保持成一细长片,因而装在相邻盘上的各条是互相连结在一起的。所以如上所述,避免了各盘边缘的弯曲,大大地有利于搬运和制造。
下一步,将带有垫9的盘3和条20的连续细长片反向倒置,放到弹性层4的上面,如图4可见。这样垫9被放到由突起17限定的盘18内。接着优选的是在密封站55,将弹性层4和盖2在一面,底盘3和突起17在另一面用热密封固定在一起。在空腔8,突起17,带有垫9和缺口7的盘18周围装设环形的热密封圈6。
上述方法生产的敷贴器的连续片在切割站56中进行切割以生产出单个的敷贴器。
本发明可能的变形
按照本发明的敷贴器和制造方法当然可以在所附的权利要求书的范围内进行修改。
因此可以改变上面可选择的材料和各个部分的形状和尺寸。特别是底结构缺口和盘并不必须是圆的,也可以有任何合适的形状,例如是椭圆的,方形的或矩形的、条20也能以不同的方式装设在底结构盘的周边,可以有不同的形状。但是重要的是要避免在敷贴器制造时盘边缘的弯曲。底结构必须是柔软的,但同时对活性剂提供不渗透的底片支持。
底结构和盖结构可由相同或不同材料制成,最好是金属箔/聚合物的叠层片,但也可以使用任何具有相同特征的其他材料。叠层片的聚合物可以是聚乙烯,聚丙烯,聚酯,含离子键的聚合物。
各处理站和生产线的各个步骤也可以在所附权利要求书的范畴内进行修改。
Claims (13)
1.在皮肤上或透过皮肤施加一种物质的局部敷贴器,包括底结构(1),它包含一盘(3),一含有活性物质的垫(9),在其一面上涂有粘合剂(5)的弹性层(4),弹性层和粘合剂有确定一空腔(8)的缺口(7),空腔中装有垫(9),底结构(1)的盘(3)装在弹性层的一面,与弹性层涂有粘合剂的面相反,并部分覆盖弹性层(4),并包括一盖结构(2),它有一分离衬和一盘(18),形成的盘在敷贴器生产和储存过程中接纳该垫(9),该盖结构(2)装到弹性层(4)的粘合剂面上,其特征在于底结构(1)装设一个或几个条(20),它从底盘(3)的周边向外延伸到弹性层(4)的周边,其特征还在于盖结构(2)和底结构(1)在空腔(8)内密封在一起。
2.如权利要求1所述的局部敷贴器,其特征在于:条(20)最好是4个,沿着盘3的周边装设,互相成90°度。
3.如权利要求1所述的局部敷贴器,其特征在于:各条(20)是由相同的材料制成,并从连续细长的片(51)中切出,但仍与盘(3)相连,因而提供一连续的细长片。
4.如前述任何一项权利要求所述的局部敷贴器,其特征在于:盖结构(2)包括一覆盖盘(12),该盘有突起(17)确定一盘(18),并有一分离衬(13),因而突起(17)覆盖带有垫(9)的空腔(8),并在垫(9)和周围的弹性层(4)之间与底盘(3)保持接触,从而构成带有该物质的垫周围的密封。
5.制造局部敷贴器的方法,包括如下各步骤:
—供给不渗透材料制成的第一连续细长片(21);
—在第一片(21)中冲压出突起(17);
—提供由弹性层(4)组成的第二连续细长片(41),在其一面上有涂刷的粘合剂(5)和在粘合剂(5)上的分离衬(13),并有缺口(7),以这样的方式放到第一片(21)上,使弹性层(4)涂刷粘合剂(5)并带有分离衬(13)的面放在第一片(21)上,从而使弹性层(4)的缺口(7)和分离衬(13)各自和第一片(21)的突起(17)处于互相对齐重叠的状态,因此确定空腔(8),
—供给一种材料的不渗透的底结构(1)的,最好是预制的,第三连续细长片(51),
—将多孔材料的垫(9)供给到第三片(51);
—将第三片(51)材料部分切除,从而供应一连续的底的细长片;
—将该带有垫(9)的连续的底的细长片放在弹性层(4)的上面,因而覆盖空腔(8),并部分覆盖弹性层(4),从而将垫(9)放在突起(17)的中间;
—将连续的敷贴器片切割成单个的如权利要求1至4所述类型的局部敷贴器。
6.如权利要求5所述的方法,其中当材料切割成带有各条(20)的盘(3)时形成底结构,其中盘(3)最好基本上成圆形或椭圆形,各条(20)从盘(3)的周边向外伸展。
7.如权利要求6所述的方法,其中各条(20)和各盘(3)通过将不是最终产品部分的材料片切掉,由柔性材料不渗透薄膜的连续细长片制造,因而在制造过程中各条(20)与各盘(3)相互连接组成底材料的一连续层。
8.如权利要求6所述的方法,其中条(20)有四个,沿着底盘(3)的周边布置,互相间基本上成90度角。
9.如权利要求5所述的方法,其中在垫被放到底结构(1)上之前将活性物质加到垫(9)。
10.如权利要求5所述的方法,其中在垫已经放到底盘(3)并与其密封之后再将活性物质加到垫(9)。
11.使用如权利要求1所述的局部敷贴器,将活性物质施加到皮肤上或透过皮肤施加。
12.如权利要求11所述的使用,其中活性物质是一种局部麻醉剂。
13.如权利要求12所述的使用,其中活性物质是EMLA。
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
SE94011335 | 1994-04-05 | ||
SE9401133A SE9401133D0 (sv) | 1994-04-05 | 1994-04-05 | Topical dressing |
SE9401133-5 | 1994-04-05 | ||
SE9403122A SE9403122D0 (sv) | 1994-09-19 | 1994-09-19 | Topical dressing II |
SE94031226 | 1994-09-19 | ||
SE9403122-6 | 1994-09-19 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1145036A true CN1145036A (zh) | 1997-03-12 |
CN1096870C CN1096870C (zh) | 2002-12-25 |
Family
ID=26662022
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN95192432A Expired - Lifetime CN1096870C (zh) | 1994-04-05 | 1995-04-05 | 局部敷贴器和制造局部敷贴器的方法 |
Country Status (32)
Country | Link |
---|---|
US (1) | US5773022A (zh) |
EP (1) | EP0755284B1 (zh) |
JP (1) | JP3023989B2 (zh) |
KR (1) | KR100348948B1 (zh) |
CN (1) | CN1096870C (zh) |
AT (1) | ATE248001T1 (zh) |
AU (1) | AU677907B2 (zh) |
BR (1) | BR9507279A (zh) |
CA (1) | CA2186038C (zh) |
CZ (1) | CZ288957B6 (zh) |
DE (1) | DE69531609T2 (zh) |
DK (1) | DK0755284T3 (zh) |
EE (1) | EE03278B1 (zh) |
EG (1) | EG20621A (zh) |
ES (1) | ES2204948T3 (zh) |
FI (1) | FI116966B (zh) |
HR (1) | HRP950154B1 (zh) |
HU (1) | HU218557B (zh) |
IL (1) | IL113034A (zh) |
IS (1) | IS1814B (zh) |
MX (1) | MX9604352A (zh) |
MY (1) | MY119000A (zh) |
NO (1) | NO312880B1 (zh) |
NZ (1) | NZ284174A (zh) |
PL (1) | PL176982B1 (zh) |
PT (1) | PT755284E (zh) |
RU (1) | RU2179428C2 (zh) |
SA (1) | SA95150634B1 (zh) |
SK (1) | SK283267B6 (zh) |
TW (1) | TW366289B (zh) |
WO (1) | WO1995026778A1 (zh) |
YU (1) | YU48921B (zh) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101500520B (zh) * | 2006-08-10 | 2014-06-25 | 3M创新有限公司 | 适形的伤口敷料 |
Families Citing this family (38)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20060002949A1 (en) * | 1996-11-14 | 2006-01-05 | Army Govt. Of The Usa, As Rep. By Secretary Of The Office Of The Command Judge Advocate, Hq Usamrmc. | Transcutaneous immunization without heterologous adjuvant |
US20060002959A1 (en) * | 1996-11-14 | 2006-01-05 | Government Of The United States | Skin-sctive adjuvants for transcutaneous immuization |
US6797276B1 (en) * | 1996-11-14 | 2004-09-28 | The United States Of America As Represented By The Secretary Of The Army | Use of penetration enhancers and barrier disruption agents to enhance the transcutaneous immune response |
US5980898A (en) * | 1996-11-14 | 1999-11-09 | The United States Of America As Represented By The U.S. Army Medical Research & Material Command | Adjuvant for transcutaneous immunization |
DE19702314C2 (de) * | 1997-01-23 | 2000-12-21 | Lohmann Therapie Syst Lts | Ablösbare Schutzfolie für wirkstoffhaltige, insbesondere selbstklebende Pflastersysteme |
US20040258703A1 (en) * | 1997-11-14 | 2004-12-23 | The Government Of The Us, As Represented By The Secretary Of The Army | Skin-active adjuvants for transcutaneous immunization |
GB9725169D0 (en) * | 1997-11-27 | 1998-01-28 | The Technology Partnership Plc | Wound dressing |
EP1165132B1 (en) * | 1999-04-08 | 2011-10-19 | Intercell USA, Inc. | Dry formulation for transcutaneous immunization |
CA2437899C (en) * | 2001-02-13 | 2012-05-15 | Gregory M. Glenn | Vaccine for transcutaneous immunization against etec-caused traveler's diarrhea |
WO2002074325A1 (en) * | 2001-03-19 | 2002-09-26 | Iomai Corporation | Patch for transcutaneous immunization |
US20040137004A1 (en) * | 2002-03-19 | 2004-07-15 | Glenn Gregory M | Patch for transcutaneous immunization |
SE0201907D0 (sv) * | 2002-06-19 | 2002-06-19 | Atos Medical Ab | Plaster for tracheostoma valves |
KR20030004257A (ko) * | 2002-12-12 | 2003-01-14 | 김시우 | 주사 및 채혈용 파스 |
US6838589B2 (en) * | 2003-02-19 | 2005-01-04 | 3M Innovative Properties Company | Conformable wound dressing |
CN1852691B (zh) | 2003-09-17 | 2012-01-11 | Bsn医疗有限责任公司 | 伤口敷料及其生产方法 |
ES2651343T3 (es) * | 2003-11-28 | 2018-01-25 | Coloplast A/S | Un producto de vendaje |
US20080171074A1 (en) | 2004-12-20 | 2008-07-17 | Oltarzhevskaya Natalie Dmitrie | Hemostatic Composition, Apparatus, and Methods |
DE102005004924A1 (de) * | 2005-02-02 | 2006-08-03 | Paul Hartmann Ag | Wundauflage |
EP2167001A4 (en) * | 2007-07-10 | 2012-10-31 | Agile Therapeutics Inc | THERMAL DELIVERY DEVICE WITH ULTRASONIC WELDING |
GEP20125717B (en) | 2007-07-10 | 2012-12-25 | Agile Therapeutics Inc | Device for medicine direct dermal delivery |
ATE485797T1 (de) * | 2007-08-21 | 2010-11-15 | Lohmann Therapie Syst Lts | Verfahren zum mehrspurigen konfektionieren transdermaler therapeutischer pflaster |
FR2933618B1 (fr) * | 2008-07-10 | 2011-01-07 | Urgo Lab | Procede de fabrication de pansements contenant au moins un actif |
BRPI0914442B1 (pt) * | 2008-10-24 | 2019-07-02 | 3M Innovative Properties Company | Sistema de liberação e de curativo para ferimentos |
US20100221313A1 (en) * | 2008-12-01 | 2010-09-02 | Innovative Pharmaceuticals, Llc | Transdermal reservoir patch |
NO330398B1 (no) * | 2009-03-03 | 2011-04-04 | Padtech As | Pad med fluidbarriere |
US11786455B2 (en) | 2011-05-10 | 2023-10-17 | Itochu Chemical Frontier Corporation | Non-aqueous patch |
MX368747B (es) | 2011-05-10 | 2019-10-14 | Itochu Chemical Frontier Corp | Parche no acuoso de lidocaína y un agente de disolución que comprende un ácido orgánico y un polialcohol que están contenidos en un emplaste para usarse en el tratamiento de dolor muscular a través de la piel. |
US9925264B2 (en) | 2011-05-10 | 2018-03-27 | Itochu Chemical Frontier Corporation | Non-aqueous patch |
WO2013048787A1 (en) | 2011-09-26 | 2013-04-04 | Yes, Inc. | Novel hemostatic compositions and dressings for bleeding |
JP6021269B2 (ja) | 2011-09-27 | 2016-11-09 | 伊藤忠ケミカルフロンティア株式会社 | 非水性貼付剤 |
USD814645S1 (en) * | 2015-08-15 | 2018-04-03 | Harald Schnidar | Transdermal adhesive article with surface ornamentation |
CN105944227A (zh) * | 2016-05-18 | 2016-09-21 | 绵阳博凡科技有限公司 | 一种局部止痛贴 |
US10864172B2 (en) * | 2018-07-25 | 2020-12-15 | Chemsultants International Inc. | Transdermal patch for oil delivery |
DE102018130469A1 (de) | 2018-11-30 | 2020-06-04 | Lts Lohmann Therapie-Systeme Ag | Transdermales therapeutisches System mit Diffusionsbarriere |
USD999384S1 (en) | 2021-10-18 | 2023-09-19 | Dbv Technologies | Patch assembly |
EP4201383A1 (en) * | 2021-12-21 | 2023-06-28 | DBV Technologies | Improved patches and methods for delivering an active substance to the skin using the same |
CA3234808A1 (en) * | 2021-10-18 | 2023-04-27 | Jerome Villette | Improved patches and methods for delivering an active substance to the skin using the same |
USD999385S1 (en) | 2021-10-18 | 2023-09-19 | Dbv Technologies | Patch assembly |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3900027A (en) * | 1974-01-02 | 1975-08-19 | Pall Corp | Process for preparing integral absorbent pad bandages and product |
DE3204582A1 (de) * | 1982-02-10 | 1983-08-25 | Hassia Verpackung Gmbh, 6479 Ranstadt | Verfahren zur kontinuierlichen herstellung von pflasterpackungen fuer die transdermale verabreichung von medikamenten |
GB8319096D0 (en) * | 1983-07-14 | 1983-08-17 | Harlands Of Hull Ltd | Topical dressings |
ES8608895A1 (es) * | 1984-08-17 | 1986-07-16 | Allpack Ind Lohnverpackung | Parche adhesivo farmaceutico y procedimiento para su fabri- cacion |
US4849224A (en) * | 1987-11-12 | 1989-07-18 | Theratech Inc. | Device for administering an active agent to the skin or mucosa |
US4915102A (en) * | 1988-09-01 | 1990-04-10 | Bertek, Inc. | Hinged dermal applicator |
AU646453B2 (en) * | 1991-04-26 | 1994-02-24 | Astra Aktiebolag | Topical dressings |
US5268179A (en) * | 1992-02-14 | 1993-12-07 | Ciba-Geigy Corporation | Ultrasonically sealed transdermal drug delivery systems |
-
1995
- 1995-03-19 IL IL11303495A patent/IL113034A/xx not_active IP Right Cessation
- 1995-03-28 HR HR950154A patent/HRP950154B1/xx not_active IP Right Cessation
- 1995-04-04 EG EG26895A patent/EG20621A/xx active
- 1995-04-05 NZ NZ284174A patent/NZ284174A/en not_active IP Right Cessation
- 1995-04-05 CZ CZ19962917A patent/CZ288957B6/cs not_active IP Right Cessation
- 1995-04-05 EP EP95916078A patent/EP0755284B1/en not_active Expired - Lifetime
- 1995-04-05 PL PL95316619A patent/PL176982B1/pl unknown
- 1995-04-05 MY MYPI95000863A patent/MY119000A/en unknown
- 1995-04-05 AT AT95916078T patent/ATE248001T1/de active
- 1995-04-05 MX MX9604352A patent/MX9604352A/es unknown
- 1995-04-05 ES ES95916078T patent/ES2204948T3/es not_active Expired - Lifetime
- 1995-04-05 CN CN95192432A patent/CN1096870C/zh not_active Expired - Lifetime
- 1995-04-05 DK DK95916078T patent/DK0755284T3/da active
- 1995-04-05 BR BR9507279A patent/BR9507279A/pt not_active IP Right Cessation
- 1995-04-05 CA CA002186038A patent/CA2186038C/en not_active Expired - Lifetime
- 1995-04-05 AU AU22703/95A patent/AU677907B2/en not_active Expired
- 1995-04-05 HU HU9702734A patent/HU218557B/hu unknown
- 1995-04-05 JP JP7525621A patent/JP3023989B2/ja not_active Expired - Lifetime
- 1995-04-05 PT PT95916078T patent/PT755284E/pt unknown
- 1995-04-05 DE DE69531609T patent/DE69531609T2/de not_active Expired - Lifetime
- 1995-04-05 KR KR1019960705516A patent/KR100348948B1/ko not_active IP Right Cessation
- 1995-04-05 WO PCT/SE1995/000368 patent/WO1995026778A1/en active IP Right Grant
- 1995-04-05 RU RU96120188/14A patent/RU2179428C2/ru active
- 1995-04-05 SK SK1259-96A patent/SK283267B6/sk not_active IP Right Cessation
- 1995-04-05 EE EE9600159A patent/EE03278B1/xx unknown
- 1995-04-05 YU YU21795A patent/YU48921B/sh unknown
- 1995-04-05 US US08/532,687 patent/US5773022A/en not_active Expired - Lifetime
- 1995-04-06 TW TW085101802A patent/TW366289B/zh not_active IP Right Cessation
- 1995-05-03 SA SA95150634A patent/SA95150634B1/ar unknown
-
1996
- 1996-10-02 NO NO19964169A patent/NO312880B1/no not_active IP Right Cessation
- 1996-10-02 IS IS4370A patent/IS1814B/is unknown
- 1996-10-04 FI FI963983A patent/FI116966B/fi not_active IP Right Cessation
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101500520B (zh) * | 2006-08-10 | 2014-06-25 | 3M创新有限公司 | 适形的伤口敷料 |
Also Published As
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN1096870C (zh) | 局部敷贴器和制造局部敷贴器的方法 | |
AU608408B2 (en) | Skin barrier product | |
US5851549A (en) | Patch, with system and apparatus for manufacture | |
MXPA96004352A (en) | Topical bandage, method of manufacturing of topical unvendage and use of a bandage top | |
CN101219088B (zh) | 贴剂包装结构 | |
CA2073274C (en) | Hydrogel bandage | |
US9877874B2 (en) | Adhesive dressing | |
CN1750800A (zh) | 合形的创伤敷料 | |
RU96120188A (ru) | Местная повязка, способ изготовления местной повязки и применение местной повязки | |
JP4171108B2 (ja) | 皮膚貼付材およびその製造方法 | |
JPH06296702A (ja) | ヒドロゲルアプリケータおよびその製造方法 | |
CN1191798C (zh) | 制造弹性粘贴绷带的方法 | |
CN1270806A (zh) | 急救绊创膏 | |
JPH08187295A (ja) | 給送装置およびその製造方法 | |
JPH07126156A (ja) | 薬物含有粘着シート及びその包装構造 | |
CN106572981B (zh) | 用于制造药物贴剂的装置 | |
JPH0780040A (ja) | 薬物含有粘着シート用包材 | |
WO1994027649A1 (en) | Patch, with system and apparatus for manufacture |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
C17 | Cessation of patent right | ||
CX01 | Expiry of patent term |
Expiration termination date: 20150405 Granted publication date: 20021225 |