CN1308529A - 含有经皮给药体系和单剂形式给药的水泡眼 - Google Patents

含有经皮给药体系和单剂形式给药的水泡眼 Download PDF

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CN1308529A
CN1308529A CN99808461A CN99808461A CN1308529A CN 1308529 A CN1308529 A CN 1308529A CN 99808461 A CN99808461 A CN 99808461A CN 99808461 A CN99808461 A CN 99808461A CN 1308529 A CN1308529 A CN 1308529A
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active component
administration
dosage form
blister
single agent
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沃尔夫冈·舍费尔
汉泽曼·弗兰克
博多·阿斯穆森
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LTS Lohmann Therapie Systeme AG
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LTS Lohmann Therapie Systeme AG
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    • 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
    • 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
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035—Blister-type containers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/325—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil
    • B65D75/327—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil and forming several compartments
    • 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
    • A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Composite Materials (AREA)
  • Mechanical Engineering (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

一种用于呈水泡眼形式的药物活性剂的给药形式,其特征在于其含有一种经皮给药的系统和相互并排的至少一种单剂活性剂。

Description

含有经皮给药体系和单剂形式给药的水泡眼
本发明涉及呈水泡眼形式的药物活性组分的剂型，其使得经皮给药体系(TTS)和至少一种单剂活性组分可能同时给药。
在激素替补疗法中，通常把基本激素与另一种激素结合一起给药，以避免产生副作用。例如，其应用于与促孕素同时给药的雌二醇给药。因为基本激素需要连续长期给药，已经证明合适的给药形式是经皮给药体系(TTS)，与之一起，以控制的方式，通过活性组分储液袋的限定的接触区域，把活性组分输送到皮肤。该体系优选包括压敏粘合剂。如果需要，与另一种激素不连续同时给药，其通常取片剂形式。这些片剂通常分别储存，并且可以根据给药方案用药，只是该方案具有一定的难度。因此，这种类型的剂型对于病人的适应性是极为不利的。
因此，考虑到适应性的问题，本发明的一个目的是，开发一种用于通过经皮和不经皮的途径，把药物活性组分同时给药的合适的包装方法。这就是要在规定的时间摄取单剂药处用药时，通过一种合适设计的包装，来保证帮助病人。
现在已经发现，在水泡眼中除了含有TTS之外，还含有至少一种单剂活性组分可以达到该目的。该TTS单独包装在一个水泡眼中，但是也可以以其它方式，例如通过压敏粘合剂接触区域固定到该剂型中。在水泡眼中调节，也是选择单剂活性组分形式的方法，其优选是片剂，当然，设想其它的附着机构也是可能的。
已经证明，对于较长时间给药，把几种水泡眼结合在一起是有利的。对于病人，这就意味着他的给药方式在几周内是清楚明确的已经固定。如果需要的话，对于经皮给药，该水泡眼系列优选地可以包括没有单剂活性组分的那些。
对于不经皮给药，通常设计单剂活性组分形式。否则，必须注意确保像团块那样的释放。除了或代替内吸的活性组分外，对于单剂活性组分也可能要含有用于局部预处理的制剂和/或TTS给药区域的后处理的制剂。例如，这些制剂可以改善活性组分由TTS的皮肤渗透性，或者防止TTS给药后伤害皮肤或甚至可逆转有害的皮肤变化。最后但非最不重要，该单剂活性组分也可以含有一种或多种TTS活性组分，以便控制住TTS时间滞后或者产生生理节奏所需要的附加原生质峰。
通过图1说明下面的实施例，借助于由8种TTS 1-8组成的单元，其是为28天治疗期而设置，该新剂型的保证适应性方面的情况汇总如下，9表示单剂活性组分，在1-4中不含有单剂活性组分。
下面的表反映对于雌激素/促孕素治疗的给药过程：
水泡眼的号数 使用水泡眼的时间
没有促孕素给药的雌激素治疗 水泡眼1水泡眼2水泡眼3水泡眼4 第1、2、3天第4、5、6、7天第8、9、10天第11、12、13、14天
与以片剂形式给药的促孕素结合的雌激素治疗 水泡眼5水泡眼6水泡眼7水泡眼8 第15、16、17天第18、19、20、21天第22、23、24天第25、26、27、28天
在14天的没有促孕素治疗之后接着在最后的2个星期，对于每一天的TTS给药(交替3天和4天)，提供促孕素给药。
正如实施例所说明的那样，本发明对于持久的改进病人对TTS与附加的单剂活性组分的给药的适应性提供一种可靠的方法。
可以通过把几种水泡眼结合在一起或在所要求的应用程序中，标记这些单独的水泡眼来增强该适应性。

Claims (7)

1.一种用于呈水泡眼形式的药物活性组分的剂型，其特征在于其含有一种与至少一种单剂活性组分并排的经皮给药的系统。
2.根据权利要求1的剂型，其特征在于几种水泡眼结合在一起，以增加适应性。
3.根据权利要求1的剂型，其特征在于在所要求的应用程序中，把单独的水泡眼进行标记，以增加适应性。
4.根据权利要求2或3的剂型，其特征在于也可以存在没有附加的单剂活性组分的水泡眼。
5.根据权利要求1-4之一或多个的剂型，其特征在于单剂活性组分的形式要用于活性组分的非经皮给药。
6.根据权利要求1-5之一或多个的剂型，其特征在于单剂活性组分的形式含有用于TTS给药之前和/或之后进行局部治疗的制剂。
7.根据权利要求1-6之一或多个的剂型，其特征在于单剂活性组分的形式含有一种或多种通过TTS给药的活性组分。
CN99808461A 1998-07-11 1999-07-02 含有经皮给药体系和单剂形式给药的水泡眼 Pending CN1308529A (zh)

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DE19831263.6 1998-07-11
DE19831263A DE19831263A1 (de) 1998-07-11 1998-07-11 Darreichungsform

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US (1) US6630149B1 (zh)
EP (1) EP1096923B1 (zh)
JP (1) JP2002520269A (zh)
KR (1) KR100529843B1 (zh)
CN (1) CN1308529A (zh)
AT (1) ATE257377T1 (zh)
AU (1) AU4905799A (zh)
BR (1) BR9912260A (zh)
CA (1) CA2336711C (zh)
DE (2) DE19831263A1 (zh)
DK (1) DK1096923T3 (zh)
ES (1) ES2214869T3 (zh)
HU (1) HUP0104941A2 (zh)
IL (1) IL140730A0 (zh)
WO (1) WO2000002538A1 (zh)

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US20040171992A1 (en) * 2003-02-28 2004-09-02 Waikiwi Corporation Cream dispenser providing sequential dispensing means
DE102006011340A1 (de) * 2006-03-09 2007-09-20 Grünenthal GmbH Wirkstoffhaltige Pflaster mit verbesserter Handhabung

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4736849A (en) * 1983-12-19 1988-04-12 Leonard Walter G Calendar-oriented pill dispenser
GB8718797D0 (en) 1987-08-07 1987-09-16 Ciba Geigy Ag Container
US5108995A (en) * 1987-09-24 1992-04-28 Jencap Research Ltd. Hormone preparation and method
DE3888269T2 (de) * 1987-09-24 1994-07-07 Jencap Research Ltd Hormon-Zusammensetzung und -Anwendung.
US5077104A (en) * 1989-12-21 1991-12-31 Alza Corporation Nicotine packaging materials
DE4223004A1 (de) * 1992-07-13 1994-01-20 Liedtke Pharmed Gmbh Einzeldosierte halbfeste topische Arzneiform zur Transdermaltherapie
DE19619045C1 (de) * 1996-05-02 1997-11-13 Jenapharm Gmbh Verwendung von Kombinationspräparaten zur Behandlung hypogonadaler Männer sowie Männern mit Hypophysenerkrankungen
DE29719070U1 (de) * 1996-10-29 1998-05-14 Byk Gulden Lomberg Chem Fab Blister für die Kombinationstherapie
FR2765483B1 (fr) * 1997-07-04 2000-02-04 Philippe Gorny Medicament destine a traiter les dysfonctions erectiles

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US6630149B1 (en) 2003-10-07
ATE257377T1 (de) 2004-01-15
WO2000002538A1 (de) 2000-01-20
HUP0104941A2 (hu) 2002-05-29
KR100529843B1 (ko) 2005-11-22
BR9912260A (pt) 2001-10-02
ES2214869T3 (es) 2004-09-16
KR20010071795A (ko) 2001-07-31
CA2336711C (en) 2007-05-29
EP1096923A1 (de) 2001-05-09
CA2336711A1 (en) 2000-01-20
DK1096923T3 (da) 2004-03-29
DE59908258D1 (de) 2004-02-12
DE19831263A1 (de) 2000-01-13
JP2002520269A (ja) 2002-07-09
IL140730A0 (en) 2002-02-10
EP1096923B1 (de) 2004-01-07
AU4905799A (en) 2000-02-01

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