WO2000002538A1 - Blister enthaltend ein transdermales therapeutisches system und eine einzeldosierte darreichungsform - Google Patents

Blister enthaltend ein transdermales therapeutisches system und eine einzeldosierte darreichungsform Download PDF

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Publication number
WO2000002538A1
WO2000002538A1 PCT/EP1999/004614 EP9904614W WO0002538A1 WO 2000002538 A1 WO2000002538 A1 WO 2000002538A1 EP 9904614 W EP9904614 W EP 9904614W WO 0002538 A1 WO0002538 A1 WO 0002538A1
Authority
WO
WIPO (PCT)
Prior art keywords
blister
dosage form
active ingredient
dose
form according
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/EP1999/004614
Other languages
German (de)
English (en)
French (fr)
Inventor
Wolfgang Schäfer
Hanshermann Franke
Bodo Asmussen
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.)
LTS Lohmann Therapie Systeme AG
Original Assignee
LTS Lohmann Therapie Systeme AG
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 LTS Lohmann Therapie Systeme AG filed Critical LTS Lohmann Therapie Systeme AG
Priority to DK99932796T priority Critical patent/DK1096923T3/da
Priority to AU49057/99A priority patent/AU4905799A/en
Priority to JP2000558798A priority patent/JP2002520269A/ja
Priority to EP99932796A priority patent/EP1096923B1/de
Priority to CA002336711A priority patent/CA2336711C/en
Priority to DE59908258T priority patent/DE59908258D1/de
Priority to IL14073099A priority patent/IL140730A0/xx
Priority to AT99932796T priority patent/ATE257377T1/de
Priority to BR9912260-0A priority patent/BR9912260A/pt
Priority to US09/743,540 priority patent/US6630149B1/en
Publication of WO2000002538A1 publication Critical patent/WO2000002538A1/de
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • 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

Definitions

  • the invention relates to a dosage form for medical active ingredients in blister form, which enables simultaneous administration of a transdermal therapeutic system (TTS) and at least one single-dose active ingredient.
  • TTS transdermal therapeutic system
  • TTS transdermal therapeutic system
  • the system is preferably pressure-sensitive adhesive. If discontinuous concomitant medication using another hormone is desired, this is usually done in tablet form. The tablets are usually stored separately and are difficult to handle according to the timing of the application. This makes this type of dosage form extremely detrimental to patient compliance.
  • a blister form in addition to the TTS metered at least one Contains active ingredient form.
  • the TTS is individually packaged in a blister, but can also be fixed to the dosage form in some other way, such as by means of the pressure-sensitive adhesive contact surface. Placement in a blister is also the method of choice for the single-dose form of active ingredient, which is preferably a tablet, although other fastening mechanisms are of course also conceivable.
  • the joining of several blister shapes has proven to be advantageous for prolonged application. For the patient, this means that his application schedule is precisely and clearly defined over weeks.
  • the series of blister forms can also contain those that do not have a single dose of active ingredient if therapeutic reasons dictate this.
  • the single dose form of active ingredient is usually designed for non-transdermal application. Otherwise, care must be taken to ensure that a bolus release is ensured.
  • the individually dosed active ingredient form can also contain preparations for topical pre- and / or post-treatment of the TTS application area. These preparations can, for example, improve the skin permeability for the active ingredient from the TTS or prevent or even reverse harmful skin changes after the application of the TTS.
  • the single-dose form of active ingredient can also contain one or more active ingredients of the TTS in order to bridge the lag time of the TTS or to generate a circadian required plasma addition peak.
  • F Gl summarizes the compliance-safe aspects of the new dosage form with the help of a unit composed of eight TTS 1 to 8, which is used for a treatment period of 28 days. gene is provided.
  • the individual dosage forms of active substance are identified by 9, 1-4 not containing any.
  • progestogen administration is provided for every day of TTS application (alternating three and four days) in the last two weeks.
  • the invention provides a safe means to sustainably improve the patient's compliance with the TTS application with an additional single-dose active ingredient form.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Mechanical Engineering (AREA)
  • Dermatology (AREA)
  • Composite Materials (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)
PCT/EP1999/004614 1998-07-11 1999-07-02 Blister enthaltend ein transdermales therapeutisches system und eine einzeldosierte darreichungsform Ceased WO2000002538A1 (de)

Priority Applications (10)

Application Number Priority Date Filing Date Title
DK99932796T DK1096923T3 (da) 1998-07-11 1999-07-02 Blister indeholdende et transdermalt terapeutisk system og en enkeltdosisindgivelsesform
AU49057/99A AU4905799A (en) 1998-07-11 1999-07-02 Blister containing a transdermal therapeutic system and a single dose form of administration
JP2000558798A JP2002520269A (ja) 1998-07-11 1999-07-02 投与剤型
EP99932796A EP1096923B1 (de) 1998-07-11 1999-07-02 Blister enthaltend ein transdermales therapeutisches system und eine einzeldosierte darreichungsform
CA002336711A CA2336711C (en) 1998-07-11 1999-07-02 Blister containing a transdermal therapeutic system and a single dose form of administration
DE59908258T DE59908258D1 (de) 1998-07-11 1999-07-02 Blister enthaltend ein transdermales therapeutisches system und eine einzeldosierte darreichungsform
IL14073099A IL140730A0 (en) 1998-07-11 1999-07-02 Blister pack containing transdermal therapeutic systems
AT99932796T ATE257377T1 (de) 1998-07-11 1999-07-02 Blister enthaltend ein transdermales therapeutisches system und eine einzeldosierte darreichungsform
BR9912260-0A BR9912260A (pt) 1998-07-11 1999-07-02 Emplastro contendo um sistema terapêutico transdérmico e dose única para ministração
US09/743,540 US6630149B1 (en) 1998-07-11 1999-07-02 Blister containing a transdermal therapeutic system and a single dose form of administration

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19831263A DE19831263A1 (de) 1998-07-11 1998-07-11 Darreichungsform
DE19831263.6 1998-07-11

Publications (1)

Publication Number Publication Date
WO2000002538A1 true WO2000002538A1 (de) 2000-01-20

Family

ID=7873833

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1999/004614 Ceased WO2000002538A1 (de) 1998-07-11 1999-07-02 Blister enthaltend ein transdermales therapeutisches system und eine einzeldosierte darreichungsform

Country Status (15)

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

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004078092A3 (en) * 2003-02-28 2005-09-15 Waikiwi Corp Cream dispenser

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102006011340A1 (de) * 2006-03-09 2007-09-20 Grünenthal GmbH Wirkstoffhaltige Pflaster mit verbesserter Handhabung

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0307352A1 (de) * 1987-08-07 1989-03-15 Ciba-Geigy Ag Arzneimittelbehältnis
WO1991009731A1 (en) * 1989-12-21 1991-07-11 Alza Corporation Nicotine packaging materials
WO1999001132A1 (fr) * 1997-07-04 1999-01-14 Real 2000 Limited Medicament, contenant de la yohimbine et de l'arginine, destine a traiter les dysfonctions erectiles

Family Cites Families (6)

* 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
US5108995A (en) * 1987-09-24 1992-04-28 Jencap Research Ltd. Hormone preparation and method
AU630334B2 (en) * 1987-09-24 1992-10-29 Jencap Research Ltd. Hormone preparations for hormone replacement therapy and contraceptive method
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 Chemische Fabrik Gmbh, 78467 Konstanz Blister für die Kombinationstherapie

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0307352A1 (de) * 1987-08-07 1989-03-15 Ciba-Geigy Ag Arzneimittelbehältnis
WO1991009731A1 (en) * 1989-12-21 1991-07-11 Alza Corporation Nicotine packaging materials
WO1999001132A1 (fr) * 1997-07-04 1999-01-14 Real 2000 Limited Medicament, contenant de la yohimbine et de l'arginine, destine a traiter les dysfonctions erectiles

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004078092A3 (en) * 2003-02-28 2005-09-15 Waikiwi Corp Cream dispenser

Also Published As

Publication number Publication date
JP2002520269A (ja) 2002-07-09
IL140730A0 (en) 2002-02-10
ES2214869T3 (es) 2004-09-16
KR100529843B1 (ko) 2005-11-22
DE19831263A1 (de) 2000-01-13
CA2336711C (en) 2007-05-29
EP1096923B1 (de) 2004-01-07
EP1096923A1 (de) 2001-05-09
HUP0104941A2 (hu) 2002-05-29
AU4905799A (en) 2000-02-01
DE59908258D1 (de) 2004-02-12
DK1096923T3 (da) 2004-03-29
ATE257377T1 (de) 2004-01-15
BR9912260A (pt) 2001-10-02
KR20010071795A (ko) 2001-07-31
CA2336711A1 (en) 2000-01-20
CN1308529A (zh) 2001-08-15
US6630149B1 (en) 2003-10-07

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