EP0967972A1 - Dehnbares transdermales therapeutisches system - Google Patents
Dehnbares transdermales therapeutisches systemInfo
- Publication number
- EP0967972A1 EP0967972A1 EP98908021A EP98908021A EP0967972A1 EP 0967972 A1 EP0967972 A1 EP 0967972A1 EP 98908021 A EP98908021 A EP 98908021A EP 98908021 A EP98908021 A EP 98908021A EP 0967972 A1 EP0967972 A1 EP 0967972A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- layer
- therapeutic system
- transdermal therapeutic
- skin
- backing layer
- 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.)
- Withdrawn
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
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
-
- 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
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7076—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising ingredients of undetermined constitution or reaction products thereof, e.g. rosin or other plant resins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/18—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing inorganic materials
Definitions
- the invention relates to an active substance-containing transdermal therapeutic system with a non-sticky backing layer, a reservoir layer containing an active substance and a self-adhesive surface facing the skin, optionally with a releasable protective layer.
- TTS Transdermal therapeutic systems
- an essentially impermeable, non-adhesive backing layer is used.
- transdermal therapeutic systems are intended to adhere to the skin, the layer facing the skin, sometimes only a part of the contour, is provided with a self-adhesive finish.
- the backing layer usually consists of pharmaceutically common materials such as plastic films; but also paper, nonwovens, textiles and metal foils are mentioned.
- the surface-stable active substance-impermeable back layer means that the patient is comfortable to wear: due to the "stiffness" or lack of elasticity of the foils used, there is practically a limitation to surface sizes of around 40 cm 2 .
- the area-related transport rate through the skin is very low for most pharmaceutical active ingredients, a larger system area would be very desirable in order to be able to offer marketable TTS for such active ingredients.
- Attempts have already been made to improve the wearing comfort by using elastic materials for the backing layer e.g. US Pat. No. 5,246,705), however, special attention has been paid to the impermeability of the material to the notified drug.
- the object of the invention is to provide a transdermal therapeutic system with an elastic or plastically stretchable backing layer, which has an improved stabilization of the active ingredient against evaporation compared to the prior art.
- TTS of the type mentioned at the outset, which is characterized by an elastic or plastically stretchable diffusible backing layer with a metal layer formed by layer growth, in particular metal vapor deposition layer, which acts as a passage barrier for auxiliaries and active substances of the reservoir layer.
- the elastic and therefore active substance-permeable backing layer comprises a metal layer formed by layer growth (sputtering, cutting, etc.), in particular a zone of vapor-deposited metal, which acts as a barrier sufficient for auxiliaries and active ingredients without preventing the desired stretching behavior of the backing layer.
- layer thicknesses of the metal layer in the range from 50 to 1500 ⁇ , in particular from 100 to 300 ⁇ .
- desired area size of the TTS plays a certain role.
- Aluminum vapor deposition layers, the production of which is generally well known per se, are particularly preferred.
- WO 91-11752 describes an estradiol TTS, for the rear layer of which a large number of materials are specified, which also comprises flexible plastic films with Al vapor deposition.
- this teaching in no way leads to the realization that the inclusion of a metal layer which is highly volatile as a barrier to loss of active ingredient and which allows the extensibility of the backing layer in the surface, in particular Al layer, in an elastic backing layer to achieve particularly suitable transdermal therapy systems.
- the metal layer not only Prevents losses due to evaporation, but at the same time offers protection against the harmful effects of light on light-sensitive substances and components.
- the metallization according to the invention in particular the aluminization of the backing layer, is not a self-contained, uniform, foil-like metal structure, but rather submicroscopic crystallites are inserted into the surface, which greatly restrict the incidence of light and diffusion, but a sufficient flexibility of the material in allow the area.
- the backing layer is diffusible and contains at least one third of the amount of active substance contained in the preparation.
- the backing layer has a dual function as part of the drug reservoir and at the same time as an element of mechanical strength and to avoid external jamming.
- the aluminization is advantageously applied to the side of the backing layer facing the skin in order to avoid abrasion due to surface abrasion on the TTS. Since the active ingredient contained in the outermost surface of the backing layer decomposes particularly in the case of light influences Exposure to light may also make sense to limit the backing layer to an extremely thin polymer layer and to include a further zone that improves the tensile strength (supporting layer) between the now very thin backing layer and the remaining elements of the transdermal therapeutic system.
- the invention can basically be used with all skin-active pharmaceutical ingredients. Of course, their use with volatile active substances and auxiliaries is particularly advantageous. Such substances are, for example, nicotine or nitroglycerin as examples of active pharmaceutical ingredients. Ethanol, propanediol and other low molecular weight alcohols, menthol, eucalyptol, limonene and many other terpenes, low molecular weight fatty acids such as B. capric acid, dimethyl sulfoxide may be mentioned as an example of typical additives in such preparations, which could migrate more or less strongly through the backing layer from the preparation.
- transdermal therapeutic system Apart from the backing layer which is permeable to the active ingredient and which contains the active ingredient and which contains the protective layer of metal vapor deposition and any support layer which may be present, the further structure of the transdermal therapeutic system is not critical for achieving the purpose according to the invention. Any type of transdermal system can therefore be used, whether it is a single or multilayer matrix system, structures with single brought fibrous preparations containing active substance, real reservoir systems with a liquid active substance reservoir or systems of another type.
- polyvinyl alcohol polyvinyl alcohol
- styrene-diene block copolymers polyurethanes
- polyvinyl chloride polymethacrylates
- an additional adhesive layer that is adhesive, adhesive and removable after application, which can be removed after the system has been applied.
- the mass is coated in a gap width of approx. 250 ⁇ on a polyester film which has been provided with a dehumidifier in such a way that, after drying for 4 hours at 35 ° C., a uniform layer with a weight per unit area of 50 g / m 2 is formed.
- the mass is coated in a gap width of approximately 150 .mu.m on a polyester film which has been provided with a seal so that after half an hour of drying at 35.degree. C. and a further 15 minutes of drying at 60.degree. C., a uniform layer with a weight per unit area of 35 g / m 2 is formed.
- phase A and phase B produced in this way are laminated together and spontaneously adhere to a manually non-detachable bond.
- the dehumidified polyester film from phase B and the adhesive layer and the backing layer are punched out in a manner known to the person skilled in the art in a contour corresponding to the geometric shape of the preparation, and the residues lying outside are removed.
- the dosage form is packaged individually in sealed bags. The user removes the drug from the packaging, removes the protective layer (release liner) for the adhesive layer, sticks the dosage form on a suitable skin area and finally removes the support layer (polyester film with adhesive).
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Dermatology (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Botany (AREA)
- Inorganic Chemistry (AREA)
- Hematology (AREA)
- Materials Engineering (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
Claims
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE19705138 | 1997-02-11 | ||
DE19705138A DE19705138A1 (de) | 1997-02-11 | 1997-02-11 | Dehnbares transdermales therapeutisches System |
PCT/EP1998/000496 WO1998034600A1 (de) | 1997-02-11 | 1998-01-30 | Dehnbares transdermales therapeutisches system |
Publications (1)
Publication Number | Publication Date |
---|---|
EP0967972A1 true EP0967972A1 (de) | 2000-01-05 |
Family
ID=7819892
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP98908021A Withdrawn EP0967972A1 (de) | 1997-02-11 | 1998-01-30 | Dehnbares transdermales therapeutisches system |
Country Status (9)
Country | Link |
---|---|
US (1) | US6277400B1 (de) |
EP (1) | EP0967972A1 (de) |
JP (1) | JP2001512428A (de) |
KR (1) | KR20000070798A (de) |
AU (1) | AU725245B2 (de) |
CA (1) | CA2279994A1 (de) |
DE (1) | DE19705138A1 (de) |
NO (1) | NO993855L (de) |
WO (1) | WO1998034600A1 (de) |
Families Citing this family (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7063859B1 (en) * | 1999-04-28 | 2006-06-20 | Noven Pharmaceuticals, Inc. | Barrier film lined backing layer composition and method for topical administration of active agents |
DE19943317C1 (de) * | 1999-09-10 | 2001-03-15 | Lohmann Therapie Syst Lts | Kunststofffolien, insbesondere für die Verwendung in einem dermalen oder transdermalen therapeutischen System und Verfahren zu ihrer Herstellung |
DE10042412B4 (de) * | 2000-08-30 | 2005-12-22 | Lts Lohmann Therapie-Systeme Ag | Transdermales therapeutisches System zur Abgabe von Venlafaxin, und seine Verwendung |
DE10056014A1 (de) * | 2000-11-11 | 2002-05-16 | Beiersdorf Ag | Mehrschichtige Trägerkonstruktion für wirkstofhaltige Pflastersyteme |
DE10056012A1 (de) * | 2000-11-11 | 2002-05-16 | Beiersdorf Ag | Flexible Barrierefolie für ein Trägermaterial für medizinische Zwecke |
DE10137405A1 (de) * | 2001-07-31 | 2003-02-20 | Beiersdorf Ag | Verfahren zur kontinuierlichen Herstellung und Beschichtung von Selbstklebemassen auf Basis von SBC mit mindestens einem pharmazeutischen Wirkstoff |
DE10236319A1 (de) * | 2002-08-08 | 2004-02-19 | Beiersdorf Ag | Hautfreundliche Wirkstoffpflaster auf der Basis von SBC mit mindestens einem pharmazeutischen Wirkstoff mit einem Gehalt von mindestens 34 Gew.-% und dessen Herstellung |
US20050191339A1 (en) * | 2002-08-08 | 2005-09-01 | Beiersdorf Ag | Skin friendly active ingredient plaster based on SBC, containing at least 34 WT.% of a pharmaceutical active ingredient and production thereof |
GB2398227B (en) * | 2003-02-13 | 2006-01-04 | Gholam Hossein Khadememamzadeh | Doner slicer |
US20070264487A1 (en) * | 2006-05-12 | 2007-11-15 | Dean Georgiades | Treated film strips |
Family Cites Families (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS5939827A (ja) | 1982-08-27 | 1984-03-05 | Nitto Electric Ind Co Ltd | 医療用外用部材 |
DE3685895T2 (de) * | 1985-02-25 | 1992-12-24 | Univ Rutgers | Dosierungssystem fuer transdermale absorption von arzneimittelwirkstoffen. |
CN1021196C (zh) * | 1986-12-29 | 1993-06-16 | 新泽西州州立大学(鲁杰斯) | 透皮雌激素/孕激素药剂单元、系统及方法 |
US4943435A (en) * | 1987-10-05 | 1990-07-24 | Pharmetrix Corporation | Prolonged activity nicotine patch |
US4994278A (en) * | 1988-03-04 | 1991-02-19 | Noven Pharmaceuticals, Inc. | Breathable backing |
DE3908431A1 (de) * | 1989-03-15 | 1990-09-27 | Lohmann Therapie Syst Lts | Transdermales system mit gestufter wirkstoffabgabe und verwendung fuer die lokale oder systemische wirkstoffverabreichung |
DE3939376C1 (de) * | 1989-11-29 | 1991-05-08 | Lts Lohmann Therapie-Systeme Gmbh & Co. Kg, 5450 Neuwied, De | |
US5240711A (en) * | 1989-11-29 | 1993-08-31 | Lts Lohmann Therapie-Systeme Gmbh & Co. Kg | Transdermal therapeutic system comprising as active component buprenorphine |
DE69108512T2 (de) * | 1990-05-17 | 1995-08-03 | Hisamitsu Pharmaceutical Co | Estradiol enthaltende transdermale zubereitung. |
-
1997
- 1997-02-11 DE DE19705138A patent/DE19705138A1/de not_active Ceased
-
1998
- 1998-01-30 WO PCT/EP1998/000496 patent/WO1998034600A1/de not_active Application Discontinuation
- 1998-01-30 US US09/367,341 patent/US6277400B1/en not_active Expired - Fee Related
- 1998-01-30 JP JP53372298A patent/JP2001512428A/ja active Pending
- 1998-01-30 EP EP98908021A patent/EP0967972A1/de not_active Withdrawn
- 1998-01-30 KR KR1019997007060A patent/KR20000070798A/ko not_active Application Discontinuation
- 1998-01-30 AU AU66177/98A patent/AU725245B2/en not_active Ceased
- 1998-01-30 CA CA002279994A patent/CA2279994A1/en not_active Abandoned
-
1999
- 1999-08-10 NO NO993855A patent/NO993855L/no not_active Application Discontinuation
Non-Patent Citations (1)
Title |
---|
See references of WO9834600A1 * |
Also Published As
Publication number | Publication date |
---|---|
AU725245B2 (en) | 2000-10-12 |
DE19705138A1 (de) | 1998-08-13 |
NO993855D0 (no) | 1999-08-10 |
KR20000070798A (ko) | 2000-11-25 |
AU6617798A (en) | 1998-08-26 |
WO1998034600A1 (de) | 1998-08-13 |
NO993855L (no) | 1999-08-10 |
JP2001512428A (ja) | 2001-08-21 |
CA2279994A1 (en) | 1998-08-13 |
US6277400B1 (en) | 2001-08-21 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
Free format text: ORIGINAL CODE: 0009012 |
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17P | Request for examination filed |
Effective date: 19990730 |
|
AK | Designated contracting states |
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AX | Request for extension of the european patent |
Free format text: SI PAYMENT 19990730 |
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RAP1 | Party data changed (applicant data changed or rights of an application transferred) |
Owner name: LTS LOHMANN THERAPIE-SYSTEME AG |
|
17Q | First examination report despatched |
Effective date: 20010410 |
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RAP1 | Party data changed (applicant data changed or rights of an application transferred) |
Owner name: HORSTMANN, MICHAEL |
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STAA | Information on the status of an ep patent application or granted ep patent |
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Effective date: 20030104 |