Transdermal therapeutic system with small application-area thick

Details Transdermal therapeutic system with small application-area thick Transdermal therapeutic system with small application-area thick

1999-04-26

2000-12-26

Clardy, S. Mark

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Web, sheet or filament bases; compositions of bandages; or...

424448, 602 41, 602 60, 602 61, 6048901, 604 19, 604289, 604290, 604304, 604307, A61K 914

Patent

active

06165499&

DESCRIPTION:

BRIEF SUMMARY
BACKGROUND OF THE INVENTION

The present invention relates to a transdermal therapeutic system for the controlled release of active substances to human or animal skin, which stands out for its small application thickness and high flexibility, as well as to processes suitable for its production.


TECHNICAL FIELD OF THE INVENTION

Systems for the controlled release of active substances to human or animal skin are known, among others, as so-called Transdermal Therapeutic Systems (TTS) or "Transdermal Delivery Systems" (TDS). Depending on their construction and type of active substance release one differentiates between so-called bag or reservoir systems and matrix systems. In the former case, these systems consist of a flat bag which comprises an active substance. One side thereof is impermeable to active and inactive ingredients and the opposite side is semipermeable and formed as a control membrane which is coated with an adhesive for adhesion to the skin. Owing to its complicated construction, production of the system requires a great deal of expenditure, since the individual components are to be produced separately and must then be joined to form a system. Moreover, the thickness of the system impairs the wearing properties. In addition, bag-type systems involve the risk of so-called "drug dumping", that is, the sudden substantial active substance release to the skin, for example, as a result of physical destruction of the membrane or bag. EP 0 285 563 describes such a transdermal therapeutic system for the combined application of estrogens and gestagens. U.S. Pat. No. 4,624,665 describes systems comprising the active substance in microencapsulated form within the reservoir. The reservoir is embedded between backing layer and membrane. The edge of the system is provided with a pressure-sensitive adhesive. Construction and production of this system are very complicated since the active substance must be microencapsulated and homogeneously distributed and then be embedded between backing layer and membrane. In addition, the system must be provided with an adhesive edge and covered with a protective layer. Matrix systems usually consist of a backing layer which is impermeable to active substances and auxiliaries and averted from the skin and an adhesive layer wherein active substance is distributed. For the purpose of protecting the adhesive layer it is provided with an antiadhesively finished protective film which has to be removed prior to application. DE-OS 20 06 969 describes such a system wherein contraceptive substances are incorporated in the adhesive component or adhesive film. This publication discloses that the adhesive film may be an acrylate. Similar to labels, matrix systems have the disadvantage that they are punched out from a self-adhesive laminate positioned on a nonstick protective layer. The stampings on the protective layer are separated in a further step to produce the finished TTS. The regions between the individual punched pieces, which consist of active substance-containing adhesive layer and backing layer, are to be disposed of as active substance-containing waste. DE 39 39 376, DE 29 08 432 and EP 0 400 078 B1 represent examples providing solutions for avoiding such waste.
The thickness of the system which results from the production method and the kind of application is a disadvantage of known matrix systems. This thickness affects the system's flexibility and therefore its wearing properties, whereas wearing comfort of the system increases with decreasing thickness. Moreover, known matrix systems are limited by the fact that neither at the same time nor in chronological order it is possible to provide alternative doses, active substance concentrations, or varying chemical system compositions differing in the active substance or a special active substance combination and providing a desired application of several active substances, which differs with respect to time or site.


SUMMARY OF THE INVENTION

It is the object of the present invention to provide a transdermal therapeutic

REFERENCES:
patent: 4624665 (1986-11-01), Nuwayser
patent: 4915950 (1990-04-01), Miranda et al.
patent: 5064422 (1991-11-01), Wick
patent: 5780047 (1998-07-01), Kamiya et al.
patent: 5843472 (1998-12-01), Ma et al.

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