Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Patent
1991-06-17
1992-07-21
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
424449, A61F 1302
Patent
active
051321157
DESCRIPTION:
BRIEF SUMMARY
This invention relates to a transdermal therapeutic system for the administration of drugs to the skin, including drug reservoir(s) having drug-releasing areas and including skin adhesion regions arranged on the skin side thereof, and to a process for the production of the therapeutic system, and to its use.
The invention is thus concerned with a transdermal therapeutic system for the administration of medicinal substances and also cosmetically effective substances to human or animal skin.
The term "therapeutic system" includes a device comprising medicaments or active substance, and an administration form, which emits one or several active agents at a pre-determined rate continuously over a fixed period of time to a pre-determined area of application.
These systems are therapeutical precision instruments, the construction of which requires exceptional provisions to ensure continuous release of the active agent.
Therapeutic systems have already been developed for various applications and also for the skin, whereby systemic as well as topical activity can be attained. The variety of active agents applicable in this way, and their different chemical, physical and pharmacological properties make it impossible to solve all therapeutic problems with only one system.
A variety of flat therapeutic systems has already become known for the administration of medicinal substances to the skin. A summary thereof may be found e.g. in "Klaus Heilmann: Therapeutische Systeme, Ferdinand Enke Verlag, Stuttgart, 1977." However, a completely satisfactory effect may not be obtained in all cases by the state of the art systems.
A conventional construction of a known transdermal therapeutic system comprises a drug reservoir in which the active substance is present in solid, liquid or dissolved form, and a layer of pressure-sensitive adhesive by which the system can be brought into close contact with the skin.
This principle is limited in cases in which the active substance does not diffuse through the adhesive layer, or where a chemical reaction occurs between the active substance and the adhesive, or where the active substance is insoluble or only poorly soluble in the adhesive. In these cases, it has been attempted to bring a non-adhesive drug-containing reservoir or the drug itself into direct contact with the skin, and to fix this reservoir or the drug itself to the skin by additional means. For this purpose, separate adhesive, e.g., in the form of strips, is suitable, or the integration of the reservoir or the drug into a plaster can be employed, such that the reservoir or the drug is surrounded by an adhesive edge (see for example DE-OS 29 02 183). If the area of contact exceeds a certain size, the constant contact with the skin which is necessary for controlled therapy is not longer ensured after wearing this type of product for an extended time, such as days or even weeks, because of the unavoidable body and muscle movements.
In DE-OS 32 02 775, it has been proposed that the drug be distributed like a screen on the adhesive surface. In principle, the resulting adhesive surface is large enough for the drug to be fixed to the skin, and should in theory allow flat fixation of the drug reservoir. However, since the drug is not on the same level as the adhesive layer, this layer is constantly under stress after adhesion to the skin. For this reason, the joined areas can loosen again very easily with the inevitable body and muscle movements, and thus affect the constant contact of the surface of the drug with the skin due to changes in pressure which arise, and thereby prevent a controlled release of the drug.
A self-adhesive plaster having separate drug segments is known from DE-OS 34 23 328. In this product, cup-shaped drug segments and adhesive segments are arranged on a non-adhesive base. This arrangement is said to provide adhesive segments and drug segments on the same level. When applying the plaster, the size of the skin contact area and thus the amount of drug released depends on the pressure of the plaster paster. Th
REFERENCES:
patent: 4687481 (1987-08-01), Nuwayser
patent: 4699792 (1987-10-01), Nick
patent: 4711781 (1987-12-01), Nick
Herrmann Fritz
Hoffmann Hans R.
Kissel Thomas
Reinhardt Joerg
Simon Gunter
Page Thurman K.
Phelan D. Gabrielle
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