Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Patent
1999-06-28
2000-12-05
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...
602 48, 602900, 424448, A61F 1300
Patent
active
061563366
DESCRIPTION:
BRIEF SUMMARY
The invention relates to a process for producing active ingredient-containing layered articles or discs with a uniform or regionally varying constitution within the layer, and to transdermal therapeutic systems having layered articles produced according to the invention.
Active ingredient-containing discs or layered articles can be used in various areas and for various purposes, but a particularly interesting application of such disc-shaped articles is as active ingredient reservoir in transdermal therapeutic systems (TTS). By these are meant active ingredient-containing systems which are placed in contact for a defined time with the surface of the skin or mucous membrane of a human or mammal.
TTS can be made self-adhesive over all or part of the surface, or become self-adhesive under the conditions at the site of application. TTS are used to deliver one or more active ingredients to the contiguous organism in an amount which is determined over time either by the release from the TTS or the absorption capacity of the organism at the site of application. This active ingredient release into the organism can remain locally restricted or else lead to distribution in the whole organism.
In addition, single disc-shaped articles can also be employed in the area of diagnostic aids to be applied dermally, such as, for example, as or for immunological test systems or test series. Systems for transdermal determination of the concentration of particular substances in body fluids, such as, for example, glucose in blood, are also conceivable. In the state of the art, TTS are usually fabricated as sheet-like structures. Such sheet-like structures are produced essentially by punching out the individual pharmaceutical forms from a sheet material which is in web form and onto which previously an active ingredient-containing pharmaceutical preparation--which has generally been made free-flowing by addition of solvent or raising the temperature--has been applied or an active ingredient-containing layered article has been placed.
This punching or cutting out singly is frequently associated with large amounts of waste material, on the one hand from technical necessity, and on the other hand due to the more or less favourable geometry of the individual form.
The typical structure of a TTS furthermore comprises various active or activating components in a multilayer system in the form of an arrangement of individual laminar components stacked one on top of another in only one spatial direction. The individual layers need not have the same shape or area, but may, for example, mutually overlap. This as a rule results in only one or a maximum of two layers being in direct contact with the site of application, whereas all the others are connected indirectly thereto.
The active ingredient can be present in one or more layers of the TTS. The amount of the active ingredient which can be introduced may in some circumstances be limited by the processes customary in the state of the art. Continuous processes with application of layers of solvent-containing active ingredient-containing compositions on to support materials in web form accordingly require a drying, and application of solvent-free compositions in a hot melt process requires corresponding cooling to be allowed.
In batchwise processes, the active ingredient or a suitable preparation thereof is metered intermittently into the substantially prefabricated TTS. The uptake of the active ingredient takes place in this case into suitable cavities or through absorbent carrier materials.
The invention now relates to a process with which it is possible to achieve improvements and extensions of the possibilities for TTS structure and production in three problem areas.
This process consists of a novel way of producing active ingredient-containing layered articles and is essentially characterized in that an elongate article having an inert enveloping surface corresponding to the contour of the layered articles to be produced and having a cross-sectional constitution corresponding to the unif
REFERENCES:
patent: 4666441 (1987-05-01), Andriola et al.
patent: 5464387 (1995-11-01), Haak et al.
patent: 5683719 (1997-11-01), Newton
Ghali Isis
LTS Lohmann Therapie-Systeme GmbH
Page Thurman K.
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