Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
2000-08-04
2004-03-09
Hartley, Michael G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
C424S443000, C424S448000, C514S964000
Reexamination Certificate
active
06703043
ABSTRACT:
The invention relates to a device for releasing at least one substance. One particular embodiment constitutes a backing material and, applied at least partially thereon, a device in the form of an adhesive composition comprising the one or more active substances that are delivered to the skin.
Transdermal therapeutic systems (TTS) are forms of administration of medicaments that deliver one or more medicaments to the skin over a defined period at their location of use. A distinction is made here between systemic and local administration forms.
With systemic administration forms, the active substance passes through the skin into the bloodstream by diffusion and can act within the body as a whole. Local administration forms, on the other hand, act only at the sites of application. The active substance remains in the skin or in the underlying layers.
Strongly adhering plasters are normally coated over their entire area with a rubber adhesive composition. The sticking of such products to the skin gives rise, following their removal, to marked skin irritations and mechanical stressing of the skin. Without auxiliary media it is impossible to break the bond painlessly. In some cases, there are allergic reactions. Furthermore, the adhesive compositions used often lead to a transfer of composition onto the skin.
The use of skin-friendly adhesive compositions, such as acrylate adhesive compositions and hydrogels, is out of the question because of their low shear stability and tack. Improvement through aftertreatment, especially crosslinking, though possible, nevertheless gives a result which is unsatisfactory overall. The proprioreceptive effect is less than that of systems with a rubber adhesive composition.
Other known adhesive systems based on conventional block copolymers are however not skin-friendly, owing to the high level of stabilizer added, or because of the high levels of cohesiveness have been found suitable to date only for industrial applications; alternatively, they cannot be formulated for strong adhesion and sticking to the skin.
The abovementioned adhesive compositions are pressure-sensitive self-adhesive compositions which may be present in a carrier matrix for processing. The term carrier matrix is understood to refer to common organic or inorganic solvents or dispersion media.
Systems without a carrier matrix are referred to as 100% systems and are likewise not unknown. A common mode of processing is that of the melt. Pressure-sensitive hot melt adhesive compositions of this kind have also already been described in the prior art. They are based on natural or synthetic rubbers and/or other synthetic polymers.
An advantage of the 100% systems is that they avoid an operation of removing the carrier matrix, i.e. the auxiliary media, thereby raising the productivity of processing and at the same time reducing the expenditure on machinery and the energy costs. In addition, this reduces the occurrence of residues of the carrier matrix, which, in turn, is beneficial to a reduction in the allergenic potential.
Because of their high level of hardness, sticking to the skin is a problem for such 100% systems.
It is also known to apply such self-adhesive compositions not only over the entire area but also in the form of a pattern of dots, for example by screen printing (DE-C 42 37 252), in which case the dots of adhesive can also differ in their size and/or distribution (EP-B 353 972), or by intaglio printing, in lines which interconnect in the longitudinal and transverse directions (DE-C 43 08 649).
The advantage of the patterned application is that the adhesive materials, given an appropriately porous backing material, are permeable to air and water vapour and, in general, are readily redetachable.
A disadvantage of these products, however, is that if the area covered by the adhesive film, which is impermeable per se, is too large there is a correpsonding reduction in the permeability to air and water vapour; the consumption of adhesive composition rises, and, if the area covered by the adhesive film is small, the adhesion properties deteriorate, i.e. the product is detached too readily from the substrate, especially in the case of heavy, textile backing materials.
Numerous embodiments of active substance plasters have already been described in the prior art, some of them operating in accordance with the reservoir principle, where the active substance is delivered, for example, by way of a membrane, in some cases also with a matrix system or with a relatively complex multilayer structure.
It is also known that the adhesive composition of the plaster can be employed as the matrix comprising active substance. In addition to self-adhesive compositions applied from solution, hotmelt self-adhesive compositions have also been proposed for this purpose, as for example in EP-A 663 431, EP-A 452 034, EP-A 305 757, DE-A 43 10 012, DE-A 42 22 334 and DE-C 42 24 325. The active substances listed in these documents, if named at all, have been systemic ones.
Examples of active substance plasters are antimycotic and keratolytic active substance plasters and those which aid the circulation.
However, plasters of this kind, which occasionally have to be applied over a relatively large area, in some cases exhibit distinct mechanical skin irritations after removal in the case of sensitive patients. In some cases there are allergic reactions. After a prolonged period of wear, their removal is to some extent painful.
A further disadvantage of the known thermally active plasters with an adhesive composition based on natural rubber, which is applied in the form of a solution with organic solvents to the plaster backing, is the comparatively low rate of release of the active substance.
The abovementioned disadvantages, and more, also apply to active substance plasters comprising substances other than those mentioned.
For instance, WO 94/02123 describes an active substance plaster based on pressure-sensitive hotmelt adhesive compositions and comprising low-melting and/or readily volatile active substances in a concentration of from 2.5 to 25% by weight. The polymers employed in that document are A-B-A triblock styrene-ethylene-butylene-styrene block copolymers which are notable for low initial tack and low bond strength on skin.
EP 0 663 431 A2, EP 0 443 759 A3, EP 0 452 034 A2 and U.S. Pat. No. 5,371,128 describe uses of pressure-sensitive hotmelt adhesives, based on silicone, with diverse additives and in differentiated forms of construction.
DE 43 10 012 A1 describes the construction of a dermal therapeutic system from meltable poly(meth)acrylate mixtures.
In particular, difficulties are apparent in the release of two or more active substances from polymer systems formed from only one type of polymer. Systems with two or more types of polymer, however, are critical in terms of their compatibility.
DE 43 16 751 C1 describes a multi-chamber system for administering active substances.
EP 0 439 180 describes an active substance plaster for administering tolubuterol.
EP 0 305 757 describes an active substance plaster for administering nicotine.
EP 0 305 758 describes an active substance plaster for administering nitroglycerine.
EP 0 305 756 describes a device for releasing substances, and the preparation and use thereof.
DE 37 43 945 describes a device for delivering substances, and the preparation process. In the case of the pressure-sensitive hotmelt adhesive composition described, which is based on SIS, the device is not self-adhesive. The processing ranges indicated therein lie well below those of hotmelt adhesive compositions and for such systems described would not provide sufficient anchorage of the adhesive composition.
WO 96/22083 indicates a polyisobutylene adhesive for transdermal purposes, having a tackifier with a high glass transition point. The adhesive is not foamed.
JP 07-196505 describes the administration of indomethacin in hotmelt pressure-sensitive adhesives. In this case, a polyethylene foam is used as backing material.
EP 0 428 017 describes an adhesive composition based on SEBS an
Himmelsbach Peter
Radloff Detlev
Beiersdorf AG
Gollamudi Sharmila S
Hartley Michael G.
Norris & McLaughlin & Marcus
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