Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
2001-01-29
2004-09-28
Harlan, Robert D. (Department: 1713)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
C523S105000, C523S111000, C424S449000
Reexamination Certificate
active
06797280
ABSTRACT:
TECHNICAL FIELD
The present invention relates to an adhesive agent composition and a permeable adhesive tape containing the adhesive agent composition, an adhesive drug composition containing the adhesive agent composition, and an adhesive tape preparation containing the adhesive drug composition.
The present invention relates in more detail to an adhesive agent composition having good adhesion to the human skin and high permeability, a permeable adhesive tape having an adhesive layer that contains the adhesive agent composition, showing firm adhesion to the skin and excellent in permeability, an adhesive drug composition containing the adhesive agent composition, and an adhesive tape preparation having an adhesive drug layer that contains the adhesive drug composition, showing firm adhesion to the skin and excellent in permeability.
BACKGROUND ART
The following materials have been actively developed: an adhesive agent composition and adhesive drug composition having good adhesion to the human skin and suitable permeability; a permeable adhesive tape having an adhesive layer that contains the adhesive agent composition; and an adhesive tape preparation having an adhesive drug layer that contains a drug, particularly a drug to be administered into a living body through the skin. Rubber-based, silicone-based, acrylic-based, vinyl acetate-based, vinyl ether-based and the like material-based adhesive agents have been used as the adhesive agents for the adhesive agent compositions and the adhesive drug compositions for the tape preparations. Of these adhesive agents, acrylic adhesive agents that show less stimulation of the skin and that are less costly are preferably used. Moreover, in order to increase the transfer to the skin of the drug in an adhesive tape preparation containing a cutaneous absorption drug, the tape preparation must be surely affixed to the skin surface. However, for an adhesive tape preparation having excessively firm adhesion strength, the corneum is sometimes peeled off to give strong stimulation of the skin when the tape preparation is peeled off the skin. In order to solve the problem, in the development of an acrylic adhesive tape preparation, the skin touch of the tape preparation should be made soft when it is allowed to adhere to the skin; moreover, in order to increase the cutaneous absorption of a drug, the adhesive agent is allowed to contain a large amount of the liquid component. For example, substances such as sorbitan esters, aliphatic esters and polyhydric alcohols are known to have the effect of promoting cutaneous absorption of drugs, and adhesive tape preparations in which the acrylic adhesive agents are allowed to contain such cutaneous absorption promoters of drugs as the above sorbitan esters have been disclosed (Japanese Unexamined Patent Publication (Kokai) Nos. 1-233212, 1-233213, 2-196714 and 2-233617). However, as a result of allowing the adhesive agent to contain such a known cutaneous absorption promoter of a drug, there arise problems as explained below. The cohesive force of the adhesive agent is lowered, and part of the adhesive layer remains, that is, retention of the adhesive layer takes place when the tape preparation is affixed to the skin and peeled off; moreover, the liquid component containing the above cutaneous absorption promoter of a drug oozes out of the adhesive layer.
Various investigations on the methods of improving the cohesive force of the acrylic adhesive agents have been carried out. One of the known methods is to subject the adhesive layer to a physical procedure such as irradiation with ultraviolet rays, an electron beam, radioactive rays or the like. These procedures such as irradiation of ultraviolet rays sometimes cause decomposition of the drug; therefore, they are not preferable ones for the adhesive agents for medical treatment.
There are other chemical procedures for improving the cohesive force of the acrylic adhesive agents. Japanese Unexamined Patent Publication (Kokai) No. 3-220120 discloses, as one of the procedures, a method of cross-linking a metal alcoholate, a metal chelate compound and/or isocyanate, etc. with a carboxyl group in an acrylic adhesive polymer. In addition to these procedures, it is known that substances such as metal salts, organic peroxides, polyurethanes and/or multifunctional compounds can be used to improve the cohesive force of the acrylic adhesive agents. However, when substances such as metal alcoholates, metal chelate compounds, isocyanates, polyurethanes and/or multifunctional compounds are used in combination with a drug having a functional group, there arise the problems that the substances and the drug mutually act to lower the cutaneous absorption of the drug, and that the adhesive agent does not show the effect of improving the cohesive force.
Furthermore, the adhesive tape preparation used for the cutaneous absorption of a drug is very excellent in administering a drug that requires continuous administration over a long period of time, an antiphlogistic antalgic that causes gastroenteropathy in oral administration, and a drug that is substantially decomposed at the initial pass in the liver. However, when the adhesive tape preparation is continuously affixed to the skin of a patient over a long period of time, there arises the problem that poisoning and itchiness of the skin appear.
In order to improve the prevention of poisoning the skin, it has heretofore been attempted to make the contents of the remaining monomers and remaining solvent as small as possible. It is fundamentally desirable to increase the permeability (dissipation of moisture) of the affixed agent and suppress the humidity (poor dissipation of moisture) of the skin in the affixed portion. However, when the sealing degree of the affixed agent is decreased by increasing the permeability, the cutaneous absorption amount of the drug is extremely decreased to create the inconvenience that achieving the initial object of the tape preparation becomes unsatisfactory. In order to keep the cutaneous absorption amount of the drug at a desired value, such a substrate having substantially no permeability or low permeability as a PET film is used in combination with a permeable adhesive layer when a nonpermeable adhesive agent is used or such an adhesive agent having permeability as an acrylic adhesive agent is used.
A so-called poultice has been known as an adhesive tape preparation causing relatively less poisoning of the skin. The poultice comprises a permeable water-containing gel adhesive layer that contains a polyacrylic acid salt or polyvinyl alcohol and a substrate showing good air permeability and stretchability such as an unwoven fabric with the adhesive layer formed on the fabric. A poultice containing, in the water-containing gel adhesive agent layer, indomethacin or ketoprofen as a medicinally effective component has been widely used as an antiphlogistic antalgic poultice in recent years. However, since the poultice shows weak adhesion to the skin, it has the following disadvantages: an auxiliary means is necessary for continuously affixing the poultice; and the gel becomes sticky when the ambient temperature rises. Therefore, an antiphlogistic antalgic tape agent has been proposed (specifications in WO 93/04677 and WO 96/08245) and practically used in place of the antiphlogistic antalgic poultice.
A rubber-based adhesive agent having a high cohesive force and high adhesion is used for the adhesive layer of such a tape preparation, and a fabric (preferably a knitted fabric) having a high stretchability is used as the substrate. As a result, the tape preparation alone can be affixed to a flexible portion such as the cubitus of a patient, and the affixed state can be maintained.
However, the rubber-based adhesive agent substantially has no permeability. Therefore, the cutaneous absorption of a drug of the tape preparation is improved at the cost of the permeability. Moreover, in general, a relatively low molecular weight chemical substance such as a tackifier must be added to the rubber-based ad
Kawaguchi Takeyuki
Kitazono Eiichi
Minematsu Hiroyoshi
Miyoshi Takanori
Harlan Robert D.
Teijin Limited
LandOfFree
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