Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Patent
1986-05-05
1990-05-15
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, 525477, A61F 1302
Patent
active
049256718
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to pressure sensitive adhesives which provide suitable adherence of objects to the human skin. The invention relates more particularly to silicone based pressure sensitive adhesives which are of particular use in transdermal therapeutic devices for attachment to the human skin.
2. Description of the Prior Art
Pressure sensitive adhesives for use on human skin are used typically in bandages or other therapeutic devices which must adhere to the skin for a prescribed period of time. Such devices are typically comprised of a plastic or cloth film layer coated with a pressure sensitive adhesive. The pressure sensitive adhesive is protected with a release substrate which is readily peelable from the adhesive coating. The pressure sensitive adhesive for use in connection with such bandages or other therapeutic device must satisfy an array of specific physical characteristics. Importantly the release substrate must be easily peelable from the adhesive coating and the adhesive must have sufficient cohesion to keep the bandage or therapeutic object in adhesive contact with the skin for a prescribed period of time. Also the adhesive must not cause skin inflammation and must be nontoxic.
Additionally a pressure sensitive adhesive as applied to a transdermal therapeutic device must meet other strict performance requirements. A transdermal device is a medicinal pouch which contains a liquid medicine or other drugs which must be absorbed gradually into the skin over a fairly long period of time. These devices typically contain a semipermeable membrane and are advantageously used with drugs which are best absorbed into the human body gradually, such as nitroglycerine or other drugs useful in treating cardiac impairment. Thus, the pressure sensitive adhesive which is coated onto the therapeutic device must not act as a barrier to interrupt the flow of a fluid from the device and into the human blood stream. Specifically, the pressure sensitive adhesive must be permeable to the drug being used. Furthermore, since the therapeutic device must remain in close adhesive contact with the skin over a period of time typically at least up to 24 hours, the adhesive should keep essentially all of the contact surface of the therapeutic device in adhesive contact with the patient's skin over this entire period. The pressure sensitive adhesive should also permit the therapeutic device to be peeled from the skin without causing discomfort and without leaving an adhesive residue on the skin which is not easily removeable.
U.S. Pat. Nos. 2,857,356 and 4,039,707 are illustrative of prior art silicone-based pressure sensitive adhesives. U.S. Pat. No. 2,857,356 discloses a pressure sensitive adhesive formed from the polymerization of a silicate resin and an organopolysiloxane fluid. The silicate resin is obtained by intercondensing a mixture comprising a cohydrolysis product of a trialkyl hydrolyzable silane and an alkyl silicate, said cohydrolysis product containing a plurality of silicone-bonded hydroxy groups. The formulation disclosed in this reference is directed principally to forming a pressure sensitive adhesive which retains a high degree of tack and cohesion over a wide temperature range, for example between about -75.degree. C. and 250.degree. C. The pressure sensitive adhesive product disclosed in this reference is directed to application principally as an adhesive coating for use in contacting polymeric material such as glass, a wide range of plastics such as polyethylyene, and also for use in connection with the manufacture of pressure sensitive tapes. There is no reference made in this disclosure to suitability of the adhesive product for application to human skin. In order to achieve the high degree of tack and cohesive strength, patentees disclose that the weight ratio of the silicate resin to the organopolysiloxane fluid should be between about 0.5/1 to 6/1, more preferably between about 1/1 to 3/1. (Column 7, lines 21 to 28). The range of fo
REFERENCES:
patent: 2857356 (1958-10-01), Goodwin
patent: 3598122 (1971-08-01), Zaffaroni
patent: 3652475 (1972-03-01), Wade et al.
patent: 4016328 (1977-04-01), Horning
patent: 4039707 (1977-08-01), O'Malley
Abber Herman
Gerry Elizabeth H.
Pennace John R.
Flexcon Company, Inc.
Horne L. R.
Kersey George E.
Page Thurman K.
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