Subsaturated nicotine transdermal therapeutic system

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...

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424448, A61F 1300

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active

053646304

ABSTRACT:
Rate controlled transdermal nicotine delivery systems are disclosed which utilize an in-line adhesive to maintain the systems on the skin. The initial equilibrated concentration of nicotine in the nicotine reservoir and the adhesive is below saturation, preferably at a thermodynamic activity no greater than 0.50, and the reservoir comprises the nicotine dissolved in a material with respect to which the rate controlling element of the device is substantially impermeable. In preferred embodiments the initial loading of nicotine in the reservoir is sufficient to prevent the activity of the nicotine in the reservoir from decreasing by more than about 75% and preferably no more than about 25% during the predetermined period of administration; and the thickness of the adhesive, rate controlling membrane and reservoir layers are selected so that at least 50% and, preferably at least 75% of the initial equilibrated nicotine loading is in the reservoir layer.

REFERENCES:
patent: 4597961 (1986-07-01), Etscorn
patent: 4624665 (1986-11-01), Nuwayser
patent: 4680172 (1987-07-01), Leeson
patent: 4758434 (1988-07-01), Kydonieus
patent: 4781924 (1988-11-01), Lee
Baker, R. W., et al., "Controlled Release: Mechanisms and Rates," Advanced Experimental Med. Biol., vol. 47, pp. 15-71 (1974).
Baker, R. W., "Analysis of Transdermal Drug Delivery Patents, 1934-1984," Membrane Technology and Research, Inc., pp. 1-10.

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