Medical device for pulsatile transdermal delivery of biologically active agents
First Claim
1. A medical device for the pulsitile administration of a drug through intact skin at a first steady state flux during a first delivery period and a second steady state flux during a second delivery period, said first and second delivery periods comprising a substantial portion of a predetermined administration period;
- said device comprising;
(a) a reservoir of said drug containing an amount of drug at least sufficient to administer drug at said first and second steady state fluxes throughout said administration period, said first steady state flux being substantially higher than said second steady states flux(b) a reservoir of a skin permeation enhancer for said drug;
said reservoir containing an amount of permeation enhancer (i) sufficient to permit administration of said permeation enhancer at permeation enhancing fluxes through said first delivery period and (ii) insufficient to permit administration of said permeation enhancer at permeation enhancing fluxes during the remainder of said administration period; and
(c) means for maintaining said device on the skin in drug and permeation enhancer transferring relationship thereto;
whereby a pulsitile drug administration pattern, having a first flux substantially higher than the flux of drug through untreated skin during said first period and a second, substantially lower flux during said second delivery period, will be obtained.
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Accused Products
Abstract
A medical device and method for the pulsatile administration of a drug through intact skin at a first steady state flux during a first delivery period and a second steady state flux during a second delivery period, said first flux being substantially higher than said second flux; said first and second delivery periods comprising a substantial portion of a predetermined administration period. The device comprises a reservoir of said drug containing an amount of drug sufficient to administer drug at said first and second steady state fluxes during administration period; a reservoir of a skin permeation enhancer for said drug; said reservoir containing an amount of said permeation enhancer sufficient to permit administration of said drug at said first flux only through said first delivery period; and means for maintaining said device on the skin in drug and permeation enhancer transferring relationship thereto a preferred embodiment delivering nitroglycerin and employing ethanol as a permeation enhancer. The device contains means for controlling the maximum delivery rate of one of said drug or enhancer. A preferred embodiment provides for the pulsatile delivery of nitroglycerin.
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Citations
35 Claims
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1. A medical device for the pulsitile administration of a drug through intact skin at a first steady state flux during a first delivery period and a second steady state flux during a second delivery period, said first and second delivery periods comprising a substantial portion of a predetermined administration period;
- said device comprising;
(a) a reservoir of said drug containing an amount of drug at least sufficient to administer drug at said first and second steady state fluxes throughout said administration period, said first steady state flux being substantially higher than said second steady states flux (b) a reservoir of a skin permeation enhancer for said drug;
said reservoir containing an amount of permeation enhancer (i) sufficient to permit administration of said permeation enhancer at permeation enhancing fluxes through said first delivery period and (ii) insufficient to permit administration of said permeation enhancer at permeation enhancing fluxes during the remainder of said administration period; and(c) means for maintaining said device on the skin in drug and permeation enhancer transferring relationship thereto;
whereby a pulsitile drug administration pattern, having a first flux substantially higher than the flux of drug through untreated skin during said first period and a second, substantially lower flux during said second delivery period, will be obtained. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 19, 20, 21)
- said device comprising;
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15. A medical device for the pulsatile administration of nitroglycerine through intact skin at a first steady state flux during a first delivery period, and a second steady state flux during a second delivery period, said first flux being higher than said second flux, said first and second delivery periods comprising a substantial portion of a predetermined administration period, said device comprising:
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(a) a nitroglycerin reservoir; (b) an ethanol reservoir; and (c) means for controlling the release rate of said ethanol; said device being characterized by having a Jdevice for nitroglycerin of at least about 28 μ
g/cm2 /hr, a Jdevice for ethanol in the range of 300-750 μ
g/cm2 /hr, said ethanol reservoir containing that amount of ethanol required to allow the activity of the ethanol in the reservoir to drop below about 0.2 at the end of said first delivery period and said nitroglycerin reservoir containing sufficient nitroglycerin to supply nitroglycerin at said first and second steady state fluxes at least until the expiration of said predetermined administration period. - View Dependent Claims (16, 17, 18, 22, 23, 24)
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25. A method for pulsatile transdermal drug delivery from a medical device applied to the skin during an administration period which comprises:
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(a) coadministering a drug and a permeation enhancer for the drug from said medical device during a first delivery period; and (b) thereafter administering said drug and no more than an enhancement ineffective amount of said permeation enhancer from said device for a second delivery period, said first and second period each being at least about 2 hours, said first and second periods comprising a substantial portion of said administration period. - View Dependent Claims (26, 27, 28, 29)
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- 30. A method for pulsatile transdermal delivery of a drug in which comprise maintaining a source of drug in drug transmitting relationship to the skin and delivering said drug through skin from said source at a first rate substantially higher than the maximum rate at which said drug permeates through untreated intact skin and thereafter administering said drug at a second rate no greater than the rate at which said drug permeates through untreated skin.
Specification