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EP0282982A2 Expired / Lapsed EP ⏱️ 0.0 years remaining

Transdermal drug delivery system

Assignee: Drug Delivery Systems Inc
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Filing: 1988-03-16
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Granted: —
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Expires: 2008-03-16
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Abstract

Abstract An electro-osmotic transdermal drug delivery system for passing a drug to the systemic blood of a patient through the skin (16). The delivery system includes a semi-dry drug patch (24) containing a water solute with the drug and a selected level of current delivered to the semi-dry patch (24). Water from the semi-dry patch (24) is limited in movement from the patch to the skin (16) particularly in lateral movement relative to the skin so that the sweat and sebaceous ducts (30) and glands (32), which ordinarily are filled with liquid, namely the solute, and act as electrical shunts for osmotic delivery of the drug, are starved of liquid so that the electrical current is diverted to the stratum corneum (28) along with the electro-osmotic movement of the liquid carrying the drug (24). This result greatly increases the total drug delivery area of the skin. In addition, because the current need not be kept at a low level to avoid irritation or damage to the skin shunts, the current of the invention can be significantly elevated so as to overcome the higher resistivity of the stratum corneum (28) to the passage of liquid and current. A current conditioner such as an oscillator can be added to the system so as to break the liquid column within the skin shunts at periodic time intervals in accordance with the natural replenishment that will occur at relatively long time periods.

Inventors

  • 👤 Dan Sibalis

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-10-23 16:36
CPC Classifications
A; A61; A61N; A61N1/00; A61N1/02; A61N1/04; A61N1/0404; A61N1/0408; A61N1/0428; A61M; A61M35/00; A61M35/003

Claims Analysis

Total Claims: 20
Claim 1
Independent Claim 336 words
An electro-osmotic transdermal drug delivery system for passing at least one drug for delivery to the systemic blood of a patient through the skin (16) having a plurality of sweat and sebaceous shunt ducts (30) opening at the surface of the stratum corneum (28), comprising, in combination, drug storage means positioned in juxtaposition with the skin (16) of the patient, said drug storage means being for holding an electrolytic liquid (24) contain­ing the at least one drug, power means for generating first and second electrical currents, said first electrical current being rela­tively high as compared to electrical current in electro-osmotic drug delivery systems, said second electrical current being greater than said first electrical current, circuit means for connecting said power means with said drug storage means and with the skin (16), the electrolytic liquid (24) containing the at least one drug being moved along with said first electrical current by electro-osmotic motion into the skin (16), said drug storage means including liquid-movement-­inhibiting means for slowing the movement of the electrolytic liquid to said shunt ducts (30) thus inhibiting refilling of said shunt ducts (30) with the electrolytic liquid (24) so that said first electri­cal current and the electrolytic liquid (24) with the at least one drug bypasses the shunt ducts (30) and is directed into the skin (16) by way of the stratum corneum (28) said first electrical current being such that when combined with said liquid-move­ ment-inhibiting means the shunt ducts (30) are re­plenished with the electrolytic liquid (24) at perio­dic time intervals so that said second electrical current is drawn away from said stratum corneum (28) to said replenished shunt ducts (30) at which time said shunt ducts (30) are emptied of said electro­lytic liquid (24) as a result of the passage of said first electrical current, whereby the shunt ducts (30) are emptied of the electro­lytic liquid (24) by the combination of the effect of said liquid-movement-inhibiting means, said first electrical current, and said electrical current, at said relatively long periodic time intervals.
Claim 2
Dependent Claim 336 words
An electro-osmotic transdermal drug delivery system for passing at least one drug for delivery to the systemic blood of a patient through the skin (16) having a plurality of sweat and sebaceous shunt ducts (30) opening at the surface of the stratum corneum (28), comprising, in combination, drug storage means positioned in juxtaposition with the skin (16) of the patient, said drug storage means being for holding an electrolytic liquid (24) contain­ing the at least one drug, power means for generating first and second electrical currents, said first electrical current being rela­tively high as compared to electrical current in electro-osmotic drug delivery systems, said second electrical current being greater than said first electrical current, circuit means for connecting said power means with said drug storage means and with the skin (16), the electrolytic liquid (24) containing the at least one drug being moved along with said first electrical current by electro-osmotic motion into the skin (16), said drug storage means including liquid-movement-­inhibiting means for slowing the movement of the electrolytic liquid to said shunt ducts (30) thus inhibiting refilling of said shunt ducts (30) with the electrolytic liquid (24) so that said first electri­cal current and the electrolytic liquid (24) with the at least one drug bypasses the shunt ducts (30) and is directed into the skin (16) by way of the stratum corneum (28) said first electrical current being such that when combined with said liquid-move­ ment-inhibiting means the shunt ducts (30) are re­plenished with the electrolytic liquid (24) at perio­dic time intervals so that said second electrical current is drawn away from said stratum corneum (28) to said replenished shunt ducts (30) at which time said shunt ducts (30) are emptied of said electro­lytic liquid (24) as a result of the passage of said first electrical current, whereby the shunt ducts (30) are emptied of the electro­lytic liquid (24) by the combination of the effect of said liquid-movement-inhibiting means, said first electrical current, and said electrical current, at said relatively long periodic time intervals.
Claim 3
Dependent Claim 68 words
The system according to claim 1, wherein said drug storage means includes a wet reservoir containing said electrolytic liquid and the at least one drug and a semi-permeable membrane (64) enclosing said wet reservoir, and said liquid-movement-inhibiting means includes said semi-permeable membrane (64) inhibiting the passage of said liquid from said wet reservoir to said skin (16) so that the shunt ducts (30) remain generally devoid of liquid.
Claim 4
Dependent Claim 62 words
The system according to claim 1 or 2, wherein said drug storage means includes a hydrogel (48) holding said liquid (34) and the drug, said hydrogel (48) being of a semi-dry consistency that inhibits the movement of water within said gel (48), particular­ly in a direction lateral to the skin (16), so that the shunt ducts (30) remain generally devoid of li­quid.
Claim 5
Independent Claim 70 words
The system according to one of the claims 1 to 3, wherein said drug storage means includes an under­surface in general contact with the skin (16) of the patient, and said drug storage means includes a layer (67) made of a hydrophobic material applied to said undersurface, said layer limiting the move­ment of water from said drug storage means, so that the shunt ducts (30) are generally devoid of liquid.
Claim 6
Dependent Claim 15 words
The system according to claim 4, wherein said hydro­phobic layer (67) is made of silicon.
Claim 7
Dependent Claim 16 words
The system according to claim 4, wherein said hydro­phobic layer (67) is made of a fluorocarbon.
Claim 8
Dependent Claim 16 words
The system according to claim 4, wherein said hydro­phobic layer (67) is made of an oil.
Claim 9
Independent Claim 64 words
The system according to one of the preceding claims, wherein said first current is a selected current such that when combined with said liquid-movement-­inhibiting means the shunt ducts (30) replenish with said liquid at periodic time intervals, said shunt ducts (30) being thereupon emptied of said liquid by the combination of the effect of said liquid-­movement-inhibiting means and said selected current at periodic intervals.
Claim 10
Independent Claim 76 words
The system according to one of the preceding claims, further including current conditioner means positioned in series with said circuit means for producing said second electrical current at said periodic time inter­vals, said periodic time intervals being relatively long periodic time intervals as compared to periodic time intervals generally used in the art of current conditioners, said increased level of current accelerat­ing the emptying said shunt ducts (30) of said liquid at said periodic time intervals.
Claim 11
Dependent Claim 20 words
The system according to claim 9, wherein said current pulsation means is an oscillator in series with said circuit means.
Claim 12
Independent Claim 30 words
The system according to one of the preceding claims, wherein said relatively long periodic time intervals are in the range of a number of minutes to a number of hours.
Claim 13
Independent Claim 20 words
The system according to one of the claims 9 to 11, wherein said current conditioning means is a current conditioner.
Claim 14
Independent Claim 20 words
The system according to one of the claims 9 to 12, wherein said current conditioning means is an oscill­ator (68).
Claim 15
Independent Claim 61 words
The system according to one of the claims 2 to 13, wherein said semi-permeable membrane (64) has an undersurface facing the stratum corneum (28), sand said liquid-movement-inhibiting means further includes a water repellent layer (67) applied to said under­surface, said water repellent layer (67) inhibiting any movement of the electrolytic liquid from said semi-permeable membrane (64) to the shunt ducts (30).
Claim 16
Dependent Claim 18 words
The system according to claim 14, wherein said water repellent layer (67) is made of a hydrophobic mate­rial.
Claim 17
Dependent Claim 12 words
The system according to claim 15, wherein said hydro­phobic material is silicon.
Claim 18
Dependent Claim 13 words
The system according to claim 15, wherein said hydro­phobic material is a fluorocarbon.
Claim 19
Dependent Claim 13 words
The system according to claim 15, wherein said hydro­phobic material is a paraffin.
Claim 20
Independent Claim 65 words
The system according to one of the preceding claims, wherein said liquid-movement-inhibiting means includes said drug storage means being made of a uniform aniso­tropic hydrogel (48) of a semi-dry consistency which limits the amount of the electrolytic liquid which said hydrogel can pass through the shunt ducts (30) so that the shunt ducts (30) do not pass said first electrical current from said drug reservoir.

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