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US4940456A Expired / Lapsed US ⏱️ 0.0 years remaining

Electrolytic transdermal delivery of proteins

Assignee: Individual
•
Filing: 1988-12-01
•
Granted: 1990-07-10
•
Expires: 2008-12-01
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Abstract

Abstract A chemical composition for electrolytic transdermal transport of a protein to the blood stream of the patient comprises: (a) a protein, (b) a cosolvent with negative Setschenow constants, and (c) water. Some of the preferred proteins are: insulin, protamine sulfate, calcitonin, glucagon, and corticotropin. Some of the preferred dissociating agents with negative Setschenow constants are: urea, propylurea, potassium iodide, sodium perchlorate, and guanidine hydrochloride. The electrolytic device containing the composition to be transdermally delivered comprises: two electrode elements separated by barrier means, a reservoir containing the composition of the invention, an electronic/electrolytic circuit including a source of a power, a cover, and adhesive means holding the device to the patient's skin. A semipermeable membrane between the patient's skin and the electrolytic device is optional.

Inventors

  • 👤 Dan Sibalis
  • 👤 Sanford Rosen

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 19:14
CPC Classifications
A; A61; A61N; A61N1/00; A61N1/02; A61N1/04; A61N1/0404; A61N1/0408; A61N1/0428; A61N1/0448; A61K; A61K9/00; A61K9/0002; A61K9/0009; A61N1/0432; A61N1/044

Claims Analysis

Total Claims: 9
Claim 1
Independent Claim 124 words
A transdermal patch for delivering at least one protein drug to the bloodstream of the patient comprising: a. at least one protein drug comprising at least one nonionic protein having more than 20 peptide units, water, and a water-destructuring agent with a negative Setschenow constant, contained in a drug reservoir, and b. electrolytic means comprising a power source connected to at least one electrode in electrolytic contact with said reservoir for transdermal transport of the nonionic protein having a current density from about 0.5 microampere/cm 2 to about 10 milliampere/cm 2 , impressed voltage between 1 and 40 volts, and a migratory water volume between 0.00I/ml/cm 2 hr and 0.0I ml/cm 2 /hr, whereby the skin of the patient is neither irritated nor erythematized.
Claim 2
Dependent Claim 124 words
A transdermal patch for delivering at least one protein drug to the bloodstream of the patient comprising: a. at least one protein drug comprising at least one nonionic protein having more than 20 peptide units, water, and a water-destructuring agent with a negative Setschenow constant, contained in a drug reservoir, and b. electrolytic means comprising a power source connected to at least one electrode in electrolytic contact with said reservoir for transdermal transport of the nonionic protein having a current density from about 0.5 microampere/cm 2 to about 10 milliampere/cm 2 , impressed voltage between 1 and 40 volts, and a migratory water volume between 0.00I/ml/cm 2 hr and 0.0I ml/cm 2 /hr, whereby the skin of the patient is neither irritated nor erythematized.
Claim 3
Dependent Claim 18 words
A transdermal patch as in claim 1, wherein the at least one nonionic protein drug is an insulin.
Claim 4
Dependent Claim 38 words
A transdermal patch as in claim 1, wherein the current density is between 0.5 microampere/cm 2 , the voltage is between 3 and 10 volts, and the migrating water volume is between 0.002 and 0.005 ml/cm 2 /hr.
Claim 5
Dependent Claim 66 words
A transdermal patch as in claim 1, wherein the water destructuring agent is selected from the group consisting of urea, alkylderivatives of urea, gaunidine salt, butanol, 2-butanol, water-soluble amides with more than three carbon atoms, sodium chloride, sodium acetate, sodium bromide, calcium chloride, sodium proprionate, sodium butyrate, sodium thiocyanate, potassium iodide, sodium perchlorate, sodium iodide, any water-soluble salt with a negative Setschenow constant, and mixtures thereof.
Claim 6
Dependent Claim 38 words
A transdermal patch as in claim 1, wherein the nonionic protein or the uncharged protein at its isoelectric point is selected from the group consisting of glucagon, protamines, adrenal cortex proteinaceous hormones, calcitonin, albumins, globulins, insulins, and mixtures
Claim 7
Dependent Claim 29 words
A transdermal patch as in claim 1, wherein the nonionic protein or the uncharged protein at its isoelectric point is a polypeptide having more than about 20 peptide units.
Claim 8
Dependent Claim 23 words
A transdermal patch as in claim 1, wherein the reservoir has a liquid volume of from about 0.01 ml to about 15 ml.
Claim 9
Dependent Claim 28 words
A transdermal patch as in claim I, further comprising a semipermeable membrane on the side of the reservoir adapted to be placed on the skin of the patient.

References Cited (Backward Citations)

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USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1993-07-09 1994-01-08 1994-07-10 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1997-07-09 1998-01-08 1998-07-10 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2001-07-09 2002-01-08 2002-07-10 $7700.00 Window Closed / Lapsed

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