초록 ▼

A transdermal medicament patch includes a biocompatible substrate having a therapeutic face on one side configured for disposition against the skin of a patient, a biocompatible adhesive on the therapeutic face, a planar medicament matrix covering a portion of the therapeutic face, and a release lin

A transdermal medicament patch includes a biocompatible substrate having a therapeutic face on one side configured for disposition against the skin of a patient, a biocompatible adhesive on the therapeutic face, a planar medicament matrix covering a portion of the therapeutic face, and a release liner covering the portion of therapeutic that is not obscured by the medicament matrix. An aperture formed through the release sheet affords direct access by medicament to the entire surface of the medicament matrix opposite from the therapeutic face of the substrate. An active electrode positioned between the medicament matrix and the therapeutic face of the substrate includes an electrically conductive backing layer positioned against the therapeutic face of the substrate and a pH-control layer covering less than all of the side of the backing layer opposite from the therapeutic face of the substrate. One active electrode design criterion relates the relative size of the pH-control layer to the size of the backing layer; another relates the size of portion of the area of the backing layer that is free of the pH-control lawyer to the size of the pH-control layer. The pH-control layer is made of an electrically conductive material capable of moderating changes in the hydrogen-ion concentration in the medicament matrix during iontophoretic current flow. An electrical contact electrically coupled through the substrate to the backing layer includes a hollow, electrically conductive snap fitting having an open end and a cooperating stud that is inserted into the open end of the snap.

대표청구항 ▼

1. An active electrode for a medicament patch of the type including a flexible, planar biocompatible substrate with a therapeutic face for disposition against the skin of a patient and a planar medicament matrix having on respective opposite sides thereof a skin contact surface and a securement surf

1. An active electrode for a medicament patch of the type including a flexible, planar biocompatible substrate with a therapeutic face for disposition against the skin of a patient and a planar medicament matrix having on respective opposite sides thereof a skin contact surface and a securement surface, the securement surface being retained against the therapeutic face of the substrate obscuring a concealed portion thereof with the balance of the therapeutic face defining an exposed portion thereof, the skin contact surface of the medicament matrix effecting electrically conductive engagement with the skin of the patient, when the exposed portion of the therapeutic face of the substrate is retained there against and the medicament matrix is permeated by a medicament, wherein said active electrode is capable of assembly in the medicament patch between the medicament matrix and the concealed portion of the therapeutic face of the substrate, and said active electrode comprises: (a) an electrically conductive backing layer having on respective opposite sides thereof a driving face and a securement surface, said securement surface becoming positioned against the concealed portion of the therapeutic face of the substrate, when said active electrode is assembled in the medicament patch; and(b) a pH-control layer on said driving face of said backing layer covering less than all of said driving face of said backing layer, said pH-control layer and the portion of said driving face free of said pH-control layer together electrically engaging the medicament matrix, said pH-control layer being made of an electrically conductive material capable of moderating changes in the hydrogen-ion concentration in the medicament matrix, when the therapeutic face of the substrate is disposed against the skin of the patient, and an electrical potential is imposed between said backing layer and the skin of the patient remote from the medicament matrix. 2. An active electrode as recited in claim 1, wherein said active electrode further comprises an electrical contact electrically coupled to the securement surface of said backing layer, and said electrical contact comprises: (a) a hollow, electrically conductive snap fitting having an open end; and(b) a cooperating, electrically insulative stud, in the assembled condition of said electrical contact said stud being inserted into said snap through said open end thereof. 3. An active electrode for a medicament patch of the type including a flexible, planar biocompatible substrate with a therapeutic face for disposition against the skin of a patient and an absorbent medicament matrix non-releasably retained against a portion of the therapeutic face of the substrate obscuring a concealed portion thereof with the balance of the therapeutic face defining an exposed portion thereof, the medicament matrix effecting electrically conductive engagement with the skin of a patient, when the exposed portion of the therapeutic face is retained there against and the medicament matrix is wetted with a medicament solution, wherein said active electrode is capable of assembly in the medicament patch between the medicament matrix and the concealed portion of the therapeutic face of the substrate, and said active electrode comprises: (a) an electrical contact;(b) a pH-control layer comprised of an electrically conductive material capable of moderating changes in the hydrogen-ion concentration in the medical matrix, when the patch is disposed against the skin of the patient and an electrical potential is imposed between said electrical contact and the skin of a patient at a location remote from the medicament matrix; and(c) an electrically conductive backing layer sandwiched between said electrical contact and said pH-control layer, the surface of said backing layer contacted by said pH-control layer defining a driving face of said backing layer, and said pH-control layer covering less than all of said driving face. 4. An active electrode as recited in claim 3, wherein said pH-control layer is comprised of a material capable of precluding electrolysis in the medical matrix, when an electrical potential is imposed between said backing layer and the skin of a patient with the medicament patch disposed there against. 5. An active electrode as recited in claim 3, wherein said pH-control layer is comprised of a material capable of neutralizing electrolysis products in the medical matrix, when an electrical potential is imposed between said backing layer and the skin of a patient with the medicament patch disposed there against. 6. An active electrode as recited in claim 3, wherein said electrical contact is electrically coupled to a securement surface of said backing layer located on the side thereof opposite from said driving face. 7. An active electrode as recited in claim 6, wherein said electrical contact comprises an assembly of: (a) a hollow, electrically conductive snap fitting having an open end; and(b) a cooperating stud, in the assembled condition of said electrical contact said stud being inserted into said snap through said open end thereof. 8. An active electrode as recited in claim 7, wherein said stud is electrically insulative. 9. An active electrode as recited in claim 8, wherein said stud comprises: (a) a shaft configured for press fit insertion through said open end of said snap fitting; and(b) a generally planar flange secured to one end of said shaft. 10. An active electrode as recited in claim 9, wherein, in said assembled condition of said electrical contact, said flange of said stud is positioned on the side of said pH-control layer opposite from said driving face of said backing layer, and said shaft of said stud passes through said pH-control layer and said backing layer to enter said open end of said snap fitting. 11. An active electrode for driving medicament into the skin of a patient from a solution of the medicament contained in a reservoir on the therapeutic face of the substrate of a transdermal medicament patch, the reservoir being disposed interior of the periphery of the therapeutic face of the substrate, and the reservoir electrically conductively engaging the skin of the patient when the therapeutic face of the substrate is disposed there against, said active electrode comprising: (a) a planar backing layer positioned between the reservoir and the substrate and comprised of an electrically conductive material, the surface of the side of said backing layer remote from the substrate defining a driving face of said backing layer; and(b) a pH-control layer on said driving face of said backing layer covering less than all of said driving face, said pH-control layer and the portion of said driving face free of said pH-control layer together electrically engaging the reservoir, said pH-control layer being comprised of an electrically conductive material capable of moderating changes in the hydrogen-ion concentration in the reservoir, when said patch is disposed against the skin of the patient, and an electrical potential is imposed between said backing layer and the skin of the patient at a location remote from the reservoir. 12. An active electrode as recited in claim 11, wherein said pH-control layer is comprised of a material capable of precluding electrolysis in the reservoir, when said patch is disposed against the skin of the patient, and an electrical potential is imposed between said backing layer and the skin of the patient at a location remote from the reservoir. 13. An active electrode as recited in claim 12, wherein said pH-control layer is comprised of a mixture of silver and silver-chloride. 14. An active electrode as recited in claim 11, wherein said pH-control layer is comprised of a material capable of neutralizing electrolysis products in the reservoir, when said patch is disposed against the skin of the patient, and an electrical potential is imposed between said backing layer and the skin of the patient at a location remote from said reservoir. 15. An active electrode as recited in claim 14, wherein said pH-control layer is comprised of potassium phosphate. 16. An active electrode as recited in claim 11, wherein the ratio of the area of said portion of said backing layer free of said pH-control layer to said pH-control layer is in a range from about 0.20 to about 8.00. 17. An active electrode as recited in claim 11, wherein the periphery of said pH-control layer is geometrically similar to the periphery of said backing layer. 18. An active electrode as recited in claim 11, wherein said pH-control layer comprises a plurality of discrete, unconnected pH-control layer components covering a corresponding plurality of discrete, unconnected portions of said driving face of said backing layer. 19. An active electrode as recited in claim 11, wherein said pH-control layer comprises a single, connected layer having an aperture formed therethrough, said driving face of said backing layer being free of said pH-control layer at said aperture. 20. An active electrode as recited in claim 19, wherein said pH-control layer has a plurality of apertures formed therethrough, said driving face of said backing layer being free of said pH-control layer at each of said plurality of said apertures. 21. An active electrode as recited in claim 20, wherein: (a) said pH-control layer comprises a field of intersecting grid lines; and(b) each of said plurality of apertures is bounded by plural of said grid lines. 22. An active electrode as recited in claim 11, wherein: (a) the periphery of said pH-control layer coincides with the periphery of said backing layer; and(b) said pH-control layer has an aperture formed therethrough, said driving face of said backing layer being free of said pH-control layer at said aperture. 23. An active electrode as recited in claim 11, wherein said pH-control layer is disposed interior of the periphery of said driving face of said backing layer. 24. An active electrode as recited in claim 23, wherein a portion of the periphery of said pH-control layer is tangential to the periphery of said driving face of said backing layer. 25. An active electrode as recited in claim 11, wherein a portion of said pH-control layer extends exterior of the periphery of said driving face of said backing layer. 26. An active electrode as recited in claim 11, further comprising an electrical contact electrically coupled to the surface of the side of said backing layer opposite from said driving face thereof. 27. An active electrode as recited in claim 26, wherein said electrical contact comprises an assembly of: (a) an electrically conductive snap fitting; and(b) a stud receivable interior of said snap fitting. 28. An active electrode as recited in claim 27, wherein said stud of said electrical contact is electrically insulative. 29. An active electrode for driving medicament from a reservoir carried on the substrate of a transdermal medicament patch, said active electrode being positionable during use between the reservoir and the substrate interior the periphery of the reservoir, said active electrode comprising: (a) an electrical contact;(b) a pH-control layer comprised of an electrically conductive material capable of moderating changes in the hydrogen-ion concentration in the reservoir, when said patch is disposed against the skin of the patient, and an electrical potential is imposed between said backing layer and the skin of the patient at a location remote from the reservoir; and(c) an electrically conductive backing layer sandwiched between said electrical contact and said pH-control layer, the surface of said backing layer contacted by said pH-control layer defining a driving face of said backing layer, and said pH-control layer covering less than all of said driving face. 30. An active electrode as recited in claim 29, wherein said electrical contact is electrically coupled to the surface of the side of said backing layer opposite from said driving face thereof, and said electrical contact comprises an assembly of: (a) an electrically conductive snap fitting; and(b) a stud receivable interior of said snap fitting. 31. An active electrode as recited in claim 29, wherein said stud of said electrical contact is electrically insulative. 32. An active electrode as recited in claim 29, wherein said pH-control layer is comprised of a material capable of precluding electrolysis in the reservoir, when an electrical potential is imposed between said backing layer and the skin of a patient with the medicament patch disposed there against. 33. An active electrode as recited in claim 29, wherein said pH-control layer is comprised of a material capable of neutralizing electrolysis products in the reservoir, when an electrical potential is imposed between said backing layer and the skin of a patient with the medicament patch disposed there against. 34. An active electrode as recited in claim 29, wherein the area of said pH-control layer is less than the area of said driving face of said backing layer. 35. An active electrode as recited in claim 29, wherein the area of said pH-control layer is equal to the area of said driving face of said backing layer. 36. An active electrode as recited in claim 29, wherein the ratio of the area of said driving face of said backing layer to the area of said pH-control layer is in a range from about 0.15 to about 1.00.