Claims for Patent: 4,460,368

Summary for Patent: 4,460,368

Title:	Trans-dermal medication system
Abstract:	A medication application system comprising a container for medication adhesively secured to the unbroken skin of a patient. The container is cup-shaped and closed on its open side by a micro-porous diaphragm or membrane through which the medication passes from the container to the skin surface where it is absorbed. Particular means are described for adhering the container to the skin and for sealing the container prior to its use. Various pharmaceutically effective medications in differing concentrations found to be effectively dispensed from the container, are described.
Inventor(s):	Allison; Kenneth C. (Crystal Lake, IL), Allison; Roger D. (Bensenville, IL), Allison; Charlotte C. (Crystal Lake, IL)
Assignee:	Almedco, Inc. (Crystal Lake, IL)
Application Number:	06/459,499
Patent Claims:	1. A medication application system for the sustained administration of acetyl salicylic acid transdermally through an area of unbroken skin, comprising a medication container including medication impermeable housing means forming a generally concave shaped cavity open on one side and having flange means extending radially outward from the periphery of said cavity opening and integral with said housing means, said flange means having an annular depression therein on the side of said flange means nearest said concave cavity opening, medication permeable micro-porous membrane means secured in said annular depression of said flange means of said housing means and covering the open side thereof to thereby form a medication holding container permeable on one side only to the passage of medication, means secured to said housing for adhering said medication holding container to the skin of a patient, and acetyl salicylic acid in an aqueous saline solution providing a positive driving force in said medication holding container, said acetyl salicylic acid being in a concentration to provide a sustained analgesic and anti-inflammatory action. 2. A medication application system for the sustained administration of acetyl salicylic acid transdermally through an area of unbroken skin, comprising a medication container including medication impermeable housing means forming a generally concave shaped cavity open on one side, said housing means further comprising filling aperture means centrally located in said concave cavity and flange means extending radially outward from the periphery of said cavity opening and integral with said housing means, said flange means having an annular depression therein, medication permeable micro-porous membrane means secured in said annular depression and covering the open side of said cavity to thereby form a medication holding container permeable on one side only to the passage of medication, means secured to said housing means for adhering said medication holding container to the skin of a patient, and acetyl salicylic acid in an aqueous saline solution in said medication holding container in a concentration to provide a sustained analgesic and anti-inflammatory action. 3. A medication application system in accord with claim 2 further comprising retaining plug means inserted in said filling aperture means to sealingly close said filling aperture. 4. A medication application system in accord with claim 3 wherein said retaining plug means comprises a molded-in-place soft rubber plug. 5. A medication application system in accord with claim 2 wherein said housing means further comprises one or more reinforcing rib means integrally formed withing said housing means and depending therefrom into said cavity for supporting said micro-porous membrane means. 6. A medication application system in accord with claim 2 wherein said skin adhering means further comprises adhesive means for adhesively securing said skin adhering means to both the opposite surface of said flange means from the side with said annular depression and to the skin of a patient. 7. A medication application system in accord with claim 6 further comprising retaining ring means mechanically secured to said housing means to thereby compress and secure said skin adhering means to said flange means, said retaining ring means further comprising coding indicia applied thereto. 8. A medication application system in accord with claim 7 further comprising release sheet means secured to said skin adhering means radially outward from said flange means, said release sheet means having a central aperture therein equal to or larger in diameter than the flange diameter of said housing means and located concentric therewith. 9. A medication application system in accord with claim 8 further comprising vapor barrier means sealingly adhered to said release sheet means and extending over said central aperture of said release sheet means to thereby block exterior access to said micro-porous membrane means. 10. A medication application system in accord with claim 8 wherein said acetyl salicylic acid solution comprises a positive driving force acqueous saline solution with aspirin in a concentration of between 0.15% and 2%. 11. A medication application system for the sustained administration of analgesic and anti-inflammatory agents, transdermally through an area of unbroken skin comprising, A medication container comprising medication impermeable housing means forming a generally concave shaped cavity open on one side, flange means extending radially outward from the periphery of said cavity opening including an annular depression therein, filling aperture means centrally located in said concave cavity and reinforcing rib means integrally formed within said housing and depending therefrom into said concave cavity, medication permeable micro-porous membrane means secured to said annular depression and covering the open side of said cavity, retaining plug means sealingly inserted in said filling aperture means, skin adhering means having a central aperture whose diameter is substantially equal to that of said cavity opening and concentric therewith, said skin adhering means being secured to said housing's flange means on the side opposite said membrane means and comprising a plurality of holes perforated in said skin adhering means in the area thereof extending radially outward from said housing flange area, release sheet means having a central aperture equal to or larger in diameter than the inside flange diameter of said housing means and located concentric therewith, said release sheet means being adhesively secured to said skin adhering means, retaining ring means mechanically secured to said housing means to thereby compress and secure said skin adhering means to said housing flange means, vapor barrier means sealingly adhered to said release sheet means and extending over said central aperture thereof to thereby block exterior access to said microporous membrane means, and an aqueous solution of said analgesic and anti-inflammatory agents in said medication holding container in a concentration sufficient to provide a sustained analgesic/anti-inflammatory action. 12. A medication application system in accord with claim 11 wherein said analgesic/anti-inflammatory agent solution comprises a 31/2% aqueous saline solution with aspirin in a concentration of between 0.15% and 2%. 13. A medication application system in accord with claim 11 wherein said analgesic/anti-inflammatory agent solution comprises a 31/2% aqueous saline solution with aspirin in a concentration of substantially 136.3 mg per 100 ml. 14. A medication application system in accord with claim 11 wherein said analgesic/anti-inflammatory agent solution comprises an aqueous saline solution of between 0.02% and 31/2% with acetaminophen in a concentration of between 0.05% and 20%. 15. A medication application system in accord with claim 11 wherein said analgesic/anti-inflammatory agent solution comprises an aqueous saline solution of between 0.02% and 20% with aspirin in a concentration of between 0.5% and 10% and acetaminophen in a concentration of between 0.05% and 10%. 16. A medication application system in accord with claim 11 wherein said analgesic/anti-inflammatory agent comprises an aqueous saline solution in a concentration of between 0.02% and 20% with Sulindac in a concentration between 0.01% and 0.20%. 17. In a medication application system for the sustained administration of a pharmacological preparation through an area of unbroken skin from a medciation contained in contact with the skin, the improvement in said container comprising medication impermeable housing means forming a generally concave cavity open on one side and having flange means extending radially outward from the periphery of said cavity opening and integral with said housing means, said flange means having an annular depression therein on the side of said flange means nearest said concave cavity opening, medication permeable micro-porous membrane means secured in said annular depression of said flange means and covering the open side of said cavity to thereby form a medication holding container permeable on one side only to the passage of medication, and means secured to said housing means for adhering said medication holding container to the skin of a patient. 18. The medication application system of claim 17 further comprising a pharmaceutically effective amount of medication in said container. 19. The medication application system of claim 18 wherein said medication comprises a 3% aqueous sodium chloride solution with 1.6% glycerin containing 40 units of insulin per ml. 20. The medication application system of claim 18 wherein said medication comprises a 31/2% aqueous sodium chloride solution with nitroglycerin between 12.5 mg and 37.5 mg per ml. 21. The medication application system of claim 18 wherein said medication comprises 0.5 mg of digitalis in 2 cc of a solution of 40% propylene glycol, 10% alcohol and water. 22. The medication application system of claim 18 wherein said medication comprises a sterile water solution containing 50 mg per ml quinidine gluconate. 23. The medication application system of claim 18 wherein said medication comprises a 31/2% aqueous sodium chloride solution containing 4 mg per ml of Hydrocortisone. 24. In a medication application system for the sustained administration of a pharmacological preparation through an area of unbroken skin from a medication container in contact with the skin, the improvement in said container comprising medication impermeable housing means forming a generally concave cavity open on one side, said housing means further comprises filling aperture means centrally located in said concave cavity and flange means extending radially outward from the periphery of said cavity opening and integral with said housing means, said flange means having an annular depression therein, medication permeable micro-porous membrane means secured in said annular depression and extending over said concave cavity to thereby form a medication holding container permeable on one side only to the passage of medication, and skin adhering means secured to said flange of said housing means on the side opposite said annular depression. 25. The medication application system of claim 24 further comprising retaining plug means inserted in said filling aperture means to sealingly close said filling aperture. 26. The medication application system of claim 24 wherein said housing means further comprises one or more reinforcing rib means integrally formed within said housing means and depending therefrom into said cavity for supporting said micro-porous membrane means. 27. The medication application system of claim 24 wherein said skin adhering means further comprises adhesive means for adhesively securing said skin adhering means to both the opposite surface of said flange means from the side with said annular depression and to the skin of a patient. 28. The medication application system of claim 27 further comprising retaining ring means mechanically secured to said housing means to thereby compress and secure said skin adhering means to said flange means, said retaining ring means further comprising coding indicia applied thereto. 29. The medication application system of claim 28 comprising release sheet means secured to said skin adhering means radially outward from said flange means, said release sheet means having a central aperture therein equal to or larger in diameter than the flange diameter of said housing means and located concentric therewith. 30. The medication application system of claim 29 further comprising vapor barrier means sealingly adhered to said release sheet means and extending over said central aperture of said release sheet means to thereby block exterior access to said micro-porous membrane means. 31. In a medication application system for the sustained administration of a pharmaceutically effective amount of a medication through an area of unbroken skin from a medication container in contact with the skin, the improvement in said container comprising medication impermeable housing means forming a generally concave shaped cavity open on one side, flange means extending radially outward from the periphery of said cavity opening including an annular depression therein, filling aperture means centrally located in said concave cavity and reinforcing rib means integrally formed within said housing and depending therefrom into said concave cavity, medication permeable micro-porous membrane means secured to said annular depression and covering the open side of said cavity, retaining plug means sealingly inserted in said filling aperture means, skin adhering means having a central aperture whose diameter is substantially equal to that of said cavity opening and concentric therewith, said skin adhering means being secured to said housing's flange means on the side opposite said membrane means and comprising a plurality of holes perforated in said skin adhering means in the area thereof extending radially outward from said housing flange area, release sheet means having a central aperture equal to or larger in diameter than the inside flange diameter of said housing means and located concentric therewith, said release sheet means being adhesively secured to said skin adhering means, retaining ring means mechanically secured to said housing means to thereby compress and secure said skin adhering means to said housing flange means, and vapor barrier means sealingly adhered to said release sheet means and extending over said central aperture thereof to thereby block exterior access to said micro-porous membrane means.

Details for Patent 4,460,368

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2001-10-29