Novel bandage for administering beneficial drug

• US 4,725,272 A
• Filed: 06/29/1981
• Issued: 02/16/1988
• Est. Priority Date: 06/29/1981
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Gale, Robert M.
• Primary Examiner(s): Richman, Barry S.
• Assistant Examiner(s): Wallen, T. J.
• Application Number:
  US06/278,364
• Time in Patent Office: 2,423 Days
• Field of Search: 128/260, 604/336, 604/337, 604/890, 604/891, 604/892, 424/19-22
• US Class Current: 424/448
• CPC Class Codes: A61K 9/7084 Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches

Abstract

A medical bandage is disclosed comprising a reservoir containing a gelled fluid, rheological agent and a drug. A method of using the bandage for producing a beneficial effect is disclosed also.

Claims

1. A method for treating angina pectoris in a human, which method comprises:

(a) placing on the skin of a human afflicted with angina pectoris a medical bandage comprising;

(1) a backing member that is substantially impermeable to the passage of a drug, one face of which forms the top of the bandage;

(2) a reservoir adjacent to the opposite face of the backing member, the reservoir comprising gelled silicone fluid, silicon dioxide, and a vasodilator having a group selected from the group consisting of ONO and ONO₂ useful for treating angina pectoris;

(3) a rate controlling membrane adjacent and below the reservoir, which membrane is permeable to the passage of the vasodilator, controls its rate of release from the bandage and is in contact with the backing member to form a substantially fluid-tight medical bandage; and

,

(4) a contact adhesive for holding the medical bandage on the skin; and

,

(b) administering the vasodilator to the skin in a therapeutically effective amount for treating said angina pectoris.

2. The method for treating angina pectoris according to claim 1, wherein the contact adhesive is adjacent and below the rate controlling membrane for holding the bandage on the skin.

3. The method for treating angina pectoris according to claim 1, wherein the vasodilator is administered in a therapeutically effective primary dose for treating said angina pectoris.

4. The method for treating angina pectoris according to claim 1 wherein the backing member is a laminate comprising a lamina of polyethylene in laminar arrangement with a lamina of aluminized polyethylene-terephthalate and a lamina of ethylene-vinyl acetate copolymer, which copolymer is adjacent to said reservoir.

5. The method for treating angina pectoris according to claim 1, wherein the backing member is a laminate comprising a lamina of aluminizied polyethylene-terephthalate, a lamina of an ionomer, and a lamina of ethylene-vinyl acetate copolymer, which copolymer is adjacent to the reservoir.

6. The method for treating angina pectoris according to claim 1 wherein the rate controlling membrane is ethylene-vinyl acetate copolymer.

7. The method for treating angina pectoris according to claim 1, wherein the vasolidator in the reservoir is nitroglycerin.

8. The method for treating angina pectoris according to claim 1, wherein during a 24 hour period more than one bandage is placed on the skin.

9. The method for treating angina pectoris according to claim 1 wherein more than one bandage is on the skin at the same time.

10. The method for treating angina pectoris according to claim 1, wherein the contact adhesive is replaced by a lamina comprising an adhesive and a protective liner is adjacent to the rate controlling membrane and the liner is pulled from the bandage before said bandage is placed on the skin.

11. The method for treating angina pectoris according to claim 1, wherein the contact adhesive is replaced by mechanical means for holding the bandage on the skin, and the rate controlling membrane is in contact with the skin.

12. The method for treating angina pectoris according to claim 1, wherein rate controlling membrane is copolymer of tetramethylene terephthalate-polytetramethylene ether glycol terephthalate.

13. The method for treating angina pectoris according to claim 1, wherein the backing member is a laminate comprising a lamina of polyethylene in laminar arrangement with a lamina of aluminized polyethylene-terephthalate and a lamina of ethylene-vinyl acetate copolymer, the reservoir comprises gelled silicone fluid, silicon dioxide, and the rate controlling membrane is ethylene-vinyl acetate copolymer.

14. The method for treating angina pectoris according to claim 1, wherein the backing member is a laminate comprising a lamina of aluminized polyethylene-terephthalate, a lamina of ionomer, and a lamina of ethylene-vinyl acetate copolymer, the reservoir comprises gelled silicone fluid, silicon dioxide, and a dosage amount of the vasodilator nitroglycerin, and the rate controlling membrane is ethylene-vinyl acetate copolymer.

15. A therapeutic system in the form of a bandage for administering a drug, the system comprising:

(a) a backing member that is substantially impermeable to the passage of drug, one surface of which defines the top of the system;

(b) a reservoir adjacent to the opposite surface of the backing member, the reservoir comprising gelled silicone fluid, silicone dioxide, and a dosage unit amount of a vasodilator drug formulation comprising a member selected from the group consisting of ONO and ONO₂ ;

(c) a membrane adjacent to and below the reservoir, the membrane comprising a composition that controls the rate of release of the drug from the system, and is in contact with the backing member to form a substantially fluid-tight system; and

,

(d) a contact adhesive means for holding the bandage on a recipient.

16. The therapeutic system in the form of a bandage according to claim 15, wherein the system is adapted for administering the drug to an animal, and the adhesive is replaced by mechanical means for holding the system on the animal.

17. The therapeutic system in the form of a bandage according to claim 15, wherein the system is adapted for administering the drug to an animal, the adhesive is in contact with the rate controlling membrane and a lamina is adjacent and below the adhesive, which lamina is substantially impermeable to the passage of a drug present in the system and is adapted to be stripped therefrom before the system is affixed to the animal.

18. The therapeutic system in the form of a bandage according to claim 15 wherein the backing member comprises a lamina of polyethylene laminated to a lamina of aluminized polyethylene-terephthalate which is laminated to a lamina of ethylene-vinyl acetate copolymer.

19. The therapeutic system in the form of a bandage according to claim 15 wherein the backing member comprises a lamina of aluminized polyethylene-terephthalate laminated to an ionomer which is laminated to a lamina of ethylene-vinyl acetate copolymer.

20. The therapeutic system in the form of a bandage according to claim 15 wherein the rate controlling membrane is ethylene-vinyl acetate copolymer.

21. The therapeutic system in the form of a bandage according to claim 15 wherein the drug formulation in the reservoir is nitroglycerin absorbed on lactose.

22. The therapeutic system in the form of a bandage according to claim 15, wherein the rate controlling membrane is ethylene-vinyl acetate copolymer having a vinyl acetate content of 9 wt%, the vasodilator is nitroglycerin, and it is administered in the therapeutically effective amount of about 10 μ

g/hr to 1200 μ

g/hr.

23. The therapeutic system in the form of a bandage according to claim 15 wherein the reservoir contains from 5 mg to 1000 mg of the vasodilator nitroglycerin, the rate controlling membrane is ethylene-vinyl acetate copolymer.

24. The therapeutic system in the form of a bandage according to claim 15 wherein the backing member comprises a lamina of polyethylene in laminar arrangement with a lamina of aluminized polyethylene-terephthalate and a lamina of ethylene-vinyl acetate copolymer;

the reservoir comprises gelled silicone fluid, silicon dioxide, and a dosage amount of the vasodilator nitroglycerin;

the membrane that controls the rate of release is ethylene-vinyl acetate copolymer; and

the system comprises an adhesive in contact with the membrane and a lamina of kraft paper, in contact with the adhesive.

25. The therapeutic system in the form of a bandage according to claim 15 wherein the backing member comprises a lamina of aluminized polyethylene-terephthalate, a lamina of ionomer, and a lamina of ethylene-vinyl acetate copolymer;

the reservoir comprises gelled silicone fluid, silicon dioxide, and a dosage amount of the vasodilator nitroglycerin;

the membrane that controls the rate of release is ethylene-vinyl acetate copolymer; and

the system comprises an adhesive in contact with the membrane and a lamina of polyvinyl chloride in contact with the adhesive.

26. The therapeutic system in the form of a bandage for administering the drug according to claim 15, wherein the drug is isosorbide dinitrate.

27. The therapeutic system in the form of a bandage for administering the drug according to claim 15, wherein the therapeutic system releases an initial pulse of drug.

28. The therapeutic system in the form of a bandage for administering the drug according to claim 15, wherein the therapeutic system releases an initial priming dose of drug and thereafter the system delivers drug at a substantially constant rate.

29. The therapeutic system in the form of a bandage for administering the drug according to claim 15, wherein the system comprises an adhesive in contact with the rate controlling membrane, and the adhesive contains a drug that is released as a priming dose.