BANDAGE FOR CONTROLLED RELEASE OF VASODILATORS

• US 3,742,951 A
• Filed: 08/09/1971
• Issued: 07/03/1973
• Est. Priority Date: 08/09/1971
• Status: Expired due to Term

• Current Assignee: Alejandro Zaffaroni
• Original Assignee: Alejandro Zaffaroni
• Inventors: Zaffaroni, Alejandro
• Primary Examiner(s): Gaudet, Richard A.
• Assistant Examiner(s): McGowan, J. C.
• Application Number:
  US05/169,977
• Time in Patent Office: 694 Days
• Field of Search: 128/155,156,260,268,296 424/18-22
• US Class Current: 424/434
• CPC Class Codes: A61K 9/7061 Polyacrylates
• 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
• CPC Class Codes: A61K 9/7092 Transdermal patches having multiple drug layers or reservoirs, e.g. for obtaining a specific release pattern, or for combining different drugs

Abstract

Medical bandage for use in the continuous administration to circulation of controlled quantities of systemically active coronary vasodilators over a prolonged period of time by absorption through the external body skin or mucosa is comprised of a backing member, a pressure-sensitive adhesive coating, and a reservoir containing the drug confined within a wall member. The wall member is formed from drug release rate controlling material to continuously meter the flow of a therapeutically effective amount of the drug from the reservoir to the skin at a controlled and predetermined rate over a period of time.

Claims

1. A medical bandage for the continuous administration to the skin or mucosa of controlled quantities of systemically active vasodilator drugs over a prolonged period of time by absorption through the external body skin or mucosa, said bandage comprising a laminate of (1) a backing member defining one face surface of the bandage;

(2) a pressure-sensitive adhesive adapted for contact with the skin or mucosa, the external surface of said pressure-sensitive adhesive defining the other face surface of the bandage and, disposed between the face surfaces defined by (1) and (2);

(3) at least one reservoir comprised of a systemically active vasodilator drug formulation confined within a wall member, said wall member being formed from drug release rate controlling material to continuously meter the flow of drug from the said reservoir to the skin or mucosa at a controlled and predetermined rate over a prolonged period of time.

2. The bandage as defined by claim 1, wherein said reservoir comprises a discrete, middle reservoir layer sandwiched between said backing member (1) and said pressure-sensitive adhesive (2).

3. The bandage as defined by claim 2, wherein the reservoir layer is comprised of a walled container having an interior chamber containing the systemically active vasodilator drug formulation.

4. The bandage as defined by claim 3, wherein only that portion of the walled container which is adapted to be brought contiguous with the skin or mucosa is formed from the drug release rate controlling material.

5. The bandage as defined by claim 2, wherein the reservoir layer is comprised of a matrix of the drug release rate controlling wall material, said matrix having the systemically active vasodilator drug formulation distributed therethrough.

6. The bandage as defined by claim 2, further comprising a solubility membrane (4) interposed between said reservoir layer and said pressure-sensitive adhesive (2).

7. The bandage as defined by claim 2, wherein one outer surface of the wall member comprising the reservoir layer also defines the said backing member (1).

8. The bandage as defined by claim 1, wherein said reservoir comprises a plurality of discrete microcapsules distributed throughout the said pressure sensitive adhesive.

9. The bandage as defined by claim 8, wherein each of said microcapsules is comprised of systemically active vasodilator drug formulation microencapsulated with the said drug release rate controlling wall material.

10. The bandage as defined by claim 8, wherein each of said microcapsules is comprised of a matrix of the drug release rate controlling wall material, said matrix having the systemically active vasodilator drug formulation distributed therethrough.

11. The bandage as defined by claim 1, wherein the pressure-sensitive adhesive is permeable to passage of the systemically active vasodilator drug formulation.

12. The bandage as defined by claim 1, wherein the vasodilator drug formulation comprises a pharmacologically acceptable solvent.

13. The bandage as defined by claim 1, wherein said drug release rate controlling material is silicone rubber.

14. The bandage as defined by claim 1, wherein said drug release rate controlling material is a hydrophilic polymer of an ester of an olefinic acid.

15. The bandage as defined by claim 1, wherein the pressure-sensitive adhesive is covered with a protective release coating.

16. The bandage as defined by claim 1, wherein the outer surface of the backing member is coated with a low adhesion backsize.

17. The bandage as defined by claim 1, wherein the vasodilator is nitroglycerin.

18. The bandage as defined by claim 1, wherein the organic nitrate vasodilator is present in an amount of from about 1 microgram to about 1 gram.

19. The method of effecting vasodilation in a mammalian organism, comprising direct application to the skin or mucosa of such organism, the bandage as defined by claim 1.