Drug dispensing device for transdermal delivery of medicaments

• US 4,675,009 A
• Filed: 03/31/1986
• Issued: 06/23/1987
• Est. Priority Date: 11/07/1977
• Status: Expired due to Term

• Current Assignee: LecTec Corporation
• Original Assignee: LecTec Corporation
• Inventors: Hymes, Alan C., Ong, Lincoln T., Persons, Garry R.
• Primary Examiner(s): NOT, DEFINED
• Application Number:
  US06/845,500
• Time in Patent Office: 449 Days
• Field of Search: 604/897, 604/304, 604/307, 128/156, 424/14, 424/22, 424/27, 424/28
• US Class Current: 604/304
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61K 9/7061 Polyacrylates
• CPC Class Codes: A61K 9/7069 obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide
• CPC Class Codes: A61L 15/225 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 15/58 Adhesives
• CPC Class Codes: A61L 15/585 Mixtures of macromolecular compounds
• CPC Class Codes: A61N 1/04 Electrodes electrosurgical electrodes A61B18/14

Abstract

A flexible, liquid-absorbing, adhesive skin reservoir includes a backing element and a substrate attached to the backing element. The substrate comprises a homogeneous, hydrophilic, stable matrix including a solid phase formed of a synthetic polymer and/or a long chain natural or synthetic polysaccharide, or a combination thereof. The liquid phase of the matrix consists of water, hydric alcohol, carbohydrates and/or proteins in an aqueous solution, and/or a combination thereof. The matrix contains a medicament therein for release to the affected areas for local and/or systemic medicinal effect.

Claims

1. A flexible, liquid-absorbent, nonbiodegradable adhesive reservoir to be applied to a patient comprising:

a flexible backing element selected from the group consisting of cotton, paper, synthetic fabric and plastic,

a substrate attached to said backing element comprising a homogeneous, hydrophilic, stable matrix being sufficiently pliant to conform to the shape of the body contours, said matrix including a solid face comprising about 1% to 50% of the total weight of the matrix and formed for a high-molecular natural and/or synthetic polysaccharide and/or a synthetic polymer selected from the group consisting of;

polyacrylic acid, polyacrylamide and their cogeners, vinyl acetate ethylene copolymer, vinyl acetate dioctyl maleate copolymer, synthetic and natural polysacchacrid gums, starch-g-poly, and a crosslinked ester of α

, β

, olefinically unsaturated carboxylic acid and a liquid phase hydrating the matrix and converting the matrix to a hydrocolloidal suspension, said liquid phase consisting of polyhydric alcohol solutions or dispersions selected from the group consisting of water solutions of carbohydrate, and/or protein, and/or polyhydric alcohol, and comprising from 50% to 98% by weight of the matrix, said matrix containing a medicament selected from the group consisting of cardiovascular drugs, vasodialators, anti-arrythmic drugs and anti-hypertensive drugs, and antibacterial agent, antiseptic agent, anti-inflammatory agent, anti-pruretic agent, hormonal agent, keratolytic agent, skin protective agent and a rubefacient agent, said reservoir when applied to a patient forming a hydrophilic bridge with the patient'"'"'s skin to allow the progressive release of the medicament across the hydrophilic bridge the hydrophilic hydrated matrix maintaining the medicament in a hydrated state allowing for free diffusion and dynamic tranfer thereof through the reservoir to the skin interface and the hydrated state of the matrix providing hydrophilic adhesive properties rendering the substrate tacky to enhance adhesion to the skin.

2. The reservoir as defined in claim 1 wherein said liquid phase comprises a water solution of a polysaccharide.

3. The reservoir as defined in claim 1 wherein said liquid phase comprises a polyhydric alcohol.

4. The reservoir as defined in claim 1 wherein said liquid phase comprises a water solution of a protein.

5. The reservoir as defined in claim 1 wherein the solid phase of said matrix includes a natural gum selected from the group consisting of gum karaya, gum acacia, and locust bean gum.

6. The reservoir as defined in claim 5 wherein said matrix is comprised of 5% to 45% by weight of gum karaya, 2% to 40% by weight of polyacrylamide, and 30% to 70% by weight of glycerol.

7. The reservoir as defined in claim 1 wherein said matrix is comprised of 10% to 50% by weight of polyacrylamide and 30% to 70% by weight of glycerol.

8. The reservoir as defined in claim 1 wherein said matrix is formed of 2% to 40% by weight of polyacrylamide, 2% to 40% by weight of polyacrylic acid, and 30% to 70% by weight of glycerol.

9. The reservoir as defined in claim 1 wherein said matrix is formed of 2% to 50% by weight of polyacrylic acid and 30% to 70% by weight of glycerol.

10. The reservoir as defined in claim 1 wherein said matrix is formed of 15% to 50% by weight of starch-g-poly, 30% to 70% by weight of glycerol, and 10% to 40% by weight of 10% nitroglycerine in propylene glycerol.

11. The reservoir as defined in claim 1 wherein said matrix is formed of 1% to 3% by weight of guar derivative, 0.03% to 1% by weight of potassium pyroantimonate crosslinkers, 80% to 95% by weight of water and 5% to 20% by weight of 50% isosorbide dinitrate in lactose.

12. The reservoir as defined in claim 1 wherein said matrix is formed of 0.8% to 7% by weight of guar derivative, 0.1% to 1% by weight of potassium pyroantimonate crosslinkers, 5% to 25% by weight of karaya, 25% to 45% by weight of glycerol, and 5% to 20% by weight of 50% isosorbide dinitrate.

13. The reservoir as defined in claim 1 wherein said matrix is formed of 0.25% to 5% by weight of locust bean gum, 0.25% to 5% by weight of xyanthan gum, 75% to 95% by weight of water, and 4.5% to 20% by weight of 50% isosorbide dinitrate in lactose.

14. The reservoir as defined in claim 1 wherein said matrix is formed of 10% to 90% by weight of ester of a,B,olefinically unsaturated carboxylic acid, 0.01% to 0.05% by weight of potassium pyroantimonate crosslinkers, 15% to 50% by weight of glycerol, and 15% to 50% by weight of 10% nitroglycerine in propolyene glycol.

15. The reservoir as defined in claim 3 wherein said medicament comprises 0.1% to 15% by weight of povidone-iodine.

16. The reservoir as defined in claim 3 wherein said medicament comprises 0.1% to 5% by weight of camphor.

17. The reservoir as defined in claim 5 wherein said medicament comprises 0.1% to 5% by weight of camphor.

18. The reservoir as defined in claim 3 wherein said medicament comprises 0.1% to 15% by weight of methyl salicylate.

19. The reservoir as defined in claim 1 wherein said matrix has adhesive properties whereby the surface which contacts the skin defines said adhesive surface.

20. The reservoir as defined in claim 1 wherein said backing element is a pressure sensitive adhesive element and defines said adhesive surface which contacts the patient'"'"'s skin.