Composition and method for transdermal lidocaine delivery
Adhesive formulations are provides for manufacturing matrix-type lidocaine patches having improved performance, manufacturability and stability.
1. A packaged matrix-type transdermal drug delivery system inside a sealed package, wherein:
a) said transdermal drug delivery system comprises (1) an adhesive matrix layer comprising a lidocaine base in a polyisobutylene adhesive matrix, wherein the adhesive matrix layer comprises from about 3.0 to about 5.0 weight parts lidocaine base, from about 84.0 to about 94.0 weight parts polyisobutylene, and from about 3.0 to about 7.0 weight parts cross-linked homopolymer of N-vinyl-2-pyrrolidone, and (2) a non-woven fabric backing layer; and
b) said sealed package comprises opposing layers of an acrylonitrile-methyl acrylate copolymer and foil liner.
2. The packaged transdermal drug delivery system of claim 1 , wherein the adhesive matrix further comprises from about 18.0 to about 24.0 weight parts mineral oil.
3. The packaged transdermal drug delivery system of claim 1 , wherein the adhesive matrix layer further comprises a sensate.
4. The packaged transdermal drug delivery system of claim 3 , wherein the sensate comprises methanediol, methoxypropanediol, isopulegol, vanillyl butyl ether, or a combination thereof.
5. The packaged transdermal drug delivery system of claim 4 , wherein the sensate comprises methoxypropanediol and vanillyl butyl ether.
6. The packaged transdermal drug delivery system of claim 5 , wherein the adhesive matrix layer comprises from about 0.5 to about 1.5 weight parts methoxypropanediol.
7. The packaged transdermal drug delivery system of claim 5 , wherein the adhesive matrix layer comprises from about 0.05 to about 0.15 weight parts vanillyl butyl ether.
8. The packaged transdermal drug delivery system of claim 1 , wherein the transdermal drug delivery system further comprises a release liner.
9. The packaged transdermal drug delivery system of claim 1 , wherein the non-woven fabric backing layer comprises polyethylene, polyester, polypropylene, polyurethane, polyvinyl alcohol, polyvinyl chloride, polyvinylidene, polyamide, vinyl acetate, an ethylene/vinyl acetate copolymer, an ethylene/ethylacrylate copolymer, a metal-vapor deposited film or sheet, a rubber film or sheet, a foil, paper, or a combination thereof.
10. The packaged transdermal drug delivery system of claim 9 , wherein the non-woven fabric backing layer comprises polyester.
11. The packaged transdermal drug delivery system of claim 8 , wherein the release liner comprises a fluoropolymer and silicone coated film.