MULTILAYER POLYMERIC DRUG DELIVERY SYSTEM
The invention relates to a customizable, solvent-free sustained release medical device for wound closure, wound healing, and the sustained release of an active. The device of the invention is composed of at least a polymeric carrier layer and optionally an oxidized regenerated cellulose layer(s). Polymeric barrier layers can be added to modify the release profile (burst, time of release, etc.) of the selected bioactive agent(s).
1 . A solvent-free sustained release device comprising:
A carrier layer having an upper surface and a lower surface, the carrier layer comprising a biocompatible, biodegradable polymer and a bioactive agent; and
A first oxidized regenerated cellulose layer laminated to the upper surface of the carrier layer.
2 . The device of claim 1 further comprising a second oxidized regenerated cellulose layer laminated to the lower surface of the carrier layer.
3 . The device of claim 1 wherein the second oxidized regenerated cellulose layer is dry, partially neutralized to a pH of from about 5 to about 7.
4 . The device of claim 3 wherein the second oxidized regenerated cellulose layer further comprises a bioabsorbable alpha-cyanoacrylate adhesive composition.
5 . A solvent-free sustained release device comprising:
A carrier layer having an upper surface and a lower surface, the carrier layer comprising a biocompatible, biodegradable polymer and a bioactive agent;
A first barrier layer having an upper surface and a lower surface, the first barrier layer comprising a biocompatible, biodegradable polymer wherein the lower surface of the first barrier layer is laminated to the upper surface of the carrier layer;
A second barrier layer having an upper surface and a lower surface, the second barrier layer comprising a biocompatible, biodegradable polymer wherein the upper surface of the second barrier layer is laminated to the lower surface of the carrier layer; and
A first oxidized regenerated cellulose layer laminated to the upper surface of the first barrier layer.
6 . The device of claim 5 further comprising a second oxidized regenerated cellulose layer laminated to the lower surface of the second barrier layer.
7 . The device of claim 5 wherein the second oxidized regenerated cellulose layer is dry, partially neutralized to a pH of from about 5 to about 7.
8 . The device of claim 7 further wherein the second oxidized regenerated cellulose layer further comprises a bioabsorbable alpha-cyanoacrylate adhesive composition.
9 . A solvent-free sustained release device comprising:
A first barrier layer having an upper surface and a lower surface;
A first adhesive layer having an upper surface and a lower surface;
A middle barrier layer, having an upper surface and a lower surface, comprising a hole;
A carrier disk comprising a bioactive agent and disposed in the hole of the middle barrier layer;
A second adhesive layer having an upper surface and a lower surface;
A second barrier layer having an upper surface and a lower surface; and
wherein the lower surface of the first barrier layer is laminated to the upper surface of the first adhesive layer, the lower surface of the first adhesive layer is laminated to the upper surface of the middle barrier layer, the lower surface of the middle barrier layer is laminated to the upper surface of the second adhesive layer, and the lower surface of the second adhesive layer is laminated to the upper surface of the second barrier layer; and
wherein the first and second barrier layers, the first and second adhesive layers, the middle barrier layer, and the carrier disk comprise a biocompatible, biodegradable polymer.