Long term drug delivery devices with polyurethane based polymers and their manufacture
View Patent ↗This invention is related to the use of polyurethane based polymer as a drug delivery device to deliver biologically active compounds at a constant rate for an extended period of time and methods of manufactures thereof. The device is very biocompatible and biostable, and is useful as an implant in patients (humans and animals) for the delivery of appropriate bioactive substances to tissues or organs. The drug delivery device for releasing one or more drugs at controlled rates for an extended period of time to produce local or systemic pharmacological effects comprises: 1. a reservoir, said reservoir comprising; 2. at least one active ingredient; and, optionally, 3. at least one pharmaceutically acceptable carrier; a polyurethane based polymer completely surrounding the reservoir.
1. An implantable drug delivery device for releasing one or more active ingredients at a substantially zero order rate in vitro by diffusion through a polyurethane based polymer for an extended period of time, said implantable drug delivery device comprising a polyurethane-based polymer configured to provide a cylindrically shaped reservoir, wherein the reservoir is sealed after being charged with an effective amount of a solid formulation comprising one or more active ingredients and wherein the one or more active ingredients and the polyurethane-based polymer are selected such that either: (i) both the one or more active ingredients and the polyurethane-based polymer exhibit hydrophilic characteristics, or (ii) both the one or more active ingredients and the polyurethane-based polymer exhibit hydrophobic characteristics.
2. The implantable drug delivery device of claim 1 , wherein the polyurethane based polymer is selected from the group consisting of thermoplastic polyurethane and thermoset polyurethane.
3. The implantable drug delivery device of claim 2 , wherein the thermoplastic polyurethane comprises macrodiols, diisocyanates, difunctional chain extenders, or mixtures thereof.
4. The implantable drug delivery device of claim 2 , wherein the thermoset polyurethane comprises multifunctional polyols, diisocyanates, chain extenders or mixtures thereof.
5. The implantable drug delivery device of claim 4 , where the thermoset polyurethane comprises a polymer chain and cross-linking members, said thermoset polyurethane further including unsaturated bonds in the polymer chains and crosslinkers, initiators, or both as cross-linking members.
6. The implantable drug delivery device of claim 1 , which is conditioned and primed under one or more parameters selected from the group consisting of time, temperature, and medium, and wherein the medium is selected to influence the desired delivery rates of the one or more active ingredients.
7. The implantable drug delivery device of claim 1 , wherein the polyurethane comprises a hydrophilic pendant group selected from the group consisting of:
ionic groups, carboxyl groups, ether groups, hydroxyl groups and mixtures of any two or more thereof.
8. The implantable drug delivery device of claim 1 , wherein the one or more active ingredients and the polyurethane-based polymer are selected such that both the one or more active ingredients and the polyurethane-based polymer exhibit hydrophilic characteristics.
9. The implantable drug delivery device of claim 1 , wherein the one or more active ingredients and the polyurethane-based polymer are selected such that both the one or more active ingredients and the polyurethane-based polymer exhibit hydrophobic characteristics.
10. The implantable drug delivery device of claim 1 , wherein the solid formulation includes one or more pharmaceutically acceptable carriers that are not required for the substantially zero order release rate in vitro of the one or more active ingredients through the polyurethane-based polymer.
11. The implantable drug delivery device of claim 10 , wherein the one or more pharmaceutically acceptable carriers are not required for the substantially zero order release rate in vitro of the one or more active ingredients as governed by Fick's Law of Diffusion.
12. An implantable drug delivery device for releasing one or more active ingredients at a substantially zero order rate in vitro by diffusion through a polyurethane-based polymer for an extended period of time to produce systemic pharmacological effects in vivo, said implantable drug delivery device comprising a polyurethane-based polymer configured to provide a cylindrically shaped reservoir, wherein the reservoir is sealed after being charged with an effective amount of a solid formulation comprising one or more active ingredients, wherein the one or more active ingredients and the polyurethane-based polymer are selected such that both the one or more active ingredients and the polyurethane-based polymer exhibit hydrophilic characteristics.
13. An implantable drug delivery device for releasing one or more active ingredients at a substantially zero order rate in vitro by diffusion through a polyurethane-based polymer for an extended period of time to produce systemic pharmacological effects in vivo, said implantable drug delivery device comprising the polyurethane-based polymer configured to provide a cylindrically shaped reservoir, wherein the reservoir is sealed after being charged with an effective amount of a solid formulation comprising one or more active ingredients, wherein the one or more active ingredients and the polyurethane-based polymer are selected such that both the one or more active ingredients and the polyurethane-based polymer exhibit hydrophobic characteristics.
14. An implantable drug delivery device for releasing one or more active ingredients at a substantially zero order rate in vitro by diffusion through a polyurethane-based polymer for an extended period of time to produce systemic pharmacological effects in vivo, said implantable drug delivery device comprising a polyurethane-based polymer configured to provide a cylindrically shaped reservoir, wherein the reservoir is sealed after being charged with an effective amount of a solid formulation comprising one or more active ingredients, and wherein the one or more active ingredients and the polyurethane-based polymer are selected such that either: (i) both the one or more active ingredients and the polyurethane-based polymer exhibit hydrophilic characteristics; or (ii) both the one or more active ingredients and the polyurethane-based polymer exhibit hydrophobic characteristics, and further wherein the solid formulation includes one or more pharmaceutically acceptable carriers that are not required for the substantially zero order release rate in vitro of the one or more active ingredients through the polyurethane-based polymer as governed by Fick's Law of Diffusion.