Long term drug delivery devices with polyurethane-based polymers and their manufacture
AssigneeEndo Pharmaceuticals Solutions Inc.
InventorsPetr Kuzma, Harry Quandt
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Abstract
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.
Claims41
An implantable drug delivery device, comprising a polyurethane-based polymer having polyether-based polyol segments represented by the formula —[O—(CH2)n]x—O—, said polyurethane-based polymer configured to provide a cylindrically shaped reservoir, wherein the reservoir is sealed after being charged with an effective amount of solid formulation comprising an active agent and one or more pharmaceutically acceptable carriers, such that the release of the active agent at a substantially zero order rate in vitro by diffusion through the polyurethane-based polymer generally increases as the equilibrium water content (% EWC) of the polymer increases, wherein the active agent is histrelin, risperidone, dexamethasone, naltrexone, metolazone, clonidine, or selegiline.
A method of delivering an active agent to a subject, comprising implanting an implantable device into the subject, wherein the implantable device comprises a polyurethane-based polymer having polyether-based polyol segments represented by the formula —[O—(CH2)n]x—O—, said polyurethane-based polymer configured to provide a cylindrically shaped reservoir, wherein the reservoir is sealed after being charged with an effective amount of solid formulation comprising an active agent and one or more pharmaceutically acceptable carriers, such that the release of the active agent at a substantially zero order rate in vitro by diffusion through the polyurethane-based polymer generally increases as the equilibrium water content (% EWC) of the polymer increases, wherein the active agent is histrelin, risperidone, dexamethasone, naltrexone, metolazone, clonidine, or selegiline.
A process for manufacturing a drug delivery device comprising:
- supplying a polyurethane-based polymer formed as a hollow tube;
- loading a solid formulation comprising one or more active ingredients into the tube;
- and sealing the tube;
- 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 wherein the drug delivery device delivers the one or more active ingredients by diffusion through the polyurethane-based polymer at a substantially zero order release rate in vitro and wherein the polyurethane-based polymer is formed from one or more polyols, wherein the general polyol structure is selected from the group consisting of:
- —[O—(CH2)n]x—O—;
- O—(CH2—CH2—CH2—CH2)x—O—;
- and
- O—[(CH2)6—CO3]n—(CH2)—O—.
Dependencies are inferred from the claim text.