Polymeric stabilizing formulations
Inventors
MENDELSOHN, Adam • DUONG, Au • FISCHER, Kathleen • Roorda, Wouter
Assignees
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Publication Number
US-10479868-B2
Publication Date
2019-11-19
Expiration Date
Abstract
The present invention provides compositions of a therapeutic agent and a polymeric stabilizing agent for stabilizing the reservoir of an implantable drug delivery system. The present invention also includes an implantable drug delivery system incorporating the composition of the present invention, as well as methods of treating diabetes using the compositions and implantable drug delivery system of the present invention.
Core Innovation
The invention provides a pharmaceutical composition for implantable nanoporous drug delivery in which a peptide therapeutic agent is combined with a polymeric stabilizing agent. The polymeric stabilizing agent comprises a polymer having a plurality of stabilizing groups, where the polymer is a dendritic polymer or a crossed-linked polymer. The stabilizing groups are intended to support stabilization of the therapeutic peptide in the composition.
The composition is disposed within a reservoir of a capsule configured for implantation. The capsule has a nanoporous membrane with a plurality of pores, and the nanoporous membrane is configured such that it is the diffusion pathway out of the reservoir for the therapeutic agent. In this arrangement, release of the polymeric stabilizing agent from the reservoir is substantially prevented.
The polymeric stabilizing agent is selected so that the polymer having the plurality of stabilizing groups has molecular dimensions larger than the pore size of the nanoporous membrane. By choosing polymer molecular dimensions larger than the membrane pore size, the stabilizing polymer is prevented from substantially diffusing through the nanoporous membrane, while the therapeutic peptide can diffuse out through the pores.
Claims Coverage
The independent claim defines 3 inventive features centered on a peptide therapeutic agent, an implantable capsule reservoir with a nanoporous membrane diffusion pathway, and pore-size-selective prevention of stabilizing polymer release.
Peptide therapeutic agent with dendritic or crossed-linked stabilizing polymer
A pharmaceutical composition comprising a therapeutic agent, wherein the therapeutic agent is a peptide, together with a polymeric stabilizing agent comprising a polymer having a plurality of stabilizing groups, wherein the polymer is a dendritic polymer or is a crossed-linked polymer.
Capsule reservoir with nanoporous membrane diffusion pathway
The pharmaceutical composition is disposed within a reservoir of a capsule having a nanoporous membrane with a plurality of pores, the capsule configured for implantation, wherein the nanoporous membrane is a diffusion pathway out of the reservoir for the therapeutic agent.
Pore-size-selective prevention of stabilizing polymer release
The polymeric stabilizing agent comprises a polymer having a plurality of stabilizing groups having molecular dimensions larger than the pore size of the nanoporous membrane, wherein the release of the polymeric stabilizing agent from the reservoir is substantially prevented.
Overall, the claim coverage centers on maintaining peptide therapeutic delivery through a nanoporous membrane while substantially preventing stabilizing polymer release via polymer molecular dimensions larger than membrane pore size.
Stated Advantages
Release of the polymeric stabilizing agent from the reservoir is substantially prevented.
The nanoporous membrane serves as a diffusion pathway out of the reservoir for the therapeutic agent.
Documented Applications
Implantable nanoporous drug delivery for therapeutic peptide delivery, including diabetes treatment concepts (type 1 diabetes and type 2 diabetes) using exenatide.
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