Homogeneous Copolymer Hydrogel for Polypeptide Sustained Release
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Solution Overview
Problem
Current hydrogel membranes are not well-suited for the controlled delivery of large macromolecules, such as bioactive proteins, due to their porosity and hydration-dependent pore size, which limits their effectiveness in therapeutic applications.
Innovation Solution
Development of an implantable device with a homogeneous copolymer matrix that forms a hydrogel with a controlled water content and includes a release agent of molecular weight at least 1000 Daltons, encasing a polypeptide formulation, such as exenatide, to provide sustained release over several months.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If hydrogel membranes with porosity are used for solute diffusion, then smaller molecules can diffuse through the structure, but the delivery of large macromolecules including bioactive proteins is limited
Solution Approach 1:
The patent changes the physical-chemical parameters of the hydrogel matrix by controlling crosslinking density and composition to create larger pore sizes and more open network structures that can accommodate macromolecules while maintaining controlled release properties
Solution Approach 2:
The patent uses composite hydrogel materials combining different polymer components with specific properties to create a matrix that provides both structural integrity and sufficient porosity for macromolecule delivery, achieving enhanced adaptability for protein therapeutics
2Adaptability or versatility
If hydrogels with higher porosity are used to improve macromolecule delivery, then larger molecules can pass through, but control over release rate and sustained delivery is reduced
Solution Approach 1:
The patent applies local quality by creating regions with different crosslinking densities and pore sizes within the hydrogel matrix, allowing simultaneous accommodation of macromolecules and maintenance of controlled release kinetics through spatially varying properties
Solution Approach 2:
The patent precisely controls physical-chemical parameters including crosslinking density, polymer concentration, and network architecture to achieve the optimal balance between macromolecule permeability and sustained release control
3Ease of manufacture
If conventional hydrogel formulations are used, then manufacturing is simpler, but the devices are not well adapted for therapeutic treatment of diseases requiring bioactive polypeptide delivery
Solution Approach 1:
The patent modifies formulation parameters such as monomer ratios, crosslinking agents, and polymerization conditions to create hydrogels with tailored properties that enable both manufacturability and therapeutic effectiveness for polypeptide delivery
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device enables controlled and sustained release of therapeutically effective amounts of bioactive polypeptides, improving glycemic control and treatment of diabetes by maintaining consistent serum levels and reducing treatment frequency.
Implementation Method 1
a homogeneous copolymer matrix that, in a hydrated state, forms a hydrogel with an equilibrium water content value ranging from about 20% to about 85%
Implementation Method 2
the release agent comprises a non-ionic surfactant, e.g., one selected from the group consisting of: Brij 35, polyoxyetheylene(20)sorbitan trioleate, Tween 20, Tween 80, Vitamin E TPGS
Implementation Method 3
The hydrogels that have been described have some porosity due to the network structure of the crosslinked polymer chains, which allow smaller molecules to diffuse through the structure
Data Source
AI summary
Described herein are implantable devices, formulations and methods of making implantable devices for the release of a polypeptide from an implantable device, and methods of use thereof.