Vitrified Bioactive Agent Delivery Device
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Solution Overview
Problem
Current methods for delivering biological agents, such as IV infusion, face challenges including rapid clearance, toxicity, and discomfort due to systemic availability, and limitations in subcutaneous injection volumes and stability of high-concentration formulations, particularly in maintaining efficacy and patient compliance.
Innovation Solution
A device for vitrifying and delivering bioactive agents, comprising a top and bottom housing with an interconnect structure that allows for deformation to minimize volume during storage and expand for reconstitution, utilizing a substrate for vitrification and reconstitution with a solvent to maintain bioactive agent stability and concentration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If IV infusion is used to deliver bioactive agents, then therapeutic efficacy is achieved through systemic availability, but rapid clearance occurs and frequent injections are required
Solution Approach 1:
The patent changes the physical state of the bioactive agent from liquid to vitrified (glassy) state, and modifies the delivery route from IV to SC. This parameter change enables the agent to be stored in a stable vitrified state and then reconstituted in vivo, achieving both high concentration delivery and extended half-life through depot formation at the injection site
Solution Approach 2:
The patent utilizes phase transition between vitrified (glassy) state and liquid state. The bioactive agent is stored in a vitrified state within the device, then reconstituted to liquid state upon contact with body fluids during SC injection. This phase transition enables long-term stable storage and controlled release, extending the duration of action
2Duration of action of moving object
If PEGylation is applied to increase plasma half-life, then persistence in circulation is enhanced, but the number of FDA-approved PEGylated biologics remains limited
Solution Approach 1:
The patent extracts the PEGylation step from the manufacturing process and replaces it with a physical vitrification approach. Instead of chemically modifying the bioactive agent with PEG, the patent stores the native agent in a vitrified state and delivers it via SC injection, achieving extended half-life without the regulatory complexities of PEGylation
Solution Approach 2:
The patent employs a disposable single-use device that eliminates the need for complex PEGylation manufacturing processes. The device is pre-filled with the vitrified bioactive agent, requiring no additional manufacturing steps beyond vitrification, thereby simplifying regulatory approval while achieving the desired pharmacokinetic profile
3Quantity of substance
If high concentration formulations are used to reduce injection volume, then subcutaneous delivery becomes feasible, but stability and efficacy are compromised
Solution Approach 1:
The patent performs preliminary vitrification of the bioactive agent during manufacturing, creating a stable glassy matrix that preserves the agent in a high-concentration state. This preliminary action prevents aggregation and degradation that would normally occur at high concentrations, enabling stable storage and delivery of concentrated formulations
Solution Approach 2:
The patent creates a composite system consisting of the bioactive agent embedded in a vitrified matrix. This composite structure provides both high concentration capability and enhanced stability, as the glassy matrix protects the agent from degradation while maintaining its bioactivity until reconstitution
4Ease of operation
If subcutaneous injection is used for patient-friendly administration, then self-administration is enabled, but injection volume is limited
Solution Approach 1:
The patent changes the physical state of the formulation from liquid to vitrified, enabling high concentration packing. This parameter change reduces the volume by a factor of 5-10 times compared to conventional liquid formulations, allowing therapeutic doses to be delivered in small volumes suitable for SC injection and self-administration
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 effectively vitrifies and reconstitutes bioactive agents, enhancing stability and concentration, thereby improving patient compliance and reducing toxicity and discomfort, while maintaining therapeutic efficacy and extending the bioactive agent's half-life.
Implementation Method 1
A device for vitrifying and delivering vitrified bioactive agents
Implementation Method 2
reconstituting the bioactive agent into the administration solvent
Data Source
AI summary
A device for vitrifying bioactive agents and delivering vitrified bioactive agents includes a top housing having an inner and outer surface and a perimeter. A bottom housing has an inner and outer surface and a perimeter. An interconnect structure interconnects the housings to define an interior volume between the inner surfaces of the top and bottom housings. The bottom housing may be formed of a flexible material such that the bottom housing is deformable between a first configuration wherein the bottom housing is curved away from the top housing, and a second configuration wherein the bottom housing is curved toward the top housing. The interconnect structure may interconnect the top and bottom housing in a first position wherein the inner surfaces are spaced apart by a first distance, and in a second position wherein the surfaces are spaced apart by a second distance that is less than the first distance.