Particle Suspension Biologic Formulation for Low-Force Injection
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Solution Overview
Problem
Current biologic drug delivery methods, particularly for monoclonal antibodies, face challenges with high viscosity and aggregation issues at high concentrations required for subcutaneous delivery, leading to patient discomfort and product loss.
Innovation Solution
A low viscosity composition of therapeutic biologics in particle form, with less than 10% aggregation, allowing concentrations between 20 mg/mL to 700 mg/mL for subcutaneous delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If high concentration of therapeutic biologic is used for subcutaneous delivery, then delivery volume is reduced, but viscosity increases excessively
Solution Approach 1:
The patent introduces particles as an intermediary carrier system. The therapeutic biologic is encapsulated within particles, which are then suspended in a low viscosity liquid carrier. This particle-mediated approach allows high concentrations of biologic (20-700 mg/mL) while the liquid carrier maintains low viscosity, thus resolving the contradiction between high concentration and low injection force.
Solution Approach 2:
The patent changes the physical state and distribution parameters of the therapeutic biologic. Instead of using high concentration in a homogeneous solution (which increases viscosity), the biologic is distributed within discrete particles suspended in a low viscosity carrier. This parameter change in formulation architecture allows high biologic concentration without the corresponding increase in bulk viscosity that would increase injection force.
2Quantity of substance
If high concentration of therapeutic biologic is used for subcutaneous delivery, then delivery volume is reduced, but aggregation increases
Solution Approach 1:
Particles serve as an intermediary structure that physically separates and isolates individual biologic molecules. By encapsulating the therapeutic biologic within particles and suspending these particles in a low viscosity carrier, the system prevents direct protein-protein interactions that lead to aggregation. This allows high biologic concentration (20-700 mg/mL) while maintaining low aggregation (<10%).
Solution Approach 2:
The patent fundamentally changes the formulation parameters by transitioning from a homogeneous high-concentration solution to a heterogeneous particle suspension system. This parameter change in physical architecture allows the biologic to be concentrated while maintaining stability, as the particles prevent the aggregation pathways that would otherwise occur at high concentrations.
3Loss of time
If high concentration of therapeutic biologic is used, then delivery frequency decreases, but product loss increases due to aggregation
Solution Approach 1:
The particle system acts as a protective intermediary that prevents aggregation-induced product loss. By encapsulating the biologic within particles and suspending them in a low viscosity carrier with minimal aggregation (<10%), the system enables high concentration formulations that can be administered less frequently (reducing delivery frequency) while maintaining product stability and minimizing loss.
4Force
If low viscosity carrier is used, then injection force is reduced, but concentration capability is limited
Solution Approach 1:
The patent uses particles as an intermediary concentration mechanism. The low viscosity liquid carrier provides easy injectability with low injection force, while the particles serve as concentrated carriers of the therapeutic biologic. This allows the system to achieve high biologic concentrations (20-700 mg/mL) within the particles themselves, while the bulk carrier remains low viscosity, thus resolving the contradiction between low injection force and high concentration capability.
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
Enables effective subcutaneous delivery with reduced injection forces and preserved biologic activity, decreasing delivery frequency and minimizing product loss.
Implementation Method 1
a plurality of particles suspended in a low viscosity pharmaceutically acceptable liquid carrier, each particle comprising at least one therapeutic biologic or a salt thereof
Data Source
AI summary
The present disclosure provides compositions and methods for treating a disease or condition in a subject in need thereof, comprising administering to the subject a pharmaceutically effective amount of a composition comprising a plurality of particles comprising at least one therapeutic biologic suspended in a pharmaceutically acceptable liquid carrier.