Protein Drug Stabilization via Buffer-Surfactant Composition
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Solution Overview
Problem
Protein drugs, particularly immunoglobulins, are prone to degradation due to denaturation and aggregation during production and storage, leading to instability in liquid formulations, which hinders their development and use in intravenous or subcutaneous injections.
Innovation Solution
A composition comprising a surfactant and a buffer with a pH ranging from 4.5 to 8 is used to stabilize protein drugs, preventing aggregation and maintaining stability over time, suitable for parenteral administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If protein drugs are formulated into liquid form for injection, then ease of administration is improved, but stability deteriorates due to aggregation and particulate formation
Solution Approach 1:
The patent introduces a specific composition containing a buffer (pH 4.5-8) and surfactant as an intermediary substance that mediates between the protein drug and the liquid formulation environment. This composition prevents direct harmful interactions between the protein and destabilizing factors in the liquid medium, thereby maintaining stability while enabling liquid formulation for injection.
Solution Approach 2:
The patent applies parameter changes by optimizing the pH range (4.5-8) and incorporating surfactants to alter the physical-chemical environment of the liquid formulation. These parameter adjustments create favorable conditions that prevent protein denaturation and aggregation, allowing the protein to remain stable in liquid form suitable for injection.
2Productivity
If protein drugs are formulated at high concentrations, then productivity is improved, but stability deteriorates due to aggravated aggregation and particulation
Solution Approach 1:
The patent utilizes parameter changes by optimizing the pH range (4.5-8) and incorporating surfactants to modify the physical-chemical conditions of the formulation. These changes reduce intermolecular interactions that lead to aggregation, enabling high concentrations to be maintained without compromising stability.
Solution Approach 2:
The buffer-surfactant composition acts as an intermediary that prevents direct protein-protein interactions at high concentrations. The surfactant molecules interpose themselves between protein molecules, preventing aggregation while allowing high concentrations to be formulated for improved productivity.
3Reliability
If stabilizing composition is added to prevent aggregation, then stability is improved, but device complexity increases due to additional formulation components
Solution Approach 1:
The patent merges multiple functions into a single stabilizing composition that combines buffer and surfactant components. This unified composition simultaneously maintains pH stability and prevents aggregation, simplifying the overall formulation process while achieving enhanced stability without requiring multiple separate additives.
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 composition effectively suppresses shear stress-induced aggregation, maintaining the protein drug's stability and bioactivity for extended periods, ensuring pharmaceutical efficacy and reducing production costs.
Implementation Method 1
a composition for the stabilization of a protein drug, including a surfactant and having pH ranging from greater than about 4.5 to about 8
Implementation Method 2
a composition for the stabilization of a protein drug, including a surfactant and having pH ranging from greater than about 4.5 to about 8
Data Source
AI summary
Disclosed is a method of preparing a stabilized liquid formulation of a protein drug, comprising admixing a protein drug with a composition for stabilization, wherein the composition for stabilization comprises a surfactant, a buffer, and a liquid medium, and has a pH from about 5 to about 8.