Stable Liquid Antibody Formulation with Surfactant and Sugar
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current formulations for anti-influenza virus antibodies lack stability across varying temperatures and long-term storage, making them unsuitable for effective prevention and treatment of diverse influenza virus subtypes.
Innovation Solution
A stable liquid pharmaceutical formulation comprising an anti-influenza virus antibody or a mixture of antibodies, combined with a surfactant, sugar or its derivative, and an amino acid, which maintains stability at 5°C, 25°C, and 40°C, and exhibits long-term storage stability up to 12 months.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If conventional liquid pharmaceutical formulations are used for anti-influenza virus antibodies, then the antibodies can be administered in liquid form, but the formulations lack stability across varying temperatures and long-term storage
Solution Approach 1:
The patent optimizes multiple formulation parameters including pH (adjusted to specific ranges using buffers like phosphate or acetate), ionic strength (controlled through salt concentration), temperature conditions (stability demonstrated across 5°C, 25°C, and 40°C), and excipient concentrations (surfactant 0.01-1%, sugar 1-20%, amino acid 0.1-10 mM). These parameter optimizations collectively achieve both liquid form stability and long-term storage capability up to 12 months
Solution Approach 2:
The formulation employs a composite system combining the anti-influenza virus antibody with multiple excipients: surfactants (e.g., polysorbate 80, poloxamer 188) to prevent aggregation, sugars or sugar derivatives (e.g., trehalose, sucrose, sorbitol) for stabilization, and amino acids (e.g., histidine, arginine) for pH buffering and chemical stability. This composite formulation approach enables simultaneous achievement of liquid stability and long-term storage
2Adaptability or versatility
If antibodies are formulated to maintain stability at multiple temperatures, then storage flexibility is improved, but formulation complexity increases
Solution Approach 1:
The patent develops a universal liquid formulation system that simultaneously provides stability across multiple temperature conditions (5°C refrigeration, 25°C room temperature, and 40°C elevated temperature). The same formulation composition with optimized excipient concentrations achieves multi-temperature adaptability without requiring temperature-specific formulations, thereby managing complexity while enhancing versatility
3Reliability
If excipients are added to stabilize the antibody, then chemical and biological stability is improved, but predicting optimal excipient types and amounts becomes difficult
Solution Approach 1:
The patent establishes specific parameter ranges for excipients based on systematic optimization: surfactant concentration (0.01-1%, w/v), sugar concentration (1-20%, w/v), amino acid concentration (0.1-10 mM), and pH (5.5-7.0). These defined parameters provide a practical framework that improves reliability while making formulation development more predictable and manageable
Data Source
AI summary
A stable liquid pharmaceutical preparation of an anti-influenza virus antibody and, more specifically, a stable liquid pharmaceutical preparation that comprises: (A) an anti-influenza virus antibody or a mixture of two or more different types of anti-influenza virus antibodies; (B) a surfactant; (C) a sugar or a sugar derivative; and (D) an amino acid. The stable liquid pharmaceutical preparation for an anti-influenza virus antibody disclosed herein has excellent storage stability at low temperature (5° C.), room temperature (25° C.), and high temperature (40° C.) and excellent long-term (12 months) storage stability, and may be administered intravenously, intramuscularly, transdermally, subcutaneously, intraperitoneally, topically, or in combinations thereof.