Acidic FGF Eye Drop Formulation for Room-Temperature Stability
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Solution Overview
Problem
Existing acidic fibroblast growth factor preparations are unstable at room temperature and have limited shelf life, requiring refrigerated storage and posing challenges for patient compliance and convenience.
Innovation Solution
A stable acidic fibroblast growth factor eye drop formulation comprising histidine, Tween 80, and heparin sodium as protein protective agents, combined with humectants, buffer salts, osmotic pressure regulators, and other additives to maintain stability and biological activity for up to 9 months at room temperature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If acidic fibroblast growth factor is stored at room temperature, then patient compliance and convenience are improved, but the stability and shelf life of the preparation deteriorates
Solution Approach 1:
The patent changes the chemical parameters of the preparation by adding specific stabilizers (histidine, Tween 80, heparin sodium) and adjusting pH to 6.0-7.0, which enables the acidic fibroblast growth factor to maintain stability at room temperature without refrigeration
Solution Approach 2:
The patent creates a composite formulation by combining acidic fibroblast growth factor with multiple stabilizing agents (histidine as a buffer, Tween 80 as a surfactant, and heparin sodium as a protective agent), where each component contributes to overall stability and allows room temperature storage
2Stability of the object's composition
If expensive human albumin is used as a stabilizer, then the stability of acidic fibroblast growth factor is improved, but production costs increase
Solution Approach 1:
The patent replaces expensive human albumin with cheaper, more accessible stabilizers (histidine, Tween 80, heparin sodium) that provide equivalent or superior stability without the high cost associated with human-derived products
Solution Approach 2:
The patent changes the compositional parameters by substituting protein-based stabilizers with small molecule stabilizers and polysorbates, reducing material cost while maintaining or improving stabilization effectiveness
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 formulation effectively maintains high biological activity and stability of acidic fibroblast growth factor for 9 months at room temperature, reducing production costs without using expensive human albumin and ensuring product quality.
Implementation Method 1
The combined protein protective agent does not need to use expensive human albumin, and effectively reduces the production costs while ensuring product quality
Implementation Method 2
the preferred pH value of the buffer salt is 6.0 to 7.0, the concentration is 0.01 to 0.05 mol/L
Implementation Method 3
the osmotic pressure regulator is selected from one or more of sodium chloride, boric acid and glucose
Data Source
AI summary
The present invention relates to a recombinant human acidic fibroblast growth factor preparation, and particularly relates to an acidic fibroblast growth factor eye drop preparation. In the eye drop preparation, a combination selected from histidine, Tween 80 and heparin sodium is used as a protein protective agent, without using human albumin as the protein protective agent, thereby reducing the costs, effectively improving the stability of the product, and maintaining high bioactivity for 9 months under the conditions of (25±2)°C and relative humidity (60±5)%.