Dual GLP-1/GIP Agonist Liquid Composition Without Antimicrobials
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Solution Overview
Problem
Existing dual GLP-1 and GIP receptor agonist polypeptide-based drugs face issues with chemical degradation, polymerization, and the need for antimicrobial agents, which affect stability and safety, particularly in liquid preparations intended for long-term storage.
Innovation Solution
A pharmaceutical composition comprising a dual GLP-1 and GIP receptor agonist, propylene glycol as a stabilizer, disodium hydrogen phosphate dodecahydrate as a buffer salt, and a pH regulator to maintain stability without antimicrobial agents, formulated into a liquid preparation with a pH of 7.2-7.6 and concentration of 5-30 mg/mL.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If antimicrobial agents are added to polypeptide-based drug preparations, then product stability against microbial degradation is improved, but drug safety is worsened due to direct injection into circulation
Solution Approach 1:
The patent removes antimicrobial agents from the formulation entirely, extracting the harmful component while addressing stability through alternative means (pH control, buffer systems, and sterile manufacturing practices) that do not compromise patient safety upon injection
Solution Approach 2:
The patent introduces pH regulators and buffer salts as intermediary substances that create an environment unfavorable to microbial growth without requiring direct antimicrobial agents, thus maintaining stability while ensuring safety
2Ease of operation
If polypeptide-based drugs are prepared as liquid preparations, then ease of administration is improved, but chemical degradation and polymerization occur more readily
Solution Approach 1:
The patent optimizes pH parameters (maintaining pH 6.5-8.0 through regulators and buffers) to minimize chemical degradation and polymerization rates, allowing liquid preparations to maintain stability while remaining easy to administer
Solution Approach 2:
The patent incorporates pH regulators and buffer salts in advance during formulation to preemptively establish a stable chemical environment that prevents degradation before it occurs, rather than attempting to correct instability after formation
3Object-affected harmful factors
If pH is controlled to physiological range (7-8) for polypeptide preparations, then biocompatibility is improved, but susceptibility to microbial degradation is worsened
Solution Approach 1:
The patent uses pH regulators and buffer salts as intermediary substances that maintain physiological pH for biocompatibility while simultaneously creating conditions that deter microbial growth, resolving the contradiction between biocompatibility and microbial resistance
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 ensures long-term stability and efficacy of the dual receptor agonist, preventing polymerization and degradation, allowing for effective treatment of metabolic disorders such as diabetes and obesity without the use of antimicrobial agents.
Implementation Method 1
A pharmaceutical composition comprising a dual GLP-1 and GIP receptor agonist, propylene glycol as a stabilizer
Implementation Method 2
disodium hydrogen phosphate dodecahydrate as a buffer salt, and a pH regulator to maintain stability
Implementation Method 3
formulated into a liquid preparation with a pH of 7.2-7.6
Data Source
Figure 1~2
AI summary
The present invention provides a dual GLP-1 and GIP receptor agonist pharmaceutical composition, comprising a dual GLP-1 and GIP receptor agonist, a stabilizer and a buffer salt. The present invention also provides use of the pharmaceutical composition in the preparation of a drug for preventing and/or treating metabolic disorder related diseases.