Liquid Oxyntomodulin Peptide Analog Formulations for Stability
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Solution Overview
Problem
Existing GLP-1 and glucagon receptor agonists, such as oxyntomodulin peptide analogs, face challenges in maintaining chemical and physical stability in liquid formulations, which is crucial for quality, safety, and delivery purposes, especially for treating conditions like type 2 diabetes and obesity.
Innovation Solution
A stable liquid formulation is developed with a pH range of 3.5 to 8.0, containing a pharmaceutically effective amount of GLP-1 and/or glucagon receptor agonists, including PEGylated oxyntomodulin peptide analogs, in an aqueous buffer solution, and is substantially free of destabilizing substances, using excipients like methionine and sorbitol to enhance stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If oxyntomodulin peptide analogs are formulated in liquid form for improved delivery and patient compliance, then ease of operation is improved, but chemical and physical stability deteriorates
Solution Approach 1:
The patent optimizes formulation parameters including pH (3.5-8.0), ionic strength, and temperature to enhance the chemical and physical stability of oxyntomodulin peptide analogs in liquid formulations, resolving the contradiction between liquid form delivery and stability maintenance
Solution Approach 2:
The patent employs stabilizing excipients and additives as intermediary substances that protect the peptide analogs from degradation in liquid formulations, enabling both improved delivery and maintained stability
2Duration of action of stationary object
If the formulation is designed for long shelf-life, then duration of action is improved, but impurity formation increases
Solution Approach 1:
The patent converts potentially harmful degradation processes into beneficial outcomes by controlling formulation conditions to redirect degradation pathways, thereby extending shelf-life while minimizing impurity formation through optimized pH and stabilizing agents
Solution Approach 2:
The patent incorporates stabilizing excipients and protective agents in the formulation that preemptively protect against degradation mechanisms, cushioning the peptide analogs from chemical and physical deterioration during storage
Data Source
AI summary
The present invention relates to GLP-1 and/or glucagon receptor agonists (for example, oxyntomodulin peptide analogs), pharmaceutically acceptable salts thereof, formulations comprising the same, and uses thereof for treating diabetes and/or obesity or associated diseases or disorders.