Rocuronium Composition pH Stability
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Solution Overview
Problem
Current rocuronium compositions are thermally unstable, requiring cold-chain storage and have limited shelf-life at room temperature, which is inconvenient and costly for healthcare providers and manufacturers.
Innovation Solution
An aqueous rocuronium composition with a pH of 2.5 to 3.5 and titratable acidity of not more than 35 mEq, which is stable at room temperature for several years, achieved through pH adjustment using hydrochloric acid and alkalizing agents, and sterilized by thermal or aseptic methods.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If rocuronium is formulated as an aqueous solution with conventional pH and buffer systems, then it provides adequate stability, but it requires cold-chain storage and has limited shelf-life at room temperature
Solution Approach 1:
The patent applies parameter changes by optimizing the pH to a specific range of 2.5-3.5 and controlling titratable acidity to not more than 35 mEq. This chemical parameter optimization enables the rocuronium composition to achieve both thermal stability and extended shelf-life at room temperature, resolving the contradiction between stability and storage duration without requiring cold-chain storage.
2Stability of the object's composition
If cold-chain storage is implemented to maintain stability, then degradation is reduced, but storage and transportation costs increase and logistics become more complex
Solution Approach 1:
The patent enables the rocuronium composition to be self-stabilizing at room temperature through optimized pH (2.5-3.5) and titratable acidity (≤35 mEq) parameters. This eliminates the need for external cold-chain infrastructure and active temperature control systems, allowing the product to maintain stability autonomously under ambient conditions and significantly simplifying storage and transportation logistics.
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 maintains stability and effectiveness for at least three years at room temperature, reducing degradation and improving storage and transportation logistics.
Implementation Method 1
The composition has a pH of 2.5 to 3.5 and a titratable acidity of not more than 35 mEq
Data Source
AI summary
The invention relates to a rocuronium composition providing no or less vascular pain to patients upon injection. The rocuronium composition has a pH of 2.5 to 3.5 and a titratable acidity of not more than 35 mEq. The rocuronium composition is stable upon thermal sterilization. Further, the rocuronium composition is stable upon storage at room-temperature.