Glutathione Aqueous Composition With CO2 Headspace pH Stability
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Solution Overview
Problem
Current therapies for chronic inflammatory lung diseases, such as cystic fibrosis and COPD, provide modest and variable improvements in lung function and quality of life, and there is a need for stable pharmaceutical preparations that can effectively treat excess mucus and inflammation.
Innovation Solution
Aqueous solutions of L-glutathione, ascorbic acid, and a bicarbonate salt are prepared under a carbon dioxide atmosphere to maintain stability, with a pH range of 6.0±0.4 maintained for 24 hours or more, packaged in a closed container with a carbon dioxide-rich headspace.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If aqueous solutions of L-glutathione, ascorbic acid, and bicarbonate salt are prepared under conventional conditions, then the preparation process is simple, but the pH stability and composition stability deteriorate over time
Solution Approach 1:
The patent applies the inert atmosphere principle by preparing and storing the aqueous solution under a carbon dioxide atmosphere. The carbon dioxide acts as an inert gas that prevents oxidation and degradation of the active ingredients (L-glutathione, ascorbic acid, and bicarbonate salt). The solution is prepared in a container filled with carbon dioxide, and the container is sealed to maintain the carbon dioxide atmosphere, thereby ensuring pH stability and composition stability over time without requiring complex stabilization additives or processes.
2Reliability
If current therapies (dornase alfa and hypertonic saline) are used, then the treatment can be administered, but the improvement in lung function and quality of life is modest and variable
Solution Approach 1:
The patent applies parameter changes by formulating a specific aqueous solution with controlled pH (maintained through carbon dioxide atmosphere) containing L-glutathione, ascorbic acid, and bicarbonate salt in specific concentrations. This controlled parameter approach (pH, composition, atmosphere) creates a more reliable and effective therapeutic formulation compared to conventional treatments, addressing the modest and variable improvements seen with dornase alfa and hypertonic saline.
3Duration of action of stationary object
If the aqueous solution is prepared without carbon dioxide atmosphere, then the preparation process is faster and simpler, but the pH drifts and composition degrades over time
Solution Approach 1:
The patent applies preliminary action by pre-filling the container with carbon dioxide atmosphere before adding the aqueous solution, or by generating carbon dioxide in situ before solution preparation. This preliminary establishment of the carbon dioxide atmosphere ensures that when the solution is prepared and stored, the pH stability and composition integrity are maintained throughout the intended duration of use, without requiring complex real-time monitoring or adjustment mechanisms.
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 solution achieves stable pH and composition over time, ensuring effective treatment of chronic inflammatory lung diseases by maintaining therapeutic efficacy and preventing degradation of the active ingredients.
Implementation Method 1
Applicant has discovered that such aqueous compositions are surprisingly stable when prepared, packaged, and stored under an atmosphere of carbon dioxide
Data Source
AI summary
This disclosure provides pharmaceutical preparations, products, and methods relating to ARINA-1 for use in treating patients with chronic inflammatory lung diseases, such as lung transplant, cystic fibrosis (CF), non-CF bronchiectasis, chronic obstructive pulmonary disease (COPD, and other inflammatory lung diseases.