Cysteamine Formulation Stability via Refrigerated Storage
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Solution Overview
Problem
Cysteamine pharmaceutical compositions are not chemically stable and degrade into impurities over time when stored at room temperature, leading to increased levels of impurities such as cystamine, 2-hydroxythiomorpholine, cystamine tartrate amide, and 2-hydroxymethylthiazolidine.
Innovation Solution
Storing cysteamine pharmaceutical compositions at refrigerated temperatures between 2° C. and 8° C. reduces the formation of impurities, with enteric coatings providing increased delivery to the small intestine and maintaining stability for up to 24 months.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If cysteamine pharmaceutical compositions are stored at room temperature, then storage and distribution are convenient, but the compositions degrade into impurities over time
Solution Approach 1:
The patent applies parameter changes by specifying precise storage temperature ranges (2°C to 8°C) to optimize the stability of cysteamine compositions. This temperature parameter control prevents degradation into impurities while maintaining practical storage and distribution capabilities.
2Stability of the object's composition
If cysteamine compositions are stored at refrigerated temperatures (2°C-8°C), then chemical stability is improved and impurity formation is reduced, but storage and distribution complexity increases
Solution Approach 1:
The patent establishes specific temperature parameters (2°C to 8°C) that balance chemical stability with practical storage considerations. This parameter optimization ensures reduced impurity formation while maintaining feasible storage and distribution infrastructure requirements.
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 method effectively stabilizes cysteamine compositions, reducing impurity levels and maintaining product quality for extended storage periods, ensuring effective treatment of conditions like cystinosis and other metabolic diseases.
Implementation Method 1
cysteamine is not chemically stable and degrades into several impurities over time... storing the pharmaceutical composition at refrigerated temperatures (e.g., 2° C.-8° C.) up to 24 months, or longer, and compositions that have been stored in such a manner that have fewer impurities than when stored at 25° C.
Data Source
AI summary
Methods of storing and methods of stabilizing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, are provided. Methods of distributing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, and methods of treating cystinosis also are provided.