DOXO-EMCH Formulation Stabilization via Ethanol-Water Solvent
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Solution Overview
Problem
Current formulations of DOXO-EMCH require cold storage and administration, leading to stability issues and patient safety concerns due to rapid degradation at room temperature, which complicates clinical use and administration.
Innovation Solution
A reconstituted formulation of DOXO-EMCH in a mixture of ethanol and water, with a volume:volume ratio of 10:90 to 90:10, and an injectable composition with Lactated Ringer's solution, stabilizing the compound at room temperature and preventing degradation into doxorubicin.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If DOXO-EMCH is formulated in current diluents and administration fluids, then the compound can be administered, but it requires cold storage at 4°C to maintain stability, which complicates administration and may harm patients
Solution Approach 1:
The patent changes the chemical composition parameters of the formulation by incorporating specific stabilizing agents and excipients that enable DOXO-EMCH to remain stable at room temperature rather than requiring cold storage, thus resolving the contradiction between stability and ease of administration
Solution Approach 2:
The patent creates a composite formulation system combining DOXO-EMCH with multiple stabilizing agents and excipients that work synergistically to maintain compound stability at room temperature, eliminating the need for refrigeration while preserving drug integrity
2Ease of manufacture
If DOXO-EMCH is reconstituted in liquid that does not maintain stability at room temperature, then reconstitution is possible, but rapid decomposition occurs, rendering the formulation unsuitable for patient use
Solution Approach 1:
The patent modifies the formulation parameters by selecting specific reconstitution liquids containing stabilizing agents that maintain DOXO-EMCH stability at room temperature, allowing easy reconstitution without compromising formulation reliability
Solution Approach 2:
The patent introduces stabilizing agents as intermediary substances that mediate between the DOXO-EMCH compound and the reconstitution liquid, preventing decomposition and ensuring formulation reliability while maintaining ease of reconstitution
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 formulation maintains stability and minimizes doxorubicin formation, allowing safe and effective administration at room temperature, enhancing clinical usability and patient safety.
Implementation Method 1
DOXO-EMCH, when present in compositions, diluents and administration fluids used in current formulations, is stable only when kept at low temperatures. The need to maintain DOXO-EMCH at such temperatures presents a major problem... DOXO-EMCH was stable only when kept at low temperatures
Data Source
AI summary
The invention relates to reconstituted formulations comprising an anthracycline compound, ethanol, and water. The invention also relates to injectable compositions comprising the reconstituted formulation and Lactated Ringer's solution. Additionally, the invention relates to methods of using the formulations and compositions.