Reduced Coenzyme Q10 Form II Crystal for Oxidation Stability
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Solution Overview
Problem
Reduced coenzyme Q10 is prone to oxidation, necessitating improved oxidation stability for use in tablet forms and formulations, particularly due to its susceptibility to air oxidation.
Innovation Solution
Development of a reduced coenzyme Q10 crystal (Form II) with a melting point of 52.0°C or more, characterized by specific X-ray diffraction peaks and controlled crystallization methods to enhance oxidation stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If reduced coenzyme Q10 is used in tablet or hard capsule form, then application versatility is improved, but oxidation stability deteriorates due to exposure to air
Solution Approach 1:
The patent applies inert atmosphere by replacing air (oxidizing environment) with nitrogen gas during storage and handling of reduced coenzyme Q10 tablets and hard capsules. This prevents oxidation by creating an oxygen-free environment, allowing the use of reduced coenzyme Q10 in various solid dosage forms without compromising its stability.
Solution Approach 2:
The patent uses nitrogen gas as an intermediary substance between the reduced coenzyme Q10 and oxygen. The nitrogen atmosphere acts as a protective barrier that prevents direct contact between the reduced coenzyme Q10 and oxidizing agents, thereby maintaining stability while enabling diverse formulation options.
2Reliability
If reduced coenzyme Q10 is stored in soft capsules with fat, then oxidation stability is improved, but manufacturing complexity increases
Solution Approach 1:
The patent replaces the complex fat-based soft capsule formulation with a simpler solid formulation (tablet or hard capsule) stored in a nitrogen atmosphere. This eliminates the need for lipid matrices and soft capsule manufacturing processes while maintaining oxidation stability through the inert gas environment.
3Reliability
If reduced coenzyme Q10 is increased in oxidation stability through coating, then reliability is improved, but manufacturing complexity and cost increase
Solution Approach 1:
The patent eliminates the need for complex coating processes (such as shellac, gelatin, or gum arabic coatings) by storing the reduced coenzyme Q10 in a nitrogen atmosphere. This provides oxidation stability through environmental control rather than through additional material layers or processing steps.
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 Form II crystal exhibits reduced oxidation rates of 0.40% or less when stored at 40°C and 75% RH for a month, maintaining stability for extended periods.
Implementation Method 1
a reduced coenzyme Q10 crystal (Form II) with a melting point of 52.0°C or more, characterized by specific X-ray diffraction peaks and controlled crystallization methods to enhance oxidation stability
Implementation Method 2
reduced coenzyme Q10 is easily oxidized by oxygen in the air
Implementation Method 3
The Form II crystal exhibits reduced oxidation rates of 0.40% or less when stored at 40°C and 75% RH for a month, maintaining stability for extended periods
Data Source
AI summary
A reduced coenzyme Q10 crystal having excellent oxidation stability is provided. The crystal has a melting point of 52.0° C. or more, as measured at a heating rate of 1° C./minute by differential scanning calorimetry (DSC), where the melting point is represented by a temperature at which a cumulative calorific value becomes 50%.