Reduced Coenzyme Q10 Form II Crystal for Oxidation Stability
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Solution Overview
Problem
Existing formulations of reduced coenzyme Q10 supplements lack sufficient oxidation stability, particularly in tablet forms, necessitating further enhancement to ensure stability during processing, distribution, and storage.
Innovation Solution
Development of a reduced coenzyme Q10 crystal, specifically Form II, with a melting point of 52.0°C or more, exhibiting characteristic X-ray diffraction peaks, and a formulation that satisfies the equation y ≥ 0.1762x + 51.327, where y is the melting point and x is the amount of the crystal, to enhance oxidation stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If reduced coenzyme Q10 is used in tablet formulations, then oral absorbability is improved, but oxidation stability deteriorates
Solution Approach 1:
The patent changes the physical parameter of melting point to improve oxidation stability. Specifically, it selects reduced coenzyme Q10 crystals with a melting point of 52.0°C or more (measured by DSC at 1°C/minute), which have been proven to exhibit higher oxidation stability compared to crystals with lower melting points. This parameter change allows the supplement to maintain reduced form stability during processing, distribution, and storage.
Solution Approach 2:
The patent utilizes the phase transition property of reduced coenzyme Q10 crystals, specifically their melting point characteristics. By selecting crystals with specific melting point ranges (52.0°C or more), the patent leverages the phase transition behavior to enhance oxidation resistance. The crystal structure and its thermal properties are exploited to protect the reduced form from oxidation during storage and handling.
2Ease of manufacture
If reduced coenzyme Q10 is stored under normal conditions, then ease of storage is improved, but oxidation resistance deteriorates
Solution Approach 1:
The patent changes the melting point parameter of the crystal to enable storage under normal conditions while maintaining oxidation stability. By selecting crystals with a melting point of 52.0°C or more, the invention achieves a balance where the supplement can be stored under ordinary conditions (40°C and 75% RH for 1 month) without significant oxidation, as demonstrated by the oxidizing rate of 0.40 or less.
3Ease of manufacture
If conventional Form I crystal is used, then manufacturing simplicity is improved, but oxidation stability deteriorates
Solution Approach 1:
The patent changes the melting point parameter from conventional Form I crystal characteristics to Form II crystal characteristics with a melting point of 52.0°C or more. This parameter change results in superior oxidation stability while maintaining manufacturability through established crystallization processes. The invention specifically identifies Form II crystal with characteristic X-ray diffraction peaks at 11.5°, 18.2°, 19.3°, 22.3°, 23.0°, and 33.3° (Cu-Kα) as the desired form.
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 developed crystal and formulation demonstrate excellent oxidation stability, maintaining a low oxidizing rate of 0.40 or less when stored at 40°C and 75% RH for 1 month, suitable for various supplement forms.
Implementation Method 1
reduced coenzyme Q10 is easily oxidized by oxygen in the air... a crystal having a higher melting point exhibits higher oxidation stability... an oxidizing rate of the crystal is 0.40 or less when the crystal is stored in a condition of 40°C and 75% RH for 1 month
Implementation Method 2
a reduced coenzyme Q10 crystal called a Form II crystal has a range of melting points depending on the manufacturing condition or the like, and that a crystal having a higher melting point exhibits higher oxidation stability... having a melting point of 52.0°C or more, as measured at a heating rate of 1°C/minute by differential scanning calorimetry (DSC)
Implementation Method 3
which exhibits characteristic peaks at diffraction angles (2θ ± 0.2°) of 11.5°, 18.2°, 19.3°, 22.3°, 23.0°, and 33.3° in powder X-ray (Cu-Kα) diffractometry
Data Source
Figure 1
Figure 2
AI summary
Provided is a crystal of reduced coenzyme Q10, the crystal having excellent oxidation stability. The crystal of reduced coenzyme Q10 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), wherein the melting point is represented by a temperature at which a cumulative calorific value becomes 50%.