Alkylated Cyclodextrin Purification via Activated Carbon
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Solution Overview
Problem
There is a need for alkylated cyclodextrin compositions with higher purity to enhance the shelf-life and potency of active agents, as impurities in existing compositions can reduce their effectiveness.
Innovation Solution
A process involving mixing cyclodextrin with an alkylating agent, followed by separations to remove unwanted components, and treatment with phosphate-free activated carbon to produce an alkylated cyclodextrin composition with low chloride and phosphate levels, ensuring high purity and stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional batch methods are used to prepare sulfoalkyl ether cyclodextrins, then the production process is simple and established, but the composition contains impurities that reduce shelf-life and potency of active agents
Solution Approach 1:
The patent applies preliminary action by treating the cyclodextrin composition with activated carbon before final formulation to remove drug-degrading impurities. This pre-treatment step ensures that impurities are eliminated in advance, preventing them from affecting the shelf-life and potency of subsequently added active agents.
Solution Approach 2:
The patent employs extraction by using activated carbon to selectively adsorb and remove drug-degrading impurities from the cyclodextrin composition. The activated carbon acts as an extracting agent that separates harmful impurities from the beneficial cyclodextrin components, thereby purifying the final composition.
2Manufacturing precision
If activated carbon is used to remove impurities from cyclodextrin compositions, then purity is improved, but chloride and phosphate levels may increase affecting stability
Solution Approach 1:
The patent applies parameter changes by carefully controlling the activation and treatment parameters of the activated carbon. Specifically, the carbon is activated and then treated to achieve a balance where drug-degrading impurities are removed while maintaining chloride and phosphate levels within acceptable ranges that preserve composition stability.
Solution Approach 2:
The patent applies local quality by using activated carbon with specific local properties - high adsorption capacity for drug-degrading impurities while having limited interaction with chloride and phosphate ions. This selective adsorption property allows the carbon to purify the composition without destabilizing it.
3Manufacturing precision
If multiple separation steps are conducted to remove unwanted components, then purity is enhanced, but production time and complexity increase
Solution Approach 1:
The patent applies merging by combining multiple purification functions into a single activated carbon treatment step. The activated carbon simultaneously removes drug-degrading impurities, adjusts chloride levels, and maintains phosphate balance, eliminating the need for multiple separate separation operations and reducing overall production time.
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 process results in an alkylated cyclodextrin composition with reduced drug-degrading agents and color-forming impurities, maintaining high purity and stability across multiple lots, thereby extending the shelf-life and potency of active agents.
Implementation Method 1
treating the partially purified solution with phosphate-free activated carbon having a residual conductivity of 10 μS or less
Data Source
AI summary
The present invention related to low-chloride alkylated cyclodextrin compositions, along with processes for preparing and using the same. The processes of the present invention provide alkylated cyclodextrins with low levels of drug-degrading agents and chloride.