Flurane Complexation with Sulfobutylether-β-Cyclodextrin
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Solution Overview
Problem
Existing formulations of flurane anesthetics face challenges in storage stability and administration, particularly due to their volatility and lipophilicity, requiring special measures for conversion into a stable and easily administrable form.
Innovation Solution
A method involving the preparation of an aqueous solution of sulfobutylether-β-cyclodextrin at controlled low temperatures (2-15°C) to form a complex with flurane, which is then separated and can be formulated as a stable aqueous or solid solution for administration, utilizing the hydrophilicity of sulfobutyl ether groups to enhance storage stability and ease of administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If flurane is formulated as a volatile liquid or gas for inhalation anesthesia, then anesthetic efficacy is achieved, but storage stability deteriorates due to high vapour pressure and low boiling point
Solution Approach 1:
The flurane molecule is nested within the hydrophilic cavity of sulfobutylether-β-cyclodextrin, forming an inclusion complex where the volatile flurane is physically enclosed by the cyclodextrin host structure, thereby reducing its volatility and improving storage stability
Solution Approach 2:
The formulation creates a composite system combining the lipophilic flurane anesthetic with the hydrophilic sulfobutylether-β-cyclodextrin carrier, resulting in a stable complex that can be administered in various forms while maintaining anesthetic efficacy
2Reliability
If flurane is complexed with cyclodextrins to improve storage stability, then volatility is reduced, but formulation complexity increases due to need for special measures and excipients
Solution Approach 1:
The sulfobutylether substitution on β-cyclodextrin modifies the physical-chemical parameters of the carrier, increasing its hydrophilicity and water solubility, which enables the complex to be formulated as stable aqueous solutions without additional excipients
Solution Approach 2:
The sulfobutylether-β-cyclodextrin acts as an intermediary carrier that bridges the lipophilic flurane and the aqueous administration medium, facilitating easy formulation while maintaining storage stability
3Reliability
If conventional cyclodextrin complexation is used, then storage stability improves, but ease of administration deteriorates due to difficulty in converting to administrable form
Solution Approach 1:
The hydrophilic modification of cyclodextrin through sulfobutylether groups changes the solubility parameters, enabling the complex to be readily dissolved in water for intravenous administration or nebulization without special measures
4Productivity
If flurane production is performed at high temperature to ensure reaction efficiency, then productivity is improved, but loss of substance increases due to release of volatile flurane
Solution Approach 1:
The complexation reaction is performed at low temperature (2-15°C) which reduces the vapour pressure and volatility of flurane, minimizing release and loss of the volatile substance while still achieving efficient complex formation
Solution Approach 2:
The reaction is conducted in a closed system under inert atmosphere, preventing escape of volatile flurane and ensuring both productivity and minimal substance loss
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 produces a stable and easily administrable flurane complex with high storage stability and high flurane content, allowing for efficient production and formulation without releasing volatile flurane, suitable for pharmaceutical use, including intravenous administration.
Implementation Method 1
Cyclodextrins generally have a toroidal shape and have a correspondingly shaped cavity. The fluranes enter into this cavity as guest molecules such that a complex of the extremely lipophilic fluranes is obtained
Implementation Method 2
The sulfobutyl ether groups particularly contribute to the increase in stability of the complex of fluranes and correspondingly substituted β-cyclodextrin
Implementation Method 3
controlling the temperature of said solution to a temperature of from 2 to 15° C.
Data Source
AI summary
A method for producing a flurane complex, comprising the steps of producing an aqueous solution of sulfobutylether-β-cyclodextrin (SBECD); controlling the temperature of said solution to a temperature of from 2 to 15° C.; adding the flurane to the aqueous solution; allowing the solution to react to produce the complex; and separating the complex.