Oil-Based Drug Formulations for Uniform Medical Device Coating
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Solution Overview
Problem
Current drug formulations for medical devices, such as stents and balloons, face issues with the physical instability and non-uniform coating of hydrophobic anti-restenotic agents like C6-ceramide, leading to decreased availability and effectiveness in preventing restenosis due to rapid evaporation of organic solvents and changes in the drug's physical form.
Innovation Solution
A formulation using a non-volatile oil-based solvent, such as Vitamin E, combined with a volatile solvent like ethanol to decrease viscosity and ensure uniform coating of medical devices, maintaining the drug in a dissolved state and preventing solid-state changes, thereby enhancing delivery and stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If organic solvents are used to coat hydrophobic drugs on medical devices, then the drug remains in a dissolved state for rapid deposition and absorption, but the solvents evaporate rapidly causing physical instability and non-uniform coating
Solution Approach 1:
The patent uses an oil-based carrier (such as Vitamin E, propylene glycol, or other biocompatible oils) as an intermediary substance to dissolve the hydrophobic drug. This carrier acts as a mediator that maintains drug solubility without the rapid evaporation problems of organic solvents, enabling both rapid deposition and physical stability. The oil-based carrier allows the drug to remain in solution during coating while preventing crystallization and flaking after deposition.
2Reliability
If the drug is coated immediately before insertion, then the drug remains available in film-like state, but the coating process becomes complex and time-consuming
Solution Approach 1:
The patent enables preliminary coating of the medical device with the drug formulation before sterilization and final device assembly. The oil-based carrier system allows the drug to be applied to the device surface in advance, where it remains stable in the oil medium without requiring immediate use. This preliminary action simplifies the overall manufacturing process by decoupling the coating step from the final device assembly, while maintaining drug availability through the stable oil-based formulation.
3Manufacturing precision
If volatile solvents are used to decrease viscosity for uniform coating, then coating uniformity improves, but the solvents evaporate rapidly causing drug crystallization and flaking
Solution Approach 1:
The patent changes the fundamental parameter of the solvent system from volatile organic solvents to non-volatile oil-based carriers. This parameter change maintains the viscosity-reducing benefit needed for uniform coating application, while eliminating the rapid evaporation that causes drug crystallization. The oil-based carrier provides sustained drug availability by preventing premature phase separation, allowing the coating to remain uniform and effective for extended periods.
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 oil-based formulation ensures uniform and sustained delivery of hydrophobic anti-restenotic agents, reducing restenosis by maintaining the drug in a deliverable form and preventing flaking or dissolution, with improved coating uniformity and prolonged drug availability on the artery wall.
Implementation Method 1
an amount of a volatile solvent sufficient to decrease the viscosity of the non-volatile oil-based solvent
Implementation Method 2
rapid evaporation of organic solvents
Data Source
AI summary
The present invention relates to oil-based formulations of hydrophobic drugs for the uniform coating of medical devices such as vascular stents and balloons. Another aspect of the present invention is an intravascular medical device having an oil-based coating suitable for delivering a water-insoluble drug, comprising one or more of an anti-oxidant, an anti-inflammatory and an anti-restenotic agent.