Elastomeric Gasket Solvent Extraction for MDI Stability
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Solution Overview
Problem
Metered dose inhalers (MDIs) using ozone-friendly propellants, such as hydrofluoroalkanes (HFAs), face challenges in maintaining the stability of pharmaceutical aerosol formulations, particularly in terms of fine particle mass (FPM), due to issues like Ostwald Ripening and drug particle adherence to container surfaces, which affects the therapeutic efficacy and consistency of the medication.
Innovation Solution
A method involving the treatment of elastomeric gaskets with an organic solvent to extract extractable compounds, such as fatty acids, which reduces drug deposition and improves the stability of the aerosol formulation, thereby maintaining higher FPM levels and reducing particle size growth during storage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If elastomeric gaskets are used in MDIs with HFA propellants, then sealing function is provided, but drug particle adherence to gasket surfaces occurs causing FPM reduction
Solution Approach 1:
The patent applies extraction by contacting the elastomeric gasket with an organic solvent to remove extractable compounds from the gasket material. This eliminates the harmful interaction between gasket compounds and drug particles while preserving the gasket's sealing function, thereby preventing FPM reduction during storage.
Solution Approach 2:
The patent changes the chemical composition parameters of the gasket by removing extractable compounds through solvent extraction. This parameter change modifies the gasket's surface properties to reduce drug particle adherence while maintaining its mechanical sealing properties.
2Ease of manufacture
If conventional gasket materials are used, then manufacturing simplicity is maintained, but Ostwald Ripening occurs causing particle size growth and formulation instability
Solution Approach 1:
The patent applies preliminary action by performing solvent extraction on the gasket before final assembly into the MDI. This pre-treatment removes extractable compounds that would otherwise cause Ostwald Ripening and formulation instability during storage, ensuring long-term stability without complicating the manufacturing process.
3Reliability
If gaskets with extractable compounds are used, then initial sealing performance is achieved, but drug deposition on gasket surfaces reduces therapeutic efficacy over time
Solution Approach 1:
The patent removes extractable compounds from the gasket through solvent extraction, eliminating the source of drug particle adherence. This preserves the gasket's sealing performance while ensuring consistent therapeutic delivery by preventing drug deposition on gasket surfaces during storage.
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 treated gaskets in MDIs demonstrate improved stability and consistency of the aerosol formulation, maintaining higher FPM levels and reducing particle size growth, ensuring consistent therapeutic delivery over time.
Implementation Method 1
contacting an elastomeric gasket material to be used in a metered dose inhaler, which gasket material comprises one or more extractable compounds, with a solution comprising an organic solvent under conditions sufficient to extract at least a portion of at least one of the one or more extractable compounds from the elastomeric gasket material
Data Source
AI summary
Methods of preparing elastomeric gasket materials for use in metered dose inhalers that include contacting an elastomeric gasket material to be used in a metered dose inhaler, which gasket material comprises one or more extractable compounds, with a solution comprising an organic solvent under conditions sufficient to extract at least a portion of at least one of the one or more extractable compounds from the elastomeric gasket material are described. Sealing gaskets made by such methods as well as metering valves, metered dose inhalers, and drug products that include such gaskets are also described.