Pharmaceutically acceptable agents for solubilizing, wetting, emulsifying, or lubricating in metered dose inhaler formulations which use HFC-227 propellant
AssigneesCenter for Innovative Technology, Virginia Commonwealth University
InventorsPeter Byron, Frank Blondino
Life of this patent
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Abstract
1,1,1,2,3,3,3-heptafluoropropane (HFC-227) has been identified as a highly polar propellant. Surfactants which have an elevated value (9.6 or greater) for their hydrophilic-lipophilic balance (HLB) can be used as suspending, wetting, and lubricating agents or cosolvents in metered dose inhaler (MDI) formulations pressurized with HFC-227 or propellant blends that contain HFC-227. Particularly preferred surfactants include polyoxyethylene sorbitan monolaurate, polyoxyethylene sorbitan mono-oleate, polyethylene glycol 300, propoxylated polyethylene glycol, polyoxyethylene 4 lauryl ether, and diethylene glycol monoethyl ether.
Claims20
An alcohol-free aerosol formulation for use in a metered does inhaler, consisting essentially of:
- greater than 90% by weight of 1,1,1,2,3,3,3-heptafluoropropane, said 1,1,1,2,3,3,3-heptafluoropropane being the sole propellant and excipient which is not a surfactant in said aerosol formulation;
- less than 5% by weight of micronized drug particles;
- and
- less than 5% by weight of at least one polar surfactant having a hydrophilic-lipophilic balance value greater than 9.6,
- said aerosol formulation being alcohol-free.
An alcohol-free aerosol formulation for use in a metered dose inhaler, consisting essentially of:
- greater than 90% by weight of a propellant blend consisting of 1,1,1,2-tetrafluoroethane and 1,1,1,2,3,3,3-heptafluoropropane, said propellant blend constituting the only excipients which are not a surfactant in said aerosol formulation;
- less than 5% by weight of micronized drug particles;
- and
- less than 5% by weight of at least one polar surfactant having a hydrophilic-lipophilic balance value greater than 9.6,
- said aerosol formulation being alcohol-free.
An alcohol-free aerosol formulation for use in a metered dose inhaler, consisting essentially of:
- greater than 90% by weight of a propellant blend consisting of at least 50% 1,1,1,2,3,3,3-heptafluoropropane and a second propellant, said propellant blend constituting the only excipients which are not a surfactant in the MDI formulation;
- less than 5% by weight of micronized drug particles;
- and
- less than 5% by weight of at least one polar surfactant having a hydrophilic-lipophilic balance value greater than 9.6,
- said aerosol formulation being alcohol-free.
Dependencies are inferred from the claim text.