Composition and method for treatment of otitis external

A process for preparing an external auditory canal patency enhancing and protective medicament comprising:

• combining at least one lipid surfactant, at least one spreading agent, and at least one propellant to form a mixture, said lipids and said spreading agents being selected from the group consisting of sterols, lipids, fatty acids, cholesteryl esters, phospholipids, carbohydrates, all in powder form, wherein said lipids and said spreading agents are insoluble in the propellants and said lipid surfactants are present in an amount effective in reducing surface tension of an air/liquid interface resident upon epithelial tissue lining the external auditory canal and said spreading agents being present in an amount effective in distributing said surfactant upon said interface when said propellants are evaporated from said mixture to form an aerosolized mixture of lipid crystals for use as the medicament.

A process for preparing an otitis externa medicament comprising:

• combining at least one lipid surfactant, at least one spreading agent, at least one therapeutically active agents effective in the treatment of otitis externa and at least one propellants to form a mixture, said lipid surfactants and said spreading agents being selected from the group consisting of sterols, lipids, fatty acids, cholesteryl esters, phospholipids, carbohydrates, all in powder form, wherein said lipids, said spreading agents and said therapeutically active agents are insoluble in the propellants and said lipid surfactants are selected to be present in an amount effective in reducing surface tension of an air/liquid interface resident upon epithelial tissue lining the external auditory canal and said spreading agents are selected to be present in an amount effective in distributing said surfactant and therapeutically active agents upon said interface when said propellants are evaporated from said mixture to form an aerosolized mixture of lipid crystals in combination with the therapeutically active agent for use as the medicament.

A method of administering therapeutically active agents, effective in the treatment of otitis externa, directly to mammalian external auditory canal tissues while simultaneously increasing canal patency comprising administering a dose of a mixture of lipid crystals in combination with said therapeutically active agents, as an aerosolized mixture, through an external auditory meatus of a mammal, said mixture being comprised of at least one lipid surfactant in an amount effective in lowering surface tension of an air/liquid interface resident upon epithelial tissue lining said canal, at least one therapeutically active agent effective in the treatment of otitis externa and at least one propellant, said lipid surfactants being selected from the group consisting of sterols, lipids, fatty acids, cholesteryl esters, phospholipids, carbohydrates, and proteins, said surfactants and therapeutically active agents all being in powder form and insoluble in the propellants,

• whereupon, when said mixture of lipid crystals is so administered, said propellants evaporate from said mixture as said crystals come into contact with, and deposit upon the epithelial lining of the external auditory canal so as to reduce the surface tension thereof while distributing said therapeutically active agent within said canal to said tissues.

A process for preparing an otitis externa medicament comprising:

• combining at least one lipid surfactant, at least one therapeutically active agent effective in the treatment of otitis externa and at least one propellant to form a mixture, said lipid surfactants being selected from the group consisting of sterols, lipids, fatty acids, cholesteryl esters, phospholipids, carbohydrates, and proteins all in powder form, wherein said lipids and said therapeutically active agents are insoluble in the propellants and said lipids are selected to be present in an amount effective in lowering surface tension of an air/liquid interface resident upon epithelium lining of the external auditory canal and effective in distributing said therapeutically active agent therewithin when said propellants are evaporated to form an aerosolized mixture of lipid crystals combined with said therapeutic agents for use as the medicament.