Abstract: The present invention provides a method for the production of medicinal aerosol compositions which are made up of a homogenous solution of aerosol propellants, a surfactant and a pharmaceutically active compound, where the process comprises purifying the surfactant, removing the water from the surfactant, and dispersing the surfactant in an aerosol propellant with a hydrophilic pharmaceutical composition and a controlled amount of water. The present invention also provides medicinal aerosol compositions produced by this method which are a homogenous solution of the pharmaceutically active compound contained in reverse micelles made up of the surfactant; and methods of using the medicinal aerosols to provide an effective amount of a therapeutic agent.

Abstract: Highly purified and recombinantly produced polypeptides and proteins can be provided to a patient to treat systemic disorders using a metered dose inhaler (MDI). The polypeptides and proteins are solubilized in reverse micelles formed from the surfactant in the MDI propellant. By controlling the molar ratio of water to surfactant, the amount of polypeptide or protein solubilized in the reverse micelles can be controlled, thereby providing an accurate dosing mechanism. In addition, controlling the molar ratio of water to surfactant also can adjust the size and shape of the reverse micelles which will affect the degree and rate of penetration of the lung mucosa for delivery of the drugs to the patient's blood stream. Proteins which may particularly benefit from the solubilization and systemic delivery process include calcitonin, oxytocin, and insulin.