Aerosol formulations including proteins and peptides solubilized in reverse micelles and process for making the aerosol formulations

摘要

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.