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Abstract

A method for treating a patient suffering from diabetes mellitus by delivering aerosolized insulin to the patient and a programmed, portable, hand-held device used in such treatment methodology is disclosed. Two basic types of drug delivery devices are disclosed for use in connection with the present invention. In accordance with the first type of device the insulin is contained within a low boiling point propellant which is held within a canister under pressure. In accordance with the second type of device the insulin is present within a container in solution and the solution is moved through a porous membrane to create an aerosolized formulation which is inhaled by the patient. In accordance with both devices a measured amount of insulin containing formulation is automatically released into the inspiratory flow path of a patient in response to information obtained from determining the inspiratory flow rate and inspiratory volume of a patient. The determination of values and release of drugs are carried out in real time. Reproducibly dosing of insulin to the patient is obtained by repeatedly providing for automatic release of insulin formulation at the same inspiratory flow rate and inspiratory volume. To maximize the efficiency of the delivery of the insulin formulation the formulation is released at an inspiratory flow rate in the range of from about 0.1 to about 2.0 liters/second and a measured inspiratory volume in the range of about 0.1 to about 0.8 liters.

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First Claim