Temperature controlling device for aerosol drug delivery

Abstract

A portable air temperature controlling device useful for warming air surrounding an aerosolized drug formulation. Warming the air of an aerosol makes it possible to reduce the diameter of aerosol particles produced by an aerosol generation device. Additionally, warming the air forces the diameter of the aerosol particles to be in the range required for systemic drug delivery independent of ambient conditions. Smaller particles can be more precisely targeted to different areas of the respiratory tract.

Description

CROSS-REFERENCES [0001] This application is a continuation-in-part application of U.S. Ser. No. 09 / 690,242 filed Oct. 16, 2000 (issued Jul. 24, 2001 as U.S. Pat. No. 6,263,872) which is a continuation of U.S. application Ser. No. 09 / 107,306 filed Jun. 30, 1998 (issued Oct. 17, 2000 as U.S. Pat. No. 6,131,570) which is a continuation-in-part of U.S. application Ser. No. 08 / 752,946 filed Nov. 21, 1996, now issued U.S. Pat. No. 5,906,202 which applications and patents are incorporated herein by reference and to which applications we claim priority under 35 U.S.C. '120.FIELD OF THE INVENTION [0002] This invention relates generally to portable devices and methods useful for optimizing the diameter distribution of a medical aerosol, and reducing the amount of variability arising from variations in ambient conditions. More specifically, this invention relates to portable devices for controlling the temperature of air to be mixed with aerosol particles of drugs to be delivered to the lung. ...

AI Technical Summary

Benefits of technology

[0032] An important advantage of the invention is that the heating device can heat a sufficient amount of air so as to evaporate a sufficient amount of carrier on aerosolized particles to make the particles consistent in diameter and sufficiently small as to improve the repeatability and efficiency of drug delivery.

[0033] It is an object of this invention to provide a portable air temperature controlling device able to warm the air which will interact with particles of an aerosolized drug formulation.

[0034] It is a further object of the invention to provide a drug delivery device containing such a heating element which is heated by a portable, self-contained energy source.

[0035] It is a further object of the invention to provide methods of administering aerosolized drug formulations in which the air, interacting with or to interact with the aerosolized formulation, is warmed using a portable air temperature controlling device.

[0036] An advantage of the present invention is that it can be used for ambulatory patients.

[0037] Another object of the invention is that it makes it possible to adjust particle diameter by adding energy to the air surrounding the particles in an amount sufficient to evaporate carrier and reduce total particle diameter.

Problems solved by technology

With any of the known methods for aerosol delivery of drugs there are difficulties with respect to making the particles sufficiently small.

Along with these difficulties there are difficulties with respect to creating particles which are relatively consistent in diameter.

These difficulties are particularly acute when attempting to provide for systemic delivery of an aerosolized drug.

Efficient storing and releasing of heat energy are basically contradictory in nature, however, and these goals remain a problem to be addressed, since increasing the efficiency of these features allows a reduction in the size and weight of the power source which must necessarily be included in a portable device.

Because the stomach presents a highly acidic environment, oral preparations of peptides are unstable and readily hydrolyzed in the gastric environment.

Currently, there are no oral preparations of therapeutic peptide agents commercially available.

However, experiments by Adjei et al. have shown that the bioavailability of leuprolide when administered intranasally is relatively low.

Local irritation has been seen with nasal delivery of insulin and has been a problem for commercialization of nasal preparations of that drug.

It is a problem with peptide hormones that they are very potent with effects that are not immediately manifested.

Images