SBIR-STTR Award

Beta agonists administered in aerosol form is one of the most potent and widely used bronchodilator therapies. In hospitals, beta agonists are usually administered by compressed air nebulizers. Numerous studies have documented the efficacy of the bronchodilator aerosol delivered from a canister nebulizer, but the major shortcoming of this form of therapy is the poor inhalation technique of some of the patients. Although the technique is relatively simple, many patients fail to learn it correctly.This proposal is for the development of a miniature pocket-sized nebulizer that is equivalent in aerosol delivery and effectiveness to conventional air-pressure-actuated nebulizers, but has the social acceptability of devices using canister inhalers. Such a nebulizer will be of value to patients who cannot or do not wish to use the canister inhalers, by permitting the aerosol treatment to be performed conveniently, at any time, and without regard to location. It will be especially valuable for infants and young children who cannot use or be taught to use canistertype inhalers.National Heart, Lung, and Blood Institute (NHLBI)

The program objective is the development of miniature devices for delivery of medicated aerosol to patients with diseases of the airways, such as chronic asthma. Aerosolized bronchodilators are widely used for self-administration from canister inhalers, but a major problem is poor inhalation by many patients who fail to learn the correct technique. Medicated aerosol is also administered by compressed air nebulizers in the home, as well as in hospitals, by a large number of patients who prefer this form of treatment to canister inhalers. During Phase I, a commercial product investigation and experimentation were carried out, as well as a design study of pressurized liquid nebulizers and a very small electrical actuator for canister inhalers, which eliminate dependence on special techniques for effective application. The liquid nebulizers included a miniature battery-operated compressor-nebulizer unit. High nebulization efficiencies achieved with an experimental pressurized liquid-jet nebulizer demonstrated the feasibility of an ultraminiature pocket nebulizer based on this principle. Tests of the miniature compressor and the electrical canister actuator on a SPART Analyzer showed improved particle-size distributions. In Phase II, it is planned to develop to readiness for production the improved devices for administration of therapeutic aerosol.

Anticipated Results:
A large market of asthmatic patients is anticipated for this pocket nebulizer for aerosol therapy. It is estimated that there are perhaps 750,000 such patients in the United States. A market of 5,000 to 10,000 miniature compressor-nebulizer units per year is anticipated.National Heart, Lung, And Blood Institute (NHLBI)