United States Patent:  6,083,922

Assignee:  Pathogenesis, Corp. (Seattle, WA)

Filed:  April 2, 1997

A method for treatment, prevention and containment of acute and chronic tuberculosis using a preservative-free concentrated tobramycin aerosol formulation delivering tobramycin to the lung endobronchial space including alveoli in an aerosol having mass medium average diameter predominantly between 1 to 5.mu.. The method comprises administration of tobramycin in concentration one to ten thousand times higher than the minimal inhibitory concentration of Mycobacterium tuberculosis. A method for containment of and decreasing infectivity periods of tuberculosis patients to shorter periods of time.

SUMMARY OF THE INVENTION

One aspect of the current invention is a method for treatment, prevention and containment of pulmonary tuberculosis or other infections caused by Mycobacterium tuberculosis, Mycobacterium bovis or other mycobacteria by administering to a subject requiring such treatment a formulation comprising about a one to ten thousands times higher concentration of tobramycin than is its minimal inhibitory concentration.

Another aspect of the current invention is a method for treatment, prevention and containment of pulmonary tuberculosis caused by Mycobacterium tuberculosis, by administering to a subject requiring such treatment twice daily, for at least five days, a formulation comprising about 8 to about 80 mg/mL of tobramycin dissolved in a full or quarter normal saline having a pH between 5.5 and 7.0 and delivered by a jet or ultrasonic nebulizer in 5 mL concentrated form in an aerosol producing a particle size having the mass medium average diameter predominantly between 1 and 5.mu..

Still another aspect of the current invention is a method for treatment of pulmonary infections caused by Mycobacterium tuberculosis by administering to a subject requiring such treatment a formulation comprising about 300 mg of tobramycin dissolved in 5 mL of a quarter normal saline adjusted to a pH about 5.5 to about 6.5.

Still yet another aspect of the current invention is an aerosol formulation comprising concentration from about 8 to about 80 mg/mL of tobramycin dissolved in about 5 mL of a full or quarter normal strength saline wherein said tobramycin concentration is one to ten thousand times higher than the minimal inhibitory concentration of tobramycin.

Claim 1 of 20 Claims

1. A method for treatment and containment of infectivity of pulmonary tuberculosis by providing a patient in need of such treatment an aerosol formulation comprising aerosolized tobramycin, said method comprising a step:

(a) administering to the patient a nebulized aerosol formulation consisting essentially of from about 40 to about 800 mg tobramycin dissolved in full strength or diluted saline adjusted to pH between 5.5 and 7.0 using a nebulizer producing an aerosolized tobramycin of particles sizes of which a mass medium average diameter is predominantly between 1 and 5.mu. once or twice daily at least until a count of Mycobacterium tuberculosis decreases to less than 10³.

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