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|Title:||Inhalable dry powder aztreonam for treatment and prevention of pulmonary bacterial infections|
|Abstract:||A method and a composition for treatment of pulmonary bacterial infections caused by gram-negative bacteria suitable for treatment of infection caused by Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Pseudomonas aeruginosa, Haemophilus influenzae, Proteus mirabilis, Enterobacter species, Serratia marcescens as well as those caused by Burkholderia cepacia, Stenotrophomonas maltophilia, Alcaligenes xylosoxidans, and multidrug resistant Pseudomonas aeruginosa, using a concentrated formulation of aztreonam, or a pharmaceutically acceptable salt thereof, delivered as an aerosol or dry powder formulation.|
|Inventor(s):||Montgomery; Alan Bruce (Seattle, WA)|
|Assignee:||Salus Pharma, Inc. (Seattle, WA)|
|Filing Date:||Dec 20, 2001|
|Claims:||1. A method of treatment for pulmonary infections caused by gram-negative bacteria Burkholderia cepacia, Stenotrophomonas maltophilia, Alcaligenes xylosoxidans, and multidrug resistant Pseudomonas aeruginosa, said method comprising steps: a. preparing a concentrated inhalable aztreonam formulation consisting of from about 1 to about 200 mg of purified aztreonam base, or a pharmaceutically acceptable salt thereof in an inhalable dry powder form, said dry powder having particle size between 1 and 5 microns and pH from 4.0 to 7.5; and b. delivering said aztreonam dry powder or the aztreonam salt to the lung endobronchial space of airways of a patient in need thereof by a dry powder or meter dose inhaler; provided that the pharmaceutically acceptable salt is not arginine. |
2. The method of claim 1 wherein the formulation is delivered one to twelve times a day, provided that if the dry powder is delivered more then twice a day, a total dose of aztreonam is not higher than 500 mg a day.
3. The method of claim 2 wherein the pharmaceutically acceptable salt is selected from the group consisting of acetate, adipate, alginate, aspartate, benzoate, benzenesulfonate, bisulfate, butyrate, camphorate, camphorsulfonate, chloride, citrate, cyclopentanepropionate, digluconate, dodecylsulfate, ethanesulfonate, glucoheptanoate, glycerophosphate, hemisulfate, heptanoate, hexanoate, fumarate, hydrochloride, hydrobromide, hydroiodide, 2-hydroxyethanesulfonate, lactate, lysinate, maleate, methanesulfonate, nicotinate, 2-napthalenesulfonate, oxalate, pamoate, pectinate, persulfate, 3-phenylpropionate, picrate, pivalate, phosphate, propionate, succinate, sulphate, tartrate, thiocyanate, p-toluenesulfonate and undecanoate.
4. The method of claim 3 comprising administration of from about 1 to about 100 mg of the aztreonam inhalable dry powder once, twice, three or four times a day.
5. The method of claim 4 comprising administration of from about 10 to about 100 mg of the aztreonam inhalable dry powder once, twice, three or four times a day.
6. The method of claim 5 comprising administration of from about 10 to about 50 mg of the aztreonam inhalable dry powder once, twice, three or four times a day.
7. The method of claim 4 wherein the dry powder is delivered by the dry powder inhaler.
8. The method of claim 4 wherein the dry powder is delivered by the metered dose inhaler.
9. The method of claim 1 wherein a delivered dose of aztreonam or the pharmaceutically acceptable salt thereof into the lung endobronchial space of airways during one administration is at least 25 mg of aztreonam or the salt thereof.
10. The method of claim 1 suitable for treatment of infections caused by the gram-negative bacteria in patients with cystic fibrosis, bronchiectasis, or in the patients on ventilators.
11. The method of claim 2, wherein the salt is a pharmaceutically acceptable acid addition salt of hydrochloric acid, sulphuric acid, phosphoric acid, oxalic acid, maleic acid, acetic acid, aspartic acid, succinic acid and citric acid.
12. The method of claim 2, wherein the salt is a pharmaceutically acceptable sodium, lithium, potassium, calcium, magnesium or aluminum salt or nontoxic ammonium, quaternary ammonium, tetramethylammonium, tetraethylammonium, methylamine, dimethylamine, trimethylamine, triethylamine, diethylamine, ethylenediamine, ethanolamine, diethylamine or ethylamine.
13. The method of claim 3 wherein the salt is chloride, bromide, sulfate, nitrate phosphate or a mixture thereof.
14. The method of claim 2, wherein a daily dose of aztreonam dry powder and frequency of delivery for effective treatment of pulmonary infection is determined by a level of aztreonam in a patient's sputum.
15. The method of claim 14 wherein the daily dose is calculated to provide from about 500 to about 2000 micrograms of aztreonam per 1 ml of sputum.
16. The method of claim 6 wherein the inhalable dry powder is supplied as a one component of a formulation for aerosolization.
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