Generated: April 30, 2017
|Title:||Inhalable aztreonam lysinate formulation 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 lysinate delivered as an aerosol or dry powder formulation.|
|Inventor(s):||Montgomery; Alan Bruce (Medina, WA)|
|Assignee:||Corus Pharma, Inc. (Seattle, WA)|
1. An inhalable composition comprising aztreonam lysinate, said composition suitable for the treatment of pulmonary bacterial infections caused by gram-negative bacteria,
wherein said aztreonam lysinate is prepared as an inhalable dry powder having a particle size with a mass medium average diameter from about 1 to about 5.mu..
2. The composition of claim 1 wherein the aztreonam lysinate is alpha aztreonam lysinate.
3. The composition of claim 1 wherein the gram-negative bacteria is Burkholderia cepacia.
4. The composition of claim 1 wherein the gram-negative bacteria is Stenotrophomonas maltophilia.
5. The composition of claim 1 wherein the gram-negative bacteria is Alcaligenes xylosoxidans.
6. The composition of claim 1 wherein the gram-negative bacteria is a multidrug resistant Pseudomonas aeruginosa.
7. The composition of claim 1 comprising from about 1 to 250 mg of the aztreonam lysinate, wherein the composition may be administered as the inhalable dry powder by a dry powder inhaler or as a diluted saline solution by a metered dose inhaler the aerosolable solution.
8. The composition of claim 7, comprising 10 to 100 of aztreonam lysinate.
9. The composition of claim 8 comprising 75 mg of aztreonam lysinate, wherein said composition may be administered twice or three times a day.
10. The composition of claim 7 wherein the aztreonam lysinate is alpha aztreonam lysinate prepared from an alpha aztreonam form.
11. The composition of claim 10 wherein said alpha aztreonam lysinate has impurity lower than 1% and stability for at least two years.
12. The composition of claim 11 wherein said alpha aztreonam lysinate contains less than 100 ppm of residual alcohol and initial levels of contaminants generated from the alpha aztreonam lysinate are less than 1%.
13. The composition of claim 10 wherein said aztreonam lysinate is in a solution comprising a volume of saline from about 1 to about 5 ml, said saline comprising between about 0.09% and about 0.9% of chloride, w/v, or an equivalent amount of bromine or iodine, wherein said solution is aerosolable and wherein said aerosolable solution has a pH from about 4.2 to about 7.5.
14. The composition of claim 13 wherein said saline comprises from about 0.1 to about 0.45% of sodium chloride, w/v, and wherein said pH is from about 5.5 to about 7.
15. The composition of claim 14 wherein the aztreonam lysinate is present in a concentration of about 75 mg/ml in said saline.
16. A method for administering aztreonam lysinate comprising administration of the composition of claim 7 by a dry powder inhaler or by a metered dose inhaler, wherein said composition may be administered one to twelve times a day, provided that if the composition is delivered more than twice a day, a total dose of aztreonam lysinate is not higher than 750 mg a day.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.