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Method for treatment of lung infections by administration of aminoglycosides by aerolisation

An aminoglycoside and drug delivery technology, which is applied in the direction of anti-infective drugs, aerosol delivery, nebulizers for treatment, etc., can solve the problems of no active ingredients, loss, residue, etc., and achieve the effect of low maximum plasma concentration

Inactive Publication Date: 2016-11-09
赛利亚医药公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0020] In addition, the prior art systems and methods for inhaled aminoglycoside administration to patients with pulmonary diseases have other disadvantages such as the amount of active ingredient not reaching the site of action due to the formulation remaining in the nebulizer after tobramycin administration residual or lost around the patient

Method used

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  • Method for treatment of lung infections by administration of aminoglycosides by aerolisation
  • Method for treatment of lung infections by administration of aminoglycosides by aerolisation
  • Method for treatment of lung infections by administration of aminoglycosides by aerolisation

Examples

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example 1

[0110] Example 1: Ex vivo delivery of tobramycin

[0111] Prior to clinical trials, when in vitro experiments are performed, the tobramycin solution according to the invention can be radioisotopically labeled to deliver a level of radioactivity that is safe for volunteers and sufficient for scintigraphy. Furthermore, these experiments also provided information on the amount of tobramycin solution remaining in the various components of the nebulizer system used.

[0112] The following solutions were used for ex vivo experiments:

[0113] 18% w / v (weight volume percent) w / v tobramycin solution, Celia Corporation, BN (number): 80000991 and 80000992

[0114] The following solutions were used for in vivo experiments:

[0115] 18% w / v w / v tobramycin solution, Celia, BN: 80000991 and 80000992

[0116] 20% w / v w / v Tobramycin Solution, Celia, BN: 80000981

[0117] Tobramycin solution with a concentration of 300mg / 5mL, Novartis, BN: X003812

[0118] Sodium pertechnetate solution ...

example 2

[0196] Example 2: In vivo data; comparison of prior art dosing regimens and dosing regimens according to the invention

[0197] In order to obtain the pulmonary deposition of tobramycin according to the treatment method of the present invention, a two-way non-randomized crossover study was carried out to investigate the use of Devices and PARI Pulmonary distribution and pharmacokinetics of tobramycin in healthy volunteers following single-dose administration with PLUS jet nebulizer. The study was designed as an open study because it was not possible to mask the identity of the aerosol delivery system used.

[0198] 18 healthy male volunteers and healthy, non-pregnant, non-lactating female volunteers were subjected to the following treatment regimens:

[0199] ■Through 7 slow and deep breaths The device delivered approximately 63 mg of tobramycin (180 mg / mL x 0.35 mL) to the lungs.

[0200] ■Pari through relaxing tidal breathing The PLUS jet nebulizer delivers approxim...

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Abstract

The present invention regards a novel administration form and a novel administration regime useful in the treatment and prevention of a bacterial lung infection in patient in need thereof, in particular by providing a composition useful for aerosolization of a highly concentrated solution of aminoglycosides such as Tobramycin.

Description

[0001] This application is a divisional application of a patent application with an international filing date of July 8, 2011, an application number of 201180034279.X, and an invention title of "Treatment of Lung Infection by Aminoglycoside Aerosol Administration". technical field [0002] The present invention relates to the treatment of lung infections, especially in the case of patients suffering from cystic fibrosis. Background technique [0003] Bacterial lung infections are a major problem and can be life threatening for patients with chronic lung diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease. [0004] In particular, cystic fibrosis (CF) is an autosomal recessive genetic disease that affects approximately 30,000 individuals in the United States and approximately 40,000 individuals in Europe. CF variation occurs in the gene encoding the chloride channel protein called CF transmembrane conductance regulator (CFTR). Patients homozygou...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K31/702A61P31/04A61P11/00
CPCA61K9/0078A61K31/702A61K9/12A61K31/7036A61P11/00A61P31/00A61P31/04A61M11/02A61M15/0065A61M15/0091
Inventor 托马斯·诺凌
Owner 赛利亚医药公司
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