Treatment of lung infections by administration of tobramycin by aerolisation

A pulmonary and drug delivery technology, used in anti-infective drugs, aerosol delivery, therapeutic nebulizers, etc., can solve the problems of no active ingredients, residues, loss, etc., and achieve the effect of low maximum plasma concentration

Inactive Publication Date: 2013-04-17
赛利亚医药公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0019] Additionally, the prior art systems and methods for inhaled aminoglycoside administration to patients with pulmonary disease 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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  • Treatment of lung infections by administration of tobramycin by aerolisation
  • Treatment of lung infections by administration of tobramycin by aerolisation
  • Treatment of lung infections by administration of tobramycin by aerolisation

Examples

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example 1

[0109] Example 1: Delivery of tobramycin in vitro

[0110] Before clinical experiments, when conducting in vitro experiments, the tobramycin solution according to the present invention can be labeled with radioisotope, and the level of radioactivity to be delivered is safe for volunteers and sufficient for scintigraphy. Moreover, these experiments also provide information on the amount of tobramycin solution remaining in the various components of the nebulizer system used.

[0111] The following solutions were used for in vitro experiments:

[0112] 18%w / v (weight and volume percentage) w / v tobramycin solution, Celia Company, BN (No.): 80009991 and 80000992

[0113] The following solutions are used for in vivo experiments:

[0114] 18% w / v w / v tobramycin solution, Celia Company, BN: 80009991 and 80000992

[0115] 20% w / v w / v tobramycin solution, Celia Company, BN: 80000981

[0116] Tobramycin solution with a brand concentration of 300mg / 5mL, Novartis, BN:X003812

[0117] Sodium pertechne...

example 2

[0195] Example 2: In vivo data; compare the prior art dosing regimen with the dosing regimen according to the present invention

[0196] In order to obtain the pulmonary deposition of tobramycin according to the treatment method of the present invention, a two-way non-random crossover study was conducted to study the use of Device and The lung distribution and pharmacokinetics of healthy volunteers after single dose administration of tobramycin with PLUS jet nebulizer. The study was designed as an open study because it was impossible to mask the identity of the aerosol delivery system used.

[0197] 18 healthy male volunteers and healthy, non-pregnant, non-breastfeeding female volunteers were given the following treatment plan:

[0198] ■Through 7 slow deep breaths The device delivers approximately 63 mg of tobramycin (180 mg / mL x 0.35 mL) to the lungs.

[0199] ■Through relaxing tidal breathing via PARI PLUS jet nebulizer delivers approximately 300mg of tobramycin Brand, 60mg / mL...

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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

Technical field [0001] The present invention relates to the treatment of lung infections, especially in the case of patients suffering from cystic fibrosis. Background technique [0002] For patients with chronic lung diseases (such as asthma, cystic fibrosis, and chronic obstructive pulmonary disease), bacterial lung infections are a major problem and can be life-threatening. [0003] In particular, Cystic Fibrosis (CF) is an autosomal recessive genetic disease that affects approximately 30,000 people in the United States and approximately 40,000 people in Europe. CF mutations occur in the gene encoding the chloride channel protein called CF transmembrane conductance regulation (CFTR). Patients who are homozygous for the defective CFTR gene usually suffer from chronic recurrent intrabronchial infections (finally fatal) and sinusitis, as well as malabsorption due to pancreatic insufficiency, increased sweat salt loss, obstructive hepatobiliary ducts and Decline in fertility. [00...

Claims

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Application Information

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