Pressurised metered dose inhalers containing solutions of beta-2 agonists

A pressurized metered dose inhalation and preparation technology, which can be used in medical preparations containing active ingredients, medical preparations without active ingredients, and liquid delivery, etc., and can solve problems such as no therapeutic effect.

Inactive Publication Date: 2009-08-12
CHIESI FARM SPA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Particles smaller than about 0.5 μm in diameter are generally considered to be of no therapeutic benefit because they can be exhaled

Method used

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  • Pressurised metered dose inhalers containing solutions of beta-2 agonists
  • Pressurised metered dose inhalers containing solutions of beta-2 agonists
  • Pressurised metered dose inhalers containing solutions of beta-2 agonists

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0092] Example 1 - Ultrafine TA 2005HFA formulation

[0093] A formulation delivering a nominal dose of 1 μg of active ingredient per actuation was prepared with the following composition:

[0094]

[0095] * Equivalent to 2.0μl

[0096] The formulation (120 actuations / jar over 30 actuations) was filled into aluminum cans coated with Teflon on the inner surface (two-stage pressure filling) and equipped with a metering valve with a 63 μl metering chamber. An actuator with a bore diameter of 0.22mm is used. Results were obtained as the average of 2 pots.

[0097] Similarly, formulations may be prepared to deliver nominal doses of 2, 3 or 4 [mu]g of active ingredient per actuation. The aerodynamic particle size distribution was determined by ACI according to page 16, lines 10-18, and the delivery characteristics of each formulation were determined according to the following parameters: i) nominal dose: theoretical dose for a single actuation; ii) delivered dose: Amount of ...

Embodiment 2

[0102] Example 2 - Ultrafine HFA formulation containing TA 2005 and 22R-budesonide

[0103] A formulation delivering a nominal dose of 1 μg of TA 2005 and 80 μg of 22R-budesonide per actuation was prepared with the following composition:

[0104]

[0105] * Equivalent to 3.3 μl

[0106] The formulation (120 actuations / jar, over 30 actuations) was filled into aluminum cans coated with Teflon on the inner surface (two-stage pressure filling) and equipped with a metering valve with a 63 μl metering chamber.

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Abstract

The present invention relates to a pressurized measured dose inhaler comprising beta2-agonists. Specifically the invention relates to a medical aerosol preparation which is fed through the pressurized measured dose inhaler. The invention relates to a pharmaceutical formulation for use in the administration of 2(1H)-quinolinone derivative long-acting beta2-agonists by inhalation. Particularly, the invention relates to a chemically stable highly efficient TA 2005 HFA solution formulation to be administered by pressurized metered dose inhalers (pMDIs) characterized by a deep lung penetration. The invention also relates to methods for the preparation of said formulation and to its use in respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD).

Description

[0001] This application was submitted on February 27, 2003, the application number is 03804972.4, and the title of the invention is "Containing β 2 - Divisional application for a pressurized metered-dose inhaler for a solution of an agonist". Background of the invention [0002] Asthma is an increasingly common disease and the most common disease in children. It is diagnosed by recurrent stridor and intermittent limitation of ventilation. Despite many advances in its understanding, the condition is poorly understood and often a poorly treated disease. Previously, contraction of airway smooth muscle was considered the most important feature of asthma. There has recently been a marked change in asthma treatment based on the fact that asthma is considered a chronic inflammatory disease. Uncontrolled airway inflammation can lead to mucosal damage and structural changes that irreversibly narrow the airways and fibrillate the lung tissue. change. Treatment therefore aims to cont...

Claims

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Application Information

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IPC IPC(8): A61K9/72A61K31/4704A61K47/34A61K45/06A61P11/06A61P11/00A61K9/12A61K9/00A61K31/00A61K31/485A61K47/10A61K47/14A61P25/04
CPCA61K31/00A61K31/485A61K47/10A61K9/008A61K45/06A61K31/4704A61P11/00A61P11/06A61P11/08A61P25/04A61K2300/00A61K9/12A61K9/00
Inventor R·J·戴维斯D·甘德顿D·A·刘易斯B·J·米金T·K·丘奇G·布拉姆比拉A·弗拉里斯
Owner CHIESI FARM SPA
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