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Formoterol/steroid bronchodilating compositions and methods of use thereof

a technology of bronchodilating compositions and steroid, which is applied in the direction of drug compositions, inorganic non-active ingredients, dispersed delivery, etc., can solve the problems of insufficient stability of compounds such as formoterol, which has many desirable properties, and is difficult to administer in liquid form

Inactive Publication Date: 2010-05-13
DEY PHARMA +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Powdered formulations are more difficult to administer, particularly to the young and elderly who are most often the patients in need of such therapy.
Compounds, such as formoterol, which has many desirable properties, are not adequately stable in aqueous solutions to be formulated as liquids.
Since some the β2-adrenoreceptor agonist compounds are not available as aqueous or liquid formulations, combinations thereof with other agents, are not available as aqueous or liquid formulations.

Method used

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  • Formoterol/steroid bronchodilating compositions and methods of use thereof
  • Formoterol/steroid bronchodilating compositions and methods of use thereof

Examples

Experimental program
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Effect test

example 1

Preparation of Solution Formulations

[0099]Polyethylene glycol 400 and / or propylene glycol and vitamin E TPGS were mixed in a stainless steel container with heating at about 42° C. until a homogeneous liquid formed. While maintaining the liquid phase, the temperature was lowered and the steroid active ingredient, e.g., budesonide or fluticasone propionate, was added. The mixing was continued until all of the drug substance had dissolved. In another container all other ingredients, including formoterol fumarate dihydrate, were mixed with about 70% water until a clear solution formed. The two solutions were mixed together until a homogeneous clear solution formed. The volume Was made up with water and the solution was mixed to give the desired composition.

[0100]Using the above procedure, the following solution compositions containing the indicated ingredients in the indicated amounts were prepared. For each steroidal anti-inflammatory agent, a low strength and a high strength formulati...

example 2

Preparation of Suspension Formulations

[0101]All ingredients, with the exception of formoterol fumarate dihydrate and the steroidal anti-inflammatory agent, e.g., budesonide or fluticasone propionate, were dissolved in about 40% water in a container with mixing. The steroidal active ingredient was added and the mixture was dispersed with high speed homogenization. Formoterol fumarate dihydrate was dissolved in about 50% water with mixing and the resulting solution was added to the steroidal suspension with mixing until a uniform suspension formed.

[0102]Using the above procedure, the following suspension formulations containing the indicated ingredients in the indicated amounts were prepared.

Budesonide / Formoterol suspension formulationsIngredientConcentrationFormoterol fumarate dihydrate5-2000 μg / mL or 50-200 μg / mLBudesonide125-500μg / mLDisodium edetate0.1-0.2mg / mLPolysorbate 800.2-0.3mg / mLSodium chloride5-10mg / mLCitrate buffer1-20mMWaterq.s.

Fluticasone propionate / Formoterol suspension...

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Abstract

Bronchodilating compositions and methods are provided. The compositions are intended for administration as a nebulized aerosol. In certain embodiments, the compositions contain formoterol, or a derivative thereof, and a steroidal anti-inflammatory agent. Methods for treatment, prevention, or amelioration of one or more symptoms of bronchoconstrictive disorders using the compositions provided herein are also provided.

Description

RELATED APPLICATIONS[0001]Benefit of priority under 35 U.S.C. §119(e) is claimed to U.S. provisional patent application Ser. No. 60 / 284,607, filed Apr. 17, 2001, to Banerjee et al. The disclosure of the above-referenced application is incorporated herein by reference in its entirety.FIELD OF THE INVENTION[0002]Compositions and methods are provided relating to treatment, prevention, or amelioration of one or more symptoms of bronchoconstrictive disorders. In particular, the compositions and methods herein include formoterol, and / or a derivative thereof, and a steroid, and / or a derivative thereof. The compositions are propellant-free, sterile unit dose or multidose inhalation solutions intended for administration via nebulization.BACKGROUND OF THE INVENTION[0003]Bronchoconstrictive disorders affect millions worldwide. Such disorders include asthma (including bronchial asthma, allergic asthma and intrinsic asthma, e.g., late asthma and airway hyper-responsiveness), chronic bronchitis a...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/56A61K31/439A61K31/135A61K9/08A61K9/00A61K31/167A61K31/537A61K31/573A61K31/58A61K45/00A61K45/06A61K47/04A61K47/12A61K47/16A61K47/34A61P11/08A61P43/00
CPCA61K9/0078A61K47/10A61K31/537A61K31/56A61K31/573A61K45/06A61K31/167A61K47/02A61K31/58A61K31/568A61K31/191A61K2300/00A61P11/00A61P11/06A61P11/08A61P43/00
Inventor BANERJEE, PARTHA S.CHAUDRY, IMTIAZ A.PHAM, STEPHEN
Owner DEY PHARMA