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Pressurized metered dose inhalers and pharmaceutical aerosol formulations

a technology of aerosol formulation and metered dose, which is applied in the directions of aerosol delivery, dispersion delivery, organic active ingredients, etc., can solve the problems of difficult formulation of conventional aerosols, and short shelf life of formulations

Inactive Publication Date: 2002-02-14
IVAX CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0024] The aerosol formulations are surprisingly stable under conditions up to about 40.degree. C. and about 75% relative humidity for at least about four weeks.

Problems solved by technology

The .beta.-agonist drug, formoterol ("eformoterol" in Europe) and its derivatives, have proven difficult to formulate in conventional aerosols.
Such formulations have exhibited short shelf-lives and require refrigeration.
Refrigeration is undesirable because many patients are required to carry the aerosol canisters on their persons.

Method used

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  • Pressurized metered dose inhalers and pharmaceutical aerosol formulations
  • Pressurized metered dose inhalers and pharmaceutical aerosol formulations

Examples

Experimental program
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Effect test

examples 4-7

[0058] Four solution aerosols according to present invention were formulated by combining the components shown in Table 2, using the method described in Example 1. To determine the stability of the solution aerosol formulations, Examples 6 and 7 were maintained for 1 month (28 days) at 40.degree. C. and 75% relative humidity, which are considered herein as accelerated conditions. The solution aerosol formulations were equilibrated at room temperature overnight before testing. The properties of the solution aerosol formulations were measured as in Example 1 and the results are shown in Table 2.

[0059] The data indicates that the dose delivered (by unit spray determination) after storage under accelerated conditions was lower than that obtained with the initial samples due to drug adsorption onto the valve gasket material. However, the solution aerosol formulations showed no signs of chemical deterioration.

examples 8 and 9

[0060] Two solution aerosols according to present invention were formulated by combining the components shown in Table 3, using the method described in Example 1. To determine the stability of the solution aerosol formulations, Example 9 was maintained for 1 month (28 days) at 40.degree. C. and 75% relative humidity, which are considered herein as accelerated conditions. The solution aerosol formulations were equilibrated at room temperature overnight before testing. The properties of the solution aerosol formulations were measured as in Example 1 and the results are shown in Table 3.

[0061] The drug could not be recovered from the gasket materials during this study, which resulted in a loss of about 15% by weight. However, the solution aerosol formulations showed no signs of chemical deterioration.

examples 10-13

[0062] Four suspension aerosols according to present invention were formulated by combining the components shown in Table 4, using the method described in Example 1. To determine the stability of the suspension aerosol formulations, Examples 12 and 13 were maintained for 1 month (28 days) at 40.degree. C. and 75% relative humidity, which are considered herein as accelerated conditions. The suspension aerosol formulations were equilibrated at room temperature overnight before testing. The properties of the suspension aerosol formulations were measured as in Example 1 and the results are shown in Table 4.

[0063] After 28 days storage, the dose delivered (by unit spray determination) in Examples 12 and 13 was less than that obtained with the initial Examples 10 and 11, but not reduced by the same degree as with the solution formulation examples.

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Abstract

Provided are pressurized metered dose inhalers containing stable formulations of a beta-agonist drug in suspension or solution. Also provided are aerosol formulations suitable for inhalation therapy containing a beta-agonist drug in suspension or solution.

Description

1. FIELD OF THE INVENTION[0001] The invention relates to pressurized metered dose inhalers and aerosol formulations for inhalation therapy.2. BACKGROUND OF THE INVENTION[0002] Because of environmental considerations, chlorohydrocarbon and chlorofluorocarbon propellants for aerosol formulations for medical uses have been largely replaced by hydrofluoroalkanes such as 1,1,1,2-tetrafluoroethane ("HFA-134a") and 1,1,1,2,3,3,3,-heptafluoroprop-ane ("HFA-227ea") that have been identified as safe for use in pressurized metered dose inhalers.[0003] Such medicinal aerosol formulations are generally of the solution or suspension type. Each type is composed of, at least, the medicament and the propellant. Some formulations also include one or more special purpose adjuvants such as a cosolvent or a surfactant (EP 0 372777). Conventional aerosol solution formulations contain low concentrations of a cosolvent more polar than the propellant. Conventional aerosol suspension formulations contain a s...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/00A61K9/12A61K9/14A61K9/72A61K31/165A61K31/167A61K47/06A61K47/10A61M11/00A61M15/00
CPCA61K9/008A61K9/124A61K31/167A61K47/10
Inventor BLONDINO, FRANK E.BRUCATO, MICHAELBUENAFE, MARIA
Owner IVAX CORP
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