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US5653962A Expired / Lapsed US ⏱️ 0.0 years remaining

Aerosol formulations containing P134a and particulate medicaments

Assignee: Glaxo Group Ltd
•
Filing: 1995-05-19
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Granted: 1997-08-05
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Expires: 2015-05-19
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Abstract

Abstract This invention relates to a pharmaceutical aerosol formulation containing a particulate medicament which is salmeterol or a physiologically acceptable salt or solvate thereof end 1,1,1,2-tetrafluoroethane as propellant, which formulation is free of surfactant or has less than 0.0001 % w/w surfactant based on the weight of medicament. The formulation may contain a further particulate medicament which is salbutamol, beclomethasone dipropionate or a physiologically acceptable salt or solvate thereof. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of the pharmaceutical aerosol formulation is also described.

Inventors

  • 👤 Rachel Ann Akehurst
  • 👤 Anthony James Taylor
  • 👤 David Andrew Wyatt

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-29 20:54
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/13; A61K31/135; A61K31/137; A61K31/138; A61K31/16; A61K31/165; A61K31/167; A61K31/33; A61K31/395; A61K31/435; A61K31/44; A61K31/4402; A61K31/445; A61K31/4458; A61K31/4523; A61K31/4535; A61K31/47; A61K31/4738; A61K31/4741; A61K31/48; A61K31/495; A61K31/505; A61K31/519; A61K31/52; A61K31/522; A61K31/56; A61K31/57; A61K31/573; A61K45/00; A61K45/06; A61K9/00; A61K9/0012; A61K9/007; A61K9/0073; A61K9/008

Claims Analysis

Total Claims: 44
Claim 1
Independent Claim 71 words
A pharmaceutical aerosol formulation consisting essentially of a particulate medicament which is salmeterol or a physiologically acceptable salt or solvate thereof and 1,1,1,2-tetrafluoroethane as propellant, which formulation contains less than 0.0001% w/w surfactant based upon the weight of medicament, the particulate medicament being present in an amount of from 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.
Claim 2
Dependent Claim 71 words
A pharmaceutical aerosol formulation consisting essentially of a particulate medicament which is salmeterol or a physiologically acceptable salt or solvate thereof and 1,1,1,2-tetrafluoroethane as propellant, which formulation contains less than 0.0001% w/w surfactant based upon the weight of medicament, the particulate medicament being present in an amount of from 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.
Claim 3
Dependent Claim 29 words
A formulation as claimed in claim 1 wherein the particulate medicament is present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation.
Claim 4
Dependent Claim 21 words
A formulation as claimed in claim 1 which has a respirable fraction of 20% or more by weight of particulate medicament.
Claim 5
Dependent Claim 18 words
A formulation as claimed in claim 1 wherein the salmeterol is in the form of its xinafoate salt.
Claim 6
Dependent Claim 63 words
A pharmaceutical aerosol formulation consisting essentially of a particulate medicament which is salmeterol or a physiologically acceptable salt or solvate thereof and 1,1,1,2-tetrafluoroethane as propellent, the particulate medicament being present in an amount of from 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns, which formulation is free of surfactant.
Claim 7
Dependent Claim 63 words
A pharmaceutical aerosol formulation consisting essentially of a particulate medicament which is salmeterol or a physiologically acceptable salt or solvate thereof and 1,1,1,2-tetrafluoroethane as propellent, the particulate medicament being present in an amount of from 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns, which formulation is free of surfactant.
Claim 8
Dependent Claim 55 words
A pharmaceutical aerosol formulation consisting of particulate medicament which is salmeterol or a physiologically acceptable salt or solvate thereof and 1,1,1,2-tetrafluoroethane as propellant, the particulate medicament being present in an amount of from 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.
Claim 9
Dependent Claim 55 words
A pharmaceutical aerosol formulation consisting of particulate medicament which is salmeterol or a physiologically acceptable salt or solvate thereof and 1,1,1,2-tetrafluoroethane as propellant, the particulate medicament being present in an amount of from 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.
Claim 10
Dependent Claim 29 words
A formulation as claimed in claim 5 wherein the particulate medicament is present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation.
Claim 11
Dependent Claim 29 words
A formulation as claimed in claim 6 wherein the particulate medicament is present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation.
Claim 12
Dependent Claim 18 words
A formulation as claimed in claim 5 wherein the salmeterol is in the form of its xinafoate salt.
Claim 13
Dependent Claim 18 words
A formulation as claimed in claim 6 wherein the salmeterol is in the form of its xinafoate salt.
Claim 14
Dependent Claim 21 words
A formulation as claimed in claim 5 which has a respirable fraction of 20% or more by weight of particulate medicament.
Claim 15
Dependent Claim 21 words
A formulation as claimed in claim 6 which has a respirable fraction of 20% or more by weight of particulate medicament.
Claim 16
Dependent Claim 89 words
A pharmaceutical aerosol formulation consisting essentially of particulate medicament which is salmeterol or a physiologically acceptable salt or solvate thereof, a particulate medicament selected from the group consisting of salbutamol, beclomethasone dipropionate and physiologically acceptable salts and solvates thereof, and 1,1,1,2-tetrafluoroethane as propellant, which formulation contains less than 0.0001% w/w surfactant based upon the weight of medicament, the particulate medicaments being present in an amount of from 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.
Claim 17
Dependent Claim 89 words
A pharmaceutical aerosol formulation consisting essentially of particulate medicament which is salmeterol or a physiologically acceptable salt or solvate thereof, a particulate medicament selected from the group consisting of salbutamol, beclomethasone dipropionate and physiologically acceptable salts and solvates thereof, and 1,1,1,2-tetrafluoroethane as propellant, which formulation contains less than 0.0001% w/w surfactant based upon the weight of medicament, the particulate medicaments being present in an amount of from 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.
Claim 18
Dependent Claim 74 words
A pharmaceutical aerosol formulation consisting of particulate medicament consisting of salmeterol or a physiologically acceptable salt or solvate thereof, a particulate medicament selected from the group consisting of salbutamol, beclomethasone dipropionate and physiologically acceptable salts and solvates thereof, and 1,1,1,2-tetrafluoroethane as propellant, the particulate medicaments being present in an amount of from 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.
Claim 19
Dependent Claim 74 words
A pharmaceutical aerosol formulation consisting of particulate medicament consisting of salmeterol or a physiologically acceptable salt or solvate thereof, a particulate medicament selected from the group consisting of salbutamol, beclomethasone dipropionate and physiologically acceptable salts and solvates thereof, and 1,1,1,2-tetrafluoroethane as propellant, the particulate medicaments being present in an amount of from 0.005 to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns.
Claim 20
Dependent Claim 29 words
A formulation as claimed in claim 13 wherein the particulate medicaments are present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation.
Claim 21
Dependent Claim 29 words
A formulation as claimed in claim 14 wherein the particulate medicaments are present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation.
Claim 22
Dependent Claim 18 words
A formulation as claimed in claim 13 wherein the salmeterol is in the form of its xinafoate salt.
Claim 23
Dependent Claim 18 words
A formulation as claimed in claim 13 wherein the salmeterol is in the form of its xinafoate salt.
Claim 24
Dependent Claim 22 words
A formulation as claimed in claim 13 which has a respirable fraction of 20% or more by weight of the particulate medicaments.
Claim 25
Dependent Claim 22 words
A formulation as claimed in claim 14 which has a respirable fraction of 20% or more by weight of the particulate medicaments.
Claim 26
Dependent Claim 13 words
A formulation as claimed in claim 13 which formulation is free of surfactant.
Claim 27
Dependent Claim 23 words
A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of the pharmaceutical aerosol formulation of claim 1.
Claim 28
Dependent Claim 29 words
A method as claimed in claim 22 wherein the particulate medicament is present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation.
Claim 29
Dependent Claim 18 words
A method as claimed in claim 22 wherein the salmeterol is in the form of its xinafoate salt.
Claim 30
Dependent Claim 21 words
A method as claimed in claim 22 which has a respirable fraction of 20% or more by weight of particulate medicament.
Claim 31
Dependent Claim 23 words
A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of the pharmaceutical aerosol formulation of claim 5.
Claim 32
Dependent Claim 18 words
A method as claimed in claim 26 wherein the salmeterol is in the form of its xinafoate salt.
Claim 33
Dependent Claim 29 words
A method as claimed in claim 26 wherein the particulate medicament is present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation.
Claim 34
Dependent Claim 23 words
A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of the pharmaceutical aerosol formulation of claim 6.
Claim 35
Dependent Claim 29 words
A method as claimed in claim 29 wherein the particulate medicament is present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation.
Claim 36
Dependent Claim 18 words
A method as claimed in claim 29 wherein the salmeterol is in the form of its xinafoate salt.
Claim 37
Dependent Claim 21 words
A method as claimed in claim 29 which has a respirable fraction of 20% or more by weight of particulate medicament.
Claim 38
Dependent Claim 19 words
A method of treating respiratory disorders which comprises administration by inhalation of the pharmaceutical aerosol formulation of claim 13.
Claim 39
Dependent Claim 29 words
A method as claimed in claim 33 wherein the particulate medicaments are present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation.
Claim 40
Dependent Claim 18 words
A method as claimed in claim 33 wherein the salmeterol is in the form of its xinafoate salt.
Claim 41
Dependent Claim 22 words
A method as claimed in claim 33 which has a respirable fraction of 20% or more by weight of the particulate medicaments.
Claim 42
Dependent Claim 19 words
A method of treating respiratory disorders which comprises administration by inhalation of the pharmaceutical aerosol formulation of claim 14.
Claim 43
Dependent Claim 28 words
A method as claimed in claim 37 wherein particulate medicaments are present in an amount of 0.01 to 1% w/w relative to the total weight of the formulation.
Claim 44
Dependent Claim 18 words
A method as claimed in claim 37 wherein the salmeterol is in the form of its xinafoate salt.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2000-08-04 2001-02-03 2001-08-05 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2004-08-04 2005-02-03 2005-08-05 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2008-08-04 2009-02-03 2009-08-05 $7700.00 Window Closed / Lapsed

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