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Serving leading biopharmaceutical companies globally:

Argus Health
Novartis
Accenture
Boehringer Ingelheim
Dow
Mallinckrodt
US Army
Johnson and Johnson
Queensland Health
Cerilliant

Generated: December 15, 2017

DrugPatentWatch Database Preview

Claims for Patent: 6,558,651

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Claims for Patent: 6,558,651

Title: Aerosols containing annealed particulate salbutamol and tetrafluoroethane
Abstract:This invention relates to aerosol formulations of use for the administration of medicaments by inhalation. More particularly, the invention relates to a pharmaceutical aerosol formulation which comprises particulate salbutamol sulphate having a crystalline form in which the outer layer of the crystals is substantially non-amorphous; and 1,1,1,2-tetrafluoroethane. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation as defined is also described.
Inventor(s): Riebe; Michael Thomas (Raleigh, NC), Dwivedi; Sarvajna Kumar (San Diego, CA), Li-Bovet; Li (Scotch Plains, NJ)
Assignee: SmithKline Beecham Corporation (Philadelphia, PA)
Application Number:09/091,496
Patent Claims: 1. A pharmaceutical aerosol formulation comprising: annealed particulate salbutamol sulphate; and a propellant comprising 1,1,1,2-tetrafluoroethane.

2. A pharmaceutical aerosol formulation comprising: annealed particulate salbutamol sulphate, wherein the annealed particulate is substantially thermally inactive as measured by microcalorimetry at about 25.degree. C. and between about 30% to about 90% relative humidity; and a propellant comprising 1,1,1,2-tetraflouroethane.

3. The pharmaceutical aerosol formulation of claim 1, wherein the annealed particulate salbutamol sulphate is micronized and includes a recrystallized outer surface layer.

4. A pharmaceutical aerosol formulation comprising: annealed particulate salbutamol sulphate having a water content of less than about 0.4% by weight; and propellant comprising 1,1,1,2-tetrafluoroethane.

5. The formulation of claim 4, wherein said annealed particulate salbutamol sulphate has a water content of less than about 0.35% by weight.

6. The formulation of claim 5, wherein said annealed particulate salbutamol sulphate has a water content of less than about 0.3% by weight.

7. The formulation of claim 1, wherein said annealed particulate salbutamol sulphate is present in an amount from 0.01% to 1% w/w.

8. The formulation claim 1, wherein said annealed particulate salbutamol sulphate is present in an amount from 0.05 to 0.2% w/w.

9. A pharmaceutical aerosol formulation consisting essentially of: annealed particulate salbutamol sulphate; and a propellant comprising 1,1,1,2-tetrafluoroethane.

10. A canister suitable for delivering a pharmaceutical aerosol formulation comprising: a container capable of withstanding the vapour pressure of a propellant comprising 1,1,1,2-tetrafluoroethane, a metering valve for containing the propellant in the container; and within the container, the pharmaceutical aerosol formulation comprising annealed particulate salbutamol sulphate and the propellant.

11. The canister of claim 10 wherein the container is a metal can.

12. The canister of claim 10, wherein the container is an aluminum can having internal surfaces, and wherein the internal surfaces are coated with a coating comprising a fluorocarbon polymer.

13. A metered dose inhaler comprising: a container adapted to contain a pharmaceutical aerosol formulation; in the container the pharmaceutical aerosol formulation comprising annealed particulate salbutamol sulphate and 1,1,1,2-tetrafluoroethane; and metering means for metering the aerosol formulation.

14. A method of treating respiratory disorders comprising: providing a pharmaceutical aerosol formulation comprising annealed particulate salbutamol sulphate and 1,1,1,2-tetrafluoroethane; and administering by inhalation of treatment effective amount of the pharmaceutical aerosol formulation.

15. A pharmaceutical aerosol formulation made by the steps comprising: providing crystalline particulate salbutamol sulphate, annealing the crystalline particulate salbutamol sulphate by subjecting said particulate salbutamol sulphate to a temperature of between about 0.degree. C. to about 100.degree. C. with a relative humidity of between about 20% to about 90% to produce annealed particulate salbutamol sulphate; and combining the annealed particulate salbutamol sulphate with a propellant comprising 1,1,1,2-tetrafluoroethane.

16. A pharmaceutical aerosol formulation made by the steps comprising: providing crystalline particulate salbutamol sulphate; annealing the crystalline particulate salbutamol sulphate by heating said particulate salbutamol under a vacuum to produce annealed particulate salbutamol sulphate; and combining the annealed particulate salbutamol sulphate with a propellant comprising 1,1,1,2-tetrafluoroethane.
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Serving leading biopharmaceutical companies globally:

Moodys
Cantor Fitzgerald
Chubb
Deloitte
Julphar
Teva
Daiichi Sankyo
Farmers Insurance
Merck
UBS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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