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Details for Patent: 6,656,453

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Details for Patent: 6,656,453

Title: Medicaments
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)
Filing Date:Jun 27, 2002
Application Number:10/185,193
Claims:1. A process of forming a pharmaceutical aerosol formulation, said process consisting essentially of: subjecting particulate salbutamol sulphate to a temperature between about 0.degree. C. and about 100.degree. C. with a relative humidity of between about 20% to about 90% to form annealed particulate salbutamol sulphate; and combining the annealed salbutamol sulphate with a propellant comprising 1,1,1,2-tetrafluoroethane to form a pharmaceutical aerosol formulation.

2. The process according to claim 1, wherein said step of subjecting particulate salbutamol sulphate to a temperature of between about 0.degree. C. and about 100.degree. C. with a relative humidity of between about 20% to about 90% comprises subjecting particulate salbutamol sulphate to a temperature of between about 10.degree. C. and about 50.degree. C. with a relative humidity of between about 55% to about 65%.

3. The process according to claim 1, wherein said step of subjecting particulate salbutamol sulphate to a temperature of between about 0.degree. C. and about 100.degree. C. with a relative humidity of between about 20% to about 90% comprises subjecting particulate salbutamol sulphate to a temperature of between about 20.degree. C. and about 30.degree. C. with a relative humidity of about 60%.

4. The process according to claim 1, wherein the annealed particulate salbutamol sulphate is present in the pharmaceutical aerosol formulation in an amount from about 0.01 to about 1% w/w.

5. The process according to claim 1, wherein the annealed particulate salbutamol sulphate is present in the pharmaceutical aerosol formulation an amount ranging from about 0.05 to about 0.2% w/w.

6. The process according to claim 1, the pharmaceutical aerosol formulation consisting essentially of the annealed particulate salbutamol sulphate and 1,1,1,2-tetrafluoroethane as propellant.

7. The process according to claim 1, wherein the annealed particulate salbutamol sulphate is substantially thermally inactive as measured by microcalorimetry at about 25.degree. C. and between about 30% to about 90% relative humidity.

8. The process according to claim 7, wherein the annealed particulate salbutamol sulphate is micronized and includes a recrystallized outer layer.

9. A process of forming a pharmaceutical aerosol formulation, said process consisting essentially of: subjecting particulate salbutamol sulphate to elevated temperatures under vacuum to form annealed particulate salbutamol sulpahte; and combining the annealed salbutamol sulphate with a propellant comprising 1,1,1,1,2-tetrafluoroethane to form a pharmaceutical aerosol formulation.

10. The process according to claim 9, wherein said step of subjecting particulate salbutamol sulphate to elevated temperatures under vacuum to form annealed particulate salbutamol sulphate comprises subjecting particulate salbutamol sulphate to a temperature of from about 40.degree. C. to about 100.degree. C.

11. The process according to claim 9, wherein said step of subjecting particulate salbutamol sulphate to elevated temperatures under vacuum to form annealed particulate salbutamol sulphate comprises subjecting particulate salbutamol sulphate to a temperature greater than about 60.degree. C.

12. The process according to claim 9, wherein the annealed particulate salbutamol sulphate is present in the pharmaceutical aerosol formulation in an amount from about 0.01 to about 1% w/w.

13. The process according to claim 9, wherein the annealed particulate salbutamol sulphate is present in the pharmaceutical aerosol formulation an amount ranging from about 0.05 to about 0.2% w/w.

14. The process according to claim 9, the pharmaceutical aerosol formulation consisting essentially of the annealed particulate salbutamol sulphate and 1,1,1,2-tetrafluoroethane as propellant.

15. The process according to claim 9, wherein the annealed particulate salbutamol sulphate is substantially thermally inactive as measured by microcalorimetry at about 25.degree. C. and between about 30% to about 90% relative humidity.

16. The process according to claim 15, wherein the annealed particulate salbutamol sulphate is micronized and includes a recrystallized outer layer.
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