Claims for Patent: 6,983,743

Summary for Patent: 6,983,743

Title:	Stainless steel canister for propellant-driven metering aerosols
Abstract:	The present invention relates to corrosion resistant stainless steel canisters for propellant-containing aerosol formulations for use in propellant gas-operated inhalers.
Inventor(s):	Hoelz; Hubert (Oberheimbach, DE), Lostritto; Richard Thomas (Gaithersburg, MD), Nagel; Juergen (Bad Kreuznach, DE), Vega; Julio Ce (Capital Federal Buenos Aires, AR)
Assignee:	Boehringer Ingelheim Pharma KG (Ingelheim, DE)
Application Number:	10/849,725
Patent Claims:	1. A metered-dose inhaler having a metal cannister to hold drug and non-CFC propellant gas, wherein the walls of the cannister are formed by an alloy comprising the following elements in the amounts indicated: Iron of about 40.0 to about 53.0%, Nickel of about 23.0 to about 28.0%, Chromium of about 19.0 to about 23.0%, Molybdenum of about 4.0 to about 5.0%, Manganese of about 0.0 to about 2.0%, Copper of about 1.0 to about 2.0%, Silicon of about 0.0 to about 1.0%, Phosphorous of about 0.0 to about 0.045%, Sulfur of about 0.0 to about 0.035% and Carbon of about 0.0 to about 0.020%; with the proviso that the alloy does not contain aluminum. 2. The metered-dose inhaler as recited in claim 1, wherein the alloy further comprises nitrogen of about 0.04 to about 0.15%. 3. The metered-dose inhaler as recited in claim 1, wherein the alloy is one according to material number 1.4539 of the steel-iron-list of the association of the German iron-works-worker. 4. The metered-dose inhaler as recited in claim 1, wherein the alloy is as follows: Chromium about 19.0 to about 21.0%, Nickel about 24.0 to about 26.0%, Molybdenum about 4.0 to about 5.0%, Copper about 1.0 to about 2.0%, Manganese about 0.0 to about 2.0%, Silicon about 0.0 to about 0.5%, Carbon about 0.0 to about .02%, and the remainder consisting essentially of Iron. 5. The metered-dose inhaler as recited in claim 1, wherein the cannister comprises a container and a valve cup with a valve embedded therein, the container constituting walls of the cannister. 6. The metered-dose inhaler as recited in claim 5, wherein the valve cup is aluminum and is sealed with a gasket relative to the interior of the container. 7. The metered-dose inhaler as recited in claim 5, wherein the valve contains one or more stainless steel springs, a valve stem, a metering chamber and a valve body, wherein one or more of the valve stem, the metering chamber and the valve body are made of material selected from steel, the alloy used for forming walls of the cannister and a plastic. 8. The metered-dose inhaler as recited in claim 7, wherein the springs are made of stainless steel, and the valve stem, the metering chamber and the valve body are made of polybutylene terephthalate. 9. The metered-dose inhaler as recited in claim 7, wherein the valve stem is sealed off from the valve cup by a gasket or gaskets. 10. The metered-dose inhaler as recited in claim 9, wherein the gasket or gaskets are made from ethylene/propylene/diene terpolymer. 11. The metered-dose inhaler as recited in claim 7, wherein the valve cup is made from the alloy used to form the container. 12. The metered-dose inhaler as recited in claim 1, wherein walls of the canister can withstand a bursting pressure of more than 30,000 hPa. 13. The metered-dose inhaler as recited in claim 12, wherein walls of the cannister can withstand a bursting pressure of more than 100,000 hPa. 14. The metered-dose inhaler as recited in claim 13, wherein walls of the cannister can withstand a bursting pressure of more than 200,000 hPa. 15. The metered-dose inhaler as recited in claim 1, wherein walls of the cannister are about 0.1 to about 0.5 mm thick. 16. The metered-dose inhaler as recited in claim 15, wherein walls of the cannister are about 0.15 to about 0.35 mm thick. 17. The metered-dose inhaler as recited in claim 16, wherein walls of the cannister are about 0.19 to about 0.30 mm thick. 18. A metered-dose inhaler according to claim 1, wherein the cannister contains a formulation comprising a fluorohydrocarbon propellant. 19. A metered-dose inhaler according to claim 18, wherein the fluorohydrocarbon propellant is selected from 1,1,1,2-tetrafluoroethane and 1,1,1,2,3,3,3-heptafluoropropane. 20. A metered-dose inhaler according to claim 18, wherein the formulation further comprises one or more electrolytes. 21. A metered-dose inhaler according to claim 18, wherein the formulation further comprises one or more acids. 22. A metered-dose inhaler according to claim 18, wherein the formulation further comprises ethanol. 23. A metered-dose inhaler according to claim 18, wherein the formulation further contains an active substance selected from ipratropium bromide, ipratropium bromide monohydrate, oxitropium bromide, albuterol, tiotropium bromide, fenoterol or fenoterol hydrobromide. 24. A metered-dose inhaler according to claim 23, where the active substance is ipratropium bromide monohydrate. 25. A metered-dose inhaler according to claim 1, wherein the cannister contains the following formulation having the following ingredients in the % by weights as indicated: TABLE-US-00007 Ipatropium bromide monohydrate 0.001+14 2.5% by weight; Absolute ethanol 0.001+14 50% by weight; 1,1,1,2-tetrafluoroethane 50.0+14 99.0% by weight; Inorganic acid 0.01+14 0.00002 normal; and Water 0.0+14 5.0% by weight. 26. A metered-dose inhaler according to claim 1, wherein the cannister contains the following formulation having the following ingredients in the % by weights as indicated: TABLE-US-00008 Ipatropium bromide monohydrate 0.001+14 2.5% by weight; Absolute ethanol 0.001+14 50% by weight; 1,1,1,2-tetrafluoroethane 50.0+14 99.0% by weight; Ascorbic acid 0.00015+14 5.0 mg/ml; and Purified water 0.0+14 5.0% by weight. 27. A metered-dose inhaler according to claim 1, wherein the cannister contains the following formulation having the following ingredients in the % by weights as indicated: TABLE-US-00009 Ipatropium bromide monohydrate 0.0187% by weight; Absolute ethanol 15.0000% by weight; 1,1,1,2-tetrafluoroethane 84.47730% by weight; Citric acid 0.0040% by weight; and Purified water 0.5000% by weight. 28. A metered-dose inhaler according to claim 1, wherein the cannister contains the following formulation having the following ingredients in the % by weights as indicated: TABLE-US-00010 Ipatropium bromide monohydrate 0.0374% by weight; Absolute ethanol 15.0000% by weight; 1,1,1,2-tetrafluoroethane 84.4586% by weight; Citric acid 0.0040% by weight; and Purified water 0.5000% by weight. 29. A metered-dose inhaler according to claim 1, wherein the cannister contains the following formulation having the following ingredients in the % by weights as indicated: TABLE-US-00011 Ipatropium bromide monohydrate +11 0.0748% by weight; Absolute ethanol 15.0000% by weight; 1,1,1,2-tetrafluoroethane 84.4212% by weight; Citric acid +11 0.0040% by weight; and Purified water +11 0.5000% by weight. 30. A metered-dose inhaler according to claim 1, wherein the cannister contains the following formulation having the following ingredients in the % by weights as indicated: TABLE-US-00012 Fenoterol hydrobromide +11 0.192% by weight; Absolute ethanol 30.000% by weight; 1,1,1,2-tetrafluoroethane 67.806% by weight; Citric acid +11 0.002% by weight; and Purified water +11 2.000% by weight.