Claims for Patent: 6,431,168

Summary for Patent: 6,431,168

Title:	Dispenser with doses' counter
Abstract:	There is provided a dispenser suitable for dispensing medicament, particularly medicament for use in the treatment of respiratory disorders. The dispenser comprises a housing (1) having a support (5); a container (2), locatable within said housing (1), having an outlet member, wherein said container (2) is movable relative to the housing (1) to enable dispensing therefrom and said outlet member is connectable with said support (5) to prevent relative movement there-between; and a dose indicator (13, 43), locatable within said housing (1). The container (2) and dose indicator (13, 43) are reversably removable from the housing (1) as a single unit.
Inventor(s):	Rand; Paul Kenneth (Redhill, GB), Brand; Peter John (Royston, GB), Godfrey; James William (Hertfordshire, GB), Bonney; Stanley George (Hertfordshire, GB)
Assignee:	Smithkline Beecham Corporation (Philadelphia, PA)
Application Number:	09/445,673
Patent Claims:	1. A dispenser for dispensing medicament comprising a housing having a support; a container, locatable within said housing, having an outlet member, wherein said container is movable relative to an housing to enable dispensing therefrom and said outlet member is connectable with said support to prevent relative movement therebetween; and an actuation indicator, locatable within said housing, wherein the container and actuation indicator are reversably removable from the housing as a single unit. 2. A dispenser according to claim 1 wherein the actuation indicator is engagable with the container in the vicinity of said outlet member. 3. A dispenser according to claim 2 wherein the actuation indicator is engagable with the outlet member. 4. A dispenser according to claim 1, wherein the actuation indicator is provided with a grip member which is engagable with a neck portion of the container. 5. A drug product according to claim 4, wherein the neck portion is adjacent to or on the outlet member. 6. A drug product according to claim 1 wherein the container is an aerosol container. 7. A dispenser according to claim 1 wherein the housing is provided with an outlet, preferably in the form of a mouthpiece. 8. A dispenser according to claim 7 comprising a passage through which dispensed doses may pass from the container to said outlet. 9. A dispenser according to claim 1 wherein said container provides measured doses. 10. A drug product according to claim 1 wherein said actuation indicator indicates the number of doses dispensed from or remaining in the container. 11. A dispenser according to claim 1, wherein the actuation indicator comprises an indexing mechanism actuated by a predetermined movement of the container relative to the housing. 12. A dispenser according to claim 11, wherein the indexing mechanism comprises a lost motion coupling to allow and compensate for excess movement of the container relative to the housing. 13. A dispenser according to claim 12, wherein the indexing mechanism indexes the actuation indicator by means of a predetermined rotary movement of a first member driven by movement relative to a second member during actuation of the dispenser. 14. A dispenser according to claim 12 13, wherein the first member comprises a pinion carried by a shaft through the lost motion coupling and the second member comprises a rack. 15. A drug product according to claim 1, actuable in response to the inward breath of a user. 16. The drug product of claim 1 wherein the container is movable relative to the housing to enable dispensing therefrom, and the outlet member is connectable with the support to prevent relative movement therebetween. 17. A drug product comprising: an aerosol canister including a can containing a drug formulation comprising a propellant and a medicament; a valve having a valve stem: an actuator removably engaging the aerosol canister; and, an actuation indicator fixedly engaging the aerosol canister. wherein the fixedly engaged container and actuation indicator are reversibly removable as a single unit. 18. The drug product of claim 17, wherein the actuation indicator includes a drive shaft frictionally coupled to a pinion, a post engaging the pinion, a yoke engaging the drive shaft, and, first and second switching latches engaging a star wheel, wherein the drive shaft, yoke, and pinion, wherein each rotate in a plane longitudinal to movement of the aerosol canister. 19. The drug product of claim 17, wherein the actuation indicator is fixed to the aerosol canister by a barbed tang fixedly engaging a ferrule fixed to the can. 20. The drug product of claim 17, wherein the actuation indicator is fixed to the aerosol canister by an adhesive, a welded shrink sleeve, a heat form, a crimp, an ultrasonic weld, an o-ring elastomer. 21. The drug product of claim 17, wherein the actuation indicator is permanently attached to the aerosol canister. 22. The drug product of claim 17, wherein the medicament is selected from the group consisting of beclomethasone, fluticasone, flunisolide, budesonide, rofleponide, mometasone, triamcinolone, noscapine, albuterol, salmeterol, ephedrine, adrenaline, fenoterol, formoterol, isoprenaline, metaproterenol, terbutaline, tiotropium, ipratropium, phenylephrine, phenylpropanolamine, pirbuterol, reproterol, rimiterol, isoetharine, tulobuterol, (-)-4-amino-3,5-dichloro-.alpha.-{{{6-{2-(2-pyridinyl)ethoxy}hexyl}methyl} benzenemethanol, esters, solvates and salts thereof, and combinations thereof. 23. The drug product of claim 17, wherein the medicament is albuterol sulphate. 24. The drug product of claim 17, wherein the medicament is salmeterol xinafoate. 25. The drug product of claim 17, wherein the medicament is fluticasone propionate. 26. The drug product of claim 17, wherein the medicament is beclomethasone dipropionate. 27. The drug product of claim 17, wherein the medicament is the combination of salmeterol xinafoate and fluticasone propionate. 28. The drug product of claim 17, wherein the medicament is salmeterol xinafoate and a salt, ester or solvate of ipratropium. 29. The drug product of claim 17, wherein the aerosol canister includes a ferrule; wherein the actuator includes a body housing the actuation indicator; and, wherein the actuation indicator includes a tubular member adapted to receive the ferrule. 30. The drug product of claim 17, wherein the actuator further includes a window to adapted to display numerals on one or more digit wheels engaging the star wheel. 31. The drug product of claim 30 comprising 3 digit wheels each having numerals 0 through 9. 32. A drug product comprising: a means for containing a drug formulation comprising a propellant and a medicament, a means for metering the drug formulation; a means for actuating the containing means; a means for removably engaging the containing and actuating means; a means for indicating actuations; and, a means for fixedly engaging the containing and indicating means. 33. A drug product for dispensing a drug formulation comprising a propellant and a medicament comprising: a means for containing the drug formulation; a means for supporting the containing means; a means for indicating actuation of the containing means; a means for fixedly engaging the containing and indicating means; and, a means for housing the containing, supporting, and indicating means. 34. A method of treating a patient comprising: providing the drug product of claim 17; actuating the drug formulation into the lungs of the patient; and, indexing the actuation indicator. 35. The method of claim 34 further including the acts of: removing the container and actuation indicator assembly from the housing; cleaning the housing; and, re-inserting the assembly into the cleaned housing. 36. A method of treating a patient comprising: providing the drug product of claim 1; actuating the drug formulation into the lungs of the patient; and, indexing the actuation indicator. 37. The method of claim 36 further including the acts of: removing the aerosol canister and actuation indicator assembly from the actuator; cleaning the actuator; and, re-inserting the assembly into the cleaned actuator.