Method And Device For Filling The Dosing Chamber Of An Inhaler For The First Time

Abstract

The invention relates to the first-time filling of a liquid conducting system in an inhaler. According to the invention, a pressure that is built up in the reservoir by mounting the closure thereupon is released when the reservoir is inserted into the inhaler so as to displace liquid from the reservoir by means of the liquid conducting system such that the dead volume of the liquid conducting system is filled with liquid and the nozzle is connected in an air-free manner to the liquid store.

1 - 27 . (canceled) 
   
   
       28 . Method for applying a pharmaceutical fluid, for the first time, to an inherently sealed tubular system capable of conveying fluid, having two open ends, the system being part of a propellant-free inhaler, characterised in that a container which contains a fluid pharmaceutical formulation is pushed manually onto the tubular bottom end of the system in pressuretight manner until the tubular end projects into the fluid and an excess pressure of at least 1 mbar prevailing in the container at the start or finish of the pushing-on operation forces some of the pharmaceutical fluid through the system, thereby reducing the excess pressure, such that the system is preferably totally filled with fluid. 
   
   
       29 . Method according to  claim 28 , characterised in that by the pushing-on process at least one and a half times as much fluid is forced through the system as corresponds to the volume of the system. 
   
   
       30 . Method according to  claim 28 , characterised in that the excess pressure in the container is generated by cold-filling the fluid pharmaceutical formulation at a temperature of less than 10° C. followed by pressuretight sealing of the container and pushing the container onto the bottom end of the hollow piston at a temperature of more than 10° C. 
   
   
       31 . Method according to  claim 28 , characterised in that the excess pressure in the container is generated by filling the fluid pharmaceutical formulation at an excess pressure of at least 10 mbar with the inclusion of a residual air bubble with a volume of at least 0.1 ml to a maximum of 0.5 ml and pushing the container onto the bottom end of the hollow piston at normal pressure. 
   
   
       32 . Method according to  claim 28 , characterised in that the system comprises at least one hollow piston having a tubular lower end and an upper end, a cylinder bore in the lower part of which the upper region of the hollow piston can be moved back and forth between two positions and an outlet nozzle which is provided at the upper end of the cylinder bore. 
   
   
       33 . Method according to  claim 28 , characterised in that the volume in that part of the system which is above the fluid level after the immersion of the tubular end is not more than 25 microlitres and the excess pressure while the cartridge is being pushed onto the tubular end is generated by the fact that the tubular end of the system projects so far into the fluid inside the container that it displaces a volume of at least 25 microlitres, more preferably at least 34 microlitres. 
   
   
       34 . Closure for a fluid-filled container which comprises, in the closed position, a connector ( 2 ) projecting into the container or located on the container, the top end of which points away from the container and the bottom end of which is aligned with the interior of the container and a tubular guide ( 12 ) starting from the top part is formed in the connector ( 2 ), characterised in that the connector ( 2 ) has a device which displaces some of the fluid in the container under the effect of an external force. 
   
   
       35 . Closure according to  claim 34 , characterised in that the guide ( 12 ) comprises at its end an expanded portion, preferably in the form of a chamber, which can be opened toward the container along the direction of the guide ( 12 ) and in which there is a displacement member which can be pushed at least partially out of the chamber in the direction of the interior of the container. 
   
   
       36 . Closure according to  claim 35 , characterised in that the displacement member has a bore, which is constructed starting from the top end of the displacement member, is aligned in a straight line with the guide ( 12 ). 
   
   
       37 . Closure according to  claim 36 , characterised in that the bore passes right through and optionally has a constriction. 
   
   
       38 . Closure according to  claim 36 , characterised in that the bore does not pass right through and has a constriction underneath which there is a hollow space closed off at the bottom. 
   
   
       39 . Closure according to  claim 38 , characterised in that the displacement member is constructed as an integral, capillaried, open-pored porous storage medium for fluid. 
   
   
       40 . Closure according to  claim 39 , characterised in that the displacement member is a dimensionally rigid body having a fluid-pervious wall, filled with sintered or non-sintered powder, or a woven or knitted or nonwoven structure or a wad of fibers. 
   
   
       41 . Closure according to  claim 39 , characterised in that the storage medium for fluid in the displacement member consists of plastics, ceramics, glass, metal or a natural substance. 
   
   
       42 . Closure according to  claim 35 , characterised in that stop means are provided on the displacement member ( 14 ) and on the guide ( 12 ), to prevent the displacement member ( 14 ) from being able to leave the guide ( 12 ) completely. 
   
   
       43 . Closure according to  claim 35 , characterised in that the wall of the displacement member ( 14 ) and the wall of the guide ( 12 ) cooperate in fluidtight manner. 
   
   
       44 . Closure according to  claim 34 , characterised in that the connector comprises at its bottom end at least two sleeves inserted telescopically one inside the other, of which at least the hollow part of the innermost sleeve is aligned directly with the guide ( 12 ). 
   
   
       45 . Closure according to  claim 44 , characterised in that the external diameter of the upper part of a respective inner sleeve is greater than the internal diameter of the bottom part of the outer sleeve enclosing it. 
   
   
       46 . Closure according to  claim 44 , characterised in that the innermost diameter of the innermost sleeve is constructed as a press fit for a cannula. 
   
   
       47 . Closure according to  claim 44 , characterised in that at least the bottom wall of the connector is constructed as a bellows made of an elastic material.