Dosage aerosols for the application of pharmaceutical formulations

Abstract

The invention relates to pharmaceutical active substances, active substance mixtures and formulations for use as an aerosol in propellant-containing [1.1.1.2-tetrafluoroethane (HFC-134a) or 1.1.1.2.3.3.3-heptafluoropropane(HFC-227)] metered-dose aerosols and the metered-dose aerosols for administering these active substances, active substance mixtures and formulations.

1 . A device for providing pharmaceutical active substances, active substance mixtures, and formulations, the device comprising a container filled with a pharmaceutical preparation, containing an active substance, an active substance mixture, or formulation in pressure-liquefied 1.1.1.2-tetrafluoroethane (HFC-134a) or 1.1.1.2.3.3.3-heptafluoropropane(HFC-227) or a mixture of HFC-134a and HFC-227 and a valve that is arranged so as to deliver single doses of a pharmaceutical preparation outside the device, characterised in that the mouthpiece tube of the device has a channel that has no or almost no dead volume.  
   
   
       2 . The device according to  claim 1 , wherein the channel is connected, via a nozzle bore, to a nozzle opening that is of funnel-shaped construction.  
   
   
       3 . Device according to  claim 2 , wherein the nozzle bore has a diameter of 0.2-0.6 mm.  
   
   
       4 . The device according to  claim 1 , wherein the nozzle opening is constructed according to  FIG. 3  or  FIG. 4 .  
   
   
       5 . The device according to  claim 1 , wherein the pharmaceutical preparation comprises an anticholinergic, betamimetic, steroid, phosphodiesterase-IV-inhibitor, LTD4-antagonist and EGFR-kinase inhibitor, antiallergic agent, ergot alkaloid derivative, triptan, CGRP-antagonist, or phosphodiesterase-V-inhibitor, or a combinations thereof.  
   
   
       6 . The device according to  claim 1 , wherein the pharmaceutical preparation comprises suspension adjuvants, surfactants, or stabilizers, or combinations thereof.  
   
   
       7 . A mouthpiece tube consisting of a shaft, a valve stem receptacle, a nozzle bore, and the mouthpiece, the mouthpiece tube accommodating the metered-dose aerosol such that the shaft of the mouthpiece tube surrounds the metered-dose aerosol, the valve stem receptacle of the mouthpiece tube encloses the valve stem of the metering valve to form a seal, and has a channel that the actual nozzle bore impacts upon at an obtuse angle to its perpendicular axis, as a result of which the pharmaceutical composition, mixture, or formulation that is liquefied under pressure is deflected through >90° from the perpendicularly downwardly arranged opening of the valve stem and passes outwards through the nozzle bore, thereby generating the spray cloud at the transition from the nozzle bore to the nozzle opening, wherein the channel has no or almost no dead volume.  
   
   
       8 . The mouthpiece tube according to  claim 7 , wherein the channel is connected, via a nozzle bore, to a nozzle opening of funnel-shaped construction.  
   
   
       9 . The mouthpiece tube according to  claim 8 , wherein the nozzle bore has a diameter of 0.2-0.6 mm.  
   
   
       10 . The mouthpiece according to  claim 7 , wherein the nozzle opening is constructed according to  FIG. 3  or  FIG. 4 .