Fluid sprinkling – spraying – and diffusing – Including supply holder for material – Follower in holder
Patent
1992-11-19
1996-03-12
Kashnikow, Andres
Fluid sprinkling, spraying, and diffusing
Including supply holder for material
Follower in holder
2223211, 2223218, 2223831, 222384, A61M 1100, B05B 1100
Patent
active
054979447
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to atomising devices and methods, notably to self contained hand held devices for dispensing a fluid medicament as droplets of a mean size less than about 10 to 12 micrometers without the use of pressurised gas or liquefied propellants, and to methods for administering fluid droplets to a locus, notably medicaments to the nasal passages or lungs.
BACKGROUND TO THE INVENTION
It is known to apply medicaments as sprays through the nose or mouth so that they are absorbed through the walls of the nasal passages or through the lungs. In order for the medicament to penetrate deep into the lung, for example into the alveolar sacs, it is considered necessary that the medicament particles or droplets have a mean size of less than 12 micrometers, for example from 1 to 5 micrometers. Whilst solid particles can be prepared with a mean size of less than 5 micrometers, problems are encountered in achieving such small sized droplets in a fluid spray.
Typically, such medicaments can be dispensed by means of bursts of large volumes of compressed air which entrain small amounts of the particulate to form a dust cloud or atomise some of a fluid to form a spray of fine droplets. However, this method results in losses of medicament and requires that the user have a source of large volumes of compressed air available and this is impractical except in a hospital environment.
For self contained hand held devices, it has been the common practice to dispense the medicament as droplets or solid particles using a liquefied propellant medium to dispense the droplets or particles from a pressurised container through a mechanical breakdown device, for example a swirl chamber and spray nozzle orifice. Whilst such a system enables a self contained and readily portable device to be constructed, the use of liquefied propellants is increasingly unacceptable from environmental and other grounds.
Thus, the use of chlorofluorocarbon type propellants (CFCs) is to be phased out for most uses under the Montreal Protocol of 1987 due to their alleged effect on the ozone layer of the atmosphere. However, despite this, it was considered that there was no viable alternative to the use of CFC propellants for medicaments, and their use in this field has been permitted to continue.
Furthermore, whilst it would be desirable to put up the medicament in the form of a solution to aid absorption of the active ingredient into the blood stream, many medicaments are insoluble in CFCs. In order to achieve a solution it is necessary to use co-solvents and surface-active agents which may introduce undesirable secondary components into the medicament formulation. Moreover, when such solutions are sprayed, the resultant droplets lose their CFC component through rapid evaporation. As a result, the user inhales droplets of varying sizes travelling at different speeds as their size changes. The rapid evaporation of CFCs also gives the disadvantage that the user experiencing an uncomfortable chilling effect as he inhales the spray. On the other hand, it is the very rapid evaporation of liquefied propellants which enables them to generate the high pressures within the dispenser required to discharge material from the dispenser.
Despite these problems with the use of CFCs, they are still considered by the pharmaceutical industry to be the only practicable method for administering many forms of medicament. As recently as March, 1990 a conference of leading experts in this field, the "Respiratory Drug Delivery II" Conference at Keystone, Colorado, U.S.A., did not contemplate that there was any other viable method of delivery for such drugs except the use of CFCs or their close analogues, such as the HFC and HCFC propellants.
In an attempt to overcome the problems associated with CFC propellants, there have been many proposals to adapt the mechanical pump type dispensers used to spray furniture 10 polishes, hair lacquers and the like. In such devices a manually operated piston and cylinder or flexing diaphragm type of pump is operated by depress
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Dunne Stephen T.
Weston Terence E.
DMW (Technology) Limited
Kashnikow Andres
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